Minutes of 278th Meeting of Registration Boardffhbcvvvh

Minutes for 278th Meeting of Registration Board
held on 29-31st January, 2018.
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Item No. Detail of Item Page No.

Item No.I Confirmation of Minutes of 277th meeting of Registration Board 04
Item No.II Pharmaceutical Evaluation & Registration Division (05 – 629)
 Pharmaceutical Evaluation Cell (PEC) 05–452
 RRR Section …. …. …. …. …. …. … 453–538
 Registration-I …. …. …. …. …. …. ... 539–563
 Registration-II …. …. …… ….. …… 564–591
 Registration-III …. …… ….. ….. ….. 592–600
 Registration-IV …. ….. ….. …… ….. 601–614
 Registration-V …. …. ….. ….. ….. … 615–629
Item No.III Biological Evaluation & Research Division 630 – 671
Item No.IV Quality Assurance & Lab Tesing Division 672 – 680
Item No.V Additional Agenda
A. Pharmaceutical Evaluation & Registration Division ….. . … 681 – 763
B. Biological Evaluation & Research Division …. …. …. . …. 764 – 774
Drug Regulatory Authority of Pakistan

T.F. Complex, Mauve Area, G 9/4
Islamabad.
Minutes for 278th Meeting of Registration Board (29-31st January, 2018), DRAP |1
278th meeting of Registration Board was held on 29-31st January, 2018 in the Committee
Room, Drug Regulatory Authority of Pakistan, G-9/4, Islamabad. The meeting was chaired by
Dr. Obaidullah, Director, Pharmaceutical Evaluation & Registration Division, DRAP. The
meeting started with recitation of the Holy Verses. The meeting was attended by the following:
1. Dr. Rafeeq Alam Khan, Member
Meritorious Professor, Department of Pharmacology,
University of Karachi
2. Maj.Gen.Dr.Tahir Mukhtar Sayed Member
Commandant AFIRM, Head of Department of Medicine,
AMC, Rawalpindi
3. Dr. Ghulam Sarwar, Member
Dean, Faculty of Pharmacy, Jinnah University for Women,
Karachi
4. Dr.Qurban Ali, Ex-Director General, Member
National Veterinary Laboratory, Islamabad.
5. Dr.Aslam Shah, Senior Manager, Member
Pharmacy & Purchase, Indus Hospital, Karachi
6. Muhammad Aslam Member
Assistant Draftsman-II, Ministry of Law & Justice
7. Dr. Amanullah Khan Member
Director, Drugs Testing Laboratory, Quetta
Government of Balochistan
8. Mr. Abid Hayat Member
Director Drugs Testing Laboratory, Peshawar
Government of Khyber Pakhtunkhwa.
9. Dr. Shafiq ur Rahman Member
Director, Drugs Testing Laboratory, Lahore
Government of Punjab.
10. Syed Muzaffar Ali Jafri Member
Director, Drugs Testing Laboratory, Karachi
Government of Sindh.
11. Dr. Shaikh Akhter Hussain, Member
Director, Medical Device / QA&LT Divisions, DRAP
12. Dr. Noor-us-Saba, Member
Director, Biological Drugs Divisions, DRAP
13. Mr. Abdullah, Additional Director (PE&R) Secretary
Dr. Shafiq ur Rahman, Director DTL, Government of the Punjab attended last two days
of the meeting. Maj.Gen. Tahir Mukhtar Syed and Mr. Abid Hayat, Director DTL KPK didn’t
attend the meeting on 31st January, 2018.
Dr. Shaikh Akhtar Hussain, Director Medical Device/QA&LT Divisions attended the
meeting on 31st January, 2018 only. Dr. M. Fakhrudding Amar, Additional Director (QC)
attended the meeting on 29-30th January, 2018 as representative of QA&LT Division, DRAP.
Mr. Zaheer-ud-Din M. Babar (Deputy Director R.I/R.IV), Tehreem Sara (Deputy

Director, RRR), Mr.Babar Khan (Deputy Director (R.III) / Incharge-PEC), Mr. Muhammad
Amin (Deputy Director, R.II) assisted in presenting the agenda of PE&R Division. M. Akhtar
Abbas Khan (Deputy Director), M. Muneeb Cheema, M.Zubair Masood and Mr. Khurram
Khalid (Assistant Directors) presented agenda of Biological Drugs Division. Mst. Sadaf Ahmad
and Mst. Gulnaz Yaqoob (Assistant Directors, QC) presented agenda of Quality Control,
Division.
Mr. Shamim Ahmed and Mr. Arshad Mehmood (PPMA), Mr. Nadeem Alamgir (Pharma
Bureau) and Mr. Atam Parkash (PCDA) attended the meeting as observers.
Item No. I: Confirmation of minutes of 277th meeting of Registration Board.
277th meeting of Registration Board was held on 27-29th December, 2017. The draft
minutes were circulated among the members of meeting on 23.01.2017 with the request to forward
their comments (if any). No comments were received and thus draft minutes were approved by
Chairman, Registration Board.
Decision: Registration Board confirmed the minutes of 277th meeting.
Pharmaceutical Evaluation Cell
S.No. Details
Case No. 01 Review of Formulations
Case No. 02 Registration applications for local manufacturing of (Human) drugs
a) Registration applications submitted with differential fee
b) Registration applications submitted with full fee
i. New cases
ii. Deferred cases
Case No. 03 Registration applications of newly granted DML or New section (Human)
a. New DML
b. New/Additional section(s)
c. Deferred cases
Case No. 04 Registration applications for local manufacturing of (veterinary) drugs
a. Routine Applications
b. Deferred Cases
Case No. 05 Registration applications of newly granted DML or New section
(Veterinary)
a. New DML /section
Case No. 06 Registration applications of categories to be considered on priority
a. Applications for registration of drugs or Local Manufacturing
b. Export Facilitation
c. Finished Import
Case No. 07 Registration applications of import cases
a. Import routine cases (Human)
b. Import routine cases (Veterinary)
c. Import Deferred cases
i. Human
ii. Veterinary
Case No. 08 Registration applications of drugs for which stability study data is
required to be verified
a. New cases
b. Deferred cases
c. Verification of stability study data
d. Exemption from onsite verification of stability data
Case No. 09 Miscellaneous Cases
Total Cases: 848
Sr. No Name of Evaluator Title
1. Mr. Muhammad Tahir Waqas Evaluator PEC-I
2. Mr. Ammar Ashraf Awan Evaluator PEC-II
3. Mr. Muhammad Haseeb Tariq Evaluator PEC-III
4. Mst.Farzana Raja Evaluator PEC-IV
5. Mst. Iqra Aftab Evaluator PEC-V
6. Mr. Muhammad Umar Latif Evaluator PEC-VI
7. Mst. Sidra Khalid Evaluator PEC-VII
8. Mst. Haleema Sharif Evaluator PEC-VIII
9. Mr. Farooq Aslam Evaluator PEC-X
10. Mst. Najia Saleem Evaluator PEC-XI
11. Syed Ajwad Bukhari Evaluator PEC-XII
12. Mst. Mehwish Javed Khan Evaluator PEC-XIII

13. Mr. Muhammad Ahsan Hafiz Evaluator PEC-XIV
Case No. 01: Review of Formulation
Evaluator PEC-III
1. Fosfomycin 250mg/5ml oral suspension
The formulation is available in Spain and registered by Spanish Agency of Medicines and
Health Products Spain in the same strength and dosage form. The details of product registration
are as follows
 Brand Name: FOSFOCINA Suspension 250mg/5ml
 Market Authorization number: 50880
 Pharmaceutical form: Oral suspension
 Composition:
Each 5ml suspension contains fosfomycin (as calcium) ……….. 250 mg
 Marketing Authorization holder: LABORATORIOS ERN, S.A. Barcelona, España
 Link for reference:
https://www.aemps.gob.es/cima/publico/detalle.html (Accessed on 19-12-2017).
The case was discussed in 277th meeting of Registration Board and was deferred for clarification
of salt form of fosfomycin. Now, the salt form has been verified from the patient information
leafelet of Fosfocina suspension and the correct salt form is Forfomycin (as Calcium). Now the
case is submitted before the Board for consideration.
Sr. Name and 1. Brand Name 2. 1. Type Form. GMP Inspection Decision of Evaluation
No. Address of Dosage Form 3. 2. Type of report previous meeting by PEC
Manufacturer / Composition 4. Application.
Applicant. Pharmacological 3. Demanded
Group. Price/Pack Size.
4. Initial Date &
Diary.
5. Date on which
fee becomes
complete
according to type
of application /
Form.
1. M/s Sigma Fosil 250mg/5ml Form 5 15-09-2017: Deferred for
Pharma Dry Suspnsion 17-11-2014 Acceptable confirmation of
International Each 5ml contains:- (219) level of formulation
Pvt. Fosfomycin (as Rs. 20,000/- cGMP approval in
Ltd E-50, Fosfomycin As Per SRO/ compliance reference
N.W.I.Z., Port Calcium) ....250mg Pack 60ml Stringent
Qasim (Anti Bacterial Regulatory
Karachi Agent ) Agencies
(M-246)
Decision: Approved with Innovator’s specifications
2. M/s Mega MEGAFOS Form-5 Deferred for GMP
Pharmaceuti Suspension Dy.No: 10547 confirmation of report
cals, 250mg/5ml dated:12.11.10 availability in within 1
Limited Each 5ml contains: Rs.8000/- reference year is not
Lahore Fosfomycin dated:12.11.10 SRA’s. confirmed
…….250mg Rs.12,000/- 2. Final notice
Antibiotic dated 05-08-13 for
rectification of
As per SRO/ shortcomings/
Pack of 60ml observations.
(M-247)
Decision: Deferred for submission of latest GMP inspection report conducted within a period of
last 1 year by DRAP
3. M/s Vision FOSF Suspension Form 5 22-2-2017: Deferred for
Pharmaceutic Each 5ml Contains:- Dy No.2047 GMP granted confirmation of
als, Plot # Fosfomycin dated 19-03-15 formulation in
22-23, (as calcium) Rs. 20,000/- reference drug
Industrial ……250 mg As Per SRO/ agencies.
Triangle Antibiotic Pack of 60ml (M-249)
Kahuta Road,
Islamabad.
4. M/s Caliph Fosfo Dry Form 5 07-03-2017 Deferred for
Pharmaceutic Suspnesion Rs. 20,000/- declaring confirmation of
als (Pvt.) Ltd, Each 5 ml (after Dy. No.905 satisfactory approval status
Plot # 17, reconstitution) dated level of GMP by reference
Special contains 13-04-2012 compliance regulatory
Industrial Fosfomycin Pack of authorities
Zone, calcium eq to 60 ml / (M-254)
Risalpur, fosfomycin...250mg Rs.97.62
KPK. Broad Spectrum
antibiotic
5. M/s GT MYFOSIN Dry Form 5 08-08-2017 Deferred for
pharma (pvt) Powder Rs. 20,000/- and report confirmation
ltd. plot # 713 Suspension Dy. No. 2692 concludes of approval
b sundar Each 5ml 11.12.2015 GMP status by
industerial reconstituted Pack size of compliance reference
estate suspension Contains 1 x 60ml as status regulatory
raiwind road Fosfomycin per authorities.
Lahore. ……..250mg price fixed by (M-256)
(Antibiotic) Government
Decision: Deferred for clarification of salt form of API in comparison to refrence product.
6. Aries ZEFCIN 250mg Form 5 10-03-17; Deferred for
Pharmaceutic oral suspension Dy No. 576 Panel evidence of
als 1-W, Each reconstituted 5 14-10-2016 recommended approval by
Industrial mL contains PKR 20,000/- grant of reference
Estate Fosfomycin calcium Dated 13-10- additional regulatory
Hayatabad monohydrate eq. to 2016 section authorities as
Peshawar, fosfomycin reference
Pakistan ……250mg submitted /
(Antibiotic) provided is from
Spain, which is
not a reference
regulatory
authority(M-268)
Decision: Deferred for following:
 Clarification of salt form of API in comparison to refrence product.
 Deferred for submission of latest GMP inspection report conducted within a period of
last 1 year by DRAP.
7. M/s Astellas Mifose Dry Form-5 13-02-2017 Deferred for
Pharmaceuti suspension 250mg Diary No:6275, very good evidence of
cal (Pvt) Ltd. /5ml 14/06/2017, level of approval of
Industrial Each 5ml Rs: 20,000/- compliance applied
Estate, suspension contains 60 ml/ As Per with GMP. formulation by
Hayatabad, Fosfomycin SRO reference
Peshawar Calcium Eq to regulatory
Fosfomycin..250mg authorities.
Broad Spectrum (M-272)
Antibiotic
8. M/s Mission Misfos 250mg/5ml Form 5 21-12-2016: Deferred for
Pharmaceuti Oral dry suspension Dy No. 718: GMP evidence of
cals (Pvt) Each 5ml contains 28-10-2015 compliant approval in
Ltd., Plot Fosfomycin as PKR 20,000/-: status. reference
No. A-94, calcium…250mg 28-10-2015 regulatory
SITE Super (Antibiotic / 60ml: Rs. 90/- authorities
Highway antibacterial) (M-273)
Karachi
Decision: Deferred for submission of latest GMP inspection report conducted within a period of
last 1 year by DRAP
Case No. 02: Registration applications for local manufacturing of (Human) drugs
a) Registration applications submitted with differential fee
Evaluator PEC-III
Sr.# Name and Brand Name Type of Form Remarks on the Remarks of the
address of (Proprietary name + Initial date, formulation (if any) Evaluator.
manufacturer / Dosage Form + diary including
Applicant Strength) Fee including International status
Composition differential fee in stringent drug
Pharmacological regulatory agencies /
Group Demanded Price / authorities
Finished product
Specification Pack size Me-too status
GMP status as
depicted in latest
inspection report
(with date) by the
Evaluator
9. M/s Medizan DELORT 5mg Form 5 CLARINEX by Firm has claimed
Laboratories Tablets Dy. No.458 Merck in house
(Pvt) Ltd, Plot 15-12-2010 (USFDA approved) specifications
No. 313, Each film coated Rs.8000/- and the product
Alenor by Macter
Industrial tablet contains:- (15-12-2010) monograph is
Triangle, Desloratadine + Last inspection not present in
Kahuta Road, ……….. 5mg Rs.12,000/- report dated any official
Islamabad (Anti Histamine) (17-11-2014) 10.4.2017 confirms pharmacopoeia
1x10’s satisfactory
As Per SRO compliance to GMP.
10. M/s Zamko ZAMPIME 500mg Form-5 Maxipime Injection  The applicant
Pharmaceutical Injection 17-05-2013 by Hospira firm do not hold
s 641-A Sunder Dy No. 3130 (USFDA) a valid DML
Industrial Each vial contains:- Rs. 20,000/-
estate, Lahore Cefepime as (16-05-2013) Maxipime inj by
Toll hydrochloride..500mg + Bristol Mayer
manufactured Rs. 30,000/- Squibb
by English Cephalosporin (17-05-2013)
Pharma, 1’s The applicant firm
Lahore Rs.300.00/Per vial do not hold a valid
DML
Decision: Registration Board rejected the application since the firm does not hold valid DML
11. M/s Zamko ZAMTAX 500mg Form-5 Claforan Injection  The applicant
Pharmaceutical Injection 17-05-2013 By firm do not hold
s 641-A Sunder Dy No. 3125 US Pharm Holding a valid DML
Industrial Each vial contains:- Rs. 20,000/- (USFDA)
estate, Lahore Cefotaxime sodium (16-05-2013)
Toll eq.to Cefotaxime + Claforan inj by
manufactured ….…..500mg Rs. 30,000/- Sanofi Aventis
by English (17-05-2013)
Pharma, Cephalosporin 1’s vial The applicant firm
Lahore Rs.140/1’s do not hold a valid
DML
Decision: Registration Board rejected the application since the firm does not hold valid DML
12. Genome NALID 80mg Tablets Form 5 Corgard 80mg tablet Firm has claimed
Pharmaceutical (DUPLICATE by Aventis in house
s (Pvt) Ltd., Each tablet contains:- DOSSIER) (MHRA Approved) specifications
Plot # 16/I- Nadolol…………….8 PKR 8,000/- and the product
Phase-IV, 0mg (17-05-2011) Norgar tablets by monograph is
Industrial (Nonselective beta- + Pulse Pharma not present in
Estate Hattar adrenergic receptor PKR 12,000/- any official
blocking agent) (26-11-2014) Panel Inspection on pharmacopoeia
10’s 14-01-2017, No
As per SRO observations as
informed by QA.
Evaluator PEC-VI
13. M/s Treat Locain Injection Form 5 Could not be  Firm has liquid
Pharmaceut 20mg/10ml Dy. No.16 confirmed injection (general)
icals, Bannu 09-6-2011 section.
Could not be
Each 10ml ampoule Rs.8,000/-
confirmed  Fee challan
contains: (9-6-2011) photocopy is
Lidocaine as HCl + Rs.12,000 attached.
Last inspection report
(anhydrous)…..20mg 29-7-2013  International
5-10-2017 the panel
(Duplicate) availability in RRA
recommended grant
(Local anaesthetic) 50’s (10ml) and me too status
of renewal and
As per SRO could not be
additional section
confirmed.
Minutes for 278th Meeting of Registration Board (29-31st January, 2018), DRAP | 10
14. Decision: Deferred for following:
 Evidence of approval of applied formulation in reference regulatory authorities/agencies
which were declared/approved by the Registration Board.
 Evidence of applied formulation/drug already approved by DRAP (generic / me-too status)
alongwith registration number, brand name and name of firm.

15. M/s Treat Treatagen Injection Form 5 USFDA Approved Fee challan
Pharmaceut 20mg/2ml Dy. No.16 10mg/ml photocopy is attached.
icals, Bannu 9-6-2011
Genticillin Paediatric
Each 2ml ampoule Rs.8,000/-
Injection 20mg/2ml
contains: (9-6-2011)
Reg # 20563
Gentamycin (as +
sulphate)……20mg Rs.12,000 Last inspection report
29-7-2013 5-10-2017 the panel
(Antibiotic) (Duplicate) recommended grant
USP 50’s (10ml) of renewal and
As per SRO additional section
16. Decision: Approved. Reference will be sent to Budget & Accounts Division for verification of
challan and Board authorized its Chairman for the issuance of registration letter.
17. M/s Treat Amikat Injection Form 5 Amikacin 250 mg/ml Firm has changed the
Pharmaceut 500mg/2ml Dy. No.177 Injection by M/s strength from 50mg/
icals, Bannu 9-06-2011 Hospira UK Ltd, ml to 500mg/ 2ml and
Each 2ml ampoule Rs. 12,000/- MHRA approved deposited Fee of
contains: (29-7-2013) Rs.20,000/- on
Amikacin (as sulfate) + Amikin Injection by 19.01.2018
…..…..500mg Rs.8,000/- M/s GSK
(9-6-2011)
(Aminoglycoside) 50’s (10ml)
Last inspection report
USP As per SRO
5-10-2017 the panel
recommended grant
of renewal and
additional section
18. Decision: Approved. Reference will be sent to Budget & Accounts Division for verification of
b) Registration Applications Submitted with Full Fee.
I. New cases
Evaluator PEC-II
19. Name and address of manufacturer / Max Pharmaceuticals, Islamabad
Applicant
Brand Name +Dosage Form + Strength Maxtelium 10mg tablets
Composition Each tablet contains:
Domeperidone……….10mg
Diary No. Date of R& I & fee Dy. No.3051; 12-07-2016; Rs.20,000/- (12-07-2016)
Pharmacological Group Antibiotic
Type of Form Form 5
Finished product Specification Manufacturers specification
Pack size & Demanded Price 1x 10’s, 3 x 10’s & 5 x 10’s; As per SRO
Approval status of product in Reference Motilium10mg tablet of M/s Janssen-Cilag Pty Ltd
Regulatory Authorities. approved by TGA of Australia
Me-too status Epodom 10mg Tablets by M/s Atlantic Pharmaceutical
(Pvt) Ltd, (Reg#062326)
GMP status Not provided
Remarks of the Evaluator.
Decision: Deferred for submission of latest GMP inspection report conducted within a
period of last 1 year by DRAP
20. Name and address of manufacturer / M/s Theramed Pharmaceutical, 45-Km, Multan Road,
Applicant Lahore.
Brand Name +Dosage Form + Strength Essam 20mg tablet
Composition Each film coated tablet contains:
Escitalopram (as oxalate) …… 20mg
Pharmacological Group Antidepressant
Type of Form Form-5
Finished product Specification USP
Pack size & Demanded Price 10’s, 14’s, 28’s; As awarded by DRAP
Approval status of product in Approved by MHRA of UK
Reference Regulatory Authorities.
Me-too status Zavesca tablet 20mg of Getz Pharma. (Reg.#045281)
GMP status Panel inspection report dated 10-10-2017 for Renewal
of DML and grant of additional sections.
Remarks of the Evaluator.  Firm has submitted one page reports of accelerated
stability studies without relevant documents i.e.
chromatograms, lab reports, raw data sheets etc.
 Upon communication of above observation firm has
submitted stability study analytical sheet which shows
that stability studies have been performed on in-house
specifications/method whereas USP monograph is
available for applied formulation.
 Only raw data sheets have been submitted, while UV
spectrums or HPLC chromatograms should be
submitted to confirm the performance of stability
studies.
Now the firm has submitted that “the accelerated
stability data analytical sheets submitted for applied
formulation are not being justified, so we are giving
undertaking/commitments, and we will submit all the
required data to DRAP before the marketing of said
product.”
Decision: Approved
Applicant Lahore.
Brand Name +Dosage Form + Strength Theravirin 50mg/5ml Syrup
Composition Each 5ml contains:
Ribavirin …… 50mg
Pharmacological Group Antiviral
Type of Form Form-5
Pack size & Demanded Price 60ml,90ml,120ml; As awarded by DRAP
Approval status of product in Rebetol 40mg/ml approved by USFDA
Me-too status Virex Syrup of M/s Wilson’s Pharmaceuticals.
(Reg.#029584)
Remarks of the Evaluator.  Evidence of approval of applied formulation in
reference regulatory authorities/agencies which were
declared/approved by the Registration Board as
submitted reference is of different composition than
applied.
 Firm has submitted one page reports of accelerated
 Upon communication of above observation only raw
data sheets have been submitted, while UV spectrums
or HPLC chromatograms should be submitted to
confirm the performance of stability studies.
 Now the firm has submitted that “the accelerated
product.”
Decision: Deferred for evidence of approval of applied formulation in reference regulatory
authorities/agencies which were declared/approved by the Registration Board.
Applicant Lahore.
Brand Name +Dosage Form + Strength Neskay 4mg tablet
Composition Each chewable tablet contains:
Montelukast (as sodium) …… 4mg
Pharmacological Group Leukotriene inhibitor
Type of Form Form-5
Pack size & Demanded Price 10’s, 14’s,20’s & 30’s; As awarded by DRAP
Approval status of product in Approved by USFDA
Me-too status Exma Tablet 4mg of M/s Asian Continental Karachi.
(Reg.#081007)
Remarks of the Evaluator.  Firm has submitted one page reports of accelerated
submitted stability study analytical sheet which
shows that stability studies have been performed on
in-house specifications/method whereas USP
monograph is available for applied formulation.
 Only raw data sheets have been submitted, while
UV spectrums or HPLC chromatograms should be
studies.
product.”
Decision: Approved.
Applicant Lahore.
Brand Name +Dosage Form + Strength Worx 40mg tablet
Composition Each enteric coated tablet contains:
Pantoprazole “as sodium sesquihydrate”…… 40mg
Pharmacological Group Proton pump inhibitor
Type of Form Form-5
Approval status of product in Approved by MHRA
Me-too status Cantrofast Tablets of M/s Candid Pharmaceuticals
(Reg.#082031)
Remarks of the Evaluator.  You have submitted one page reports of accelerated
submitted stability study analytical sheet which
shows that stability studies have been performed on
in-house specifications/method whereas USP
monograph is available for applied formulation.
 Only raw data sheets have been submitted, while
UV spectrums or HPLC chromatograms should be
studies.
undertaking/commitments, and we will submit all
the required data to DRAP before the marketing of
said product.”
Decision: Approved
Applicant Lahore.
Brand Name +Dosage Form + Strength Seef 50mg tablet
Levosulpride …… 50mg
Pharmacological Group Antipsycotic
Type of Form Form-5
Finished product Specification Manufacturer’s specifications.
Approval status of product in Levidomed 50mg tablets of M/s Medochemie Ltd.
Reference Regulatory Authorities. approved by AIFA of Italy.
Me-too status Sulvoric 50mg of M/s High-Q, Karachi (Reg.#070485)
Remarks of the Evaluator.  No USP or BP monograph is available for applied
formulation.
 Firm has submitted one page reports of accelerated
 Upon communication of above observation only raw
data sheets have been submitted, while UV spectrums
or HPLC chromatograms should be submitted to
confirm the performance of stability studies.
product.
Decision: Approved with innovator’s specification
Applicant Lahore.
Brand Name +Dosage Form + Strength Seef 25mg tablet
Levosulpride …… 25mg
Diary No. Date of R& I & fee Dy. No.1634 30-11-2016; Rs.20,000/- (30-11-2016)
Pharmacological Group Antipsycotic
Type of Form Form-5
Approval status of product in Levidomed 25mg tablets of M/s Medochemie Ltd.
Reference Regulatory Authorities. approved by AIFA of Italy.
Me-too status Sulvoric 25mg of M/s High-Q, Karachi (Reg.#070484).
formulation.
 You have submitted one page reports of accelerated
 Upon communication of above observation only
raw data sheets have been submitted, while UV
studies.
said product.”
Applicant Lahore.
Brand Name +Dosage Form + Strength Spar 20mg tablet
Piroxicam β-Cyclodextrin …… 20mg
Diary No. Date of R& I & fee Dy. No.1635 30-11-2016; Rs.20,000/- (30-11-2016)
Pharmacological Group NSAID
Type of Form Form-5
Approval status of product in Approved by ANSM of France
Me-too status Ripax 20 mg by M/s Hilton
formulation
 You have submitted one page reports of accelerated
 Upon communication of above observation only
raw data sheets have been submitted, while UV
studies.
said product.”
Decision: Approved with innovator’s specification.
Applicant Lahore.
Brand Name +Dosage Form + Strength Essam 10mg tablet
Escitalopram (as oxalate) …… 10mg
Type of Form Form-5
Pack size & Demanded Price 10’s, 14’s, 28’s; As awarded by DRAP
Me-too status Zavesca tablet 10mg of Getz Pharma. (Reg.#045279)
Remarks of the Evaluator.  You have submitted one page reports of accelerated
submitted stability study analytical sheet which shows
that stability studies have been performed on in-house
specifications/method whereas USP monograph is
 Only raw data sheets have been submitted, while UV
studies.
product.”
Decision: Approved.
28. Name and address of manufacturer / M/s Jinnah Pharmaceuticals (Pvt.) Ltd, 13-Km Lahore
Applicant Road, Multan
Brand Name +Dosage Form + Strength Lowcost 4mg sachet
Composition Each sachet contains:
Montelukast (as sodium) …… 4mg
Pharmacological Group Leukotriene antagonist
Type of Form Form-5
Pack size & Demanded Price 1 x 14’s; Rs. 182/-
Approval status of product in Approved by USFDA
Me-too status Aerotel Sachet of M/s Highnoon Laboratories.
(Reg.#044768)
GMP status Last inspection dated 01-06-2016
Remarks of the Evaluator. Latest GMP inspection report conducted within a period
of last 1 year by DRAP.
Decision: Registration Board referred the case to QA & LT Division to conduct GMP
inspection of Firm on priority. The Board also directed the firm to change the brand name.
29. Name and address of manufacturer / M/s Jinnah Pharmaceuticals (Pvt.) Ltd, 13-Km Lahore
Applicant Road, Multan
Brand Name +Dosage Form + Strength Pediawin sachet
Sodium chloride …… 2.6gm
Sodium citrate ……. 2.90gm
Potassium chloride ….. 1.50gm
Glucose anhydrous …… 13.5 gm
Pharmacological Group ORS
Type of Form Form-5
Finished product Specification International Pharmacopoeia
Pack size & Demanded Price 1 x 20 ’s: Rs. 300/-
Approval status of product in WHO recommended Low osmolar ORS formulation
Me-too status Oragil Sachet of M/s Glitz Pharmaceuticals
(Reg.#038628)
GMP status Last inspection dated 01-06-2016
Remarks of the Evaluator. Latest GMP inspection report conducted within a period
Decision: Registration Board referred the case to QA & LT Division to conduct GMP
inspection of Firm on priority.
Evaluator PEC-VII
30. Name and address of manufacturer / M/s Nawan Lab 136 sector 15, Korangi industrial area,
Applicant Karachi
Brand Name +Dosage Form + Strength Ceftrix 1gm Injection IM
Composition Each vial contains:
Ceftriaxone (as ceftriaxone sodium)…..….1 gm
Diary No. Date of R& I & fee Dy.No. 162, 03-2-2017, Rs.20,000/-
Pharmacological Group Cephalosporin Antibiotic
Type of Form Form-5
Finished Product Specification USP
Pack size & Demanded Price 1’s / As Per SRO
Approval status of product in Ceftriaxone of sandoz (USFDA)
Me-too status 3-zone of Zeb
GMP status Last GMP Inspection conducted on 26-9-2017 with
conclusive remarks of satisfactory.
Remarks of Evaluator
Decision: Approved
Applicant Karachi
Brand Name +Dosage Form+ Strength Ceftrix 250 Injection IM
Ceftriaxone (as ceftriaxone sodium)…..….250 mg
Diary No. Date of R& I & fee Dy.No. 42, 12-1-2017, Rs.20,000/=
Type of Form Form-5

Approval status of product in Ceftriazone of sandoz (USFDA)
conclusive remarks of follow up.
Decision: Approved
Applicant Karachi
Brand Name +Dosage Form + Strength Ceftrix 500 Injection IM
Ceftriaxone (as ceftriaxone sodium)…..….500 mg
Diary No. Date of R& I & fee Dy.No. 1065, 12-1-2017, Rs.20,000/=
Type of Form Form-5

Approval status of product in Ceftriazone of sandoz (USFDA)
conclusive remarks of follow up.
Decision: Approved
33. Name and address of manufacturer / M/s Semos Pharmaceuticals, Plot # 11, sector 12-A,
Applicant Industrial area, North Karachi
Brand Name +Dosage Form + Strength Oxiten 20mg Tablet
Diary No. Date of R& I & fee Dy. NO.1078, 10-01-2017, Rs: 20,000/-
Composition Each film coated tablet Contains:
Paroxetine as HCl …..…20mg
Pharmacological Group Antidepressant (SSRI)
Type of Form Form 5
Pack size & Demanded Price 10’s 14’s, 20’s, 50’s &100’s / As per PRC
Approval status of product in PAXIL by Apotex (US FDA)
Me-too status Peroxa of organic Pharma
GMP status Last inspection conducted on 17-10-2017“with good GMP
compliance.”
Decision: Approved
34. Name and address of manufacturer / M/S Reign Pharmaceuticals, Karachi contract
Applicant manufacturing by M/s Semos Pharmaceuticals, Plot # 11,
sector 12-A, Industrial area, North Karachi
Brand Name +Dosage Form + Strength REXONE 500MG IV INJECTION
Composition Each vial Contains:
Ceftriaxone sodium eq.to Ceftriaxone ……….500mg.
Pharmacological Group 3RD Generation Cephalosporin
Type of Form Form 5
Pack size & Demanded Price 1’s (270/- As per PRC)
Approval status of product in Ceftriaxone By Lupin pharma (USFDA)
Me-too status 3-Zone by Zeb pharma
compliance.”
Remarks of the Evaluator. • Reign Pharmaceuticals has 9 section,
Firm are already contract manufacturing for:
1. Medisure = 3 products
Decision: Approved
Applicant manufacturing M/s Semos Pharmaceuticals, Plot # 11,
Brand Name +Dosage Form + Strength REXONE 1000 MG IV INJECTION
Ceftriaxone sodium eq.to Ceftriaxone…….1000mg.
Pharmacological Group 3rd Generation Cephalosporin
Type of Form Form 5
Pack size & Demanded Price 1’s (As per PRC)
Approval status of product in Ceftriaxone By Lupin pharma (USFDA)
Me-too status 3-Zone by Zeb pharma
compliance.”
Decision: Approved
Brand Name +Dosage Form + Strength REFTOX 500mg IV Injection
Cefotaxime (as sodium) eq.to Cefotaxime……….500mg.
Pharmacological Group Cephalosporine Antibiotic (intravenous Use)
Type of Form Form 5
Approval status of product in Claforan Injection by M/s US Pharm Holdings, (USFDA)
Me-too status Baxim Injection 500mg by M/s Nabiqasim
compliance.”
Decision: Approved
Brand Name +Dosage Form + Strength REFTOX 250MG IV INJECTION
Cefotaxime (as sodium) USP eq.to
Cefotaxime……….250mg.
Pharmacological Group Cephalosporin Antibiotic (intravenous Use)
Type of Form Form 5
Approval status of product in Cefotaxime of HOSPIRA ( Health Canada )
Me-too status Baxim Injection 250mg by M/s Nabiqasim
compliance.”
Decision: Approved
Brand Name +Dosage Form + Strength RAYFIX DS 200mg/5ml Dry suspension
Composition Each 5ml reconstituted Suspension Contains:
Cefixime trihydrate eq. to
Cefixime ….200mg.
Pharmacological Group Cephalosporin
Type of Form Form 5
Pack size & Demanded Price 30ml, 60ml / As per PRC
Approval status of product in Suprax of Lupin (USFDA)
Me-too status Cefiget of Getz
compliance.”
Remarks of the Evaluator. Reign Pharmaceuticals has 9 section,
Decision: Approved
Brand Name +Dosage Form + Strength RAYFIX DS 100mg/5ml
Composition Each 5ml reconstituted Suspension Contains:
Cefixime trihydrate eq. to Cefixime ….100mg.
Pharmacological Group Antibacterial for Systemic use, belonging to class of
cephalosporin
Type of Form Form 5
Pack size & Demanded Price 30ml, 60ml (30ml 150/-) As per PRC
Approval status of product in SUPRAX 100mg/5ml dry powder suspension by M/s
Reference Regulatory Authorities. LUPIN LTD (USFDA)
Me-too status Cefamax 100mg/5ml dry suspension by M/s Pulse Pharma
compliance.”
Decision: Approved
Brand Name +Dosage Form + Strength RAYFIX 400mg Capsule
Composition Each Capsule Contains:
Cefixime trihydrate eq. to Cefixime ….400mg.
Pharmacological Group Antibacterial for Systemic use, belonging to class of
cephalosporin
Type of Form Form 5
Finished Product Specification JP
Pack size & Demanded Price 5’s As per PRC
Approval status of product in SUPRAX Capsule 400mg by M/s LUPIN LTD (USFDA)
Me-too status Cefiget 400mg Capsules by M/s Getz Pharma
compliance.”
Decision: Approved
Brand Name +Dosage Form + Strength REFTOX 1000mg IV INJECTION
Cefotaxime (as sodium) eq.to Cefotaxime……….1000mg.
Pharmacological Group Cephalosporin Antibiotic (intravenous Use)
Type of Form Form 5
Pack size & Demanded Price 1’s (235/- As per PRC)
Approval status of product in Claforan Injection by M/s US Pharm Holdings, USFDA
Me-too status Baxim Injection 1gm IV by M/s Nabiqasim
compliance.”
Decision: Approved
Brand Name +Dosage Form + Strength SEBROL Forte 650mg/50mg Tablet
Diary No. Date of R& I & fee Dy. NO 997, 13-02-2017, Rs: 20,000/-
Composition Each Tablet Contains:
Paracetamol (BP)………650mg.
Orphenadrine Citrate(BP)…….50mg.
Pharmacological Group Analgesic/ Muscle relaxants
Type of Form Form 5
Finished Product Specification Innovator
Pack size & Demanded Price 10’s , 20’s, 50’s, 100’s As per SRO
Approval status of product in NA
Me-too status Nuberol forte of M/s Searle Pakistan
compliance.”
Remarks of the Evaluator. Evidence of approval of applied formulation in reference
regulatory authorities/agencies missing
authorities/agencies which were declared/approved by the Registration Board
Brand Name +Dosage Form + Strength SEBROL 450mg/35mg Tablet
Composition Each Tablet Contains:
Paracetamol ………450mg.
Orphenadrine Citrate …….35mg.
Pharmacological Group Analgesic/ Muscle relaxants
Type of Form Form 5
Finished Product Specification Innovators
Pack size & Demanded Price 10’s , 20’s, 50’s, 100’s /As per PRC
Approval status of product in NORGESIC Tablets -TGA Australia
Me-too status NUBEROL Searle Pakistan
compliance.”
Decision: Approved with innovator’s specifications
Brand Name +Dosage Form + Strength RANCE 500mg Tablet
Composition Each extended release tablet contains:
Ranolazine ……500mg.
Pharmacological Group Antianginal drugs
Type of Form Form 5
Finished Product Specification Manufacturer
Pack size & Demanded Price 7’s 10’s, 14’s, 20’s, 50’s As per PRC
Approval status of product in RANEXA by GILEAD (USFDA)
Me-too status Rangizin XR 1000mg by M/s Macter Intr. Karachi
(Reg#076770)
compliance.”
Remarks of the Evaluator. USP/BP monograph of this formulation is not available.
Brand Name +Dosage Form + Strength RANCE 1000mg Tablet
Diary No. Date of R& I & fee Dy. NO. 995, 13-02-2017, Rs: 20,000/-
Ranolazine ……1000mg.
Pharmacological Group Antianginal drugs
Type of Form Form 5
Pack size & Demanded Price 7’s 10’s, 14’s, 20’s, 50’s As per PRC
Approval status of product in RANEXA by GILEAD (USFDA)
Me-too status Rangizin XR 1000mg by M/s Macter Intr. Karachi
(Reg#076770)
compliance.”
Remarks of the Evaluator. USP/BP monograph of this formulation is not available.
Brand Name +Dosage Form + Strength Mzapine 30mg Tablet
Composition Each Film coated tablet Contains:
Mirtazapine …..…30mg
Pharmacological Group Antidepressants (Central alpha 2 antagonist)
Type of Form Form 5
Pack size & Demanded Price 10’s 14’s,20’s, 50’s,100’s, 500’s, 1000’s (As per PRC)
Approval status of product in Mirtazapine 30 mg Film-Coated Tablets (MHRA)
Me-too status Ramargon Lisko Pakistan
compliance.”
Decision: Approved
Brand Name +Dosage Form + Strength Mzapine 15 mg Tablet
Mirtazapine …..…15 mg
Pharmacological Group Antidepressants (Central alpha 2 antagonist)
Type of Form Form 5
Pack size & Demanded Price 10’s 14’s,20’s, 50’s,100’s, 500’s, 1000’s (As per PRC)
Approval status of product in Mirtazapine 15 mg Film-Coated Tablets (MHRA)
Me-too status Ramargon Lisko Pakistan
compliance.”
Decision: Approved
Brand Name +Dosage Form + Strength DRONE 100mg Tablet
Composition Each Film coated tablet contained:
Trazodone HCl……..100mg
Type of Form Form 5
Pack size & Demanded Price 10’s 14’s, 20’s, 30’s, 50’s, & 100’s (As per PRC)
Approval status of product in Trazodone Hydrochloride of Apotex (USFDA)
Me-too status Trozolam Lisko Pakistan
compliance.”
Decision: Approved with change of brand name.
Brand Name +Dosage Form + Strength DRONE 50 mg Tablet
Composition Each Film coated tablet contained:
Trazodone HCl……..50 mg
Type of Form Form 5
Pack size & Demanded Price 10’s 14’s, 20’s, 30’s, 50’s, & 100’s (As per PRC)
Approval status of product in Trazodone Hydrochloride of Apotex (USFDA)
Me-too status Trozolam Lisko Pakistan
compliance.”
Brand Name +Dosage Form + Strength C-PINE 100mg Tablet
Diary No. Date of R& I & fee Dy. NO.1077 , 10-01-2017, Rs: 20,000/-
Clozapine ….100mg.
Pharmacological Group Atypical antipsychotic
Type of Form Form-5
Pack size & Demanded Price 10’s, 14’s, 20’s,30’s, 50’s, & 100’ AS per PRC
Approval status of product in CLOZAPINE of Ivex (US FDA)
Me-too status Zydex Of Genome
compliance.”
Decision: Approved with USP specifications
Brand Name +Dosage Form + Strength C-PINE 25 mg Tablet
Diary No. Date of R& I & fee Dy. NO.1076 , 10-01-2017, Rs: 20,000/-
Clozapine ….25 mg.
Pharmacological Group Atypical antipsychotic
Type of Form Form-5
Pack size & Demanded Price 10’s, 14’s, 20’s,30’s, 50’s, & 100’ AS per PRC
Approval status of product in CLOZAPINE of Ivex (US FDA)
Me-too status Zydex Of Genome
compliance.”
52. Name and address of manufacturer / M/s Noa Hemis Pharmaceutical., Plot # 154, sector 23,
Applicant Korangi, kharachi
Brand Name +Dosage Form + Strength Ildren Cream 10 mg
Composition Each gram of Ildren Cream Contain:
Luliconazole …….10mg
Rs. 30,000/- 29-12-2017 (Duplicate)
Pharmacological Group Antifungal
Type of Form Form-5 D (revised from form 5)
Pack size & Demanded Price 60 g /As per Policy

Approval status of product in Luzu (1%) of Medicis (USFDA)
Me-too status NA
GMP status Last GMP Inspection of Noa Hemis Pharmaceuticals.
Conducted on 14-6-17 with conclusive remarks of both
derive and ability to demonstrate appropriate corrective
actions.
Remarks of the Evaluator. No USP or BP monograph is available for applied
formulation.
Complete stability data
Decision: Deferred for submission of stability data as per format decided in instant meeting.
53. Name and address of manufacturer / M/s Noa Hemis Plot #154, Sector 23, Korangi
Applicant industrial area Karachi.
Brand Name +Dosage Form + Strength Prego 75mg Tablet
Diary No. Date of R& I & fee Dy.184, 23-02-2015, Rs.20,000/-
Rs. 30,000/- 29-12-2017 (Duplicate)
Composition Each Film coated tablet contains:
Tapentadol (as HCl)……75 mg
Pharmacological Group Centrally acting analgesic
Finished Product Specification Manufacture
Pack size & Demanded Price 1x10’s; 2x 10’s / As per PRC
Approval status of product in Reference Nucynta by Depomed (USFDA)
Regulatory Authorities.
Me-too status NA
GMP status Last GMP Inspection of Noa Hemis
Pharmaceuticals. Conducted on 14-6-17 with
conclusive remarks of both derive and ability to
demonstrate appropriate corrective actions.
Remarks of the Evaluator.  No USP or BP monograph is available for
applied formulation.
 Complete stability data
Decision: Deferred for submission of stability data as per format decided in instant
meeting.
Brand Name +Dosage Form + Strength Prego 50 mg Tablet
Diary No. Date of R& I & fee Dy. 179, 23-02-2015, Rs.20,000/-
Rs. 30,000/- 29-12-2017 (Duplicate)
Tapentadol (as HCL)……50 mg
Pharmacological Group Centrally acting analgesic
Pack size & Demanded Price 1x10’s, 2x 10’s / As per PRC
Approval status of product in Reference Nucynta by Depomed (USFDA)
Me-too status NA
Remarks of the Evaluator.  No USP or BP monograph is
Decision: Deferred for submission of stability data as per decision of Registration
Board.
Brand Name +Dosage Form + Strength Salifum 500mcg Tablet
Diary No. Date of R& I & fee Dy.No.181, 23-02-2015, Rs.20,000/-
Rs. 30,000/- 29-12-2017 (Duplicate)
Roflumilast…………..500 mcg
Pharmacological Group Selective phosphodiesterase 4 (PDE4) inhibitors
Pack size & Demanded Price Form-5 (Rs.20,000/-)
10’s; 14’s; 28’s / As per PRC
Approval status of product in Reference Daliresp By Astrazeneca Pharms (USFDA)
Me-too status NA
Remarks of the Evaluator.  No USP or BP monograph is
Decision: Deferred for submission of stability data as per decision of Registration
Board.
56. Name and address of manufacturer / M/s ATCO Laboratories Limited, B-18 SITE Karachi.
Applicant
Brand Name +Dosage Form + Strength Isocort-D 0.1/1% w/w Cream
Composition Each gm contains:-
Diflucortolone valerate………… 1 mg
Isoconazole Nitrate ……………..10 mg
Pharmacological Group Anti fungal & anti inflammatory
Type of Form Form-5
Pack size & Demanded Price 5g, 10 g, 15 g, 20 g / As per SRO
Approval status of product in Travocort cream of M/s Bayer Austria approved by
Reference Regulatory Authorities. AGES of Austria
Me-too status Difzole Cream of M/s Vega Pharmaceuticals
GMP status Panel inspection conducted on 28-2-2017 and report
concludes that firm is operating at the good GMP
compliance.
Remarks of Evaluator No USP or BP monograph is available for applied
formulation.
57. Name and address of manufacturer / M/s ATCO Laboratories Limited, B-18 SITE Karachi.
Applicant
Brand Name +Dosage Form + Strength Isocort 1% w/w Cream
Isoconazole Nitrate ……………..10 mg
Type of Form Form-5
Pack size & Demanded Price 5g, 10 g, 15 g, 20 g / As per SRO
Approval status of product in Travogen Crème of Austria
Me-too status Isocon of Valor Pharmaceuticals
Minutes for 278 Meeting of Registration Board (29-31st January, 2018), DRAP
th
| 29
concludes that firm is operating at the good GMP
compliance.
formulation.
58. Name and address of manufacturer / M/s Hilton Pharma, Plot 13, 14, sector 15, Korangi
Applicant industrial area. Karachi
Brand Name +Dosage Form + Strength Valsan 320 mg Tablet
Composition Each Film coated tablet contains:-
Valsartan....320mg
Pharmacological Group Angiotensin-II receptor antagonist)
Type of Form Form-5
Pack size & Demanded Price 14’s; 28’s / As per SRO
Approval status of product in Diovan by Novartis Pharmaceuticals (USFDA)
Me-too status Diovan by Novartis Pharma. Karachi
GMP status Last GMP Inspection dated 19-7-2017 with conclusive
remarks of satisfactory cGMP compliance.
Decision: Approved
59. Name and address of manufacturer / M/s Hilton Pharma, Plot 13, 14, sector 15, Korangi
Applicant industrial area. Karachi
Brand Name +Dosage Form + Strength Valsan 40 mg Tablet
Composition Each film coated tablet contains:-
Valsartan....40 mg
Pharmacological Group Angiotensin-II receptor antagonist
Type of Form Form-5
Pack size & Demanded Price 14’s; 28’s/ As per SRO
Approval status of product in Valsartan by OHM Labs Inc (USFDA)
Me-too status Valtec of Tabros Pharma
remarks of satisfactory cGMP compliance.
Decision: Approved
60. Name and address of manufacturer / M/s Mafins Pharma A-5 S.I.T.E Super Highway, Karachi
Applicant
Brand Name +Dosage Form + Strength Mexomin 15mg Tablet
Meloxicam ……….15mg
Type of Form Form-5
Pack size & Demanded Price As per SRO

Approval status of product in Mobic tablets by Boehringer
Reference Regulatory Authorities. (USFDA Approved)
Me-too status Megit of Glitz Pharma
remarks of good cGMP compliance.
Decision: Approved
Applicant
Brand Name +Dosage Form + Strength Esbafin 20mg Tablet
Ebastine…20mg
Pharmacological Group Anti-histamine
Type of Form Form-5
Approval status of product in Kastine tablet approved by Netherland
Me-too status Atmos of Scotmann Pharmaceuticals
Decision: Approved
Applicant
Brand Name +Dosage Form + Strength Dicmaf 75mg Tablet
Composition Each film coated sustained release tablet contains:
Diclofenac Sodium….75 mg
Type of Form Form-5
Approval status of product in Dicloflex 75 mg SR of Dexcel Pharma UKMHRA
Me-too status ARDI [Diclofenac (Na):75mg] of English pharma
Decision: Approved
Applicant
Brand Name +Dosage Form + Strength Esbafin 10mg Tablet
Ebastine…….10mg
Pharmacological Group Anti-histamine
Type of Form Form-5

Approval status of product in Kestine 10mg Film coated tablet by M/s Almirall
Reference Regulatory Authorities. Pharmaceuticals,
(ANSM France Approved)
Me-too status Ebofor 10mg Tablet by M/s Genome Pharmaceutical
Decision: Approved
Applicant
Brand Name +Dosage Form + Strength Drown 40mg Tablet
Composition Each uncoated tablet contains:
Drotaverine HCl……40 mg
Pharmacological Group Serotonin receptor antagonists/Antispasmodic
Type of Form Form-5

Approval status of product in Approved by 3 EMA member states i.e. Poland,
Reference Regulatory Authorities. Hungary, Latvia
Me-too status Draza 40mg Tablet By Opal Karachi
formulation.
Decision: Approved with innovator’s specification and change of brand name
Applicant
Brand Name +Dosage Form + Strength Drown 80mg Tablet
Drotaverine HCl……80mg
Pharmacological Group Serotonin receptor antagonists/Antispasmodic
Type of Form Form-5

Approval status of product in Approved by 3 EMA member states i.e.Lithuania,
Reference Regulatory Authorities. Hungary, Latvia.
Me-too status NO-SPA FORTE of Sanofi
formulation.
Applicant
Brand Name +Dosage Form + Strength Flofin 400mg Tablet
Composition Each Film coating tablet contains:-
Metronidazole……400mg
Pharmacological Group Antiprotozoal and anti-bacterial
Type of Form Form-5
Approval status of product in Flagyl tablets 400 mg (MHRA)
Me-too status Flagyl 400mg Tab. By Sanofi
Decision: Approved
Applicant
Brand Name +Dosage Form + Strength M-Nol 100mg Tablet
Atenolol………..100 mg
Pharmacological Group Antihypertensive/Beta Blocker
Type of Form Form-5

Approval status of product in Atenolol 100mg Film-Coated Tablets (MHRA)
Me-too status Adonax of Evron (Pvt) Ltd.
Decision: Approved
Applicant
Brand Name +Dosage Form + Strength Mexomin 7.5 mg Tablet
Meloxicam ……….7.5 mg
Type of Form Form-5
Approval status of product in Mobic tablets by Boehringer
Me-too status Megit of Glitz Pharma
Decision: Approved
Applicant
Brand Name +Dosage Form + Strength Gulofin 4mg Tablet
Glimepiride…..... 4mg
Pharmacological Group Sulphonyl urea
Type of Form Form-5
Approval status of product in Amaryl (Sanofi Aventis US)
Reference Regulatory Authorities. (FDA)
Me-too status Campride 4mg Tablet by Mendoza Reg. 067230
Decision: Approved
Applicant
Glimepiride.... 3mg
Pharmacological Group Sulphonylurea
Type of Form Form-5
Approval status of product in Amaryl of Sanofi Aventis (MHRA)
Me-too status Amaryl of Sanofi Aventis
Decision: Approved
Applicant
Glimepiride....1mg
Pharmacological Group Sulphonyl urea
Type of Form Form-5
Approval status of product in Amaryl (Sanofi Aventis US) (FDA)
Me-too status Amaryl of Sanofi Aventis
Decision: Approved
Applicant
Brand Name +Dosage Form + Strength Fluxafin 20mg Capsule
Composition Each Capsule contains:
Fluoxetine as hydrochloride…20mg
Pharmacological Group Antidepressant ( SSRI)
Type of Form Form-5
Approval status of product in Prozac 20mg capsule by M/S Eli Lilly And Co, USFDA
Reference Regulatory Authorities. approved
Me-too status Depex 20mg capsule by M/s Merck (Reg#020245)
Decision: Approved
Applicant
Brand Name +Dosage Form + Strength Arlofin DS 40mg/240mg Tablet
Artemether……40mg
Lumefantrine……240mg
Pharmacological Group Anti-malarial
Type of Form Form-5
Finished Product Specification International Pharmacopoeia
Approval status of product in WHO
Me-too status Artem plus by Hilton
Decision: Approved
Applicant
Brand Name +Dosage Form + Strength Citam 400mg Tablet
Composition Each film coating tablet contains:-
Cimetidine…………400mg
Pharmacological Group (H2 Blocker)
Type of Form Form-5

Approval status of product in Cimetidine of Teva (USFDA)
Me-too status Tagamet by GSK
Decision: Approved
Applicant
Brand Name +Dosage Form + Strength Dicmaf SR 100mg Tablet
Composition Each sustained release tablet contains:
Diclofanec sodium…......... 100mg
Type of Form Form-5
Approval status of product in VOLTAREN-XR of M/s Novartis approved USFDA
Me-too status Fist SR Tablets 100 mg of M/s Shaigan Pharmaceuticals
Decision: Approved
Applicant
Brand Name +Dosage Form + Strength Mybrofen 400mg Tablet
Composition Each sugar coated tablet contains:-
Ibuprofen….400mg
Type of Form Form-5
Approval status of product in Apsifen. Ibuprofen Tablets 400 mg (MHRA)
Me-too status Brofen 400mg Tab. By Abbott.
Decision: Approved
Applicant
Brand Name +Dosage Form + Strength Clomafin 500mg Tablet
Composition Each vaginal tablet contains:
Clotrimazole……….500 mg
Pharmacological Group Anti-fungal
Type of Form Form-5
Finished Product Specification BP
Approval status of product in Boots Thrush 500mg Vaginal Tablet (MHRA)
Me-too status Davizol-V Of Davis
Decision: Approved
Applicant
Brand Name +Dosage Form + Strength Fluco 150mg Capsule
Composition Each capsule contains:
Fluconazole……..150 mg
Type of Form Form-5
Approval status of product in Azocan 150 of M/s FDC International Ltd. (MHRA)
Me-too status Fantizol Capsule by Apex Karachi.
Decision: Approved
Applicant
Brand Name +Dosage Form + Strength Irow-F 100mg/0.35mg Tablet
Composition Each chewable tablet contains
Iron (III) Hydroxide Polymaltose Complex eq to
elemental iron………………100mg
Folic acid………..0.35mg
Pharmacological Group Haematinics
Type of Form Form-5
Approval status of product in NA
Me-too status RBC-F tablets by Genix
Applicant
Brand Name +Dosage Form + Strength Clarofin 500mg Tablet
Clarithromycin……500 mg
Type of Form Form-5
Approval status of product in Biaxin Xl of M/s Abbvie approved by USFDA
Me-too status Clarion XR Tablets by M/s Ferozsons Labs
(Reg#068466)
Decision: Approved
Applicant
Brand Name +Dosage Form + Strength Miforec 5mg Tablet
Composition Each tablet contains:-
Amlodipine Besilate equivalent to Amlodipine….5mg
Pharmacological Group (Calcium channel blocker)
Type of Form Form-5

Approval status of product in Norvasc by Pfizer (USFDA Approved)
Me-too status Amlobest of Pearl Pharmaceuticals
Decision: Approved
Applicant
Brand Name +Dosage Form + Strength Clarofin 250mg Tablet
Composition Each Film Coated Tablet Contains:-
Clarithromycin ….. 250 mg
Type of Form Form-5

Approval status of product in BIAXIN of M/s Abbvie approved by USFDA
Me-too status Klarinor 250 mg Tablets by M/S Nortech
Pharmaceuticals (Pvt) Ltd
Decision: Approved
Applicant
Brand Name +Dosage Form + Strength Clomafin 20mg Cream vaginal
Composition Each gm contains:
Clotrimazole….20mg
Type of Form Form-5

Approval status of product in Canesten 2% Thrush Cream by M/s Bayer (MHRA
Reference Regulatory Authorities. Approved)
Me-too status M-GYNO of Mediate Pharmaceuticals (Pvt) Ltd
Decision: Approved
Applicant
Brand Name +Dosage Form + Strength Gulofin 2mg Table
Glimepiride……. 2mg
Pharmacological Group Sulphonylurea
Type of Form Form-5
Approval status of product in Amaryl tablets (1mg, 2mg, 4mg) by M/s Zentiva,
Reference Regulatory Authorities. USFDA Approved
Me-too status Glimsaf 2mg tablet by M/s Saaf Pharmaceuticals (Reg #
070369)
Decision: Approved
Applicant
Brand Name +Dosage Form + Strength Mifcoxib 200mg Capsule
Celecoxib…….200mg
Pharmacological Group Anti- inflammatory
Type of Form Form-5
Approval status of product in Celebrex 200mg capsule of M/S GD Searle approved by
Reference Regulatory Authorities. USFDA
Me-too status Lecob 200mg Capsule by M/s. Epharm Lab. Karachi
Applicant
Brand Name +Dosage Form + Strength Gapin 300mg Capsule
Gabapentin……….300 mg
Pharmacological Group Anti-epileptic
Type of Form Form-5
Approval status of product in Gabapentin capsules 300mg by Sandoz/Actavis Elizabeth
Reference Regulatory Authorities. approved by USFDA
Me-too status Gab of TG pharma
Decision: Approved
Applicant
Brand Name +Dosage Form + Strength Aclomin 100mg Tablet
Aceclofenac…..100mg
Type of Form Form-5

Approval status of product in Aceclofenac 100 mg film-coated Tablets by MHRA
Me-too status Acfonac 100mg Tablets by M/s Medicraft
Pharmaceuticals (Pvt) Ltd., (Reg.#081743)
Remarks of Evaluator This formulation is not present in any pharmacopeia.
Applicant
Brand Name +Dosage Form + Strength Arlofin 20mg/120mg Tablet
Composition Each tablet contains
Artemether …..20mg
Lumefantrine …..120mg
Pharmacological Group Antimalarial
Type of Form Form-5
Approval status of product in WHO recommended formulation
Me-too status Artem by Hilton Pharma
Decision: Approved
Applicant
Brand Name +Dosage Form + Strength Mafodin 120mg Tablet
Fexofenadine HCl….120mg
Pharmacological Group H1 Receptor Antagonist
Type of Form Form-5
Approval status of product in Fexofenadine 120 mg Film-Coated Tablets (MHRA)
Me-too status Fexo by Hilton Pharma
Decision: Approved
Applicant
Brand Name +Dosage Form + Strength Mekofin 5 mg Tablet
Montelukast Sodium eq. to Montelukast …5mg
Pharmacological Group leukotriene inhibitor
Type of Form Form-5
Approval status of product in Montelukast USFDA Approved
Me-too status Montekast 5mg Tablets of M/s Legacy Pharmaceuticals
(Pvt) Ltd.
Decision: Approved
Applicant
Brand Name +Dosage Form + Strength Albofin 200mg Table
Albendazole……….200 mg
Pharmacological Group Anthelmintic drug
Type of Form Form-5
Approval status of product in ALBENZA FDA approved
Me-too status Acure Tablet 200mg Pharmix Labs Lahore (Reg.#.
025875)
Decision: Approved
Applicant
Brand Name +Dosage Form + Strength Mooflox 400mg Tablet
Composition Each film coated tablet contains;
Moxifloxacin (as hydrochloride)...400mg
Type of Form Form-5
Approval status of product in Avelox 400 mg film-coated tablets by M/s Bayer plc,
Reference Regulatory Authorities. (MHRA approved)
Me-too status Metoxim 400mg Tablet by M/s Foray Pharmaceutical
(Reg No:056083)
Applicant
Brand Name +Dosage Form + Strength Arlofin Forte Tablet
Artemether…………80 mg
Lumefantrine…….480 mg
Pharmacological Group Anti-malarial
Type of Form Form-5
Approval status of product in WHO recommended formulation
Me-too status Artem plus by Hilton
Decision: Approved
Applicant
Brand Name +Dosage Form + Strength Alofin 4mg Tablet
Composition Each tablets contains
Chlorpheniramine Maleate….4mg
Pharmacological Group Antagonist of histamine at H1 receptor
Type of Form Form-5
Approval status of product in Boots Allergy Relief 4 mg Tablets (MHRA)
Me-too status Fenram of Albro Pharma
Decision: Approved
95. Name and address of Manufacturer / M/s Genix Pharma, 44, 45-B, Korangi Creek Road
Applicant Karachi
Brand Name+ DosageForm+ Strength Genmide (Furosemide) oral solution
Composition Each 5 ml contains:
Furosemide---.----40 mg
Diary No. Date of R&I & fee Dy.No.2299, 24-01-2017, Rs.20,000/-
Pharmacological Group Diuretic
Type of Form Form-5
Pack Size & Demanded Price 60 ml, 90 ml, 120 ml / As per SRO
Approval status of product in Frusol 40 mg/5 ml (MHRA)
Reference Regulatory Authorities
Me-too status Basix of Xenon Pharmaceuticals
conclusive remarks of satisfactory cGMP compliance.
Remarks of Evaluator Liquid oral general section present.
Decision: Approved
Applicant Karachi
Brand Name+DosageForm+Strength Caroxin (digoxin)oral solution
Composition Each ml contains:
Digoxin-------0.05 mg
Pharmacological Group Cardiac Glycosides
Type of Form Form-5
Pack Size & Demanded Price 60 ml, 90 ml, 120 ml/ As per SRO
Approval status of product in Digoxin elixir 0.05MG/ML (USFDA)
Me-too status Doxin of Xenon Pharmaceuticals (Pvt) Ltd
Remarks of Evaluator On asking for clarification, firm claim that there
formulation is not an elixir although provided reference is
of elixir and there formulation also contain ethanol.
Decision: Deferred for clarification of dosage form since reference product is available as
“Elixir” whereas firm has stated that applied formulation is not an Elixir.
Applicant Karachi
Brand Name+DosageForm+Strength Genmide (Furosemide 50/5 ml) oral solution
Furosemide-------50 mg
Type of Form Form-5
Pack Size & Demanded Price 60 ml, 90 ml, 120 ml/ As per SRO
Approval status of product in Frusol 50 mg/5 ml (MHRA)
Me-too status Basix 10 mg/ml of Xenon Pharmaceuticals
Remarks of Evaluator Liquid oral general section present.
Decision: Approved
Evaluator PEC-VI
98. Name and address of manufacturer / M/s OBS Pakistan, Karachi
Applicant
Brand Name +Dosage Form + Strength Irbiac 150mg tablet
Irbesartan…..150mg
Diary No. Date of R& I & fee Dy. No.27; 13-1-2016 ; Rs.20,000/- (8-1-2016)
Pharmacological Group Anti-hypertensive Angiotensin II receptor
Type of Form Form-5
Pack size & Demanded Price 10’s, Rs.300/-; 14’s, Rs.420/-;
20’s, Rs.600/-; 28’s, Rs.840/-
Approval status of product in Reference USFDA approved
Me-too status Aproval tablets of M/s Sanofi Aventis.
GMP status Last inspection report 15-11-2017 based on the areas
visited people met and documentation reviewed and
found good and compliant as per GMP requirement.
Decision: Approved
Applicant
Brand Name +Dosage Form + Strength Irbiac-H 300mg+ 25mg tablet
Hydrochlorothiazide…..25mg
Pharmacological Group Anti-hypertensive (Angiotensin II receptor
antagonist/Diuretic)
Type of Form Form-5
Pack size & Demanded Price 10’s, Rs.750/-; 14’s, Rs.1050/-
20’s, Rs.1500/-; 28’s, Rs.2100/-
Approval status of product in Reference Avalide 300/25 mg film-coated tablets by M/s Sanofi-
Regulatory Authorities. Aventis U.S. LLC (USFDA Approved)
Me-too status Co-Aprovel 300/25mg tablets of M/s Sanofi Aventis
(Reg#053883)
Decision: Approved
Applicant
Brand Name +Dosage Form + Strength Irbiac-H 150mg+ 12.5mg tablet
Hydrochlorothiazide…..12.5mg
Pharmacological Group Anti-hypertensive (Angiotensin II receptor
antagonist/Diuretic)
Type of Form Form-5
Pack size & Demanded Price 10’s, Rs.350/-; 14’s, Rs.490/-
20’s, Rs.700/-; 28’s, Rs.980/-
Approval status of product in Reference Avalide 150/12.5 mg film-coated tablets by M/s Sanofi-
Regulatory Authorities. Aventis U.S. LLC (USFDA Approved)
Me-too status Co-Aprovel 150/12.5 mg tablets of M/s Sanofi Aventis
(Reg#043095)
Decision: Approved
Applicant
Brand Name +Dosage Form + Strength Amlowell HCT tablets
Amlodipine besylate eq to Amlodipine…..10mg
Valsartan……160mg
Hydrochlorothiazide……12.5mg
Pharmacological Group Antihypertensive
Type of Form Form-5
Finished product Specification Manufacturer’s Specification
Pack size & Demanded Price 14’s, 28’s, As per SRO
Approval status of product in Reference Exforge HCT by Novartis Pharma
Regulatory Authorities. (USFDA)
Me-too status Exforge by Novartis Pharma
Remarks of the Evaluator. Firm has initially submitted application on form-5D.
Now they have changed it to form-5.
Decision: Approved
Applicant
Hydrochlorothiazide……25mg
Pharmacological Group Anti-hypertensive
Type of Form Form-5
Approval status of product in Reference Exforge by Novartis Pharma
Decision: Approved
Applicant
Hydrochlorothiazide……12.5mg
Type of Form Form-5
Decision: Approved
Applicant
Type of Form Form-5
Decision: Approved
Applicant
Type of Form Form-5
Decision: Approved
106. Name and address of manufacturer / M/s Aspin Pharma, Karachi
Applicant
Brand Name +Dosage Form + Strength Acneris Plus Gel 0.1% + 2.5%
Adapalene…….1mg
Benzoyl peroxide…..25mg
Pharmacological Group Retinoid and Oxidizing agent combination
Type of Form Form-5
Pack size & Demanded Price 15gm, 30gm, 45gm, 60gm, 90gm, As per SRO
Me-too status Adalen e-B Gel Reg # 76683
GMP status Last GMP compliant dated 18.08.2017
Remarks of the Evaluator. Firm has initially applied on form-5D. Now they
changed it to Form-5.
Decision: Approved
Evaluator PEC-III
107. Name and address of manufacturer / M/s WelWink Pharmaceuticals, 70 KM, G.T. Road
Applicant Industrial Estate, Gujranwala Cantt
Brand Name +Dosage Form + Strength Avelon 400 mg Tablet
Moxifloxacin hydrochloride equivalent to
Moxifloxacin… 400mg
Diary No. Date of R& I & fee Dy No. 1020: 6-10-2015
Fee adjustment Rs. 20,000/- vide letter No. F.6-5/2015-
Reg-III dated 03-10-2016
Pharmacological Group Quinolone Antibiotic
Type of Form Form 5
Finished product Specifications Firm has claimed in house specification
Pack size & Demanded Price 1 x 5’s: As fixed by MOH
Approval status of product in Reference AVELOX by Bayer HealthCare Pharmaceuticals Inc.
Regulatory Authorities (MHRA Approved)
Me-too status Avelox by Bayer
GMP status Last inspection report dated 20-12-2017confirms that the
firm is operating at satisfactory level of compliance in all
sections except liquid injectable section.
Remarks of the Evaluator The application fee is adjusted with reference to letter
No. F.6-5/2015-Reg-III, stating that the extra fee Rs.
440,000/- submitted by the firm mistakenly for the
extension in contract manufacturing of products, has
been approved for adjustment against the registration
applications.
Brand Name +Dosage Form + Strength Coxil Tablet 50/12.5mg
Losartan Potassium…………50mg
Hydrochlorothiazide….12.5mg
Diary No. Date of R& I & fee Dy No. 1020: 6-10-2015. Fee adjustment Rs. 20,000/-
vide letter No. F.6-5/2015-Reg-III dated 03-10-2016
Pharmacological Group Angiotensin II antagonists and diuretics
Type of Form Form 5
Finished product Specifications USP
Pack size & Demanded Price As fixed by MOH
Approval status of product in Reference Cozaar-Comp 50/12.5mg by Merck Sharp & Dhome
Regulatory Authorities (USFDA Approved)
Me-too status Co-Eziday tablets by werrick
applications.
Decision: Approved
Brand Name +Dosage Form + Strength Febink 40mg Tablet
Febuxostat … 40 mg
Fee adjustment Rs. 20,000/- vide letter No. F.6-5/2015-
Reg-III dated 03-10-2016
Pharmacological Group Xanthine Oxidase Inhibitor,
Type of Form Form 5
Finished product Specifications Firm has claimed In-house specification
Approval status of product in Reference ULORIC by Takeda Pharmaceuticals
Me-too status Zurig by Getz
applications.
Brand Name +Dosage Form + Strength Febink 80mg Tablet
Febuxostat … 80 mg
Pharmacological Group Xanthine Oxidase Inhibitor,
Type of Form Form 5
Approval status of product in Reference ULORIC by Takeda Pharmaceuticals
Me-too status Zurig by Getz
applications.
Brand Name +Dosage Form + Strength Fexwink 120 mg Tablet
Fexofenadine hydrochloride…………..120mg
Pharmacological Group Antihistamines for systemic use
Type of Form Form 5
Approval status of product in Reference Fexofenadine tablets by Dr. Reddy
Me-too status Fendina tablets by Highnoon
applications.
Decision: Approved
Brand Name +Dosage Form + Strength Hepvir 0.5 mg tablet
Entecavir (as monohydrate)………..0.5mg
Type of Form Form 5
Approval status of product in Reference Baraclude 0.5mg tablet by Bristol-Myers Squibb
Me-too status Envir tablet by Highnoon
applications.
Decision: Approved
Brand Name +Dosage Form + Strength Malwink 200 mg Tablet
Hydroxychloroquine sulphate…..200mg
Pharmacological Group Antimalarial
Type of Form Form 5
Approval status of product in Reference Plquenil tablets by Concordia Pharms
Me-too status HCQ tablets by Getz
applications.
Decision: Approved
Brand Name +Dosage Form + Strength Ondaz 8mg Tablet
Ondansetron (as hydrochloride dihydrate)…..8mg
Pharmacological Group Serotonin 5HT3 receptor antagonist
Type of Form Form 5
Approval status of product in Reference Ondemet 8mg tablet by Alliance Pharmaceuticals
Me-too status Danset tablets by CCL
applications.
Decision: Approved
Brand Name +Dosage Form + Strength Parwink 37.5mg/325 Tablet
Composition Each film coated tablet contains
Tramadol hydrochloride………. 37.5 mg
Paracetamol……………. 325mg
Pharmacological Group Non opoid and Opioid Analgesic
Type of Form Form 5
Approval status of product in Reference ULTRACET tablet by Janssen
Me-too status Zultracet tablet by Wilshire
applications.
Decision: Approved
Brand Name +Dosage Form + Strength Rasovil 20 mg Tablet
Rosuvastatin (as calcium)…20mg
Pharmacological Group HMG CoA reductase inhibitor/ Antihyperlipidemic
Type of Form Form 5
Finished product Specifications Firm has claimed in house specifications
Approval status of product in Reference Crestor 20mg Tablets by M/s AstraZeneca
Regulatory Authorities (USFDA approved)
Me-too status Rosut 20mg Tablet by M/s Genome Pharmaceuticals
applications.
Brand Name +Dosage Form + Strength Rexil 1mg Tablet
Risperidone……..…1mg
Pharmacological Group Antipsychotic
Type of Form Form 5
Approval status of product in Reference Risperdal 1mg film-coated tablets by Janssen
Regulatory Authorities (MHRA approved)
Me-too status Risperdal 1mg Tablet by M/s Janssen
applications.
Decision: Approved
Brand Name +Dosage Form + Strength Rexil 2mg Tablet
Risperidone……..…2mg
Type of Form Form 5
Approval status of product in Reference Risperdal 2mg film-coated tablets by Janssen
Me-too status Risperdal 2mg Tablet by M/s Janssen
applications.
Decision: Approved
Brand Name +Dosage Form + Strength Riva 10 mg Tablet
Rivaroxaban………….10mg
Pharmacological Group Antithrombotic Agents
Type of Form Form 5
Approval status of product in Reference Xarelto by Janssen Pharm
Me-too status Xarelto by Bayer
applications.
Brand Name +Dosage Form + Strength Riva 20 mg Tablet
Rivaroxaban………….20mg
Pharmacological Group Antithrombotic Agents
Type of Form Form 5
Approval status of product in Reference Xarelto by Janssen Pharm
Me-too status Xarelto by Bayer
applications.
Brand Name +Dosage Form + Strength Savink 400 mg Tablet
Sevelamer Hydrochloride…400mg
Pharmacological Group Drugs for treatment of hyperkalemia and
hyperphosphatemia
Type of Form Form 5
Approval status of product in Reference Renagel 400mg Tablet by M/s Genzyme Corporation,
Me-too status Renavel 400mg Tablet by M/s AllianzeMed
applications.
Brand Name +Dosage Form + Strength Sitamet 50/500mg Tablet
Sitagliptin (as phosphate monohydrate)….50mg
Metformin hydrochloride...500mg
Pharmacological Group Hypoglycemic agents
Type of Form Form 5
Pack size & Demanded Price 2 x 7’s: as fixed by MOH
Approval status of product in Reference Janumet 50mg/500mg Tablets by M/s Merck
Me-too status Duvel Plus 50mg/500mg Tablet by M/s Martin Dow
applications.
Decision: Approved with Innovator’s specifications.
Brand Name +Dosage Form + Strength Sitamet 50/1000mg Tablet
Sitagliptin (as phosphate monohydrate)….50mg
Pharmacological Group Hypoglycemic agents
Type of Form Form 5
Pack size & Demanded Price 2 x 7’s: as fixed by MOH
Me-too status Duvel Plus 50mg/1000mg Tablet by M/s Martin Dow
applications.
Brand Name +Dosage Form + Strength Tebink 125mg Tablet
Terbinafine (as hydrochloride)……….125mg
Pharmacological Group Antifungals for systemic use
Type of Form Form 5
Approval status of product in Reference Terbinafine hydrochloride tablets by Stada
Me-too status Lamisil tablets by Novartis
applications.
Decision: Approved
Brand Name +Dosage Form + Strength Trexim 250 mg Capsule
Tranexamic acid …….250mg
Pharmacological Group Anti – Fibrinolytic
Type of Form Form 5
Finished product Specifications JP
Approval status of product in Reference Hexatron capsule 250 mg by M/s Nippon
Regulatory Authorities (PMDA Japan Approved)
Me-too status Trasamin 250mg Capsule by M/s Hilton
applications.
Decision: Approved
Brand Name +Dosage Form + Strength Welgab 100 mg Capsule
Pregabalin…………100mg
Pharmacological Group Anticonvulsant
Type of Form Form 5
Approval status of product in Reference Lyrica by PF Prism
Me-too status Gabica by Getz Pharma
applications.
Brand Name +Dosage Form + Strength Welpride 25mg Tablet
Levosulpiride ………..25 mg
Type of Form Form 5
Pack size & Demanded Price As approved by MOH
Approval status of product in Reference LEVOPRAID 25 mg tablet
Regulatory Authorities (AIFA Italy Approved)
Me-too status Vesulpid tablet by Martin Dow
applications.
128. Name and address of manufacturer / M/s Medizan Laboratories (Pvt) Ltd., Plot No. 313,
Applicant Industrial Triangle, Kahuta Road, Islamabad
Brand Name +Dosage Form + Strength PCM ER Tablets
Composition Each extended release tablet contains
Potassium citrate………..1080mg (10mEq)
Diary No. Date of R& I & fee Dy No. 3026: 12-7-2016 PKR 20,000/-: 4-7-2016
Pharmacological Group Urinary Alkalinizing agent
Type of Form Form 5
Pack size & Demanded Price 100’s: As per SRO
Approval status of product in Reference Urocit-K tablets by Mission Pharma
Me-too status Lospin Tablets by Valor Pharmaceuticals
GMP status Last inspection report dated 10-4-2017 confirms
satisfactory compliance to GMP
Remarks of the Evaluator
Decision: Approved
129. Name and address of manufacturer / M/s Medizan Laboratories (Pvt) Ltd., Plot No. 313,
Applicant Industrial Triangle, Kahuta Road, Islamabad
Brand Name +Dosage Form + Strength Contra capsules 100mg
Composition Each capsule contains
Itraconazole (IR Pellets 22%)……….100mg
Type of Form Form 5
Approval status of product in Reference Sporanox capsule 100mg by Janssen Cilag
Me-too status Icon capsule by Ferozesons
Remarks of the Evaluator  Source of pellets: M/s Vision Pharmaceuticals
Evaluator PEC-XI
130. Name and address of manufacturer / M/s Hiranis Pharmaceuticals (Pvt.) Ltd., Plot No. E-145
Applicant to E-149, North Western Industrial Zone, Port Qasim,
Karachi.
Brand Name +Dosage Form + Strength Onisa oral solution 4mg/5ml
Ondansetron (as hydrochloride dihydrate)…...….4mg
Pharmacological Group HT3- receptor antagonist
Type of Form Form-5
Pack size & Demanded Price 60ml; As per PRC
Approval status of product in Reference Zofran 4mg/5ml oral solution (USFDA approved)
Regulatory Authorities
Me-too status (with strength and dosage Dantron syrup of M/s Shrooq pharmaceuticals (077076)
form)
GMP status Last GMP inspection conducted on 07-09-2017, and the
report concludes that the firm was considered to be
operating at satisfactory compliance with GMP
guidelines.
Decision: Approved
Karachi.
Brand Name +Dosage Form + Strength Onisa tablet 8mg
Ondansetron (as hydrochloride dihydrate)…...….8mg
Pharmacological Group HT3- receptor antagonist
Type of Form Form-5
Pack size & Demanded Price As per PRC; As per PRC
Approval status of product in Reference Zofran 8mg tablets (USFDA approved)
Me-too status (with strength and dosage Zofran tablets 8mg of M/s GSK
form)
guidelines.
Decision: Approved
Karachi.
Brand Name +Dosage Form + Strength Epigo 250mg/5ml syrup
Sodium valproate eq. to Valproic acid…...….250mg
Pharmacological Group Antiepileptic
Type of Form Form-5
Finished product Specifications Manufacturer’s specifications
Approval status of product in Reference Depakene (USFDA approved)
Me-too status (with strength and dosage Epival of M/s Abbott
form)
guidelines.
Remarks of the Evaluator The firm has claimed manufacturer’s specifications
while the official monograph of Valproic acid oral
solution is available in USP.
Decision: Approved with USP specifications and change of brand name
Karachi.
Brand Name +Dosage Form + Strength Epigo 250mg tablet
Composition Each delayed release tablet contains:
Divalproex sodium eq. to Valproic acid…...….250mg
Type of Form Form-5
Approval status of product in Reference Depakote (USFDA approved)
Me-too status (with strength and dosage Epival tablets 250mg of M/s Abbott
form)
guidelines.
Karachi.
Brand Name +Dosage Form + Strength Epigo 500mg tablet
Composition Each delayed release tablet contains:
Divalproex sodium eq. to Valproic acid…...….500mg
Type of Form Form-5
Pack size & Demanded Price 20’s, 10x10’s; As per PRC
Approval status of product in Reference Depakote (USFDA approved)
Me-too status (with strength and dosage Epival tablets 500mg of M/s Abbott
form)
guidelines.
Decision: Approved with change of brand name
135. Name and address of manufacturer / M/s Unisa Pharmaceutical Industries Ltd., G.T. Road
Applicant Adamzai, Akora Khattak, District Nowshera.
Brand Name +Dosage Form + Strength Unibicarb injection 8.4%

Sodium bicarbonate…….………….0.084g
Diary No. Date of R& I & fee Dy.No.392;(16-11-2016);Rs.20,000/-(16-11-2016)
Pharmacological Group Irrigation solution
Type of Form Form-5
Finished product Specifications BP
Pack size & Demanded Price 20ml; As per SRO
Approval status of product in Reference ANSM approved
Me-too status (with strength and dosage Sobicarb of M/s. Zafa
form)
GMP status Last GMP inspection conducted on 22-09-2017 and the
report concludes that the overall GMP compliance of the
firm was found good.
Remarks of the Evaluator The firm has claimed BP specifications but the official
monograph is available in USP.
Decision: Approved with USP specifcations.
136. Name and address of manufacturer / M/s Unisa Pharmaceutical Industries Ltd., G.T. Road
Applicant Adamzai, Akora Khattak, District Nowshera.
Brand Name +Dosage Form + Strength Unisol-NS injection
Sodium chloride…….………….0.009g
Pharmacological Group Electrolyte
Type of Form Form-5
Pack size & Demanded Price 20ml; As per SRO
Approval status of product in Reference Sodium Chloride 0.9% solution for injection (MHRA
Regulatory Authorities approved)
Me-too status (with strength and dosage Zeesol-NS of M/s. Shahzaib
form)
Remarks of the Evaluator The firm has claimed BP specifications but the official
monograph is available in USP.
137. Name and address of manufacturer / M/s Aims Pharmaceuticals, Plot No. 291, Industrial
Applicant Triangle, Kahuta, Islamabad.
Brand Name +Dosage Form + Strength Aimdu gel
Composition Each gram contains:
Anhydrous Benzoyl peroxide (as hydrous benzoyl
peroxide) ……..50mg
Clindamycin (as phosphate) ………10mg
Diary No. Date of R& I & fee Dy. No.1735;(01-12-2016); Rs.20,000/-(01-12-2016)
Pharmacological Group Antibacterial
Type of Form Form 5
Pack size & Demanded Price 10gram;As per SRO
Approval status of product in Reference Duac once daily (MHRA approved)
Me-too status (with strength and dosage Hyclin gel of M/s Hygeia pharmaceuticals
form)
report concludes that the firm is operating at reasonable
level of GMP compliance.
Remarks of the Evaluator  The firm has approved Ointment (General) section,
confirmed from letter No.F.6-1/2009-Lic (M-216).
 Firm has claimed manufacturer’s specifications and
no official monograph is available for applied
formulation in USP & BP.
Decision: Deferred for submission of latest GMP inspection report as submitted inspection
report does not declare GMP compliant status.
138. Name and address of manufacturer / M/s Aims Pharmaceuticals, Plot No. 291, Industrial
Applicant Triangle, Kahuta, Islamabad.
Brand Name +Dosage Form + Strength Azaim 500mg tablets
Azithromycin (as dihydrate)…………….500mg
Diary No. Date of R& I & fee Dy. No.1736;(01-12-2016); Rs.20,000/-(01-12-2016)
Type of Form Form 5
Pack size & Demanded Price Not demanded; As per SRO
Approval status of product in Reference MHRA approved
Me-too status (with strength and dosage Plivazith 500 mg tablet of M/s Pliva
form)
report concludes that the firm is operating at reasonable
Decision: Deferred for submission of latest GMP inspection report as submitted inspection
report does not declare GMP compliant status.
139. Name and address of manufacturer / M/s Innvotek Pharmaceuticals, Plot No. 35, Industrial
Applicant Triangle, Kahuta Road, Islamabad.
Brand Name +Dosage Form + Strength Trend eye ointment
Neomycin (as sulphate)……………….3500 IU
Dexamethasone…….………………….1 mg
Polymixin B sulphate…….……..…….6000 IU
Pharmacological Group Steroid, antibacterial agent
Type of Form Form-5
Pack size & Demanded Price 3.5gm; Rs.140/-
Approval status of product in Reference Maxitrol ophthalmic ointment (MHRA approved)
Me-too status (with strength and dosage Maxitrol ophthalmic ointment of M/s Novartis
form)
report concludes that viewing the facts the company is
following the GMP guidelines as of today.
Decision: Approved
140. Name and address of manufacturer / M/s Medisynth Pharmaceuticals, Plot No. 55, Street No.
Applicant S-5, National Industrial Zone, Rawat, Islamabad.
Brand Name +Dosage Form + Strength Dultin 30mg capsules
Duloxetine hydrochloride as EC 17% pellets eq. to
duloxetine……….30mg
Source of pellets: Vision pharmaceuticals
Pharmacological Group SNRI
Type of Form Form-5
Pack size & Demanded Price 1x10’s and 2x7’s; As fixed by MoH
Approval status of product in Reference Cymbalta (USFDA approved)
Me-too status (with strength and dosage Dulan 30mg capsule of M/s Hilton Pharma
form)
report concludes that the firm is operating at fair level
of GMP compliance.
Decision: Deferred for confirmation whether the pellets of Duloxetine are of USP grade or
otherwise.
Brand Name +Dosage Form + Strength Tirasynth 500mg tablets
Levetiracetam……….500mg
Type of Form Form-5
Pack size & Demanded Price 3x10’s; As fixed by MoH
Approval status of product in Reference Keppra(USFDA approved)
Me-too status (with strength and dosage Eppra of M/s Global Pharma
form)
of GMP compliance.
Remarks of the Evaluator Original fee challan for Tirasynth 500mg capsules is
attached instead of Tirasynth 500mg tablets.
Decision: Deferred for evidence of fee submitted for applied formulation.
Brand Name +Dosage Form + Strength Pregab 100mg capsules
Pregabalin……….100mg
Pharmacological Group Antiepileptic agent
Type of Form Form-5
Pack size & Demanded Price 2x7’s; As fixed by MoH
Approval status of product in Reference Lyrica (USFDA approved)
Me-too status (with strength and dosage Zeegap 100mg capsules by M/s Hilton Pharma
form)
of GMP compliance.
Remarks of the Evaluator Firm has claimed manufacturer’s specifications and no
official monograph is available for applied
Brand Name +Dosage Form + Strength Flusynth 150mg capsules
Fluconazole……….150mg
Type of Form Form-5
Pack size & Demanded Price 1x1’s;As fixed by MoH
Approval status of product in Reference Dizole 150mg Capsule by M/s Alpha Pharm, Australia
Me-too status (with strength and dosage Diflucan 150mg capsule by M/s Pfizer, Karachi.
form)
of GMP compliance.
Remarks of the Evaluator Firm has claimed manufacturer’s specifications but the
official monograph is available for applied formulation
in BP & JP.
Decision: Approved with BP specifications
144. Name and address of manufacturer / M/s Caraway Pharmaceuticals, Plot No. 12, Street N-3,
Applicant National Industrial Zone, Rawat, Islamabad.
Brand Name +Dosage Form + Strength Sitamin tablets 50mg/500mg
Sitagliptin (as phosphate monohydrate)…...….50mg
Metformin hydrochloride…………………...500mg
Pharmacological Group Anti-diabetic
Type of Form Form-5
Pack size & Demanded Price 2x7’s; As per SRO
Approval status of product in Reference Janumet of Merck Sharp & Dohme Corp (USFDA
Me-too status (with strength and dosage Jentin 50mg/500mg tablets of M/s Searle
form)
GMP status Last GMP inspection conducted on 19-12-2017, and
the report concluded that the overall GMP compliance
is Good as of today.
Remarks of the Evaluator Firm has claimed USP specifications but no official
monograph is available for applied formulation in USP
& BP.
Brand Name +Dosage Form + Strength Sitamin tablets 50mg/1000mg
Sitagliptin (as phosphate monohydrate)…...….50mg
Metformin hydrochloride…………………...1000mg
Type of Form Form-5
Approval status of product in Reference Janumet of Merck Sharp & Dohme Corp (USFDA
Me-too status(with strength/dosage form) Jentin 50mg/1000mg tablets of M/s Searle
Remarks of the Evaluator Firm has claimed USP specifications but no official
monograph is available for applied formulation in USP
& BP.
Brand Name +Dosage Form + Strength Tramaway Plus tablets
Tramadol hydrochloride…....….37.5mg
Paracetamol………………..…..325mg
Pharmacological Group Analgesic and antipyretic, opioid analgesic
Type of Form Form-5
Approval status of product in Reference Tramacet tablets (MHRA approved)
Me-too status (with strength and dosage Misadol Plus tablet of M/s Mission pharma
form)
report concluded that the overall GMP compliance is
Good as of today.
Decision: Approved
Brand Name +Dosage Form + Strength Caraline 600mg tablets
Linezolid…....….600mg
Type of Form Form-5
Approval status of product in Reference Zyvox (USFDA approved)
Me-too status (with strength and dosage Linzol 600 mg tablets of M/s Regal pharmaceuticals
form)
in USP & BP.
Brand Name +Dosage Form + Strength Uromin 80mg tablets
Febuxostat…....….80mg
Pharmacological Group Antigout
Type of Form Form-5
Pack size & Demanded Price 30’s; As per SRO
Approval status of product in Reference Uloric 80mg tablets (USFDA approved)
Me-too status (with strength and dosage Zurig 80mg tablets of M/s Getz pharma
form)
149. Name and address of manufacturer / M/s Welwrd Pharmaceuticals, Plot No.3, Block A,
Applicant Phase I-II, Industrial Estate Hattar.
Brand Name +Dosage Form + Strength Fomet 50mg/500mg tablet
Vildagliptin…………...….50mg
Metformin hydrochloride…..500mg
Type of Form Form-5
Pack size & Demanded Price As per SRO; As per SRO
Approval status of product in Reference Galvumet (TGA approved)
Me-too status (with strength and dosage Galvus met 50mg/500mg tablet of M/s Novartis
form)
report concludes that overall the firm is GMP
compliant.
in USP & BP.
Decision: Approved with Innovator’s specifications with a shelf life of 18 months.
150. Name and address of manufacturer / M/s Welwrd Pharmaceuticals, Plot No.3, Block A,Phase
Applicant I-II, Industrial Estate Hattar.
Brand Name +Dosage Form + Strength Zeficam 8mg tablet
Lornoxicam…………...….8mg
Type of Form Form-5
Pack size & Demanded Price Not demanded; As per SRO
Approval status of product in Reference Xefo 8 mg tablet (EMA approved)
Me-too status (with strength and dosage Xefo 8mg tablets of M/s Everest Pharmaceuticals
form) (070158)
report concludes that overall the firm is GMP compliant.
in USP & BP.
151. Name and address of manufacturer / M/s Shaigan Pharmaceuticals, 14 Km, Adyala Road, Post
Applicant Office Dahgal, Rawalpindi.
Brand Name +Dosage Form + Strength Bivolol tablet
Nebivolol (as hydrochloride) …….………….2.5 mg
Pharmacological Group Cardioselective beta-blocker
Type of Form Form-5
Finished product Specifications Innovator’s specifications
Pack size & Demanded Price 1x14’s; Rs.106/-
Me-too status (with strength and dosage Nebil tablets 2.5mg of M/s Getz
form)
report concludes that the company is found complying
GMP as of today.
Remarks of the Evaluator Firm has claimed innovator’s specifications and no
in USP & BP.
Nebivolol (as hydrochloride) …….………….5 mg
Type of Form Form-5
Me-too status (with strength and dosage Nebil tablets 5mg of M/s Getz
form)
GMP as of today.
in USP & BP.
Nebivolol (as hydrochloride) …….………….10 mg
Type of Form Form-5
Me-too status (with strength and dosage Nebil tablets 10mg of M/s Getz
form).
GMP as of today.
in USP & BP.
Brand Name +Dosage Form + Strength Rivarox forte tablets
Rivaroxaban…….………….15mg
Pharmacological Group Anticoagulant
Type of Form Form-5
Approval status of product in Reference Xarelto (MHRA approved)
Me-too status(with strength/dosage form) Xarelto of M/s Bayer Health Care
GMP as of today.
Brand Name +Dosage Form + Strength Rivarox DS tablets
Type of Form Form-5
Me-too status (with strength and dosage Xarelto of M/s Bayer Health Care
form)
GMP as of today.
156. Name and address of manufacturer / M/s Shaigan Pharmaceuticals, 14 Km, Adyala Road,
Applicant Post Office Dahgal, Rawalpindi.
Brand Name +Dosage Form + Strength Rivarox tablets
Type of Form Form-5
Me-too status (with strength and dosage Xarelto of M/s Bayer Health Care
form)
GMP as of today.
Brand Name +Dosage Form + Strength Ivadin-5 tablets
Ivabradine as hydrochloride…….………….5mg
Pharmacological Group Anti-anginal
Type of Form Form-5
Pack size & Demanded Price 1x14’s; Rs.428.40/-
Approval status of product in Reference Corlanor (USFDA approved)
Me-too status (with strength and dosage Sivab tablets of M/s Getz
form)
GMP as of today.
in USP & BP.
Brand Name +Dosage Form + Strength Ivadin-7.5 tablets
Ivabradine as hydrochloride………….7.5mg
Pharmacological Group Anti-anginal
Type of Form Form-5
Pack size & Demanded Price 1x14’s; Rs.585.40/-
Approval status of product in Reference Corlanor (USFDA approved)
Me-too status (with strength and dosage Sivab tablets of M/s Getz
form)
GMP as of today.
in USP & BP.
Brand Name +Dosage Form + Strength Bilex capsules
Ursodeoxycholic acid………….250mg
Pharmacological Group Bile acid preparation
Type of Form Form-5
Me-too status (with strength and dosage Triptor capsule 250mg of M/s CCL pharma
form)
GMP as of today.
Decision: Approved
Brand Name +Dosage Form + Strength Bilex Forte capsules
Ursodeoxycholic acid………….500mg
Pharmacological Group Bile acid preparation
Type of Form Form-5
Approval status of product in Reference Ursochol (Sweden approved)
Me-too status (with strength and dosage Triptor capsule 500mg of M/s CCL pharma
form)
GMP as of today.
Decision: Approved
161. Name and address of manufacturer / M/s Shaigan Pharmaceuticals, 14 Km, Adyala Road,
Applicant Post Office Dahgal, Rawalpindi.
Brand Name +Dosage Form + Strength Oxyplex injection
Iron (as Ferric carboxymaltose)………….50mg
Pharmacological Group Haematinic
Type of Form Form-5
Pack size & Demanded Price 10ml x1’s; Rs.6670/-
Approval status of product in Reference Ferinject 50 mg iron/mL solution for injection/infusion
Me-too status (with strength and dosage Ferinject Injectable of M/s. RG pharmaceutica
form)
GMP as of today.
162. Name and address of manufacturer / M/s Hygeia Pharmaceuticals, Plot No. 295, Industrial
Brand Name +Dosage Form + Strength Hist tablets 24mg
Betahistine dihydrochloride ……….……….24 mg
Pharmacological Group Anti- vertigo
Type of Form Form-5
Pack size & Demanded Price 3x10’s; As recommended by the PRC
Approval status of product in Reference Serc (TGA approved)
Me-too status (with strength and dosage Serc of M/s Highnoon
form)
report concludes that the company is found to be
operating at satisfactory level of GMP guidelines as per
Drugs Act, 1976 and rules framed there under.
Remarks of the Evaluator  Clarification regarding coating of the applied
formulation; as description of the formulation in the
finished product specifications is stated as “film
coated tablets” and also the outline of method of
manufacturing contains “coating step” while master
formulation does not contain “composition of film
coating solution”.
 In response, the firm has submitted that Betahistine
dihydrochloride 24mg tablets are core tablets not the
film coated tablets. This is a mistake not to mislead
the authority but of less knowledge and not proper
checkup from the reference authorities.
The firm has submitted revised form-5, master
formulation, outline of method of manufacturing and
finished product specifications, accordingly.
Decision: Deferred for submission of fee for revision of formulation
Brand Name +Dosage Form + Strength Hist tablets 16mg
Betahistine dihydrochloride ……….……….16 mg
Pharmacological Group Anti- vertigo
Type of Form Form-5
Approval status of product in Reference Serc (TGA approved)
Me-too status (with strength and dosage Serc of M/s Highnoon
form)
Remarks of the Evaluator  Clarification regarding coating of the applied
formulation; as description of the formulation in the
finished product specifications is stated as “film
coated tablets” and also the outline of method of
manufacturing contains “coating step” while master
formulation does not contain “composition of film
coating solution”.
 In response, the firm has submitted that Betahistine
dihydrochloride 16mg tablets are core tablets not the
film coated tablets. This is a mistake not to mislead
the authority but of less knowledge and not proper
checkup from the reference authorities.
The firm has submitted revised form-5, master
formulation, outline of method of manufacturing and
finished product specifications, accordingly.
Brand Name +Dosage Form + Strength Dibi tablets 1mg
Glimepiride ……….……….1mg
Pharmacological Group Antidiabetic
Type of Form Form-5
Approval status of product in Reference Amaryl (MHRA, USFDA approved)
Me-too status (with strength and dosage Glimera 1mg tablets of M/s PPP
form)
Remarks of the Evaluator The firm has revised formulation from film coated to
uncoated tablets without submission of fee.
Decision: Deferred for submission of fee for revision of formulation.
Brand Name +Dosage Form + Strength Dibi tablets 2mg
Glimepiride ……….……….2mg
Type of Form Form-5
Approval status of product in Reference Amaryl (MHRA, USFDA approved)
Me-too status (with strength and dosage Glimera 2mg tablets of M/s PPP
form)
Remarks of the Evaluator The firm has revised formulation from film coated to
uncoated tablets without submission of fee.
166. Name and address of manufacturer / M/s Medizan Laboratories Pvt. Ltd. Plot No.313,
Applicant Industrial Triangle, Kahuta Road Islamabad.
Brand Name +Dosage Form + Strength Busron 5mg tablets
Buspirone hydrochloride………. 5mg
Pharmacological Group Anxiolytics
Type of Form Form-5
Pack size & Demanded Price 30’s; As decided by the Ministry of Health
Approval status of product in Reference Buspar (USFDA approved)
Me-too status (with strength and dosage Buspar tablets 5mg of M/s Bristol Myers, Karachi
form)
operating at reasonably acceptable compliance with
GMP guidelines as of today.
Remarks of the Evaluator  The firm has revised formulation from film coated
to uncoated tablets without submission of fee.
 Discontinued in USFDA but Federal Register
determination that product was not discontinued or
withdrawn for safety or efficacy reasons
167. Name and address of manufacturer / M/s Medizan Laboratories Pvt. Ltd. Plot No.313,
Applicant Industrial Triangle, Kahuta Road Islamabad.
Brand Name +Dosage Form + Strength Busron 10mg tablets
Buspirone hydrochloride………. 10mg
Pharmacological Group Anxiolytics
Type of Form Form-5
Pack size & Demanded Price 30’s; As decided by the Ministry of Health
Approval status of product in Reference Buspar (USFDA approved)
Me-too status (with strength and dosage Nanzo 10mg tablet of M/s. Wilshire Laboratories
form)
Remarks of the Evaluator  The firm has revised formulation from film coated
to uncoated tablets without submission of fee.
 Discontinued in USFDA but Federal Register
determination that product was not discontinued or
withdrawn for safety or efficacy reasons
168. Name and address of manufacturer / M/s Pakistan Pharmaceutical Products (Pvt.) Ltd. D-
Applicant 122, S.I.T.E. Karachi.
Brand Name +Dosage Form + Strength Leukastin tablets 5mg
Montelukast (as sodium)……….5mg
Type of Form Form-5
Approval status of product in Reference Singulair 5mg chewable tablets (USFDA approved)
Me-too status (with strength and dosage Montiget 5mg chewable tablet of M/s Getz Pharma
form)
report concludes that based on the people met, focused
areas visited, documents reviewed and observation
made it is concluded that the firm has
complied/improved according to the directions of the
FID. Panel was satisfied for the improvements
undertaken by the firm.
Decision: Approved.
169. Name and address of manufacturer / M/s Pakistan Pharmaceutical Products (Pvt.) Ltd. D-
Brand Name +Dosage Form + Strength Leukastin tablets 4mg
Montelukast (as sodium)……….4mg
Type of Form Form-5
Approval status of product in Reference Singulair 4mg chewable tablets (USFDA approved)
Me-too status (with strength and dosage Montiget 4mg chewable tablet of M/s Getz Pharma
form)
report concludes that based on the people met, focused
areas visited, documents reviewed and observation
made it is concluded that the firm has
complied/improved according to the directions of the
FID. Panel was satisfied for the improvements
undertaken by the firm.
Decision: Approved
Evaluator PEC-IV
170. Name and address of manufacturer / M/s OBS Pakistan Pvt. Ltd. C-14, S.I.T.E. Karachi
Applicant
Brand Name +Dosage Form + Strength Citap-M 50+850mg tablet
Sitagliptin (as phosphate monohydrate) ………50mg
Metformin hydrochloride……………850mg
Pharmacological Group Antihyperglycemic
Type of Form Form-5
Pack size & Demanded Price 14’s and 28’s; As per DPC
Approval status of product in Janumet tablets of (TGA approved)
Me-too status (with strength and S-Gliptin Plus Tablets of M/s Barrett Hodgson
dosage form)
report concludes that firm Is operating
at satisfactory level of GMP
Remarks of the Evaluator  The official monograph of the product is not
available in any pharmacopoeia.
171. Name and address of manufacturer / M/s OBS Pakistan Pvt. Ltd. C-14, S.I.T.E. Karachi
Applicant
Brand Name+Dosage Form + Strength Citap 50mg tablet
Diary No. Date of R& I & fee Dy. No1856; 17-02-2017; Rs.20,000/- (17-02-2017)
Type of Form Form-5
Approval status of product in Januvia tablets of (FDA approved)
Me-too status (with strength and A-Glip Tablets of M/s Atco Labs
dosage form)
GMP status Last GMP inspection conducted on 11-04-2017and the
Remarks of the Evaluator The official monograph of the product is available in
USP.
172. Name and address of manufacturer / M/s OBS Pakistan Pvt. Ltd. C-14, S.I.T.E.
Applicant Karachi
Brand Name+Dosage Form + Strength Citap 25mg tablet
Diary No. Date of R& I & fee Dy. No1857; 17-02-2017; Rs.20,000/- (17-02-2017)
Type of Form Form-5
Approval status of product in Januvia tablets of (FDA approved)
Me-too status (with strength and A-Glip Tablets of M/s Atco Labs
dosage form)
GMP status Last GMP inspection conducted on 11-04-2017,and the
Remarks of the Evaluator The official monograph of the product is available in
USP.
Decision: Approved with USP specification
173. Name and address of manufacturer / M/s Gulf Pharmaceuticals Plot # 49 street-5 National
Applicant Industrial zone Rawat Islamabad,
Brand Name+Dosage Form + Strength Gulped 25mg Tablet
Levosulpiride……….25 mg
Diary No. Date of R& I & fee Dy.No.2684; 24-02-2017; Rs.20,000/- (24-02-2017)
Type of Form Form 5
Finished product Specifications Manufacturer specification
Pack size & Demanded Price 2 x 10’s ; As per SRO
Approval status of product in Approved by Italian Medicine Agency
Me-too status (with strength and Scipride tablet M/s Getz Pharma
dosage form)
report concludes that firm is complying GMP.
Decision: Deferred for clarification of formulation since reference product is available as
uncoated tablet whereas firm has applied for film coated formulation.
174. Name and address of manufacturer / M/s Gulf Pharmaceuticals Plot # 49 street-5
Applicant National Industrial zone Rawat Islamabad,
Brand Name+Dosage Form + Strength Gulped 50mg Tablet
Levosulpirid……….50mg
Type of Form Form 5
Pack size & Demanded Price 2 x 10’s ; As per SRO
Approval status of product in Approved by Italian Medicine Agency
Me-too status (with strength and Scipride tablet M/s Getz Pharma
dosage form)
report concludes that firm is complying GMP.
uncoated tablet whereas firm has applied for film coated formulation.
175. Name and address of manufacturer / M/s. S.J & G Fazul Ellahie Limited, E/46, S.I.T.E,
Applicant Karachi
Brand Name+Dosage Form + Strength Neugast 50mg Capsule
Pregabalin………..50 mg
Pharmacological Group Anti epileptic
Type of Form Form 5
Finished product Specifications Manufacutrer specification
Pack size & Demanded Price 14’s; As per PRC
Approval status of product in Lyrica of (USFDA approved)
Me-too status (with strength and Gabica Capsule by M/s Getz Pharma
dosage form)
conclusive remarks of good level of cGMP compliance.
Applicant Karachi
Type of Form Form 5
Approval status of productin Lyrica of (USFDA approved)
dosage form)
GMP status Last GMP Inspection conducted on 12-01-2017
with conclusive remarks of good level of cGMP
compliance.
Applicant Karachi
Type of Form Form 5
dosage form)
Applicant Karachi
Diary No. Date of R& I & fee Dy.No. 310; 22-02-2017; Rs.20,000/-(20-02-2017)
Type of Form Form 5
dosage form)
Evaluator PEC-VIII
179. Name and address of Manufacturer / M/s Shawan Pharmaceuticals, Plot # 37 National industrial
Applicant zone, Rawat.
Brand Name+DosageForm+Strength Onze-F Capsules 3/25 mg
Composition Each Capsule contains
Olanzapine……………...3 mg
Fluoxetine (as hydrochloride)...…25 mg
Diary No. Date of R&I & fee DyNo.181; 03-11-2016; Rs. 20000/-
Pharmacological Group SSRIs / Antipsychotic
Type of Form Form-5
Finished Product Specification USP Specifications
Pack Size & Demanded Price 14’s; As per SRO
Approval status of product in Symbyax 3 mg/25 mg Capsules of Eli Lilly , USA
Reference Regulatory Authorities (USFDA)
Me-too status Olanzo-F 3/25 mg Capsules of Regal pharmaceuticals
GMP status GMP inspection dated 01-06-2017, concluding compliant
status.
Decision: Approved
Brand Name+DosageForm+Strength Onze-F Capsules 6/25 mg
Olanzapine……………...6 mg
Fluoxetine (as hyrochloride)...…25 mg
Pharmacological Group SSRIs / Antipsychotic
Type of Form Form-5
Pack Size & Demanded Price 14’s & 30’s ; As per SRO
Approval status of product in Symbyax 6 mg/25 mg Capsules of Eli Lilly , USA
Reference Regulatory Authorities (USFDA)
Me-too status Olanzo-F 6/25 mg Capsules of Regal pharmaceuticals
status.
Decision: Approved
Brand Name+DosageForm+Strength Fungi-Go Capsules 150 mg
Fluconazole…….150 mg
Pharmacological Group Triazol Antifungal
Type of Form Form-5
Finished Product Specification Manufacturer’s specifications
Pack Size & Demanded Price 1’s ; As per SRO
Approval status of product in Approved in MHRA
Me-too status Fiscon 150mg capsule of Fassgen
status.
Remarks of Evaluator Applied formulation is present in BP
Decision: Approved with BP specifications
182. Name and address of Manufacturer / M/s NOA HEMIS Pharmaceuticals, Plot No. 154 Sector 23
Applicant Korangi Industrial Area, Karachi.
Brand Name+DosageForm+Strength Extam-D Capsule 500mg
Tranexamic acid… 500mg
Diary No. Date of R&I & fee Dy No.1159; 15-12-2015; Rs.20,000/-
Pharmacological Group Hemostatics /Antifibrinolytics
Type of Form Form-5
Finished Product Specification Manufacturer’s Specification
Pack Size & Demanded Price 10’s, 20’s; As per PRC
Approval status of product in Not provided, however firm submitted reference of
Reference Regulatory Authorities Hemostan has approved in Phillipines.
Me-too status Maxna 500mg capsules by Novartis.
remarks of cGMP compliance.
Remarks of Evaluator  Evidence of approval of applied formulation in
183. Name and address of Manufacturer / M/s Crystolite Pharmaceuticals, Plot No. 1 & 2, Street S-2
Applicant National Industrial Zone, Rawat,
Brand Name+DosageForm+Strength Sorlit Capsule 120mg
Composition Each filled capsule contains:
Orlistat…..120 mg
(50 %pellets)
Source of pellets; M/s Vision Pharmaceuticals, Islamabad
Diary No. Date of R&I & fee Dy No.137; 02-11-2016; Rs.20,000/-, 80,000
Pharmacological Group Anti-Obesity
Type of Form Form-5
Finished Product Specification USP specifications
Pack Size & Demanded Price 3×10’s ; As per SRO
Approval status of product in Approved in USFDA
Me-too status Orlis 120mg capsule of Ferozsons
GMP status GMP Inspection report conducted on 17th October 2017
concluded that firm is operating at good level of GMP.
Decision: Approved
184. Name and address of Manufacturer / M/s Crystolite Pharmaceuticals, Plot No. 1 & 2, Street S-2
Applicant National Industrial Zone, Rawat,
Brand Name+DosageForm+Strength Sorlit Capsule 60mg
Composition Each filled capsule contains:
Orlistat…………….60 mg
(50 %pellets)
Source of pellets; M/s Vision Pharmaceuticals, Islamabad
Pharmacological Group Anti-Obesity
Type of Form Form-5
Pack Size & Demanded Price 3×10’s ; As per SRO
Approval status of product in Approved in USFDA
Me-too status Orlis 60mg capsule of Ferozsons
Decision: Approved
185. Name and address of Manufacturer / M/s Welwrd Pharmaceuticals, Plot No.3, Block A, Phase I-
Applicant II, Industrial Estate, Hattar.
Brand Name+DosageForm+Strength Welmet Tablet 50/1000
Sitagliptin (as phosphate monohydrate)…50mg
Metformin hydrochloride…500mg
Pharmacological Group Anti-hyperglycemic
Type of Form Form-5
Finished Product Specification Manufacturer’s Specifications
Pack Size & Demanded Price As per SRO
Approval status of product in Approved in US-FDA
Me-too status Juvia-M Plus 50mg/500mg Tablet of Helix Karachi.
GMP status GMP Inspection conducted on 14th June 2017 concluded
that firm is GMP compliant.
186. Name and address of Manufacturer / M/s Werrick Pharmaceuticals, 216-217,I-10/3, Industrial
Applicant Area, Islamabad.
Brand Name+DosageForm+Strength Nicotab tablet 10mg
Nicorandil…10mg
Pharmacological Group Arterial and venous vasodilator
Type of Form Form-5
Me-too status Nicoril tablets 10mg of Ferozsons Labs.
GMP status GMP inspection conducted on 07-12-2017 shows that firm
is operating at good level of GMP compliance
Decision: Approved with BP specification.
187. Name and address of Manufacturer / M/s Werrick Pharmaceuticals, 216-217,I-10/3,

Applicant Industrial Area, Islamabad.
Brand Name+DosageForm+Strength Nicotab tablet 20mg
Nicorandil…20mg
Type of Form Form-5
Decision: Approved with BP specification.
188. Name and address of Manufacturer / M/s Werrick Pharmaceuticals, 216-217,I-10/3, Industrial
Brand Name+DosageForm+Strength Regain plus tablet 1mg/500mg
Composition Each sustained release bilayer tablet contains:
Glimeperide(as immediate release)…1mg
Metformin hydrochloride(as sustained release)…500mg
Type of Form Form-5
Pack Size & Demanded Price 30’s, 50’; As per SRO
Approval status of product in Not provided
Me-too status Amaryl-M tablets 1+500mg tablet of Sanofi Aventis
is operating at good level of GMP compliance.
Remarks of Evaluator  Evidence of approval status of applied formulation
in reference agencies.
Brand Name+DosageForm+Strength Regain plus tablet 2mg/500mg
Glimeperide (as immediate release)…2mg
Type of Form Form-5
Brand Name+DosageForm+Strength Frecid plus liquid 500mg/267mg
Composition Each 10ml liquid suspension contains:
Sodium alginate…500mg
Sodium bicarbonate…267mg
Pharmacological Group Haemostatic agent/Alkalizing agent
Type of Form Form-5
Me-too status Not confirmed
 Evidence of me too of applied formulation.
 Evidence of applied formulation/drug already approved by DRAP (generic / me-too
status) alongwith registration number, brand name and name of firm
which were declared/approved by the Registration Board
 Clarification of pharmacological group.
191. Name and Address of the Kanel Pharmaceuticals. Plot # 6, St No. SS-3, National
Manufacturer/Applicant Industrial Zone, Rawat
Brand Name + Dosage form + Strength Alzil-M 10mg Tablets
Memantine hydrochloride….10mg
Diary No. Date of R&I & Fee Dy No.15; 02-02-2017; Rs. 20000/-
Pharmacological Group NMDA receptor antagonist.
Type of Form Form-5
Packed Size and Demanded Price 1 X 14’s : As per SRO
Me-too Status Rement 10mg Tablet of High-Q Pharmaceuticals
GMP Status Panel inspection dated 20-12-2017 recommends renewal
of DML by the way of formulation for the following
section namely along with additional sections as under;
Tablet section
Capsule section
For grant of additional sections namely;
Cream/Ointment section(general)
Topical lotion section(general)
Capsule section(Ceph)
Dry suspension section(Ceph)
Dry vial Injection(Ceph)

Brand Name + Dosage form + Strength Koxib 100mg Capsules
Composition Each hard gelatin capsule contains:
Celecoxib…100mg
Pharmacological Group COX- 2 inhibitor
Type of Form FORM-5
Packed Size and Demanded Price 1 x10’s , 2 x10’s, 3 x10’s: As per SRO
Reference Regulatory Authorities CELBREX (PFIZER,USA)
Me-too Status Orthocel 100mg Capsule of Lisko Pharmaceuticals
Tablet section
Capsule section
Remarks of Evaluator Latest inspection report.
Brand Name + Dosage form + Strength Koxib 200mg Capsules
Celecoxib …200mg
Pharmacological Group COX- 2 inhibitor
Type of Form FORM-5
Packed Size and Demanded Price 1 x10’s , 2 x10’s, 3 x10’s: As per SRO
Reference Regulatory Authorities CELBREX (PFIZER,USA)
Me-too Status Orthocel 200mg Capsule of Lisko Pharmaceuticals
Tablet section
Capsule section
Remarks of Evaluator Latest inspection report.
Brand Name + Dosage form + Strength Quepine 25 Mg Tablets
Quetiapine (as fumerate)…25mg
Type of Form FORM-5
Packed Size and Demanded Price 1 x 10’s, 2 x 10’s , 3 x 10’s : As per SRO
Me-too Status Qusel 25mg tablet of Hilton
Tablet section
Capsule section
Remarks of Evaluator Firm has claimed Manufacturer specifications but the
applied formulation exist in USP.
Decision: Approved with USP specifcation
Brand Name + Dosage form + Strength Valken-A 160/10 mg Tablets
Valsartan….160mg
Amlodipine (as besylate)….10mg
Type of Form Form-5
Packed Size and Demanded Price 1 x 14’s: As per SRO
Reference Regulatory Authorities EXFORGE (NOVARTIS)
Me-too Status Co-Valzaar 10mg/160mg Tablet of Vision
Pharmaceuticals.
Tablet section
Capsule section
Decision: Approved with USP specification.
Evaluator PEC-XIII
196. Name and address of manufacturer / M/s Highnoon Laboratories Limited, 17.5km Multan Road,
Applicant Lahore.
Brand Name +Dosage Form + Viforge Tablet 40mg
Strength
Composition Each film-coated tablet contains:
Valsartan ………….………40mg
Pharmacological Group Angiotensin-II Antagonist
Type of Form Form-5
Finished product Specification U.S.P.
Pack size & Demanded Price 10’s, 14’s, 28’s, 56’s & as per PRC
Approval status of product in Valsartan 40mg film-coated tablet of M/s Actavis UK
Reference Regulatory Authorities. limited (emc-MHRA Approved)
Me-too status Sevia 40mg tablet of M/s Sami Pharmaceuticals
GMP status Last GMP inspection was conducted on 06-07-2017
which concludes good level of GMP compliance.
197. Name and address of manufacturer / M/s High-Q Pharmaceuticals, Plot No. 224/23 Korangi
Applicant Industrial Area, Karachi.
Brand Name +Dosage Form + Fungix capsule 50mg
Strength
Composition Each hard-gelatin capsule contains:
Fluconazole ………...50mg
Type of Form Form-5
Finished product Specification Manufacturer’s
Pack size & Demanded Price 7’s, 10’s & as per leader price
Approval status of product in Diflucan 50mg hard capsules of M/s Pfizer limited (emc
Reference Regulatory Authorities. MHRA Approved)
Me-too status Diflucan 50mg hard capsules of M/s Pfizer
Pharmaceuticals, Pakistan (Reg. # 011827)
GMP status Last GMP inspection was conducted on 19-07-2017 and
the report shows grant of GMP certificate.
Remarks of the Evaluator  The applied drug is in British Pharmacopoeia.
Decision: Approved with BP specifications and change of brand name
Strength
Fluconazole ………….……...150mg
Type of Form Form-5
Pack size & Demanded Price 1’s, 2’s, 4’s,7’s, 10’s & as per PRC
Approval status of product in Diflucan 150mg hard capsules of Pfizer limited (emc
Pharmaceuticals, Pak (Reg.# 011828)
Strength
Fluconazole ……………….200mg
Type of Form Form-5
Pack size & Demanded Price 1’s, 4’s & as per PRC
Approval status of product in Diflucan 200mg hard capsules of M/s Pfizer limited (emc
Pharmaceuticals, Pak (Reg.# 011829)
200. Name and address of manufacturer / M/s Valor Pharmaceuticals, 124/A Kahuta Road Industrial
Applicant Triangle Zone Islamabad.
Brand Name +Dosage Form + Isozam capsules 10mg
Strength
Isotretinoin ...………..10mg
Pharmacological Group Retinoid
Type of Form Form-5
Finished product Specification Not provided
Pack size & Demanded Price 10’s & as per SRO
Approval status of product in Absorica capsules of M/s Sun Pharm INDS INC (USFDA
Me-too status IsoPearl 10mg capsules of M/s Pearl Pharma (Reg. #
054814)
the report reveals satisfactory level of GMP compliance.
Remarks of the Evaluator  Specs not provided while the applied drug is
available in British Pharmacopoeia.
 Comes with following boxed-warning of being
involved in causing birth defects.
WARNING: CAUSES BIRTH DEFECTS
 Absorica™ must not be used by female patients who are
or may become pregnant. There is an extremely high risk
that severe birth defects will result if pregnancy occurs
while taking Absorica™ in any amount, even for short
periods of time. Potentially any fetus exposed during
pregnancy can be affected .  There are no accurate means
of determining whether an exposed fetus has been affected
.  Absorica™ is available only through a restricted
program called the iPLEDGE program. Prescribers,
patients, pharmacies, and distributors must enroll in the
program
Decision: Registration board deferred the case for evaluation as per decision of 250th meeting
of Registration Board for review of formulation.
201. Nameb and address of manufacturer / M/s Valor Pharmaceuticals, 124/A Kahuta Road Industrial
Applicant Triangle Zone Islamabad.
Brand Name +Dosage Form + Isozam Capsules 20mg
Strength
Isotretinoin ...………..20mg
Type of Form Form-5
Approval status of product in Absorica 20mg capsules of M/s Sun Pharm INDS INC
Me-too status Iso-A 20mg capsules of M/s Pearle Pharma
the report reveals satisfactory level of GMP compliance.
Remarks of the Evaluator  Specs not provided while the applied drug is
available in British Pharmacopoeia.
 Comes with following boxed-warning of being
involved in causing birth defects.
WARNING: CAUSES BIRTH DEFECTS
 Absorica™ must not be used by female patients who are
or may become pregnant. There is an extremely high risk
that severe birth defects will result if pregnancy occurs
while taking Absorica™ in any amount, even for short
periods of time. Potentially any fetus exposed during
pregnancy can be affected .  There are no accurate means
of determining whether an exposed fetus has been affected
.  Absorica™ is available only through a restricted
program called the iPLEDGE program. Prescribers,
patients, pharmacies, and distributors must enroll in the
program
Decision: Registration board deferred the case for evaluation as per decision of 250th meeting
of Registration Board for review of formulation.
202. Name and address of manufacturer / M/s OBS Pakistan (Pvt) Limited, C-14, S.I.T.E, Karachi
Applicant
Brand Name +Dosage Form + Amloperin Tablet 4/5mg
Strength
Perindopril Erbumine………….……………..…..4mg
Amlodipine Besylate eq. to Amlodipine………...5mg
Diary No. Date of R& I & fee Dy. No. 4157; 10-03-2017; Rs.20,000/- (10-03-2017)
Type of Form Form-5
Pack size & Demanded Price 14’s, 28’s & as per DPC
Approval status of product in Perindopril ter-butylamine/ Amlodipine CF 4/5mg un-
Reference Regulatory Authorities. coated tablets (Approved in Netherland)
Me-too status Coversam 4/5mg tablet of M/s Servier Research & Pharm
aceuticals, Pakistan (Reg. # 065962)
the report concludes good level of GMP compliance.
203. Name and address of manufacturer / M/s OBS Pakistan (Pvt) Limited, C-14, S.I.T.E, Karachi
Applicant
Brand Name +Dosage Form + Amloperin Tablet 8/5mg
Strength
Perindopril Erbumine………….………………..8mg
Amlodipine Besylate eq. to Amlodipine ….…....5mg
Diary No. Date of R& I & fee Dy. No. 4156;10-03-2017; Rs.20,000/- (10-03-2017)
Type of Form Form-5
Pack size & Demanded Price 14’s, 28’s & as recommended by the PRC (MOH)
Approval status of product in Perindopril ter-butylamine/ Amlodipine CF 8/5mg un-
Reference Regulatory Authorities. coated tablets (Approved in Netherland)
Me-too status Coversam 8/5mg tablet of M/s Servier Research &
Pharmaceuticals (Reg.# 065961)
204. Name and address of manufacturer / M/s Hiranis Pharmaceuticals, Plot # E-145-E-149, North
Applicant Western Industrial Zone
Brand Name +Dosage Form + Lgnil tablet 10mg
Strength
Cetirizine dihydrochloride……........................10mg
Diary No. Date of R& I & fee Dy. No.14; 13-03-2017, Rs.20,000/- ( 13-03-2017)
Pharmacological Group Antihistamine
Type of Form Form-5
Finished product Specification B.P.
Pack size & Demanded Price as per PRC & as per PRC
Approval status of product in Wockhardt Allergy and Hay fever Relief 10mg film-coated
Reference Regulatory Authorities. tablets of M/s Wockhardt UK Ltd (emc MHRA)
Me-too status Zyrtec 10mg tablet of M/s GSK Pharmaceuticals
the report concludes:
“The overall GMP compliance was found at
satisfactory level. Moreover, the firm is advised to submit
the action plan on above mentioned suggestions.”
Decision: Approved
Brand Name +Dosage Form + Alertrin tablet 10mg
Strength
Loratadine ……………..…10mg
Pharmacological Group Anti- histamine
Type of Form Form-5
Pack size & Demanded Price As per PRC & as per PRC
Approval status of product in Loratadine Mylan film-coated tablets (Approved in
Reference Regulatory Authorities. Netherland)
Me-too status Tirlor 10mg tablet of M/s Novartis Pharmaceuticals
Decision: Approved
Brand Name +Dosage Form + Teczine tablet 5mg
Strength
Levocetirizine Dihydrochloride……………….5mg
Pharmacological Group H1-receptor antagonist, Antihistamine
Type of Form Form-5
Approval status of product in Levocetirizine Dihydrochloride 5mg film-coated tablet of
Reference Regulatory Authorities. M/s Actavis UK limited (emc MHRA Approved)
Me-too status Setzine tablet 5mg of M/s Macter Pharmaceuticals (Regd.#
048585)
Decision: Approved
Brand Name +Dosage Form + Atizor capsule 250mg
Strength
Azithromycin dihydrate eq. to Azithromycin…….250mg
Pharmacological Group Macrolide Antibiotic
Type of Form Form-5
Pack size & Demanded Price as per PRC & as per PRC
Approval status of product in Azithromycin dihydrate capsule 250mg of M/s Amneal
Reference Regulatory Authorities. Pharma Europe Limited (emc-MHRA Approved)
Me-too status Azomax capsule of M/s Novartis Pharma (Regd.# 022200)
Decision: Approved
Brand Name +Dosage Form + Olivastin tablet 20mg
Strength
Ebastine …..………………20mg
Pharmacological Group Histamine H1-Receptor Antagonist; Anti-histamine
Type of Form Form-5
Finished product Specification J.P.
Pack size & Demanded Price 14’s & as per PRC
Approval status of product in Kestine tablet 20mg (Approved in Netherland)
Me-too status Kestine tablet 20mg of M/s Highnoon, Pakistan (Reg.#
025432)
Decision: Approved
Brand Name +Dosage Form + Mecomin tablet 500mcg
Strength
Composition Each sugar-coated tablet contains:
Mecobalamin……………..500mcg
Pharmacological Group Coenzyme –type Vitamin B12
Type of Form Form-5
Finished product Specification JP
Approval status of product in Approved by PMDA of Japan
Me-too status Elgin 500 mcg tablet of M/s Novartis Pharma (Pvt)
Limited (Reg. # 032638)
“The overall cGMP compliance was found at
Decision: Approved
210. Name and address of manufacturer / M/s Unisa Pharmaceuticals Industries, G.T Road Adamzai,
Applicant Akora, Khattak, Nowshehra, KPK
Brand Name +Dosage Form + Unilyte-M 500ml Infusion (5% Dextrose & Electrolytes)
Strength
Dextrose anhydrous…………………5g
Calcium Chloride dihydrate……0.022g
Potassium Chloride……………...0.150g
Sodium Chloride………………...0.216g
Sodium Acetate Trihydrate……..0.313g
Water for injection……………….q.suff.
Pharmacological Group Electrolytes and carbohydrates
Type of Form Form-5
Pack size & Demanded Price 500ml, 1000ml & as recommended by PRC (MOH)
Me-too status Medilyte-M of M/s MediPak limited
Remarks of the Evaluator The approved drug could not be verified in the
reference authorities.
Brand Name +Dosage Form + Unitol-20 (Mannitol 20%) 500ml Injection
Strength
Mannitol………………20g
Type of Form Form-5
Finished product Specification Manufacturer
Pack size & Demanded Price 500ml & as per SRO
Me-too status MANNITOL INJECTION 20% of M/s HYDARI INT
KARACHI (Reg.# 019512)
Decision: Approved with USP specifications.
Brand Name +Dosage Form + Unistill (water for injection) 10ml
Strength
Composition Each ampoule contains:
Water for injection…………… 10ml
Pharmacological Group Solvent
Type of Form Form-5
Finished product Specification BP
Me-too status Water for Injection of M/s Visison Pharma (Reg.# 032340)
Decision: Approved
Brand Name +Dosage Form + Unioflox IV Infusion 200mg/100ml
Strength
Ofloxacin…………………..200mg
Type of Form Form-5
Finished product Specification B.P.
Approval status of product in Tarivid IV Infusion solution of M/s Sanofi (emc MHRA
Reference Regulatory Authorities Approved)
Me-too status Geoflox of M/s Geoffman Pharmaceuticals
Decision: Deferred for evidence of approval of applied formulation in LDPE packaging
material by reference regulatory authorities/agencies which were declared/approved by the
Registration Board.
Brand Name +Dosage Form + Unistill (water for injection) 30ml
Strength
Water for injection…………… 30ml
Pharmacological Group Solvent
Type of Form Form-5
Approval status of product in MHRA Approved
Me-too status Zeinject of M/s Shahzeb Pharmaceuticals
Decision: Approved
Brand Name +Dosage Form + Unilevoflox IV Infusion 100ml
Strength
Levofloxacin (as Hemihydrate)………500mg
Type of Form Form-5
Approval status of product in Emc MHRA Approved
Me-too status Aksolox of M/s Akson Pharma
Decision: Deferred for evidence of approval of applied formulation in LDPE packaging
material by reference regulatory authorities/agencies which were declared/approved by the
Registration Board.
216. Name and address of manufacturer / M/s Wenovo Pharmaceuticals, Plot #31, 32, Punjab Small
Applicant Industrial state, Taxilla.
Brand Name +Dosage Form + Ceforex Injection 1gm
Strength
Cefotaxime as Sodium eq. to Cefotaxime …….1gm
Diary No. Date of R& I & fee Dy. No.2920 ; 16-12-2016; Rs.20,000/- (16-12-2016)
Pharmacological Group 3rd generation cephalosporin antibiotic
Type of Form Form-5
Pack size & Demanded Price 1’s & as recommended by PRC (MOH)
Approval status of product in Cefotaxime 1gm injection (MHRA Approved)
Me-too status Cefomerc 1gm Injection of M/s Merck Pvt limited
Remarks of the Evaluator Generic name is mentioned on fee-challan.
Decision: Approved
217. Name and address of manufacturer / M/s Wenovo Pharmaceuticals, Plot #31,32, Punjab Small
Brand Name +Dosage Form + Ceforex Injection 250 mg
Strength
Cefotaxime as Sodium eq. to Cefotaxime…..…….250mg
Type of Form Form-5
Me-too status Novosef Injection 250mg of M/s Himont Pharmaceuticals.
Decision: Approved
Brand Name +Dosage Form + Ceforex Injection 500 mg
Strength
Cefotaxime (as Sodium)…….500mg
Type of Form Form-5
Pack size & Demanded Price 1x10ml & as recommended by PRC (MOH)
Approval status of product in Cefotaxime 500 mg injection of Wockhardt UK (MHRA
Me-too status Novosef Injection 500mg of M/s Himont Pharmaceuticals.
Decision: Approved
Brand Name +Dosage Form + Guycef Powder for Injection 1gm
Strength
Ceftazidime (as Pentahydrate)……….1gm
Type of Form Form-5
Approval status of product in Ceftazidime injection of Wockhardt UK (MHRA
Me-too status Biozid 1gm Injection of Bio-Labs (Pvt) limited
Decision: Approved
220. Name and address of manufacturer / M/s Wenovo Pharmaceuticals, Plot #31, 32, Punjab Small
Brand Name +Dosage Form + Guycef Powder for Injection 250 mg
Strength
Ceftazidime (as Pentahydrate)……….250mg
Type of Form Form-5
Pack size & Demanded Price 1x10ml & as recommended by PRC (MOH)
Me-too status Biozid 250mg Injection of Bio-Labs (Pvt) limited
Decision: Approved
Brand Name +Dosage Form + Guycef Powder for Injection 500 mg
Strength
Ceftazidime (as Pentahydrate)……….500mg
Type of Form Form-5
Pack size & Demanded Price 10ml & as recommended by PRC (MOH)
Approval status of product in Ceftazidime 500mg powder injection of Wockhardt UK
Reference Regulatory Authorities (emc MHRA Approved)
Me-too status Biozid 500mg Injection of Bio-Labs (Pvt) limited
Decision: Approved
222. Name and address of manufacturer / Barrett Hodgson Pakistan (Pvt) Limited , F/423, S.I.T.E.,
Applicant Karachi
Brand Name +Dosage Form + Diabold Plus SR 2mg/500mg tablet
Strength
Composition Each bilayered tablet contains:
Glimepiride………………………..2mg
Metformin HCl (as sustained release)……………500mg
Diary No. Date of R& I & fee Dy. No.3017; 19-12-2016; NO-FEE CHALLAN
Pharmacological Group Oral antidiabetic agent
Type of Form Form-5
Pack size & Demanded Price 3x10’s & Rs.690/-
Approval status of product in Not available
Me-too status Amaryl M (SR) Sanofi Aventis (Pak) limited
GMP status Last inspection was conducted on 08-08-2017 and the
report concludes satisfactory level of GMP compliance.
Remarks of the Evaluator Issue of adjustment of extra fee deposited.
The applied drug couldn’t be searched in the reference
authorities.
223. Name and address of manufacturer / M/s Maple Pharma (Pvt) Limited, 147/23, Korangi
Applicant Industrail Area, Karachi
Brand Name +Dosage Form + Zarc 2.5 mg Tablet
Strength
Bisoprolol Hemifumarate ……….….2.5 mg
Pharmacological Group Cardio selective beta blocker
Type of Form Form 5
Pack size & Demanded Price 14’s , As per PRC
Me-too status Actim Tablet of Sami (Reg No. # 045362)
the report concludes acceptable level of GMP
compliance.
Brand Name +Dosage Form + Zarc 5 mg Tablet
Strength
Bisoprolol Hemifumarate………….....….5 mg
Type of Form Form 5
compliance.
Brand Name +Dosage Form + Zarc 10 mg Tablet
Strength
Bisoprolol Hemifumarate…………….10 mg
Type of Form Form 5
Pack size & Demanded Price 10’s & 14’s , As per PRC
compliance.
Brand Name +Dosage Form + Asumide 20 mg Tablet
Strength
Furosemide ….............……20 mg
Type of Form Form- 5
Pack size & Demanded Price 100’s/ as per PRC
Me-too status Lasix by Sanofi-Aventis (Reg# 006040)
compliance.
Decision: Approved
Brand Name +Dosage Form + Strength Asumide 40 mg Tablet
Furosemide ……………………40 mg
Type of Form Form-5
Me-too status Lasix by Sanofi-Aventis (Reg# 000229)
compliance.
Decision: Approved
228. Name and address of manufacturer / M/s Noa-Hemis Pharmaceuticals, Plot # 154, Sector 23,
Applicant Korangi industrial Area, Karachi
Brand Name +Dosage Form + Strength Noagyl Tablet 200mg
Metronidazole …………………200mg
Pharmacological Group Antiamoebic/ Anti-infective
Type of Form Form-5
Finished product Specification In-house
Pack size & Demanded Price 20x10’s & as per PRC
Approval status of product in Flagyl tablet of M/s Sanofi Aventis UK (emc MHRA
Me-too status Amezole tablet 200mg of M/s Ferozesons Labs
GMP status Last GMP Inspection dated 14-06-2017 with satisfactory
remarks of GMP compliance.
Remarks of the Evaluator. On fee- challan, the generic name i.e. metronidazole
is mentioned instead of the brand name i.e. “Noagyl
200mg tablet.”
Brand Name +Dosage Form + Strength Noagyl Tablet 400mg
Metronidazole …………………400mg
Type of Form Form-5
Pack size & Demanded Price 20x10’s & as per PRC
Approval status of product in Flagyl tablet of M/s Sanofi Aventis
Me-too status Amezole of M/s Ferozesons
Remarks of the Evaluator. On fee- challan, the generic name i.e. metronidazole
400mg tablet.”
Brand Name +Dosage Form + Strength Noagyl Suspension 200mg/5ml
Metronidazole (as Benzoate)…………………200mg
Type of Form Form-5
Pack size & Demanded Price 60ml/ 120ml & as per PRC
Approval status of product in Flagyl suspension of M/s Sanofi Aventis
Me-too status Amezole suspension of M/s Ferozesons
Remarks of the Evaluator On fee- challan, the generic name i.e. metronidazole
400mg tablet.”
231. Name3 and address of manufacturer / M/s Martin Dow, Plot # 37, Sector 19, Korangi Industrial
Applicant Area, Karachi.
Brand Name +Dosage Form + Strength Spaspan Plus Tablets 10mg + 500mg
Hyoscine Butylbromide …………10mg
Paracetamol …………………… 500mg
Pharmacological Group Antispasmodic + Analgesic
Type of Form Form 5
Pack size & Demanded Price 10 x 10’s & Rs. 750.00/100’s
Approval status of product in Buscopan Plus 10mg /500mg tablets of M/s Boehringer
Reference Regulatory Authorities. Ingelheim Limited (Germany Approved)
Me-too status G-Pan Plus Tablets of M/s Global Pharmaceuticals
(Reg. # 066325)
232. Name and address of manufacturer / M/s Martin Dow, Plot # 37, Sector 19, Korangi Industrial
Brand Name +Dosage Form + Strength Spaspan Tablets 10mg
Hyoscine Butylbromide ………..………….10mg
Pharmacological Group Antispasmodic
Type of Form Form 5
Pack size & Demanded Price 10 x 10’s & Rs. 650.00/ 100’s
Approval status of product in Buscopan 10mg tablets of M/s Boehringer Ingelheim
Reference Regulatory Authorities. Limited United Kingdom (MHRA approved)
Me-too status Hyoscine compound tablet of M/s Wilshire Laboratories
GMP status Last GMP inspection was conducted on 08-06-2017 and the
report concludes good level of GMP compliance.
233. Name3 and address of manufacturer / M/s Martin Dow, Plot # 37, Sector 19, Korangi Industrial
Applicant Area, Karachi
Brand Name +Dosage Form + Strength Xalisap Tablets 400mg
Doxofylline ………………………400mg
Pharmacological Group Anti-asthmatic
Type of Form Form 5
Approval status of product in Approved by Italian Medicine Agency (AIFA)
Me-too status Agolix of Hiranis
Remarks of the Evaluator The applied drug couldn’t be searched in reference
authorities.
234. Name
4 and address of manufacturer / M/s Martin Dow, Plot # 37, Sector 19, Korangi Industrial
Brand Name +Dosage Form + Strength Xalisap Syrup 100mg/5ml
Composition Each 5ml syrup contains:
Doxofylline ………100mg
Pharmacological Group Anti-asthmatic
Type of Form Form 5
Finished product Specification Manufacturer’s specifications
Pack size & Demanded Price 60ml & 120ml & as per PRC
Approval status of product in Ansimar M/s ABC FARMACEUTICI SPA
Reference Regulatory Authorities. (Italy)Italian Medicine Agency (AIFA) approved
Me-too status Agolix syrup of Hiranis
235. Name
4 and address of manufacturer / M/s Pharm evo (Pvt) Limited, Plot # A-29, North Western
Applicant Industrial Zone, Port Qasim, Karachi
Brand Name +Dosage Form + Strength Xilica Capsule 25mg
Pregabalin ………………..25mg
Type of Form Form-5
Me-too status Gablin of CCL
GMP status Last inspection report conducted on 04-08-2017
concluding satisfactory level of GMP compliance
Remarks of the Evaluator The applied product is non-pharmacopoeial.
236. Name4 and address of manufacturer / M/s Hilton Pharma , Plot 13-14, Sector 15, Korangi
Applicant Industrial Area, Karachi
Brand Name +Dosage Form + Strength Flux oral solution 20mg/5ml
Composition Each 5ml of solution contains:
Fluoxetine hydrochloride eq. to Fluoxetine…..20mg
Pharmacological Group SSRI
Type of Form Form-5
Pack size & Demanded Price 60ml, 120ml & as per DPC
Me-too status Lovan 20mg/5ml oral solution of M/s CCL Pharma (Reg.#
023850)
GMP status Last GMP Inspection was conducted on 19-07-2017 and
the report concludes satisfactory level of GMP
compliance.
Decision: Approved
237. Name4 and address of manufacturer / M/s Scilife Pharma Private Limited, Plot # FD-57/58-A2,
Applicant Korangi Creek Industrial Park, Karachi
Contract Manufacturer: M/s Opal Laboratories (Pvt)
limited, Plot # LC-41, L.I.T.E., Landhi, Karachi.
Brand Name +Dosage Form + Strength Scifix Tablet 200mg
Cefixime (as Trihydrate)…………200mg
Pharmacological Group Antibacterial (Cephalosporin)
Type of Form Form-5
Pack size & Demanded Price 1x10’s & as per PRC policy 2015
Approval status of product in USFDA Approved
Me-too status Cefiget tablet 200mg of M/s Getz Pharma
GMP status Last GMP inspection of M/s Scilife was conducted on
14-06-2017 with satisfactory remarks of GMP
compliance.
Last GMP inspection of M/s Opal was conducted on
08-12-2016 and the date of signature mentioned on the
same report is 05-04-2017 and the report concludes:
“To keep an eye on momentum of
progress towards committed compliance, annual
surveillance inspection after 12 months is recommended.”
Remarks of the Evaluator. Letter of intent is submitted.
Agreement between both the firms has also been
submitted.
Manufacturer firm has relevant section i.e. tablet
(Cephalosporin) section.
Applicant has five approved sections and their no drug
is already registered on contract basis.
Submitted Opals’ inspection report seems to be
incomplete as the date of inspection and date of
signature of the concerned area FID are different.
Moreover, annual inspection after 12 months is
recommended in the conclusion of the submitted report.
Decision: Deferred for confirmation by QA&LT Division regarding latest GMP inspection
report conducted within a period of last 1 year by DRAP
238. Name4 and address of manufacturer / M/s Weather Folds Pharmceuticals, Plot # 69/2, Phase II
Applicant Industrial Area, Hattar.
Brand Name +Dosage Form + Strength Foldtralin Tablets 50mg
Sertraline as hydrochloride eq. to Sertraline……50 mg
Pharmacological Group Selective serotonin reuptake inhibitor (SSRI)
Type of Form Form 5
Pack size & Demanded Price 2x10’s; as per PRC
Me-too status Graset 50mg film-coated tablet of M/s Glitz Pharma
concluding the firm was GMP compliant.
Remarks of the Evaluator On fee-challan brand name is not mentioned.instead the
generic i.e.Sertraline is written.
Decision: Approved
Brand Name+Dosage Form+Strength Foldtralin Tablets 100mg
Composition Each film-coated tablet contains
Sertraline as hydrochloride eq.to Sertraline …...100 mg
Pharmacological Group Selective serotonin reuptake inhibitor (SSRI)
Type of Form Form 5
Pack size & Demanded Price 2x10’s, 3 x 10’s: As per PRC
Me-too status Graset 100mg film-coated tablet of M/s Glitz Pharma
concluding the firm was GMP compliant as per DRAP
guidelines.
Remarks of the Evaluator. On application: brand name is Foldtralin.
On form 5: wenotraline.
Fee-challan: sertraline.
Decision: Approved
Brand Name+Dosage Form+Strength Noxifold Tablet 8mg
Lornoxicam………..8mg
Pharmacological Group NSAIDs
Type of Form Form 5
Finished product Specification Innovator’s specifications
Pack size & Demanded Price 5’s, 10’s & 30’s ; As per PRC
Approval status of product in Xefo Rapid 8mg film-coated tablets of M/s Takeda EMA
Reference Regulatory Authorities. Approved
Me-too status Ringatil 8mg film-coated tablet of M/s Cirin
Pharmaceuticals
GMP status Last inspection report conducted on 15-09-2017 concluding
the firm was GMP compliant as per DRAP guidelines.
Remarks of the Evaluator On fee-challan brand name is not mentioned. Instead
the generic is written.
Brand Name+Dosage Form+Strength Levetfold tablets 250mg
Levetiracetam……………..250mg
Type of Form Form 5
Pack size & Demanded Price 30’s: As per PRC
Approval status of product in Keppra Tablets by UCB (USFDA Approved)
Me-too status Keppra tablets 250mg of GSK (Pak)
guidelines.
the generic is written
Decision: Approved
Brand Name+Dosage Form+Strength Levetfold Tablets 500mg
Levetiracetam…………...500mg
Type of Form Form 5
Pack size & Demanded Price 30’s: As per PRC
Approval status of product in Keppra Tablets of M/s UCB Labs.(USFDA Approved)
Me-too status Keppra tablets 500mg of (GSK Pak)
guidelines.
Decision: Approved
Brand Name+Dosage Form+Strength Axlin Capsule 75mg
Pregabalin …… 75mg
Pharmacological Group Anticonvulsants, Antiepileptics
Type of Form Form 5
Finished product Specification Innovator’s specifications
Pack size & Demanded Price 10’s, 14’s, 20’s: As per PRC
Approval status of product in Lyrica capsule of M/s PF Prism (USFDA Approved)
Me-too status Lyrica Capsule of Pfizer (Pak)
guidelines.
244. Name7 and address of manufacturer / M/s Nabi Qasim Industries (Pvt) Limited, 17/24, Korangi
Brand Name +Dosage Form + Linox 400mg Tablets
Strength
Linezolid ………….. …..400mg
Pharmacological Group Antibacterial agent
Type of Form Form 5
Pack size & Demanded Price 12’s & 10’s: As per PRC
Approval status of product in This strength is Discontinued in USFDA but not for safety
Reference Regulatory Authorities reasons (Approved strengths are100mg & 600mg)
Me-too status Lyzon 400mg Tablets of M/s Getz Pharma
GMP status QA Division vide letter No.F.4-4/89-QA dated 18-01-2018
clarified that as per panel Inspection Reports Dated 03-08-
2017 and 02-11-2017, the firm Nabiqasim Industries (Pvt)
Ltd., Plot No. 17, Sector 24, Korangi Industrial Area,
Karachi was considered to be operating at acceptable level
of compliance of GMP requirements.
Remarks of the Evaluator The appied formulation is non-pharmacopoeial.
245. Name
7 and address of manufacturer / M/s Nabi Qasim Industries (Pvt) Limited, 17/24, Korangi
Brand Name +Dosage Form + Strength Redupres HCT tablet 80mg/12.5mg
Valsartan …………………..… 80mg
Hydrochlorothiazide….. …… 12.5mg
Pharmacological Group Antihypertensive with diuretic
Type of Form Form 5
Approval status of product in Diovan HCT 80mg/12.5mg tab (Novartis UK & USA)
Reference Regulatory Authorities USFDA & MHRA Approved
Me-too status Co-Valsan 80mg/12.5mg tablet of M/s Hilton Pharma
Decision: Approved
Brand Name+Dosage Form+Strength Redupres HCT 160/12.5 Tablet
Valsartan ………………….. 160mg
Hydrochlorothiazide……… 12.5mg
Type of Form Form 5
Pack size & Demanded Price 14’s, 28’s & as per PRC
Approval status of product in Diovan HCT 160mg/12.5mg (Novartis UK & USA)
Me-too status Co-Valsan 160mg/12.5mg of M/s Hilton Pharma
Decision: Approved
Brand Name+Dosage Form+Strength Redupres HCT 160mg/25mg Tablet
Valsartan …………….….. 160mg
Hydrochlorothiazide.. 25mg
Type of Form Form 5
Finished product Specification USP Specification
Approval status of product in Diovan HCT 160mg/25mg tabs (Novartis UK & USA)
Me-too status Co-Valsan 100mg/25mg of M/s Hilton Pharma
Decision: Approved
Brand Name+Dosage Form+Strength Co-Redupres 5mg/160mg/12.5mg tablet
Amlodipine Besylate eq. to Amlodipine …………5mg
Valsartan ……………………………………….160mg
Hydrochlorothiazide……………………………12.5mg
Pharmacological Group Angiotensin II antagonist and Calcium channel blockers
with diuretic.
Type of Form Form 5
Approval status of product in Exforge HCT Tablet 5/160/12.5(Novartis USA)
Reference Regulatory Authorities USFDA Approved
Me-too status Exforge HCT 5/160/12.5 (Novartis Pharma-Karachi)
Remarks of the Evaluator The applied drug is non-pharmacopoeial.
Following boxed-warning is given on label claim in
USFDA :
WARNING: AVOID USE IN PREGNANCY
When pregnancy is detected, discontinue Exforge HCT as
soon as possible. Drugs that act directly on the renin-
angiotensin system can cause injury or death to the
developing fetus.
Decision: Approved with box warning.
Brand Name+Dosage Form+Strength Co-Redupres 5/160/25 Tablet
Amlodipine Besylate eq. to Amlodipine ………….5mg
Valsartan ………………………..………………160mg
Hydrochlorothiazide ……………………………..25mg
with diuretic.
Type of Form Form 5
Finished product Specification U.S.P. Specification
Pack size & Demanded Price 14’s ,28’s & as per PRC
Approval status of product in Exforge HCT Tablet 5mg/160mg/25mg
Reference Regulatory Authorities (Novartis USA)
Me-too status Exforge HCT 5mg/160mg/25mg (Novartis Pharma-
Karachi)
USFDA :
soon as possible.Drugs that act directly on the renin-
developing fetus.
Decision: Approved with box warning
250. Name
Brand Name +Dosage Form + Strength Co-Redupres 10/160/12.5 Tablet
Amlodipine Besylate eq. to Amlodipine ………10mg
Valsartan…………………..………….……… 160mg
Hydrochlorothiazide ……………..………….. 12.5mg
with diuretic.
Type of Form Form 5
Approval status of product in Exforge HCT Tablet 10/160/12.5
Me-too status Exforge HCT 10/160/12.5 (Novartis Pharma-Karachi)
USFDA :
developing fetus.
Decision: Approved with box warning
251. Name
Brand Name +Dosage Form + Strength Co-Redupres 10/160/25 Tablet
Amlodipine Besylate eq. to Amlodipine ………. 10mg
Valsartan ……………………….…………….…160mg
Hydrochlorothiazide ……………...…………….. 25mg
with diuretic.
Type of Form Form 5
Approval status of product in Exforge HCT Tablet 10/160/25
Me-too status Exforge HCT 10/160/25 (Novartis Pharma-Karachi)
Remarks of the Evaluator Fee challan is of another strength i.e. 5mg/320 mg
while the applied one is10mg/160mg/25mg.
The applied drug is non-pharmacopoeial.
USFDA :
developing fetus.
Decision: Deferred for submission of evidence of fee challan for applied formulation.
252. Name
Brand Name +Dosage Form + Strength Co-Redupres 10/320/25 Tablet
Amlodipine Besylate eq. to Amlodipine ………. 10mg
Valsartan ……………...……………….……… 320mg
Hydrochlorothiazide ………………..………….. 25mg
with diuretic.
Type of Form Form 5
Approval status of product in Exforge HCT Tablet 10/320/25
Reference Regulatory Authorities (Novartis USA)USFDA Approved
Me-too status Exforge HCT 10/160/25 (Novartis Pharma-Karachi)
USFDA:
soon as possible. Drugs that act directly on the renin-
developing fetus.
253. Name8 and address of manufacturer / M/s UDL Pharmaceuticals, DHA Phase-II, Karachi.
Applicant Contract Manufacturer: M/s Nabi Qasim Industries (Pvt)
Limited, 17/24, Korangi Industrial Area, Karachi.
Brand Name +Dosage Form +Strength Ometec I.V. Infusion 40mg (Lyophilized powder for
infusion)
Omeprazole Sodium eq. to Omeprazole (Lyophilised)
…………………………………………………. 40mg
Pharmacological Group Proton Pump Inhibitor
Type of Form Form-5
Approval status of product in Reference Losec IV Infusion AstraZeneca, Auckland (New Zealand,
Regulatory Authorities UK)
Me-too status Loprot IV 40MG of M/s Nabiqasim Industries (Reg.#
070680)
GMP status Last inspection conducted on 03-08-2017 and report
concludes that firm is operating at an acceptable level of
compliance with GMP. inspection reports of both
Remarks of the Evaluator The manufacturer firm has lyophilized /Vial (General)
section.
approved sections of UDL
no. of already approved drugs on contract
manufacturing of UDL
inspection reports of both
Decision: Approved
254. Name8 and address of manufacturer / M/s UDL Pharmaceuticals, DHA Phase-II, Karachi.
Applicant Contract Manufacturer: M/s Nabi Qasim Industries (Pvt)
Limited, 17/24, Korangi Industrial Area, Karachi.
Brand Name +Dosage Form + Strength Esmocid I.V.40mg Injection (Lyophilized powder for
infusion)
Esomeprazole Sodium eq. to Esomeprazole (Lyophilized)
…………………………………40mg
Type of Form Form-5
Pack size & Demanded Price 1’s As per PRC
Approval status of product in Reference Nexium for Injection 40mg
Regulatory Authorities AstraZeneca, Auckland (New Zealand, UK)
Me-too status Nexum IV 40mg of M/s Getz Pharma (Reg.# 050651)
concludes that firm is operating at an acceptable level of
compliance with GMP.
Remarks of the Evaluator The manufacturer firm has lyophilized /Vial (General)
section.
approved sections of UDL
already approved drugs on contract manufacturing of
UDL
inspection reports of both
255. Name
8 and address of manufacturer / M/s Zephyr Pharmatec (Pvt) limited, A-39, SITE II, Super
Applicant Highway, Karachi
Brand Name +Dosage Form + Strength Emedy 4mg Capsule
Thiocolchicoside….4mg
Pharmacological Group Muscle -relaxant
Type of Form Form 5
Pack size & Demanded Price 10’s & 20’s; As per PRC
Approval status of product in Reference Approved by France (ANSM)
Me-too status Thiolax Capsule 4 mg by M/s SJ&G Fazul Ellahie
(Reg.#055404)
concluding good level of GMP compliance
256. Name
9 and address of manufacturer / M/s Zephyr Pharmatec (Pvt) limited, A-39, SITE II, Super
Brand Name +Dosage Form + Strength Xotab 40mg Tablet
Febuxostat………………40 mg
Pharmacological Group Xanthine Oxidase Inhibitor
Type of Form Form 5
Approval status of product in Reference Approved by USFDA
Me-too status Adenuric Tablet 40mg by M/s S.J. & G. Fazul Ellahie
(Reg.#067033)
257. Name and address of manufacturer / M/s Zephyr Pharmatec (Pvt) limited, A-39, SITE II, Super
Brand Name +Dosage Form +Strength Xotab 80mg Tablet
Febuxostat……..80 mg
Pharmacological Group Xanthine Oxidase (XO) inhibitor
Type of Form Form 5
Finished product Specification Innovator’s specification
Approval status of product in Reference Approved by USA
Me-too status Adenuric Tablet 80mg by M/s SJ&G Fazul Ellahie
(Reg.#067034)
Brand Name +Dosage Form + Strength Coxia 60mg Tablet
Etoricoxib………………..60 mg
Type of Form Form 5
Finished product Specification Innovator’s specification
Approval status of product in Reference Approved by UK
Me-too status Berica Tablets 60mg by M/s SJ&G Fazul Ellahie
(Reg.#076119)
Brand Name +Dosage Form + Strength Ornate 100mg Tablet
Cefpodoxime proxetil eq. to Cefpodoxime……100 mg
Pharmacological Group Cephalosporin Antibacterial
Type of Form Form 5
Finished product Specification USP specification
Approval status of product in Reference Approved by UK (MHRA)
Me-too status Cefprox Tablets 100mg by M/s SJ&G Fazul Ellahie
(Reg.#030013)
Decision: Registration Board rejected the application since firm do not have approved
manufacturing facility of “Tablet (Cephalosporin)” section.
Brand Name +Dosage Form + Strength Ornate 40mg/5ml Dry Suspension
Cefpodoxime Proxetil eq. to Cefpodoxime…….40 mg
Pharmacological Group Cephalosporin Antibacterial
Type of Form Form 5
Finished product Specification U.S.P. specification
Pack size & Demanded Price 50ml; As per PRC
Me-too status Cefprox Suspension 40mg / 5ml by M/s SJ&G Fazul
Ellahie (Reg.#030015)
Decision Approved
Brand Name +Dosage Form +Strength Biofix 150mg Tablet
Ibandronate sodium eq. to Ibandronate acid…..150mg
Pharmacological Group Bisphosphonates
Type of Form Form 5
Finished product Specification USP specification
Me-too status Bionic Tablets 150mg by M/s SJ&G Fazul Ellahie
(Reg.#058637)
Decision: Approved
262. Name and address of manufacturer / M/s Akson Pharmaceutical (Pvt) Ltd. Plot No 9-B/1 & 2,
Applicant Old Industrial Area, Mirpur Azad Kashmir
Brand Name +Dosage Form + Strength Noran- Plus 20 Capsules
Omeprazole……………………… 20mg
Sodium Bicarbonate……………1100mg
Pharmacological Group Proton pump inhibitor/antacid
Type of Form Form-5
Pack size & Demanded Price 1x10’s & 2x7’s As per SRO
Approval status of product in Reference Zegerid (USFDA approved)
Me-too status Zoltar Insta of M/s Pharmevo
concluding firm to be GMP compliant.
263. Name and address of manufacturer / M/s Akson Pharmaceutical (Pvt) Ltd. Plot No 9-B/1 & 2,
Applicant Old Industrial Area, Mirpur Azad Kashmir
Brand Name +Dosage Form + Strength Noran- Plus 40 Capsules
Omeprazole……………………… 40mg
Sodium Bicarbonate……………1100mg
Pharmacological Group Proton pump inhibitor/antacid
Type of Form Form-5
Pack size & Demanded Price 1x10’s & 2x7’s As per SRO
Approval status of product in Reference Zegerid (USFDA approved)
Me-too status Zoltar Insta of M/s Pharmevo
concluding firm to be GMP compliant.
264. Name and address of manufacturer / M/s Medisynth Pharmaceuticals., Plot No. 55,Street S5
Applicant National Industrial Zone, Rawat, Islamabad
Brand Name +Dosage Form + Strength Pregab 75 mg Caps
Composition Each capsule Contains:
Pregabalin…..75mg
Pharmacological Group Anti-epileptics
Type of Form Form-5
Finished product Specification Manufacturers
Pack size & Demanded Price As per SRO & as per SRO
GMP status Last inspection report conducted on 19-09-2017 &
concluded satisfactory GMP compliance status.
265. Name and address of manufacturer / Medisynth Pharmaceuticals, Plot # 55, Street No. S-5,
Brand Name +Dosage Form+Strength Blofen 10mg Tablets
Baclofen…………..10mg
Pharmacological Group Muscle relexant
Type of Form Form-5
Pack size & Demanded Price 14’s, 28’s & as per SRO
Approval status of product in Reference Lioresal tablets of M/s Novartis pharma (MHRA
Regulatory Authorities. approved)
Me-too status Lioresal tablets of M/s Novartis pharma Pakistan
Decision: Approved
Brand Name +Dosage Form + Strength Synmol Tablet
Composition Each sustained release tablet contains:
Tramadol…….37.5mg
Paracetamol……325 mg
Pharmacological Group Opiate analogue + Analgesic.
Type of Form Form-5
Approval status of product in Reference Ultra Cet by Janssen pharma (USFDA)
Me-too status Acetra by Amarant
Decision: Deferred for clarification of applied dosage form as reference product is not approved
as sustained release tablet.
Brand Name +Dosage Form + Strength Aknisyn 25mg Capsule
Acitretin…..25mg
Type of Form Form-5
Pack size & Demanded Price 30s As per SRO
Approval status of product in Reference Acitretin 25 mg Capsules by M/s Genus
Regulatory Authorities. Pharmaceuticals (MHRA Approved)
Me-too status Acetin 25 mg capsule of M/s Genome
Pharmaceuticals (Reg#064013)
Decision: Approved
Brand Name +Dosage Form + Strength Herpein 1mg Tablet
Entecavir (as monohydrate) ………… 1mg
Pharmacological Group Anti-viral
Type of Form Form-5
Pack size & Demanded Price 30s & as per SRO
Approval status of product in Reference Baraclude-MHRA
Me-too status Obee by Genome pharma
concluded satisfactory GMPcompliance status.
Decision: Approved
Brand Name +Dosage Form + Strength Dultin capsule 60mg
Composition Each Delayed-release Capsule(enteric-coated pellets17%)
contains:
Duloxetine (as hydrochloride)….60 mg
Pharmacological Group Anti-depressant
Type of Form Form-5
Pack size & Demanded Price 10’s, 14’s & as per SRO
Approval status of product in Reference Approved in USFDA
Me-too status Zenbar capsule 60mg by Searle, Karachi
Remarks of the Evaluator Source of pellets is Vision Pharmaceuticals.
otherwise.
270. Name and address of manufacturer / M/s Werrick Pharmaceuticals, 216-217, I-10/3, Industrial
Brand Name +Dosage Form + Strength Softin- Forte Capsules 375mg
Composition Each hard capsule contains:
Carbocisteine……………….375mg
Pharmacological Group Mucolytic agent
Type of Form Form-5
Finished product Specification Not claimed
Approval status of product in Reference Mucodyne 375mg capsules of M/s Sanofi Aventis (UK)
Me-too status Rhinathiol 375mg capsules of M/s Sanofi Aventis
the report concludes very good level of GMP Compliance.
Brand Name +Dosage Form + Strength Softin- Forte Syrup 2%
Carbocisteine………………….100mg
Type of Form Form-5
Approval status of product in Reference Could not be confirmed
Me-too status Rhinathiol 2% of M/s Sanofi Aventis
Brand Name +Dosage Form + Strength Softin- Forte Syrup 5%
Carbocisteine………………….250mg
Diary No. Date of R& I & fee Dy. No.2058;03-04-2017;Rs.20,000/- (03-04-2017)
Type of Form Form-5
Approval status of product in Reference Mucodyne Oral solution of M/s Sanofi Aventis (UK)
Me-too status Rhinathiol 5% for adults of M/s Sanofi Aventis
Decision: Approved with innovator’s specification and change of brand name.
273. Name and address of manufacturer / M/s Saffron Pharmaceuticls , (Pvt) limited,
Applicant
Brand Name +Dosage Form +Strength Higab 75mg capsules
Pregabalin……………………….75mg
Diary No. Date of R& I & fee Dy. No.1635; 29-03-2017;Rs.20,000/-(28-03-2017)
Pharmacological Group Anti-epileptic/ Anti-convulsant
Type of Form Form-5
Approval status of product in Reference Lyrica Capsule by PF Prism
Regulatory Authorities. (USFDA Approved)
report concludes renewal of DML.
274. Name and address of manufacturer / M/s MTI Medical (Pvt) Limited, 586-587 Sunder Estate,
Applicant Lahore
Brand Name +Dosage Form + Strength Ferinto Injection 500mg/10ml
Composition Each 10ml ampoule contains:
Iron as ferric carboxymaltose ……………………500mg
Diary No. Date of R& I & fee Dy.No.344;15-03-2017; Rs.20,000/- (15-03-2017)
Pharmacological Group Prevention and treatment of Iron deficiency anaemia
Type of Form Form-5
Approval status of product in Reference Ferinject 50mg/ml (ANSM,France)
Me-too status Ferinject 50mg/ml of RG pharma
the report concludes grant of GMP Certificate.
Remarks of the Evaluator The generic name is mentioned on fee- challan instead
of the brand one.
SRA
275. Name and address of manufacturer / M/s Scilife Pharma (Pvt) limited, Plot #FD-57/58-A2,
Applicant Korangi Creek Industrial Park, Karachi.
Brand Name +Dosage Form + Strength Aricid XL 500mg tablet
Composition Each film-coated (Extended-Release) tablet contains:
Clarithromycin……………………………...500mg
Type of Form Form-5
Pack size & Demanded Price 5’s & as per DPC
Approval status of product in Reference Clarithromycin 500mg tablet of M/s Teva Labs (USFDA
Regulatory Authorities. Approved)
Me-too status Klaricid 500mg tablet of M/s Abbott Labs (Pak)
GMP status Last inspection was conducted on 05-12-2017 for renewal
/ grant of GMP Certificate and the report concludes good
compliance of GMP.
276. Name and address of manufacturer / M/s Navegal Laboratories, 41/1-A2, Phase-1, Industrial
Applicant Estate, Hattar
Brand Name +Dosage Form + Strength Levitab 250mg tablet
Levetiracitam…..250mg
Pharmacological Group Anti-epileptic agent
Type of Form Form-5
Pack size & Demanded Price 1x15’s, As per SRO
Approval status of product in Reference MHRA Approved
Me-too status Levotam of M/s Platinum Pharmaceutcal Pvt. Ltd.
“The firm is advised to keep and maintain all the
consumption scale/storage record as per SOPs and
intimate the undersigned upon consumption of raw
material for verification and issue of consumption
certificate”.
Previous inspection of this firm conducted on 11-03-2017
concludes:
“They are advised to maintain the GMP training
record and self GMP training record. However, the GMP
was satisfactory.”
Decision: Approved
Brand Name +Dosage Form + Strength Levitab 500mg tablet
Levetiracitam…..500mg
Pharmacological Group Anti Epileptic agent
Type of Form Form-5
Me-too status Levotam, Platinum Pharmaceutcal Pvt. Ltd.
certificate”.
concludes:
Decision: Approved
Brand Name +Dosage Form + Strength Lacmide 50mg tablet
Lacosamide…..50mg
Type of Form Form-5
Me-too status Lacolep, Hilton Pharma
certificate”.
concludes:
Lacosamide…..100mg
Type of Form Form-5
Me-too status LACOLEP, Hilton Pharma
certificate”.
concludes:
Type of Form Form-5
certificate”.
concludes:
Diary No. Date of R& I & fee Dy. No. 1420 ;15-3-2017 ;Rs.20,000/- (15-3-2017)
Type of Form Form-5
certificate”.
concludes:
Brand Name +Dosage Form + Strength COLENZA 25/6mg Capsules
Fluoxetine (as HCl)…..25mg
Olanzapine……………6mg
Diary No. Date of R& I & fee Dy. No.1424 ;15-3-2017 & Rs.20,000/-(15-3-2017)
Pharmacological Group Anti depressant/Antipsycotic
Type of Form Form-5
Me-too status CO-DEPRICAP, Nabiqasim Industries Pvt. Ltd.
certificate”.
concludes:
Remarks of the Evaluator Observations are being observed in two last
consecutive GMP inspection reports.
Decision: Approved
Brand Name +Dosage Form + Strength BUPRESS 75mg tablet
Composition Each Film Coated tablet contains:
Bupropion hydrochloride …..75mg
Pharmacological Group Anti Depressant agent
Type of Form Form-5
Me-too status BURTIN 75mg, Genome Pharmaceuticals
certificate”.
concludes:
Decision: Approved
Brand Name +Dosage Form + Strength BUPRESS XL 150mg tablet
Composition Each Extended Release tablet contains:
Bupropion hydrochloride…..150mg
Type of Form Form-5
Me-too status BURTIN XL 150mg, Genome Pharmaceuticals
certificate”.
Another inspection of this firm conducted on 11-03-2017
concludes:
Remarks of the Evaluator Observations are being observed in two last
consecutive GMP inspection reports.
Decision: Approved
Brand Name+Dosage Form + Strength BUPRESS XL 300mg tablet
Composition Each Extended Release tablet contains:
Bupropion HCl…..300mg
Diary No. Date of R& I & fee Dy. No. 1426;15-3-2017 ; Rs.20,000/- (15-3-2017)
Type of Form Form-5
Me-too status BURTIN XL 300mg, Genome Pharmaceuticals
certificate”.
Previous inspection of this firm conducted on 11-03-
2017 concludes:
Decision: Approved
Brand Name +Dosage Form + Strength Binasil 250mg tablet
Terbinafine (as HCl)…..250mg
Diary No. Date of R& I & fee Dy. No.1428 ; 27-03-2017;Rs.20,000/- (15-3-2017)
Pharmacological Group Anti-Fungal agent
Type of Form Form-5
Me-too status Levotam of Platinum Pharmaceuticals
certificate”.
2017 concludes:
Decision: Approved
Brand Name +Dosage Form + Strength TALOSIN 0.4mg Capsules
Tamsulosin HCl …….0.4mg
Diary No. Date of R& I & fee Dy. No.1429;15-3-2017 ; Rs.20,000/- (15-3-2017)
Pharmacological Group alpha1-adrenoceptor blocker
Type of Form Form-5
Me-too status Duodart Of GSK
certificate”.
2017 concludes:
Decision: Deferred for source of pellets, along with stability studies data, GMP certificate of
supplier and differential fee in case of import of pellets.
Brand Name +Dosage Form + Strength SURGX H 5/160/25mg tablet
Amlodipine (as Besylate) ….5mg
Valsartan ………………160mg
Hydrochlorothiazide …..…25mg
Type of Form Form-5
Me-too status EXFORGE HCT NOVARTIS PHARMA
certificate”.
2017 concludes:
USFDA :
When pregnancy is detected, discontinue Exforge
HCT as soon as possible.Drugs that act directly on the
renin-angiotensin system can cause injury or death to
the developing fetus
Brand Name +Dosage Form + Strength SURGX H 10/160/25mg tablet
Amlodipine (as Besylate)…….. ….10mg
Valsartan ………………………160mg
Hydrochlorothiazide ………..…..…25mg
Diary No. Date of R& I & fee Dy. No.1430 ; 15-3-2017 ; Rs.20,000/- (15-3-2017)
Type of Form Form-5
Me-too status EXFORGE HCT NOVARTIS PHARMA
certificate”.
2017 concludes:
Remarks of the Evaluator Following boxed-warning is given on label claim in
USFDA :
developing fetus.
Brand Name +Dosage Form + Strength SURGX H 5/160/12.5mg tablet
Amlodipine (as Besylate)………5mg
Valsartan ………………….160mg
Hydrochlorothiazide …..…..12.5mg
Type of Form Form-5
Me-too status EXFORGE HCT of NOVARTIS PHARMA
certificate”.
2017 concludes:
USFDA:
developing fetus.
Brand Name +Dosage Form + Strength SURGX H 10/160/12.5mg tablet
Amlodipine (as Besylate)……… ….10mg
Hydrochlorothiazide ………….…12.5mg
Type of Form Form-5
Me-too status EXFORGE HCT of NOVARTIS PHARMA
certificate”.
2017 concludes:
USFDA :
developing fetus.
Brand Name +Dosage Form + Strength Surgx 5/160mg tablet
Amlodipine (as Besylate)…………...5mg
Type of Form Form-5
Approval status of product in Reference Exforge 5/160mg tablet of M/s Novartis Pharma (UK)
Regulatory Authorities. Limited (emc-MHRA Approved)
Me-too status Exforge 5/160mg tablet of M/s Novartis Pharma (Pak)
Limited
certificate”.
2017 concludes:
Decision: Approved
Amlodipine (as Besylate).…………10mg
Type of Form Form-5
Limited
certificate”.
2017 concludes:
Decision: Approved
Amlodipine (as Besylate)………….5mg
Type of Form Form-5
Limited
certificate”.
2017 concludes:
Decision: Approved
Brand Name +Dosage Form + Strength Prepain 75mg Capsules
Pregabalin …….75mg
Diary No. Date of R& I & fee Dy. No.1439 ; 27-03-2017 ; Rs.20,000/- (27-03-2017)
Type of Form Form-5
Me-too status LYRICA PFIZER LABORATORIES
certificate”.
2017 concludes:
Decision: Approved with innovator’s specification and change of brand name.
Type of Form Form-5
Me-too status Lyrica of Pfizer Laboratories
certificate”.
2017 concludes:
Diary No. Date of R& I & fee Dy. No. 1437 ; 27-03-2017 ; Rs.20,000/- (27-03-2017)
Type of Form Form-5
Me-too status Lyrica of Pfizer Laboratories
certificate”.
2017 concludes:
298. Name\ and address of manufacturer / M/s Navegal Laboratories, 41/1-A2, Phase-1, Industrial
Brand Name +Dosage Form+ Strength P-Lip 1mg tablet
Pitavastatin (as Calcium)…..1mg
Diary No. Date of R& I & fee Dy. No. 1444;27-03-2017; Rs.20,000/- (15-3-2017)
Pharmacological Group Hydroxymethylglutaryl coenzyme A (HMG-CoA)
reductase inhibitor (Anti Hyper-lipidaemia)
Type of Form Form-5
Me-too status Pitalo Genix Pharma
certificate”.
concludes:
Decision: Approved with JP specifications
Brand Name +Dosage Form+ Strength P-Lip 2mg tablet
Type of Form Form-5
Me-too status PITALO GENIX PHARMA
certificate”.
concludes:
Brand Name+Dosage Form + Strength P-Lip 4mg tablet
Diary No. Date of R& I & fee Dy. No. 1429 ; 27-03-2017 Rs.20,000/- (15-3-2017)
Type of Form Form-5
Finished product Specification nManufacturer’s Specification
Me-too status PITALO GENIX PHARMA
certificate”.
concludes:
Decision: Approved with JP Specifications
Brand Name+Dosage Form +Strength LOPAM 1mg Tablet
Lorazepam ….1mg
Pharmacological Group Benzodiazepine
Type of Form Form-5
Me-too status ATIVAN PFIZER LABORATORIES LTD
certificate”.
concludes:
Decision: Approved
Brand Name +Dosage Form + Strength LOPAM 2mg Tablets
Lorazepam …………….….2mg
Pharmacological Group Benzodiazepine
Type of Form Form-5
Me-too status ATIVAN by PFIZER LABORATORIES LTD
certificate”.
concludes:
Decision: Approved
303. Name and address of manufacturer / M/s Genome Pharmaceuticals (Pvt.) Ltd, Plot No. 16/1,
Applicant Phase-IV, Industrial Estate Hattar District Haripur (KPK).
Brand Name +Dosage Form + Strength Glucovid Tablets 50mg/ 500mg
Composition Dy. No.931, 21-03-2017& Rs. 20,000/-(20-03-2017)
Diary No. Date of R& I & fee Each film coated tablet contains:
Vildagliptin…………………….50mg
Metformin HCl…………....…..500mg
Type of Form Form 5
Approval status of product in Reference Eucreas (EMA,TGA) & Galvusmet By Novatis
Regulatory Authorities. Europharma Limited, Frimley Business Park Camberley
Me-too status Galvus met 50/500mg tablet of M/s Novartis & Viglip-M
Tablet by Himot Pharma, Ferozpur, Lahore.
GMP status Panel Inspection on 14-01-2017, No observations as
informed by QA.
Brand Name +Dosage Form + Strength Glucovid Plus Tablets 50mg/ 850mg
Composition Dy.No.929,21-03-2017 & Rs. 20,000/-(20-03-2017 )
Diary No. Date of R& I & fee Each film-coated tablet contains:
Metformin HCl…………....…..850mg
Type of Form Form 5
Finished product Specification Manufacturer Specification
Approval status of product in Reference Approved by MHRA of UK & Galvusmet By Novatis
Me-too status GALVUS MET 50MG/850mg Tablet of M/s Novartis
Pharma (Reg.#066106) & Viglip-M Tablet by Himot
Pharma, Ferozpur, Lahore.
“ The panel recommends the grant of Lanso- SR
(Dexlansoprazole)30mg cap & Asperam
(Escitalopram)10mg chewable tab for registration.
Brand Name +Dosage Form + Strength Glucovid Extra Tablets 50mg/ 1000mg
Composition Dy. No.930,21-03-2017& Rs. 20,000/-(20-03/2017)
Metformin HCl…………....…1000mg
Type of Form Form 5
Finished product Specification Manufacturer Specification
Approval status of product in Reference Approved by MHRA of UK & Galvusmet By Novatis
Me-too status GALVUS MET 50MG/1000mg Tablet of M/s Novartis
Pharma (Reg.#066107) & Viglip-M Tablet by Himot
Pharma, Ferozpur, Lahore.
informed by QA.
Brand Name +Dosage Form + Strength Bisol-H Tablets 5mg/ 6.25mg
Composition Dy. No.1417, 27/03/2017 & Rs. 20,000/- (24/03/2017)
Bisoprolol………………….…………5mg
Hydrochlorothiazide………………6.25mg
Pharmacological Group Anti-hypertensive Combination
Type of Form Form 5
Approval status of product in Reference Ziac Tablets by Teva Pharms
Me-too status G Actim-H by Sami & Corbis-H Tablets By Efroze
Chemicals Industries (PVT) Ltd.
informed by QA.
Decision: Approved
Brand Name +Dosage Form + Strength Coregen Tablets 6.25mg
Composition Dy. No.1634, 29-03-2017& Rs. 20,000/- (29-03-2017)
Carvedilol…………………….….6.25mg
Pharmacological Group Beta Blocking Agent
Type of Form Form 5
Approval status of product in Reference MHRA Approved & COREG By Smithkline Beecham
Regulatory Authorities. Limited, UK.
Me-too status Carveda tablets 6.25mg tablets of M/s Ferozesons Labs
informed by QA.
Decision: Approved
308. Name and address of manufacturer / M/s Genome Pharmaceuticals (Pvt.) Ltd,
Applicant Plot No. 16/1, Phase-IV, Industrial Estate Hattar District
Haripur (KPK).
Brand Name +Dosage Form + Strength Coregen Tablets 25mg
Carvedilol…………………….….25mg
Diary No. Date of R& I & fee Dy. No.1418, 29/03/2017&Rs. 20,000 (29/03/2017 )
Type of Form Form 5
Approval status of product in Reference MHRA Approved & COREG By Smithkline Beecham
Regulatory Authorities. Limited, UK.
Me-too status Carveda tablet 25mg of M/s Ferozsons (Reg.no.027548)
informed by QA.
Decision: Approved
309. Name and address of manufacturer / M/s Jenner Pharmaceuticals (Pvt) Limited, 26-Km,
Applicant Lahore, Sharaqpur Road Sheikhupura
Brand Name +Dosage Form + Strength Noxicam Tablets 8mg
Composition Each film coated Tablet Contains:
Lornoxicam……………… 8 mg
Diary No. Date of R& I & fee Dy No. 722, 20.03.2017&Rs. 20000/17.03.2017
Pharmacological Group Antirheumatics (anti-inflammatory agents)
Type of Form Form-5
Finished product Specification Innovator Specifications
Pack size & Demanded Price 10’s, As per SRO
Approval status of product in Reference EMA Xefo 8mg Tablets by Nycomed UK Ltd
Regulatory Authorities. United Kingdom
Me-too status Zafon Tablets 8mg by Getz
“Overall the firm is satisfactory regarding building,
equipment and functioning of HVAC system. However,
they were advised to improve their documentation
regarding the production and quality control, they
agreed.”
310. Name and address of manufacturer / M/s Jenner Pharmaceuticals (Pvt) Limited, 26-Km,
Applicant Lahore, Sharaqpur Road Sheikhupura
Brand Name +Dosage Form + Strength Levectam tablet 250mg
Composition Each Film Coated Tablet Contains:
Levetiracetam…………….250 mg
Diary No. Date of R& I & fee Rs. 20000/17.03.2017;R&I Dy.No.724 Dated:-20.03.2017
Pharmacological Group Anti Epileptic
Type of Form Form-5
Finished product Specification USP Specifications
Approval status of product in Reference MHRA
Regulatory Authorities. Levetiracetam Sandoz 250 mg Tablets by Sandoz Limited
United Kingdom
Me-too status Keppra 250 mg Tablets By GSK
“Overall the firm is satisfactory regarding building,
equipment and functioning of HVAC system. However,
they were advised to improve their documentation
regarding the production and quality control, they
agreed.”
Decision: Approved
311. Name and address of manufacturer / M/s Bosch Pharmaceuticals (Pvt) limited, Bosch House, 221,
Applicant sector 23, Korangi Industrial Area, Karachi.
Brand Name +Dosage Form +Strength Caloc-V Tablets 10mg/80mg
Amlodipine (as Besylate)…………..10mg
Valsartan…………………………....80mg
Pharmacological Group Treatment of essential hypertension
Type of Form Form-5
Approval status of product in Reference Exforge Tablets of M/s Novartis Europharm limited (UK)
Me-too status Valam Tablets of M/s Consolidated Chemical Laboratories
GMP status Last GMP inspection was conducted on 20-03-2017 which
concludes an acceptable level of GMP compliance but
available/approved sections are not mentioned in the report.
Decision: Approved
Brand Name +Dosage Form + Strength Caloc-V-HCT Tablets 5mg/160mg/12.5mg
Amlodipine (as Besylate)……………5mg
Valsartan…………………………..160mg
Hydrochlorothiazide ……………..12.5mg
Diary No. Date of R& I & fee Dy. No.1075; 22-11-2016; Rs.20, 000/- (28-10-2016)
Type of Form Form-5
Approval status of product in Reference Exforge HCT Tablets of M/s Novartis Europharm limited
Regulatory Authorities. (UK)
Me-too status Exforge HCT Tablets of M/s Novartis Pharma, Karachi.
USFDA :
developing fetus.
Brand Name +Dosage Form + Strength Caloc-V-HCT Tablets 10mg/160mg/12.5mg
Valsartan…………………………….160mg
Hydrochlorothiazide ……………….12.5mg
Type of Form Form-5
USFDA :
developing fetus.
Brand Name +Dosage Form + Strength Caloc-V-HCT Tablets 10mg/320mg/25mg
Amlodipine (as Besylate)…………..10mg
Valsartan…………………………..320mg
Hydrochlorothiazide ……………….25mg
Diary No. Date of R& I & fee Dy. No.1073; 22-11-2016; Rs.20, 000/- (28-10-2016)
Type of Form Form-5
USFDA :
developing fetus.
315. Name and address of manufacturer / M/s Welmark Pharmaceuticals, Plot # 3, Block-A, Phase I-II,
Applicant Industrial Estate, Hattar
Brand Name +Dosage Form + Strength Amloval tablets 5mg/160mg
Amlodipine Besylate……………5mg
Valsartan……………………...160mg
Pharmacological Group Calcium channel blocker + Angiotensin receptor blocker
Type of Form Form-5
Pack size & Demanded Price 14’s & as fixed by government
Limited
report concludes satisfactory compliance.
Decision: Approved
Brand Name +Dosage Form + Strength Amloval tablets 10mg/160mg
Valsartan……………………………160mg
Pharmacological Group Calcium channel blocker+ angiotensin receptor blocker
Type of Form Form-5
Pack size & Demanded Price 28’s & as fixed by government
Limited
Decision: Approved
Brand Name +Dosage Form + Strength Welzolid Dry suspension 100mg/5ml
Composition Each 5ml reconstituted suspension contains:
Linezolid……………………………..100mg
Type of Form Form-5
Pack size & Demanded Price 1’s & as fixed by Govt.
Approval status of product in Reference Zyvox for suspension of M/s Pfizer Labs (USFDA
Me-too status Nezolid dry suspension of M/s Searle Pharmaceuticals
Brand Name +Dosage Form + Strength Clacin 250mg dry powder suspension
Clarithromycin ………………250mg
Pharmacological Group Macrolide (Antibiotic)
Type of Form Form-5
Approval status of product in Reference Klaricid 250mg dry suspension of M/s Abbott Laboratories
Me-too status Maclacin 250mg suspension of M/s Bosch Pharma
report concludes very good compliance of GMP.
Remarks of the Evaluator Firm has applied for suspension while the submitted fee-
challan is of tablet (under slip # 0581800).
So, firm was issued a letter on 11th Jan, 2018 against the
following short-coming:
“Submitted fee-challan does not mention the
applied drug.”
In reply to this short-coming, the firm has submitted the
photocopy of fee- challan for the relevant drug instead of
the original one.
Decision: Deferred for confirmation of fe challan and source of granules, along with stability
studies data, GMP certificate of supplier and differential fee in case of import of pellets.
319. Name and address of manufacturer / M/s Shaigan Pharmaceuticals, Pvt limited, 14 Km,
Applicant Adayala Road, Post Office Dahgal, Rawalpindi.
Brand Name +Dosage Form + Strength Dilgem M Tablets
Metformin HCl……………….500mg
Glimepride……………………….2mg
Pharmacological Group Biguanide / Sulfonyl Urea
Type of Form Form-5
Pack size & Demanded Price 3x10’s & Price as per SRO
Approval status of product in Reference Not available
Me-too status Pamaryl Plus of M/s Himont Pharma
the report concludes issuance of GMP certificate for export
purpose.
Brand Name +Dosage Form + Strength Zevast Tablets 10mg/10mg
Ezetimibe ……………….10mg
Simvastatin.……………..10mg
Pharmacological Group Cholesterol Absorption Inhibitor/ HMG-CoA reductase
inhibitor
Type of Form Form-5
Approval status of product in Reference Not Provided
Me-too status Simbex tablet 10/10 of Searle Pharma
purpose.
Remarks of the Evaluator Non-pharmacopoeial as is not present in B.P. & U.S.P.
The drug is applied as film-coated while it is approved in
USFDA, MHRA, Netherland, Australia & France as
uncoated.
Decision: Deferred for clarification of applied formulation since reference product is approved
as uncoated tablet where as firm has applied for film coated tablet.
Pharmacological Group Cholesterol Absorption Inhibitor/station
Type of Form Form-5
Me-too status Simbex tablet 10/40 of Searle Pharma
purpose.
The drug is applied as film-coated while it is approved
in USFDA, MHRA, Netherland, Australia & France as
uncoated.
Brand Name +Dosage Form + Strength Diasar HCT 5/160/12.5 Tablets
Amlodipine as Besylate………..5mg
Valsartan……………………..160mg
Hydrochlorothiazide………...12.5mg
Pharmacological Group Angiotensin II antagonist /calcium antagonist/Thiazide
diuretic
Type of Form Form-5
Pack size & Demanded Price 14’s & Price as per SRO
Approval status of product in Reference Exforge HCT of M/s Novartis (USA)
Me-too status Exforge HCT of M/s Novartis
purpose.
USFDA :
developing fetus.
Brand Name +Dosage Form + Strength Diasar HCT 10/320/25 Tablets
Valsartan………………………320mg
Hydrochlorothiazide…………....25mg
diuretic
Type of Form Form-5
purpose.
USFDA:
developing fetus.
Decision: Approved with USP specifications and box warning
diuretic
Type of Form Form-5
purpose.
USFDA:
developing fetus.
Amlodipine as Besylate…………5mg
diuretic
Type of Form Form-5
purpose.
USFDA:
developing fetus.
Brand Name +Dosage Form + Strength Diasar HCT 10/160/12.5mg Tablets
Hydrochlorothiazide………….12.5mg
diuretic
Type of Form Form-5
purpose.
USFDA:
developing fetus.
Pharmacological Group Lipid lowering agend/HMG-CoA reductase
Type of Form Form-5
Approval status of product in Reference Not available
Me-too status Simbex tablet 10mg/20mg of Searle Pak (Pvt) Limited
purpose.
The drug is applied as film-coated while it is approved
in USFDA, MHRA, Netherland, Australia & France as
uncoated.
II. Deferred cases
Evaluator PEC-XIV
328. Name and address of manufacturer / M/s Martin Dow Ltd, Plot No. 37, Sector 19, Korangi
Applicant Industrial Area Karachi
Brand Name +Dosage Form + Strength Selocure Tablets 5mg
Sodium Picosulfate Monohydrate eq. to Sodium
Picosulfate …5mg
Diary No. Date of R& I & fee Dy. No. 262, 9-11-2016 , Rs.20,000/- (8-11-2016)
Pharmacological Group Stimulant laxative
Type of Form Form-5
Finished product Specifications Manufacturer
Pack size & Demanded Price 30’s,60’s, 100’s, As per brand leader
Approval status of product in Reference Could not be confirmed.
Me-too status U-Salax by Usawa (Reg. 075548)
GMP status 7-06-2017, 8-06-2017, Good level of compliance
Previous Decision Deferred in 275th meeting for evidence of approval of
applied formulation in reference regulatory authorities.
Evaluation by PEC The approval status of applied product in Germany has
been verified i.e., Laxoberal laxative tablets of Sanofi
Aventis Germany.
Decision: Approved
329. Name and address of manufacturer / M/s Hiranis Pharmaceuticals, Plot no E- 145 to E-149,
Applicant northwestern industrial zone port qasim, Karachi
Brand Name +Dosage Form + Strength Sirograf Tablet 1mg
Sirolimus........1mg
Diary No. Date of R& I & fee Dy.2024, 20-11-2013, 20,000/-
Pharmacological Group Immunosuppressant for alograft rejections
Type of Form Form-5
Pack size & Demanded Price As per PRC
As per PRC
Approval status of product in Reference Rapamune 1mg tablet of PF Prsim CV, USFDA
Me-too status Rapamune Tablet of Wyeth Medica (Reg # 031376)
GMP status Inspection report dated 23-09-2013 showing compliance
of GMP as Good”.
Remarks of the Evaluator 
Previous Decision Deferred in 262nd meeting for confirmation of
manufacturing facility
Evaluation by PEC  Registration Board in 271st meeting decided to grant
registration of these products in general manufacturing
areas with condition that manufacturer shall provide
safety and protective measures for workers and
personnel which remain in direct contact or are
involved in close handling of these drugs.
 The firm has submitted copy of inspection report
conducted on 07-09-2017 which showed overall cGMP
compliance at satisfactory level. However, the firm was
advised to submit the action plan on mentioned
suggestions.
 The firm has applied film coated tablet however, in
reference country the description of tablet could not
verified.
Decision: Registration Board was apprised of following product development details of
reference product “Rapamune 1 mg coated tablets” approved by EMA:
“In order to facilitate dosing and patient compliance, different approaches to finding a stable
solid dosage form of sirolimus were investigated. In order to improve the stability and
bioavailability of the coated tablet, the active substance, sirolimus, has been incorporated in a
NanoCrystal Colloidal Dispersion (Nanodispersion) in which the drug particle size is reduced to
nanometer dimensions in the presence of a stabiliser (poloxamer 188). The Nanodispersion
containing sirolimus and the stabiliser is added to a sugar coating suspension, used to coat inert
tablet cores previously overcoated with shellac and inert filler coats. The last coat is the colour
coat. The specification proposed for the Nanodispersion is considered adequate to control the
relevant physico-chemical characteristics. Batch analyses data are also provided.
The inert tablet cores were prepared by a direct compression manufacturing process typical for
this type of product. Then two different coating layers were applied, a shellac seal coating and a
filling suspension coating. The manufacturing process of the 2 mg strength is almost identical to
the process for the 1 mg strength apart from the thin sugar seal introduced between the colour
and the active coat.”
(Ref: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-
_Scientific_Discussion/human/000273/WC500046434.pdf ) accessed on 31-01-2018
Registration Board considering the above data of reference product deferred the case for
clarification of manufacturing method for applied formulation as per reference product.
Brand Name +Dosage Form + Strength Sirograf Oral Solution
Composition Each 50ml contains:-
Sirolimus........50mg
Diary No. Date of R& I & fee Dy.2038, 20-11-2013, 20,000/-
Pharmacological Group Immunosuppressant for alograft rejections
Type of Form Form-5
As per PRC
Approval status of product in Reference Rapamune 1mg/ml oral solution of PF Prsim CV, USFDA
Me-too status Rapamune solution of Wyeth (Reg # 027339)
of GMP as Good”.
Previous Decision Deferred in 262nd meeting for confirmation of
manufacturing facility.
Evaluation by PEC  Registration Board decided to grant registration of
these products in general manufacturing areas with
condition that manufacturer shall provide safety and
protective measures for workers and personnel which
remain in direct contact or are involved in close
handling of these drugs.
 The firm has submitted copy of inspection report
compliance at satisfactory level. However, the firm was
suggestions.
Decision: Registration Board approved registration of product with change of brand name in
general manufacturing areas with condition that manufacturer shall provide safety and
protective measures for workers and personnel which remain in direct contact or are involved
in close handling of these drugs.
Brand Name +Dosage Form + Strength Erdozet Capsule 150mg
Composition Each capsule contains:-
Erdosteine……...150mg
Diary No. Date of R& I & fee Dy.2033, 26-11-2013, Rs.20000/-
Type of Form Form-5
Finished product Specifications Manufacturer’s Specifications
Pack size & Demanded Price As per PRC / As per PRC
Approval status of product in Reference Erdotin Capsules by Edmond Pharma, Galen Pharma
Regulatory Authorities Uk,Italy,
Me-too status DOSTIN capsule of Brookes Pharma
of GMP as Good”
Previous Decision Deferred in 264th meeting for evidence of approval of
applied formulation by reference regulatory authorities.
Evaluation by PEC The approval status of applied formulation in Italy as
“Erdotin Capsule of Rottapharma SPA, AIFA Italy” has
been verified with following link:
https://farmaci.agenziafarmaco.gov.it/bancadatifarmaci/far
maco?farmaco=026283 (Accessed on: 09-01-2018)
The firm has submitted copy of inspection report
compliance at satisfactory level. Moreover, the firm was
suggestions.
332. Name and address of manufacturer / M/s FYNK Pharmaceuticals, 19-Km G.T Road, Kala Shah
Applicant Kaku, Lahore
Brand Name +Dosage Form + Strength Rivrin 400mg Capsule
Ribavirin………… 400mg
Diary No. Date of R& I & fee Dy. No.3562 ,23-05-2012 , Rs.8,000/- (23-05-2012),
Rs.12,000/- (17-03-2015)
Type of Form Form-5
Finished product Specifications USP Specifications
Pack size & Demanded Price 10’s: Rs. As per SRO
Approval status of product in Reference Ribavirin Tablets 400mg of Zydus Pharmaceuticals,
Regulatory Authorities USFDA
Me-too status Ribazole Tablets of M/s. Getz Pharma
concludes that firm is complying most of the cGMP
Guidelines and exhibit positive approach towards
compliance. However short comings pointed out should be
rectified within 15 days.
Remarks of the Evaluator Last inspection report is of 3-5-2016.
International availability in reference regulatory authorities
cannot be confirmed
Previous Decision Deferred in 272nd meeting for followings:
 Submission of latest GMP inspection report
conducted within 1 year.
 Evidence of approval status of applied
formulation in reference regulatory authorities.
Evaluation by PEC The firm has submitted revised form-5 along with fee of
Rs.20,000/- for revision of dosage form in line with
reference country as follows:
Each film coated tablet contains:
Ribavirin…………….400mg
GMP inspection on 20-09-2017 concluded that overall
condition of the firm is satisfactory. However, the firm is
advised to comply all advises/shortcomings which are
mentioned.
Decision: Registration Board approved the revised formulation detailed as under:
“Rivrin 400mg tablet
Ribavirin…………….400mg”
Brand Name +Dosage Form + Strength Lotrigin Tablet 50mg
Composition Each tablet contains:-
Lamotrigine……..50mg
Diary No. Date of R& I & fee Dy No. 2356: 30-5-2016PKR 20,000/-: 30-5-2016
Pharmacological Group (anticonvulsants and Anti epileptic drug)
Type of Form Form 5
Pack size & Demanded Price 1 x 30’s
Approval status of product in Reference Lamictal tablets by GSK
Me-too status Lamictal tablets by GSK
compliance. However short comings pointed out should be
rectified within 15 days
Remarks of the Evaluator Firm has applied for film coated tablet while the product
approved by MHRA is uncoated tablet
 GMP inspection is older than 1 year
Previous Decision Deferred in 274th meeting for followings:
 GMP inspection report conducted within a period of
last 1 year
 Clarification of formulation since the product approved
by reference regulatory authorities is uncoated tablet
and the firm has applied for film coated tablet
Evaluation by PEC  The firm has submitted revised Form-5 along with fee
of Rs.20,000/- from coated tablet to uncoated tablet in
line with reference country.
 The firm has submitted copy of GMP inspection on 20-
09-2017 concluded that overall condition of the firm is
satisfactory. However, the firm is advised to comply all
advises/shortcomings which are mentioned.
“Lotrigin Tablet 50mg
Each uncoated tablet contains:
Lamotrigine……..50mg”
Brand Name +Dosage Form + Strength Lispril tablet 10 mg
Lisinopril………….….10 mg
Diary No. Date of R& I & fee Dy No.442; 11-03-2015; Rs.20,000/-
Pharmacological Group Angiotensin Converting Enzyme Inhibitor/
Cardiovascular Drug
Type of Form Form-5
Pack size & Demanded Price 2 ×10’s/ As per PRC
Me-too status Zestril tablet 10 mg by ICL Pharma
GMP status GMP inspection conducted on 20-09-2017cocncluding
GMP compliant status at satisfactory level.
Remarks of the Evaluator Box warning in USFDA: ACE inhibitors may cause death
to the developing fetus.
Previous Decision Deferred in 275th meeting for clarification of applied
composition as reference product is available as Lisinopril
(as dihydrate) whereas firm has applied with Lisinopril
only.
Evaluation by PEC  The firm has submitted revised Form-5 along with fee
of Rs.20,000/- clarifying salt form as follows:
 Each tablet contains:
 Lisinopril (as dihydrate)…………..10mg.
 Copy of GMP inspection on 20-09-2017 concluded that
overall condition of the firm is satisfactory. However,
the firm is advised to comply all advises/shortcomings
which are mentioned.
“Lispril tablet 10 mg
Lisinopril (as dihydrate)…………..10mg.”
335. Name and address of manufacturer / M/s Barrett Hodgson Pakistan, F/423, S.I.T.E, Karachi.
Applicant
Brand Name +Dosage Form + Strength Barinez 50mcg Nasal sprays
Composition Each spray contains: Mometasone furoate…50mcg
Pharmacological Group Corticosteroid
Type of Form Form-5
Finished product Specifications BP Specifications
Pack size & Demanded Price 60 sprays, 120 sprays, 140 sprays; Rs. 300/-,600/-,700/-, or
As per PRC
Me-too status Rinelon of Schering plough
satisfactory compliance to GMP.
Previous Decision Deferred in 275th for clarification of salt form of API as
reference product is available as Mometasone furoate (as
monohydrate)
Evaluation by PEC  The firm has stated that the product Mometasone
furoate Nasal spray is present in British Pharmacopoeia
and we are following the pharmacopoeial specifications
of API and finished product.
 The definition of applied product in British
Pharmacopoeia is that “Mometasone Nasal spray is an
aqueous suspension of Mometasone Furoate in suitable
pressurized container fitted with an appropriate nasal
delivery system”.
Decision: Deferred for confirmation of ,manufacturing facility
336. Name and address of manufacturer / M/s Barrett Hodgson Pakistan, F/423, S.I.T.E, Karachi.
Applicant
Brand Name +Dosage Form + Strength Solubar capsules 0.4mg
Tamsulosin hydrochloride …0.4mg
(as modified release pellets)
Source of pellets: RA Chem, India.
Diary No. Date of R& I & fee Dy No.258; 12-09-2014; Rs.20,000/-,Rs.80,000/- (10-08
2014, 24-04-2017)
Pharmacological Group Anti- adrenergic
Type of Form Form-5
Finished product Specifications As per Innovator’s specification
Pack size & Demanded Price 10’s, 20’s; Rs.650/-, Rs.1300/-
Me-too status Maxflow capsule of CCL
GMP status Panel Inspection of M/s Barrett Hodgson conducted on 18-
21 January and 02 February 2016 recommends renewal of
DML.
Remarks of the Evaluator Firm has claimed Innovator specifications and the applied
formulation is present in available BP.
Previous Decision Deferred in 272nd meeting for latest GMP inspection report
which should have been conducted within the period of
last one year.
Evaluation by PEC  The firm has submitted copy of inspection on 08-08-
2017, overall GMP compliance for maintenance of
testing equipment, machines, manufacturing areas,
utilities and documents/records were found quite
satisfactory.
 The firm has submitted USP monograph for applied
formulation and requested for grant of USP
specification while initially firm had claimed
innovator’s specifications.
Decision: Approved with USP specifcations
337. Name and address of manufacturer / M/s Sami Pharma, karachi
Applicant
Brand Name +Dosage Form + Strength Duxet DR 60mg capsules
Duloxetine HCl delayed release pellets eq to
Duloxetine….…..60mg
Diary No. Date of R& I & fee Dy.No.442, 21-3-2017; Rs.20,000/- (14-11-2017),
Rs.80,000 (17-3-2017 )
Pharmacological Group Selective serotonin and nor-epinephrine reuptake inhibitor
Type of Form Form-5
Finished product Specifications USP Specification
Approval status of product in Reference Cymbalta Capsules by Lilly
Me-too status Dulan 60mg Capsules by Hilton
GMP status Last inspection report 3-10-2017 firm was considered to
be operating at good level of compliance with GMP and
has potential for further improvement.
Remarks of the Evaluator Pellets are imported from RA chem, India. GMP of RA
chem is valid upto 28-3-2018. Stability studies are
provided.
Previous Decision Deferred in 276th for confirmation whether imported
pellets of Duloxetine are of USP grade or not.
Evaluation by PEC The firm has submitted as under :
 Duloxetine HCl Delayed Release Pellets have no
pharmacopeal monograph because “pellets” are not
included in any pharmacopoeia.
 Pharmacopeal monograph of API (Duloxetine HCl) is
however available and the API used by the
manufacturer for producing Duloxetine HCL Delayed
Release Pellets is of Pharmacopeal grade only viz.
USP/EP.
 For analysis of finished product, we will follow USP
method and will accordingly claim our products to be
of USP specs.
 Source of pellets is RA chem, India which is an
approved source; copy of COA of pellets is attached.
Decision: Approved
Applicant
Duloxetine…. …..40mg
Diary No. Date of R& I & fee Dy.438, 21-3-2017; Rs.20,000/- (14-11-2017), Rs.80,000
(17-3-2017 )
Type of Form Form-5
Approval status of product in Reference Approved inMHRA
Regulatory Authorities Dutor 40 mg Capsules of Dr. Ebeling&Assoc GMBH,
Me-too status Worth 40 mg Capsules of Werrick pharmaceuticals.
chem is valid upto 28-3-2018. Stability studies are
provided.
Evaluation by PEC The firm has submitted as under:
USP/EP.
of USP specs.
Decision: Approved.

Applicant
Diary No. Date of R& I & fee Dy. No.441, 21-3-2017; Rs.20,000/- (14-11-2017),
Rs.80,000 (17-3-2017 )
Type of Form Form-5
Me-too status Dulan capsules of M/s Hilton Pharma (Pvt.) Limited
Karachi (Reg.# 055447)
chem is valid up to 28-3-2018. Stability studies are
provided.
USP/EP.
of USP specs.
Decision: Approved
Applicant
Diary No. Date of R& I & fee Dy. No.437, 21-3-2017; Rs.20,000/- (14-11-2017),
Rs.80,000 (17-3-2017 )
Type of Form Form-5
chem is valid up to 28-3-2018. Stability studies are
provided.
USP/EP.
of USP specs.
Decision: Approved.
341. Name and address of manufacturer / M/s Vega Pharmaceuticals (Pvt.) Ltd., Plot No. 4, 30 Km,
Applicant Multan Road, Lahore.
Brand Name +Dosage Form + Strength Sporin 0.05% Eye drops
Ciclosporin………….0.5 mg
Pharmacological Group Calcineurin inhibitor, immunosuppressant
Type of Form Form-5
Pack size & Demanded Price 10ml; Rs.200/-
Approval status of product in Reference Restasis 0.05% (USFDA)
Me-too status Caylor 0.05% eye drops of M/s Valor pharmaceuticals
GMP status Last inspection conducted on 08-03-2016 for grant of
GMP certificate and the panel recommends considering
the firm for grant of cGMP certificate for export purposes.
Remarks of the Evaluator  The packaging is not as per innovator.
 Restasis multidose ophthalmic emulsion is
packaged in a sterile, multi-dose preservative-free bottle.
Each bottle consists of a white opaque LDPE bottle, a
white opaque polypropylene top with unidirectional valve
and air filter, a protective olive green polypropylene cap,
and a clear disposable shipping cover over the colored cap.
Previous Decision  Deferred for following reasons:
 Latest GMP inspection report conducted during last
one year.
 Clarification regarding primary packaging as per
innovator’s approval.
 Confirmation of use of preservative in already
approved formulations by DRAP and its justification
in terms of incompatibilities in formulation.
Evaluation by PEC  The firm has submitted copy of inspection on 17-07-
2017 concluding that firm has maintained a good level
of GMP compliance as per schedule B-II of the Drugs
(LRA) Rules.
 LDPE bottles will be used for primary packaging as we
are already manufacturing and marketing almost 40
products of eye drops in the same primary packaging.
No special packaging is required for ciclosporin eye
drop emulsion. Already available brands in local
market approved by DRAP, are using LDPE bottles as
primary packaging .e.g. C-SPOR Ophthalmic Emulsion
manufactured by Ophth Pharma D.R.No. 061165.
 Formulation already approved by DRAP is preservative
free and we have also submitted revised formulation
free of preservative.
Decision: Deferred for clarification of the followingobservation:
“Reference product is packaged in a sterile, multi-dose preservative-free bottle. Each bottle
consists of a white opaque LDPE bottle, a white opaque polypropylene top with unidirectional
valve and air filter, a protective olive green polypropylene cap. Whereas the firm has not
described any such protective measures i.e. LDPE bottle polypropylene top with unidirectional
valve and air filter. Hence it is to be clarified that how the sterility of the applied formulation
will be maintained without the above cited protective measures in the packaging material.
342. Name and address of manufacturer / M/s. Epharm Laboratories, A-40, Road No. 1, S.I.T.E,
Applicant Super Highway Industrial Area, North , Karachi
Brand Name +Dosage Form + Strength Izmepra Plus Capsule (20mg+1100mg)
Omeprazole powder ..20mg
Sodium Bicarbonate….1100mg
Diary No. Date of R& I & fee Dy. No. 291, 25-08-2015 , Rs. 20,000/- (24-08-2015)
Pharmacological Group Proton pump inhibitor/Antacid
Type of Form Form-5
Finished product Specifications Innovator Specs.
Pack size & Demanded Price 2x7’s Blister pack, As per SRO
Me-too status Encid by Wilson
GMP status Last inspection conducted on 15-09-2016, “Good”.
Previous Decision Deferred in 274th meeting for the submission of GMP
inspection report within the period of last one year.
Evaluation by PEC The firm has submitted copy of panel inspection on 27-4-
2017 recommending grant of GMP certificate to the site.
Decision: Approved.
343. Name and address of manufacturer / M/s. Epharm Laboratories, A-40, Road No. 1, S.I.T.E,
Applicant Super Highway Industrial Area, North , Karachi
Brand Name +Dosage Form + Strength Mirofer Injection
Iron-III Hydroxide Polymaltose Complex eq. to elemental
Iron…100mg
Diary No. Date of R& I & fee Dy. No. 289, 25-08-2015 , Rs. 20,000/- (24-08-2015)
Type of Form Form 5
Pack size & Demanded Price 5mlx5, Ampoule As per SRO
Me-too status Venofer by Gastro care
GMP status Last inspection conducted on 15-09-2016, “Good”.
Remarks of the Evaluator  Method of sterilization of product is filtration rather
than terminal sterilization. Firm has not justified on
the basis of scientific data.
 Pharmacotherapeutic group: Anti-anaemic
preparation, iron, parenteral preparation.(MHRA)
Previous Decision Deferred in 274th meeting for the submission of GMP
inspection report within the period of last one year.
Evaluation by PEC The firm has submitted copy of panel inspection on 27-4-
2017 recommending grant of GMP certificate to the site.
Decision: Approved
344. Name and address of manufacturer / M/s CKD Pharmaceuticals, Karachi
Applicant
Brand Name +Dosage Form + Strength Cekamox 250mg Capsule
Amoxicillin (as trihydrate)………..250 mg
Type of Form Form 5
Pack size & Demanded Price Rs. 71.40/20’s, Rs. 356.98/100’s, Rs. 1785/500’s
Approval status of product in Reference Approved by MHRA of UK
Me-too status Enmox 250mg Capsule of M/s English Pharm,
(Reg.#065933)
acceptable compliance to GMP
Previous Decision Deferred in 274th meeting for evidence of section approval
granted by CLB, for Penicillin (capsule) section.
Evaluation by PEC  The firm has submitted evidence of approval of section
i.e., Capsule (Penicillin) Section. The CLB in its 238th
meeting held on 19th November, 2014 has considered
and approved the Regularization/Authentication of
existing facility according to approved layout plan for
the following sections:
1. Tablet (General) section
2. Capsule (General) section
3. Cream/Ointment/Gel (General) Section
4. Oral Liquid (General) Section
5. Capsule (Cephalosporin) Section
6. Oral Dry powder Suspension (Cephalosporin)
7. Capsule (Penicillin) Section
8. Tablet (Penicillin) Section
9. Oral Dry Powder Suspension (Penicillin) section
Decision: Approved
Applicant
Brand Name +Dosage Form + Strength M/s CKD Pharmaceuticals, Karachi
Composition Cekamox 500mg Capsule
Diary No. Date of R& I & fee Each capsule contains
Pharmacological Group Dy. No.360; 16-03-2016; Rs.20,000/- (16-03-2016)
Type of Form Antibiotic
Finished product Specifications Form 5
Pack size & Demanded Price USP
Approval status of product in Reference Rs. 172.32/20’s, Rs. 430.80/50’s, Rs. 861.60/100’s,
Regulatory Authorities Rs.4308.00/500’s
Me-too status Approved by MHRA of UK
GMP status Enmox 500mg Capsule of M/s English Pharm,
(Reg.#065934)
Remarks of the Evaluator Last inspection report dated 16-7-2017 confirms
granted by CLB, for Penicillin (capsule) section.
9. Oral Dry Powder Suspension (Penicillin)
section
Decision: Approved
Applicant
Brand Name +Dosage Form + Strength Cekamox Drops
Composition Each 1.25ml Contains:
Type of Form Form 5
Pack size & Demanded Price Rs. 26.00/10ml, Rs. 51.75/20ml
Me-too status Amoxil drops of M/s GSK (Reg.#000509)
granted by CLB, for Penicillin (Dry Powder suspension)
section.
9. Oral Dry Powder Suspension (Penicillin) section
Decision: Approved
347. Name and address of manufacturer / M/s. Atlantic Pharmaceuticals Labs, 89-D, industrial state,
Applicant Hayatabad, Peshawar
Brand Name +Dosage Form + Strength Transol NS Infusion
Composition Dyn:83, 17-5-2016, Rs.20,000/-
Diary No. Date of R& I & fee Each 20ml contains:-
Sodium Chloride………..0.18g
Pharmacological Group Electrolyte solution
Type of Form Form-5
Finished product Specifications B.P
Pack size & Demanded Price 20 ml (As Per SRO)
Approval status of product in Reference Sodium Chloride 0.9% Intravenous Infusion by M/s
Regulatory Authorities Eastgate Way (MHRA )
Me-too status Floline IV Infusion by M/s Mediflow
GMP status Last GMP Inspection dated ……. with conclusive remarks
of satisfactory level of cGMP compliance.
Remarks of the Evaluator Latest GMP inspection report (which should have been
conducted within the period of last one year) missing
Previous Decision Deferred in 274th meeting for submission of latest GMP
inspection report conducted within period of one year.
Evaluation by PEC The firm has submitted copy of inspection report on 17-
03-2017 concluding that overall the firm has improved the
GMP compliance and purchased some new equipments in
QC and overall GMP was satisfactory.
Decision: Deferred for confirmation whether manufacturing facility of Liquid injectables is
approved for “ Small Volume Parenterals” or “ Large Volume Parenterals”
Brand Name +Dosage Form + Strength Transol 25 Infusion
Glucose Anhydrous…...25g
Pharmacological Group Electrolyte solution
Type of Form Form-5
Finished product Specifications B.P
Pack size & Demanded Price 100 ml (As Per SRO)
Approval status of product in Reference Dextrose 25% by M/s Hospira (USFDA )
Me-too status Local. Medisol 25% by M/s Medipak.
Brand Name +Dosage Form + Strength Parasol 1gm I.V Infusion
Diary No. Date of R& I & fee Each ml of I.V infusion contains:-
Paracetamol………………….10mg
Pharmacological Group Antipyretic and analgesic
Type of Form Form-5
Finished product Specifications Innovator’s specifications.
Pack size & Demanded Price 100ml (Rs.80.00)
Approval status of product in Reference PERFALGAN 10 mg/ml, solution for infusion of M/s
Regulatory Authorities Bristol-Myers Squibb (MHRA)
Me-too status Provas of Sami pharma
350. Name and address of manufacturer / M/s Innvotek Pharmaceuticals, Plot # 35, Industrial Estate,
Applicant Kahuta Triangle, Kahuta Road Islamabad
Brand Name +Dosage Form + Strength Opcon-A Ophthalmic Solution
Naphazoline Hydrochloride ….0.25mg
Pheniramine Maleate……..0.3mg
Pharmacological Group Decongestant and antiallergic
Type of Form Form 5
Pack size & Demanded Price 15ml: Rs. 120/-
Approval status of product in Reference Naphacon A 0.025%/0.3% ophthalmic solution by Alcon
Me-too status Opticon A 0.025%/0.3% by Winthrox
GMP status According to last inspection report dated 09-03-2017 the
company is complying with the GMP guidelines
Remarks of the Evaluator Internationally available and me-too formulation is
available as 0.025%/0.3% while firm has applied for
0.025/0.03%.
Previous Decision Deferred in 274th meeting for clarification of applied
formulation since the product approved by reference
regulatory authorities and DRAP is 0.025%/0.3% while
the firm has applied for 0.025%/0.03%. Registration Board
further deferred this case for submission of fee PKR
20,000/- and revised Form-5 and master formulation.
Evaluation by PEC The firm has submitted revised Form-5 along with fee of
Rs. 20,000/-. New formulation is as under:
Each ml contains:
Pheniramine Maleate…………3mg
The firm has requested new brand name “Nephtek-P”.
“Opcon-A Ophthalmic Solution
Each ml contains:
Pheniramine Maleate…………3mg”
351. Name and address of manufacturer / M/s Medizan Laboratories (Pvt) Ltd. Plot No. 313,
Applicant Industrial Triangle Kahuta Road Islamabad
Brand Name +Dosage Form + Strength Cyfix SR 15mg Capsule
Composition Each capsules contains:
Cyclobenzprine hydrochloride sustained release pellets
l…….15mg
Pharmacological Group Centrally acting muscle relaxant
Type of Form Form 5
Approval status of product in Reference Amrix Capsule by Teva Pharms
Me-too status Cyclorest ER capsule by Martin Dow
GMP status Last inspection conducted on 10-4-2017 satisfactory
compliance to GMP
Remarks of the Evaluator  Source, COA, stability study data and GMP of
manufacturer of pellets is not provided
Previous Decision Registration Board in 274th meeting deferred the case for
following submissions:
 Source of pellets
 Certificate of analysis of pellets
 Real time and accelerate stability study data of 3
batches of pellets conducted as per the
requirements of zone IV-A
 GMP of manufacturer of pellets
 Differential fee (if pellets are imported).
Also deferred the case due to observations related to GMP
made by panel of inspection for the product sofomed
(Sofosbuvir 400mg)
Evaluation by PEC The firm has submitted followings:
Source of pellets: Vision Pharmaceuticals
COA, stability studies and valid GMP from vision pharma
submitted.
Copy of inspection conducted on 20-11-2017, the firm was
considered to be operating at reasonably acceptable
compliance with GMP guidelines as of today.
Decision: Approved
Brand Name +Dosage Form + Strength Cyfix SR 30mg Capsule
Composition Each capsules contains:
Cyclobenzprine hydrochloride sustained release pellets
…….30mg
Pharmacological Group Centrally acting muscle relaxant
Type of Form Form 5
Approval status of product in Reference Amrix Capsule by Teva Pharms
Me-too status Cyclorest ER capsule by Martin Dow
compliance to GMP
Remarks of the Evaluator  Source, COA, stability study data and GMP of
Previous Decision Registration Board in 274th meeting deferred the case for
following submissions:
 Real time and accelerate stability study data of 3
batches of pellets conducted as per the
requirements of zone IV-A
 Differential fee (if pellets are imported).
Also deferred the case due to observations related to GMP
made by panel of inspection for the product sofomed
(Sofosbuvir 400mg)
Evaluation by PEC The firm has submitted followings:
Source of pellets: Vision Pharmaceuticals
COA, stability studies and valid GMP from vision pharma
submitted.
Copy of inspection conducted on 20-11-2017, the firm was
Decision: Approved
Brand Name +Dosage Form + Strength Easyfix Tablet
Composition Each Film coated Tablet contains
Sodium Fusidate ……..250mg
Pharmacological Group Antiinfective
Type of Form Form 5
Pack size & Demanded Price 1 x 10’s: As per SRO
Approval status of product in Reference Fucidin Tablet by Leo Lab
Me-too status Fuci-Bax by Baxter Pharma
compliance to GMP
Previous Decision Registration Board in 274th meeting deferred the case due
to observations related to GMP made by panel of
inspection for the product sofomed (Sofosbuvir 400mg).
Evaluation by PEC Copy of inspection conducted on 20-11-2017, the firm was
Decision: Approved with Innovator’s specifications and change of brand name.
354. Name and address of manufacturer / M/s. Fredmann Pharmaceuticals, Mirpur, Azad Kashmir
Applicant
Brand Name +Dosage Form + Strength Isocare Gel 10gm
Isotretinoin ………………….0.05%
Erythromycin………………..2%
Diary No. Date of R& I & fee 598, 28-01-2016, Rs.20,000/-, 28-01-2016
Pharmacological Group Antibiotic, Vitamin A Derivative
Type of Form Form-5
Finished product Specifications As per innovator’s specifications
Pack size & Demanded Price 10gm; Rs.230/-
Approval status of product in Reference Isotrexin gel of GSK, MHRA
Me-too status Isotrexin Gel of GSK Pharmaceuticals
GMP status GMP inspection on 29-01-2015 rated as good.
Remarks of the Evaluator GMP inspection report is not within the period of 1 year.
inspection report which should have been conducted
within period of one year.
Evaluation by PEC GMP inspection conducted on 24-11-2017, the firm was
considered to be operating at a fair level of cGMP as of
today. Improvements have been agreed by the
management to submit the compliance at earliest.
355. Name and address of manufacturer / M/s. Fredmann Pharmaceuticals, Mirpur, Azad Kashmir
Applicant
Brand Name +Dosage Form + Strength Nosin 2.5mg Tablet
Tibolone………………..2.5mg
Diary No. Date of R& I & fee 597, 28-01-2016, Rs.20,000/-, 28-01-2016
Pharmacological Group Gonadomimetics
Type of Form Form-5
Finished product Specifications As per innovator’s specifications
Pack size & Demanded Price 3×10’s; Not Proposed
Approval status of product in Reference Livial 2.5mg Tablet, MHRA
Me-too status Tibopause Tablets of Zafa pharma (Reg #024213)
GMP status GMP inspection on 29-01-2015 rated as good.
Remarks of the Evaluator  GMP inspection report is not within the period of 1
year.
inspection report which should have been conducted
within period of one year.
Evaluation by PEC GMP inspection conducted on 24-11-2017, the firm was
considered to be operating at a fair level of cGMP as of
today. Improvements have been agreed by the
management to submit the compliance at earliest.
Decision: Deferred for confirmation whether approved section is for “Tablet Hormone
(Steroidal)” or “Tablet Hormone (Non-steroidal)”.
356. Name and address of manufacturer / M/s. Albro Pharmaceuticals, Lahore
Applicant
Brand Name +Dosage Form + Strength Albomox tablet 400mg
Moxifloxacin as HCl……400mg
Diary No. Date of R& I & fee Dy. No.51; 23-2-2011; Rs.12,000/- (19-2-2015);
Rs.8,000/- (3-01-2011)
Type of Form Form-5
Finished product Specifications Manufacturer’s Specification
Approval status of product in Reference Avelox 400 mg film-coated tablets by M/s Bayer plc,
Me-too status Metoxim 400mg Tablet by M/s Foray Pharmaceutical
(Reg No:056083)
GMP status Last inspection report 18-03-2016, the management
requested for time to overcome shortcoming and submit
the compliance report accordingly.
Remarks of the Evaluator  Fee challan photocopies are provided.
Previous Decision Deferred for submission of last GMP inspection report
conducted within a year (M-274)
Evaluation by PEC Firm has submitted last GMP inspection report dated 26-
10-2017, 6-12-2017, the panel decided to recommend the
renewal of DML.
Decision: Approved with Innovator’s specifications. Reference will be sent to Budget &
Accounts Division for verification of challan and Board authorized its Chairman for the
issuance of registration letter.
357. Name and address of manufacturer / M/s. Genix Pharma, Karachi
Applicant
Brand Name +Dosage Form + Strength Mycfe 500mg tablet
Mycophenolate Mofetil (USP)………500mg
Diary No. Date of R& I & fee 1473, 31-07-2013, 20,000/-
Pharmacological Group Immunosuppresant
Type of Form Form-5
Finished product Specifications Mfg. specs
Approval status of product in Reference Cellcept (Roshe Palo), USFDA
Me-too status Cellcept of Roche Pakistan)
GMP status Inspection conducted on 8-8-2017, the firm was considered
to be operating at a satisfactory level of compliance. The
firm was suggested to purchase Liquid particle Counter for
QC Lab on immediate basis. It was also suggested to
increase the office area for the staff and QC lab area.
Previous Decision Deferred in 258th meeting for finalization of requirement
manufacturing facility
Evaluation by PEC  Registration Board in 271st meeting decided to grant
registration of these products in general manufacturing
areas with condition that manufacturer shall provide
safety and protective measures for workers and
personnel which remain in direct contact or are
involved in close handling of these drugs.
Decision: Registration Board approved registration of product in general manufacturing areas
with condition that manufacturer shall provide safety and protective measures for workers and
personnel which remain in direct contact or are involved in close handling of these drugs.
358. Name and address of manufacturer / M/s. Genix Pharma, Karachi
Applicant
Brand Name +Dosage Form + Strength Fovir Film Coated Tablet (300mg)
Tenofovir disoproxil fumarate…………... 300 mg
Eq. to tenofovir disoproxil……….245mg
Diary No. Date of R& I & fee Dy. No.177,R&I Dated 27-8-2014, Rs. 20,000
Type of Form Form 5
Finished product Specifications International Pharmacopoeia
Pack size & Demanded Price 10's,20's,30's,as Per PRC,Alu-Alu blister
Approval status of product in Reference Viread by Gilead Science(USFDA)
Me-too status Epivir Tab by Genome Pharmaceuticals
GMP status Last GMP Inspection Date:26-01-2017, “Acceptable
level” of compliance.
Remarks of the Evaluator Approved in FDA with Black box Warnings: Lactic
Acidosis/Severe Hepatomegaly With Steatosis And Post
Treatment Exacerbation of Hepatitis
Previous Decision Deferred in 269th meeting for submission of last GMP
inspection report conducted within last one year
Evaluation by PEC  Inspection conducted on 8-8-2017, the firm was
considered to be operating at a satisfactory level of
compliance. The firm was suggested to purchase Liquid
particle Counter for QC Lab on immediate basis. It was
also suggested to increase the office area for the staff
and QC lab area.
Decision: Approved with International Pharmacopoeia specifcations.
359. Name and address of manufacturer / M/s Pfizer Pakistan Limited, Head Office: 12, Dockyard
Applicant Road, West Wharf, Karachi.
Plant site:B-2 SITE, Karachi
Brand Name +Dosage Form + Strength ZOLOFT Tablets 100mg
Sertraline as HCl…… 100mg
Diary No. Date of R& I & fee Dy. No. 944, Dated 16/11/2015,
Rs 20,000/= Dated 16/11/2015,
Pharmacological Group Anti-Depressant (SSRI Inhibitor)
Type of Form Form – 5
Pack size & Demanded Price Pack Size: 3×30’s/ Price: As per S.R.O
Approval status of product in Reference Lustral film coated tablets 100mg by M/s Pfizer, MHRA
Regulatory Authorities Approved.
Me-too status Ertalin 100mg tablet by M/s Genome Pharmaceuticals
(Reg # 076845)
GMP status Last inspection report Dated 16/05/2016 confirms the
maintenance of GMP in warehouse, manufacturing and
packaging areas.
Remarks of the Evaluator  The firm has claimed In House manufacturing
specifications while the product is present in USP/BP.
 Registration letter for the same product was issued to the
firm on 27th December, 1997 for the same product. The
firm has stated that the product could not be renewed in
time and the registration became invalid. The firm has
submitted the application for re-registration of the
product.
Previous Decision Deferred in 274th meeting for the submission of last
inspection report conducted within the last one year.
Evaluation by PEC  Panel inspection conducted on 30-10-2017 found an
optimal level of compliance and unanimously
recommended the renewal of DML.
 However, it was advised that the firm must have
separate facility for manufacturing of their only
registered corticosteroid products.
Decision: Approved as per Innovator’s specifications.
360. Name and address of manufacturer / M/s Pfizer Pakistan Ltd. B-2, SITE, Karachi.
Applicant
Brand Name +Dosage Form + Strength Norvasc V Tablet 5/80
Composition Dy.No. 1632, 22-8-2016, Rs.20,000/-
Amlodipine (as Besylate)…………5 mg
Valsartan…………..80 mg
Type of Form Form-5
Pack size & Demanded Price 2x7’s / As per brand leader
Approval status of product in Reference Exforge by Novartis Pharma GmbH, (USFDA)
Me-too status Exforge by Novartis Pharma. Karachi (R. No. 047569)
GMP status Last GMP Inspection dated 9-9-14 for grant to additional
section
Remarks of the Evaluator Firm claimed that nothing is due on their part as there GMP
compliance is of world class standard, they verbally
requested for inspection to federal drug inspector many
time, but inspection was not conducted, so they requested to
consider the same in front of the registration board.
Decision: Approved
Applicant
Type of Form Form-5
Me-too status Exforge by Novartis Pharma. Karachi (R. No. 047570)
GMP status Last GMP Inspection dated9-9-14 for grant to additional
section
Decision: Approved
Applicant
Type of Form Form-5
Me-too status Exforge by Novartis Pharma. Karachi
GMP status Last GMP Inspection dated9-9-14 for grant to additional
section
Decision: Approved
363. Name and address of manufacturer / Palpex pharmaceuticals (pvt) Ltd. Plot # FD-46-A8
Applicant korangi Creek Industrial Park Karachi.
Brand Name +Dosage Form + Strength ARTEPEX Injection 80 mg/ml (IM)
Composition Each Ampoule (1ml) contains
Artemether ………80 mg
Diary No. Date of R& I & fee Dy. No.5753, Dated 12/06/2017,
Rs 20,000/= Dated 12/06/2017,
Pharmacological Group Antimalarials
Type of Form Form – 5
Pack size & Demanded Price Pack Size: 1×5’s, Price: As per S.R.O
Approval status of product in Reference WHO pre-qualified drug product
Me-too status Artham Injection by M/s Weatherfold Pharmaceuticals
(Reg # 56053)
GMP status New License
Remarks of the Evaluator  The firm has claimed USP specification and the
product is not present in USP, however the product is
present in I.P.
 The injection is oil based while the master formulation
shows that the firm has used water for injection as
vehicle.
Previous Decision Deferred in 272nd meeting for clarification of vehicle used
in the manufacturing process as the drug is oil based while
water for injection is used as solvent
Evaluation by PEC  The firm has submitted revised master formulation and
has changed the vehicle from “water for Injection” to
“Peanut oil”.
Decision: Approved with International Pharmacopoeia specifications
364. Name and address of manufacturer / M/s Zafa Pharmaceuticals, L-4/1, A&B, Block 21, Federal
Applicant B Industrial area, Karachi.
Brand Name +Dosage Form + Strength Irofit 50mg/5ml Syrup
Iron-III Hydroxide Polymaltose Complex eq. to elemental
iron…50mg
Pharmacological Group Anti-anemic preparations
Type of Form Form-5
Finished product Specifications Manufacturer’s specifications.
Pack size & Demanded Price 60 ml / As per SRO
Approval status of product in Reference NA
Me-too status BISLERI of Sami pharmaceutics
GMP status --
Remarks of the Evaluator Latest GMP inspection report is required
inspection report conducted within a period of last 1 year
by DRAP
Evaluation by PEC Inspection conducted on 02-08-2017, the firm was found
at satisfactory level of compliance. The observations were
discussed at length with management and they assured for
rectification at earliest.
365. Name and address of manufacturer / M/s Caliph Pharmaceuticals (Pvt) Ltd, Risalpur, KPK
Applicant
Brand Name +Dosage Form + Strength Zinc Dry Suspension
Composition Each 5ml of reconstituted suspension contains:
Zinc sulphate monohydrate 22.40mg equivalent to
Elemental Zinc……10mg
Diary No. Date of R& I & fee Dy. No. 1031, dated 05-10-2015, Rs 20,000/-
Pharmacological Group Anti-diarrheal
Type of Form Form-5
Finished product Specifications USP specifications
Pack size & Demanded Price 100ml; As per DRAP policy
Approval status of product in Reference --
Me-too status Zincat oral solution of M/s Atco Labs Karachi
GMP status 22-03-2017 Routine GMP Inspection
Good Compliance.
Previous Decision Deferred in 255th meeting of Registration Board for review
of formulation.
Evaluation by PEC The firm has submitted revised Form-5 along with fee of Rs.
20,000/- (Challan No. 0705460 dated 15-1-2018) and
revised formulation is as under:
Each 5ml contains:
Elemental zinc (as Zinc sulphate monohydrate)…….20mg
The firm has stated that Registration Board in 273rd meeting
has approved the said formulation.
However, WHO model list of essential medicines
recommends solid oral dosage form of Zinc sulfate.
“Zincafe syrup
Each 5ml contains:
Elemental zinc (as Zinc sulphate monohydrate)…….20mg”
366. Name and address of manufacturer / M/s Treat Pharmaceuticals, Bannu
Applicant
Brand Name +Dosage Form + Strength Amikat Injection 250mg/2ml
Amikacin as Sulphate….250mg/2ml
Diary No. Date of R& I & fee Dy. No.520; 9-06-2013; Rs.12,000/- (29-7-2013);
Rs.8,000/- (09-6-2011)
Pharmacological Group Aminoglycosides antibiotic
Type of Form Form-5
Finished product Specifications Manufacturer Specification’s
Pack size & Demanded Price 2ml ampoule; As per SRO
Me-too status Aimwel injection 250mg by Welmark Reg no. 068218
GMP status Last Inspection report 8-10-2016 The firm is directed to
conduct self GMP inspection. All the shortcomings have
discussed with management and they agreed to rectify.
Remarks of the Evaluator Fee challan photocopy is attached.
Firm has claimed 5% overage without scientific
justification.
International availability in reference regulatory authorities
cannot be confirmed
Previous Decisions Deferred for submission of justification for 5% overage of
active ingredient in master formulation and evidence of
approval status of applied formulation in reference
regulatory authorities. (M-272)
Deferred again in 273rd meeting for evidence of approval
in reference regulatory authorities and me-too status
Evaluation by PEC The firm has submitted revised form-5 along with fee of
Rs. 20,000/- (Challan No. 0735130 dated 28-12-2017) for
revision of formulation in line with reference country
(Amikacin sulfate 250mg/ml of West-Ward Pharms,
USFDA) and me-too reference has also been confirmed.
“Amikat Injection 250mg/ml
Each ml contains:
Amikacin (as sulphate)…….250mg
Pack size: 1ml”
367. Name and address of manufacturer / M/s Adamjee Pharmaceuticals (Pvt) Ltd, Plot 39, Sector
Applicant 15, Korangi Industrial Area, Karachi.
Brand Name +Dosage Form + Strength Lanza Capsule 10mg
(Other proposed brand names: Zypine capsule, Lanzin
Capsule)
Olanzapine (as citrate)….10mg
Pharmacological Group Antipsychotics
Type of Form Form-5
Approval status of product in Reference Not provided
Me-too status Olanziscot capsule 10mg of Scotmann Pharmaceuticals
(Reg.#028270)
GMP status GMP inspection conducted on 14-07-2017 rated GMP
compliance level as good.
Remarks of the Evaluator  Evidence of international availability
 Firm has claimed USP specs and the product is not
present in USP.
Previous Decisions Deferred in 275th meeting for confirmation of approval of
applied formulation in reference regulatory
authorities/agencies.
Evaluation by PEC The availability of product has been verified in Spanish
Medicine agencie. The website link is as below:
https://cima.aemps.es/cima/dochtml/ft/74752/FT_74752.ht
ml (Accessed on: 22-01-2018)
Firm has submitted revised formulation stating
composition as under:
“Each capsule contains:
Olanzapine….10mg”
368. Name and address of manufacturer / M/s Adamjee Pharmaceuticals (Pvt) Ltd, Plot 39, Sector
Applicant 15, Korangi Industrial Area, Karachi.
Brand Name +Dosage Form + Strength Lanza Capsule 5mg
(Other proposed brand names: Zypine capsule, Lanzin
Capsule)
Olanzapine (as citrate)….5mg
Pharmacological Group Antipsychotics
Type of Form Form-5
Approval status of product in Reference Not provided
Me-too status Olanziscot capsule 5mg of Scotmann Pharmaceuticals
(Reg.#028269)
GMP status GMP inspection conducted on 14-07-2017 rated GMP
compliance level as good.
Remarks of the Evaluator  Evidence of international availability
 Firm has claimed USP specs and the product is not
present in USP.
Previous Decisions Deferred in 275th meeting for confirmation of approval of
applied formulation in reference regulatory
authorities/agencies.
Evaluation by PEC The availability of product has been verified in Spanish
Medicine agencie. The website link is as below:
https://cima.aemps.es/cima/dochtml/ft/74752/FT_74752.ht
ml (Accessed on: 22-01-2018)
Firm has submitted revised formulation stating
composition as under:
“Each capsule contains:
Olanzapine….5mg”
369. Name and address of manufacturer / M/s. Fynk Pharmaceuticals, Lahore
Applicant
Brand Name +Dosage Form + Strength Dueox 30mg Capsules
Composition Each delayed release capsule contains:
Enteric coated pellets of Duloxetine hydrochloride 17%
w/w eq. to Duloxetine…….30mg
Source of pellets : M/s Vision Pharmaceuticals.
Type of Form Form 5
Pack size & Demanded Price 1 x 10’s; As per PRC
Approval status of product in Reference Approved by US FDA
compliance. However short comings pointed out should
be rectified within 15 days.
Remarks of the Evaluator  You have claimed manufacturer’s specifications
whereas USP monograph is available for applied
formulation. However you may submit finished
product specifications in the light of Registration
Board’s decision in the 267th meeting
 Source of pellet submitted mentions in-house
specifications, while pellets complying with USP
specifications shall be used.
 Latest inspection report conducted within one year
shall be submitted.
Previous Decisions Deferred for following observations:
 Firm has claimed manufacturer’s specifications
formulation.
Latest inspection report conducted within one year shall be
submitted
Evaluation by PEC  The firm has submitted USP monograph for
the applied formulation.
 Source of pellets: Vision Pharma (COA,
Stability studies of three batches and valid GMP
provided).
 GMP inspection on 20-09-2017 concluded
that overall condition of the firm is satisfactory.
However, the firm is advised to comply all
otherwise.
370. Name and address of manufacturer / M/s. Fynk Pharmaceuticals, Lahore
Applicant
Brand Name +Dosage Form + Strength Dueox 60mg Capsules
Composition Each delayed release capsule contains:
Enteric coated pellets of Duloxetine hydrochloride 17%
w/w eq. to Duloxetine…….60mg
Source of pellets : M/s Vision Pharmaceuticals.
Type of Form Form 5
Pack size & Demanded Price 1 x 10’s; As per PRC
compliance. However short comings pointed out should
be rectified within 15 days.
Remarks of the Evaluator  You have claimed manufacturer’s specifications
formulation. However you may submit finished
product specifications in the light of Registration
Board’s decision in the 267th meeting
 Latest inspection report conducted within one year
shall be submitted.
Previous Decisions Deferred for following observations:
 Firm has claimed manufacturer’s specifications
formulation.
Latest inspection report conducted within one year shall be
submitted
Evaluation by PEC  The firm has submitted USP monograph for
 Source of pellets: Vision Pharma (COA,
Stability studies of three batches and valid GMP
provided).
 GMP inspection on 20-09-2017 concluded
that overall condition of the firm is satisfactory.
However, the firm is advised to comply all
otherwise.
371. Name and address of manufacturer / M/s. CKD Pharmaceutical Pakistan (Pvt) Ltd, Plot # 50/28,
Applicant Korangi Industrial Area, Karachi
Brand Name +Dosage Form + Strength Benzap-SR 15 Capsule
Cyclobenzaprine Hydrochloride (Extended release
pellets)…………15mg
Diary No. Date of R& I & fee 76, 19-01-2016, 20,000/-, 04-01-2016
Pharmacological Group Muscle relaxant
Type of Form Form-5
Pack size & Demanded Price Rs.290.00/14’s
Rs.150.00/7’s
Approval status of product in Reference Amrix extended release capsule of Teva Pharms intl,
Regulatory Authorities (USFDA)
Me-too status Emrix-SR of Getz Pharma
acceptable compliance to GMP.
Remarks of the Evaluator  However, pellet details were not provided.
Previous Decision Deferred in 274th meeting for submission of pellet details.
Evaluation by PEC Source of pellets: Vision Pharma
Pellet details have been submitted by the firm.
Decision: Approved
372. Name and address of manufacturer / M/s. CKD Pharmaceutical Pakistan (Pvt) Ltd, Plot # 50/28,
Brand Name +Dosage Form + Strength Benzap-SR 30 Capsule
Cyclobenzaprine Hydrochloride (Extended release
pellets)…………30mg
Pharmacological Group Muscle relaxant
Type of Form Form-5
Pack size & Demanded Price Rs.380.00/14’s; Rs.195.00/7’s
Approval status of product in Reference Amrix extended release capsule of Teva Pharms intl,
Regulatory Authorities (USFDA)
Me-too status Emrix-SR of Getz Pharma
acceptable compliance to GMP.
Remarks of the Evaluator  However, pellet details were not provided.
Evaluation by PEC Source of pellets: Vision Pharma
Pellet details have been submitted by the firm.
Decision: Approved
373. Name and address of manufacturer / M/s Nimrall Laboratories, Plot # 24 Street # SS-3, Rawat
Applicant Industrial Estate, Islamabad
Brand Name +Dosage Form + Strength Linospan 600mg Tablets
Linezolid………..600mg
Type of Form Form 5
Pack size & Demanded Price 3x10’s: As per SRO
Approval status of product in Reference Linezolid tablet by Pfizer
Me-too status Linez by Nexus
GMP status
Remarks of the Evaluator  Latest GMP inspection report (which should have been
conducted within the period of last one year) is not
provided.
Previous Decision Deferred in 273rd meeting for GMP inspection report
conducted within a period of last 1 year.
Evaluation by PEC Inspection conducted on 21-12-2017 concluded fair level
of compliance (Needs active improvements).
Decision: Approved
374. Name and address of manufacturer / M/s Pakistan Pharmaceutical Products (Pvt.) Ltd., D-122,
Applicant S.I.T.E. Karachi.
Brand Name +Dosage Form + Strength Lacosam 50mg Tablet
Lacosamide……50 mg
Pharmacological Group (Anticonvulsants and antiepileptics)
Type of Form Form 5
Approval status of product in Reference Vimpat tablets by UCB Pharma
Me-too status Lacolep by Hilton
concludes that firm was considered to be operating at
satisfactory level of GMP guidelines
Previous Decision Registration Board in 274th deferred the case in the light of
recent GMP inspection report dated 1-08-2017, in which
some critical /major and other observations were also
noted which need to be addressed promptly for attaining a
better level of compliance and for product safety.
Evaluation by PEC The firm has submitted latest inspection conducted on 12-
12-2017 which concluded that
“The firm has complied/improved according to directions
of the FID. Panel was satisfied for the improvements
undertaken by the firm to comply with the observations
dated 1st and 2nd August, 2017. The panel advised the firm
to continue the improvements process as per cGMP
guidelines.”
Decision: Approved
375. Name and address of manufacturer / M/s Pakistan Pharmaceutical Products (Pvt.) Ltd., D-122,
Applicant S.I.T.E. Karachi.
Brand Name +Dosage Form + Strength Lacosam 100mg Tablet
Lacosamide……100 mg
Pharmacological Group (Anticonvulsants and antiepileptics)
Type of Form Form 5
Approval status of product in Reference Vimpat tablets by UCB Pharma
Me-too status Lacolep by Hilton
concludes that firm was considered to be operating at
satisfactory level of GMP guidelines
guidelines.”
Decision: Approved
376. Name and address of manufacturer / M/s Pakistan Pharmaceutical Products (Pvt.) Ltd., D-
Brand Name +Dosage Form + Strength Promol 6 Plus suspension
Paracetamol…………………....250mg
Pharmacological Group Analgesic, antipyretic
Type of Form Form-5
Pack size & Demanded Price 60ml;As per PCA
Approval status of product in Reference Paracetamol 250mg/5ml oral suspension (MHRA
Me-too status Calpol-6 Plus of M/s GSK
GMP status 1-08-2017, During the inspection some critical /major and
other observations were also noted which need to be
addressed promptly for attaining a better level of
compliance and for product safety.
guidelines.”
Decision: Approved
377. Name and address of manufacturer / M/s Pakistan Pharmaceutical Products (Pvt.) Ltd., D-
Brand Name +Dosage Form + Strength Vilda 50mg tablet
Vildagliptin…………………....50mg
Pharmacological Group Anti-hyperglycemic agent
Type of Form Form-5
Pack size & Demanded Price 2x14’s;As per PCA
Approval status of product in Reference Galvus 50mg tablets (MHRA approved)
Me-too status Galza of M/s CCL
GMP status 1-08-2017, During the inspection some critical /major and
other observations were also noted which need to be
addressed promptly for attaining a better level of
compliance and for product safety.
guidelines.”
378. Name and address of manufacturer / M/s Pakistan Pharmaceutical Products Pvt. Ltd. D-122,
Applicant SITE, Karachi.
Brand Name +Dosage Form + Strength Carboxy Plus Syrup
Diary No. Date of R& I & fee Each 5ml of constituted contains:
Carbocisteine…….100 mg
Promethazine HCl….2.5 mg
Pharmacological Group Mucolytic/ Antihistamine (Cough Suppressant)
Type of Form Form-5
Finished product Specifications Innovator
Pack size & Demanded Price 120 ml / As per SRO
Approval status of product in Reference Rhinathiol Promethazine Syrup of Sanofi Aventis France.
Regulatory Authorities (ANSM France)
Me-too status Carbex plus by Platinum
GMP status Last GMP Inspection of Pakistan Pharmaceutical products
Conducted on 27-12-16 with conclusive remarks of
satisfactory level of cGMP compliance. .
guidelines.”
379. Name and address of manufacturer / M/s Pakistan Pharmaceutical Products Pvt. Ltd. D-122,
Applicant SITE, Karachi.
Brand Name +Dosage Form + Strength Promol Paediatric Suspension
Diary No. Date of R& I & fee Each 5ml contains:
Paracetamol…………120 mg
Pharmacological Group Analgesic, Antipyretic
Type of Form Form-5
Approval status of product in Reference Boots Paracetamol 3 Months Plus 120mg/5ml Suspension
Regulatory Authorities by M/s The Boots Company Plc (MHRA)
Me-too status Calpol Suspension by M/s GSK
GMP status Last GMP Inspection of Pakistan Pharmaceutical products
Conducted on 27-12-16 with conclusive remarks of
satisfactory level of cGMP compliance.
guidelines.”
Decision: Approved
380. Name and address of manufacturer / M/s Pakistan Pharmaceuticals Products (Pvt.) Ltd.,
Applicant Karachi
Brand Name +Dosage Form + Strength Xomelox Eye Drops 5mg/ml
Moxifloxacin hydrochloride eq. to Moxifloxacin …..5 mg
Type of Form Form 5
Pack size & Demanded Price As per SRO.
Me-too status Opmox Eye Drop by M/s Ophth-Pharma (Pvt.) Ltd,
Karachi (Reg#058367)
concludes satisfactory level of GMP compliance
guidelines.”
Decision: Approved
381. Name and address of manufacturer / M/s. Genome Pharmaceuticals, 16/1, phase IV, industrial
Applicant estate, Hattar
Brand Name +Dosage Form + Strength Rivroxa 2.5 mg Tablet
Diary No. Date of R& I & fee Each Film Coated Tablet Contains:-
Rivaroxaban …2.5 mg
Pharmacological Group Antithrombotic
Type of Form Form-5
Finished product Specifications As per innovator
Pack size & Demanded Price 1x10’s / 3x10’s (As Per SRO)
Approval status of product in Reference Xareltto (ANSM, France)
Me-too status NA
concludes that firm is following the GMP guidelines.
Remarks of the Evaluator Evidence of me too can’t be verified
Previous Decision Deferred in 274th meeting for evidence of me-too status.
Evaluation by PEC The firm has submitted evidence of me-too reference
“Xarelto 2.5mg By M/s. Bayer Pakistan (Pvt) Limited,
Karachi, (Reg # 074794)”.
Panel Inspection on 14-01-2017, No observations as
informed by QA.
382. Name and address of manufacturer / M/s. Pharmevo (Private) Limited, Plot A-29, North
Brand Name +Dosage Form + Strength Evofix Tablet 200mg
Cefixime as trihydrate…200mg
Diary No. Date of R& I & fee 714, 29-04-2016, Rs. 20,000/- (28-04-2016)
Type of Form Form 5
Approval status of product in Reference Suprax 200 mg Film coated
Me-too status Fedxime by Fedro
GMP status  Last inspection conducted on 27.01.17 and report
concludes that overall compliance status is found
competing well within prevailing bracket of acceptable
compliance level.
 Present in USFDA and MHRA as film coated.
Previous Decision Deferred in 274th meeting for the clarification of dosage
form as reference product is available as film coated tablet
whereas firm has applied with uncoated tablet.
Evaluation by PEC  The firm has submitted revised technical documents
for applied formulation as Film Coated Tablet same as
reference country.
 Firm has submitted fee for revision of formulation
details of which are as under:
Rs. 5000/- (Challan No. 0730111 dated 31-01-2018)
Rs. 15,000/- (Challan No. 0015351 dated 31-01-2018)
Decision: Approved
383. Name and address of manufacturer / M/s Martin Dow Ltd, Plot No. 37, Sector 19, Korangi
Applicant Industrial Area Karachi
Brand Name +Dosage Form + Strength Toradol Tablet
Composition Each Film Coated Tablet Contain:
Ketorolac tromethamine….10mg
PKR 20,000/-: 4-11-2015
Pharmacological Group Anti-inflammatory and ant rheumatic product
Type of Form Form 5
Pack size & Demanded Price 10’s, 20’s, 30’s: As per PRC
Approval status of product in Reference Ketorolac by Teva
Me-too status Could not be confirmed
GMP status Last inspection report dated 7, 8 June 2017 confirms good
compliance to GMP
Remarks of the Evaluator Me-too status could not be confirmed
Previous Decision Deferred in 273rd meeting for submission of evidence of
me-too status
Evaluation by PEC The firm has submitted me-too reference “Kelac tablet of
Rotex pharma (Reg # 060804)” which was confirmed from
276th minutes of Registration Board.
Decision: Approved
384. Name and address of manufacturer / M/s. Polyfine ChemPharma, 51-Industrial Area,
Applicant Hayatabad Peshawar
Brand Name +Dosage Form + Strength Ozem 40 mg Capsules
Composition Each capsule contains;
Omeprazole (as enteric coated pellets 8.5%)…....40mg
Pharmacological Group PPI
Type of Form Form 5
Approval status of product in Reference Omeprazole by Actavis
Me-too status Xempra 40mg Capsule by Genome Pharmaceutical
GMP status GMP Inspection Date: 17-03-2017, Satisfactory
Remarks of the Evaluator Source, COA, stability study data and GMP of
Evaluation by PEC Source of pellets: Pharmagen Ltd, Lahore
Pellet details have been submitted.
Decision: Deferred for evidence of approval of manufacturing facility of M/s Pharmagen for
Omeprazole Delayed release pellets by CLB.
385. Name and address of manufacturer / M/s. Polyfine Chempharma, 52-Hayatabad Industrial
Applicant Estate, Peshawar
Brand Name +Dosage Form + Strength Doxofid Syrup 100mg/5ml
Composition Dy. No.543, R&I Dated 28-11-14, Rs. 20,000
Doxofylline…………….100mg
Pharmacological Group Anti-Asthmatic
Type of Form Form 5
Finished product Specifications Reference not provided
Pack size & Demanded Price 60ml, 120ml glass bottles,As per SRO
Approval status of product in Reference
Not provided
Me-too status Profylline Syrup by Kaizen (R. No. 0737449)
GMP status GMP inspection date:17-03-2017, Satisfactory
Remarks of the Evaluator  Not found in reference regulatory authority.
Previous Decision Deferred in 270th meeting for confirmation of approval
status in reference regulatory authorities.
Evaluation by PEC The approval status of applied formulation has been
verified in Italy AIFA. The description of formulation is as
under
200mg / 10ml syrup
100 ml of syrup contain:
Active principle
Doxofillline………2g
Excipients
Sucrose, ethyl alcohol, methyl p-hydroxybenzoate, mint
essence, glycontrinated ammonium,
purified water as required
https://farmaci.agenziafarmaco.gov.it/bancadatifarmaci/far
maco?farmaco=033876 (Accessed on: 24-01-2017)
386. Name and address of manufacturer / M/s Barrett Hodgson (Pvt) Ltd, F-423, S.I.T.E., Karachi;
Applicant Contract manufactured by Nabiqasim Industries (Pvt) Ltd,
17/24, Korangi Industrial Area, Karachi.
Brand Name +Dosage Form + Strength Acireg I.V. Injection(for infusion) 40mg
Esomeprazole Sodium equivalent to Esomeprazole (as
lyophilized powder for
injection)…………….………..40mg
Type of Form Form-5
Finished product Specifications Innovators’ specifications
Pack size & Demanded Price 1’s; Rs.350/- or as per PRC
Approval status of product in Reference USFDA Approved
Me-too status Nexum IV 40mg infusion of M/s Getz Pharma
(Reg.#050651)
GMP status Last inspection report of M/s Barrett Hodgson is of 02-02-
2016 in which renewal of DML has been granted while the
report of M/s Nabiqasim Industries is dated as 03-08-2017
and the report concludes acceptable level of GMP
compliance.
Remarks of the Evaluator i. The applicants’ firm has eleven approved sections.
ii. The already approved drugs on contract
manufacturing are four.
iii. The manufacturers’ firm does possess the
lyophilized/vial general section/facility.
Previous Decision Deferred in 273rd meeting for clarification from QA&LT
Division regarding GMP status of the firm in the light of
observations made by the panel of inspection.
Evaluation by PEC QA & LT vide letter No.F4-4/89-QA (Vol-I) dated 18-01-
2018 informed that the firm M/s. Nabiqasim Industries
(Pvt) Ltd was considered to be operating at acceptable
level of compliance of GMP requirements as per panel
inspection reports dated 03-08-2017 and 16-11-2017.
Sr. Name of Brand Name Dy No. Internation Decision of Evaluation by Decisio of 278th
No the Firm Composition Date al Previous PEC meeting
Finished Pack Size availability meeting
Product Specs and Price Me-too
status
GMP
Status and
date
387. M/s Swiss Spasno 40mg 11-01-11 Spasfon – Deferred as Firm has Approved with
Pharmaceu Injection Dy.No.87 France product is under submitted master Innovator’s
ticals Each 4ml Form 5 Spasfon – review and fee formulation, specifications.
(Pvt.) Ltd, contains:- Rs.8000/- Himont challan method of Reference will be
A/159, Hydrated Rs.12,000/ (M-260) manufacturing sent to Budget &
S.I.T.E, Phloroglucinol. - Last and complete Accounts Division
Super 40mg 05-2-2013 inspection Keeping in view Form 5 for the for verification of
Highway, Trimethylphloro (Photocopy report the approval said product. challan and Board
Karachi glucinol 0.04mg ) dated status of above authorized its
Priority # (Anti Pack size 15-09- formulations in Chairman for the
1060 Spasmodic) 2017 ANSM France issuance of
Manufacture per PRC confirms the Registration registration letter.
Specification good Board approved
complianc the above
e to GMP formulation of
Phloroglucinol
40mg/Trimethyl
phloroglucinol
0.04mg injection
and deferred all
the cases for
evaluation as per
the checklist
approved in
st
251 meeting
(M-268)
388. M/s. Olive Febres 2.5mg Form 5 GMP Deferred for The firm has Registration
Laboratori Tablets Fast Track inspection clarification for submitted copy Board approved
es, 52-S6 Each film As per within last requirement of of inspection registration of
National coated Tablet SRO 30’s 1 year manufacturing report conducted product in general
Industrial contains: Dy.3260 could not for product. on 01-08-2017, manufacturing
Zone, Letrozole 21-5-2013 be (M-242). the firm was areas with
Rawat, ..2.5mg Rs.60,000/ confirmed Deferred in 275th considered to be condition that
Rawalpind Non-steroidal - meeting for operating at a manufacturer shall
i aromatase submission of good level of provide safety and
inhibitor latest GMP GMP as of today. protective
inspection report However, measures for
conducted suggestions for workers and
within a period improvement personnel which
of last 1 year by have been agreed remain in direct
DRAP. upon by the contact or are
management. involved in close
handling of these
drugs.
389. M/s Sami Cynfo 1g IV 31-10-2011 Deferred in 260th The reference of Approved with
Pharmaceu Injection Dy.No.283 meeting for applied innovator’s
ticals Each Rs.8000/- confirmation of formulation has specification
(Pvt.) Ltd, combination Rs.l2,000/- Firm is approval status been verified
th st
Minutes for 278 Meeting of Registration Board (29-31 January, 2018), DRAP | 186
F-95, Off. pack contains: 31-07-2013 GMP by reference from ANSM.
Hub River Sterile powder (Photocopy compliant regulatory Fosfocine 1g IV
Road, of fosfomycin ) as per authorities and powder for
S.I.T.E, sodium eq. to Rs. 110/- inspection Pakistan and fee solution for
Karachi Fosfomycin…. per vial dated 03- challan infusion.
…1g 11-2015
Focin 1g IV of
M/s. Tabros
(Reg # 017677).
Inspection 04-
05-2017, The
firm was
considered to be
operating at
Good level of
compliance.
390. M/s Avograf 1mg Form 5 Astagraf by Deferred in Registration Registration Board
Genome Capsules 18-6-2012 Astellas 264th meeting Board in 271st approved
Pharmaceu Each capsule Dy No. 483 (USFDA). for meeting registration of
ticals, contains:- Rs.8000/- confirmation of decided to grant product in general
Hattar Tacrolimus Rs.12,000/- manufacturing registration of manufacturing
………..1mg 26-11-2014 facility. these products areas with
Immunumodula 10’s Inograf by in general condition that
tor (Calcineurin As Per Platinum manufacturing manufacturer shall
inhibitor) SRO areas with provide safety and
condition that protective
Manufacturer’s Last manufacturer measures for
Specs inspection shall provide workers and
report safety and personnel which
29-08-2016 protective remain in direct
The firm measures for contact or are
has overall workers and involved in close
improved personnel handling of these
GMP which remain in drugs.
direct contact or
are involved in
close handling
of these drugs.
Panel
Inspection on
14-01-2017, No
observations as
informed by
QA.
391. M/s Avograf 5mg Form 5 Astagraf by Deferred in Registration Registration Board
Genome Capsules 18-6-2012 Astellas 264th meeting Board in 271st approved
Pharmaceu Each capsule Dy No. 551 (USFDA). for meeting registration of
ticals, contains:- Rs.8000/- confirmation of decided to grant product in general
Hattar Tacrolimus Rs.12,000/- Inograf by manufacturing registration of manufacturing
………..5mg 26-11-2014 Platinum facility. these products areas with
10’s in general condition that
(Calcineurin As Per Last manufacturing manufacturer shall
inhibitor) SRO inspection areas with provide safety and
report 29- condition that protective
Manufacturer’s 08-2016 manufacturer measures for
Specs The firm shall provide workers and
has overall safety and personnel which
improved protective remain in direct
GMP measures for contact or are
workers and involved in close
personnel handling of these
which remain in drugs.
direct contact or
are involved in
close handling
of these drugs.
Panel
Inspection on
14-01-2017, No
observations as
informed by
QA.
392. M/s Mexate 10mg Form-5 Mextrex Deferred for Registration Registration Board
Genome Tablet Dy. No: (Pfizer Ltd) requirement Board in 271st deferred the case
Pharmaceu Each film 2746 MHRA of anticancer meeting for further
ticals, coated tablet dated. Cytotrexate tablet decided to grant deliberation
Hattar contains: 11.04.2013 (LCPW, section. registration of regarding
Methotrexate Rs.20,000/- Lahore) these products manufacturing
…… 10mg As per PRC in general facility for
(Methotrexate is 10’s manufacturing Cytotoxic drugs
a folic acid areas with
antagonist and condition that
is classified as manufacturer
an shall provide
antimetabolite safety and
cytotoxic agent) protective
(USP specs) measures for
workers and
personnel
which remain in
direct contact or
are involved in
close handling
of these drugs.
Panel
Inspection on
14-01-2017, No
observations as
informed by
QA.
393. M/s Mexate 2.5mg Form-5 Mextrex Deferred for Registration Registration Board
Genome Tablet Dy. No: (Pfizer Ltd) requirement Board in 271st deferred the case
Pharmaceu Each film 2745 MHRA of anticancer meeting for further
ticals, coated tablet dated. Cytotrexate tablet decided to grant deliberation
Hattar contains: 11.04.2013 (LCPW, section. registration of regarding
Methotrexate Rs.20,000/- Lahore) these products manufacturing
…… As per PRC in general facility for
2.5mg 100’s manufacturing Cytotoxic drugs
(cytotoxic areas with
antimetabolite) condition that
manufacturer
shall provide
safety and
protective
measures for
workers and
personnel
which remain in
direct contact or
are involved in
close handling
of these drugs.
Panel
Inspection on
14-01-2017, No
observations as
informed by
QA.
394. M/s BRONCHS Form 5 Not found Deferred for The approval Approved with
Genome 200mg Sachet Dy No. 166 in confirmation of status of innovator’s
Pharmaceu Each sachet dated reference formulation in applied specification
ticals, contains: 10.03.2015 agencies. reference drug formulation has
Hattar Acetylcysteine 20000/- Mucolator agencies. been confirmed
…………...200 As per (Abbott as
S.I.T.E. mg SRO/ Laboratories “Acetylcysteine
16/I, Phase (Mucolytic 30’s ) 200 mg Powder
IV, Agent) Inspection For Oral
Industrial (Manufacturer of the Solution of
Estate specs) firm was NTC S.r.l., Italy
Hattar carried (MHRA)” also
Pakistan out on 10- approved in
04-15 276th meeting.
(Sachet by the area
General) FID
Letter No. by nothing
F.3- was
7/95-Lic reported in
(Vol-I) violation of
dated GMP.
07-04-15
Evaluator PEC-II
395. Name and address of manufacturer / M/s Tabros Pharma Pvt Ltd, Karachi.
Applicant
Brand Name +Dosage Form + Strength Topmus Ointment 0.03%
Tacrolimus (as monohydrate) ………0.03%w/w
Diary No. Date of R& I & fee Dy. # 328 dated 28-10-2013 ; Rs 20,000/-
Pharmacological Group Immunosuppressant
Type of Form Form 5
Finished product Specification Manufacturer’s specification
Pack size & Demanded Price Rs180/5gm; Rs.350/10gm
Me-too status Limus 0.03% Ointment by NabiQasim Industries
(Reg.#055577)
GMP status GMP dated 17-05-2017 with Good compliant status
Previous remarks of the Evaluator.
Previous decision Deferred in 258th meeting of Registration Board for the
finalization of required manufacturing facility
Evaluation by PEC Firm has referred to 271st meeting of Registration Board
wherein the Board decided to grant registration of above
applied products in general manufacturing areas with
protective measures for workers and personnel which remain
in direct contact or are involved in close handling of these
drugs.
Decision: Registration Board approved registration of product with in general manufacturing
areas with condition that manufacturer shall provide safety and protective measures for workers
and personnel which remain in direct contact or are involved in close handling of these drugs.
396. Name and address of manufacturer / M/s Tabros Pharma Pvt Ltd, Karachi.
Applicant
Brand Name +Dosage Form + Strength Topmus Ointment 0.1%
Tacrolimus (as monohydrate)…………0.1%w/w
Diary No. Date of R& I & fee Dy. # 327 dated 28-10-2013 ; Rs 20,000/-
Pharmacological Group Immunouppressant
Type of Form Form 5
Pack size & Demanded Price Rs. 3250/30gm
Rs.1200/10gm
Me-too status Limus 0.1% Ointment by NabiQasim Industries
(Reg.#045215)
GMP status GMP dated 17-05-2017 with Good compliant status
Previous remarks of the Evaluator.
Previous decision Deferred in 258th meeting of Registration Board for the
finalization of required manufacturing facility
Evaluation by PEC Firm has referred to 271st meeting of Registration Board
wherein the Board decided to grant registration of above
applied products in general manufacturing areas with
protective measures for workers and personnel which remain
in direct contact or are involved in close handling of these
drugs.
Decision: Registration Board approved registration of product with in general manufacturing
areas with condition that manufacturer shall provide safety and protective measures for workers
and personnel which remain in direct contact or are involved in close handling of these drugs.
397. Name and address of manufacturer / M/s. Unison Chemical Works, Post Office Araian, 15 Km,
Applicant Raiwind Road, Lahore.
Brand Name +Dosage Form + Strength Samtek 75mg Tablets
Composition Each modified release tablet contains:-
Diclofenac Sodium (as Delayed release core) ….75mg
Misoprostol....200mcg
Diary No. Date of R& I & fee Dy. # 154 dated 10-09-2013 ; Rs 60,000/- (09-09-2013)
Pharmacological Group NSAID/Prostagalandin analouge
Type of Form Form 5 (Fast Track)
Pack size & Demanded Price Rs. 239/- per 20’s
Me-too status Cytopan-75 Tablets of M/s Ointment by Getz Pharma
Pakistan (Pvt) Ltd (Reg.#024014)
GMP status GMP dated 12-07-2017 concluding fair level of compliance.
Previous remarks of the Evaluator. General tablet section available as per inspection report
dated 21/06/2013
Previous decision Deferred in 242nd meeting of Registration Board for the
finalization of required manufacturing facility for PSI for ,
confirmation of manufacturing and storage facility and
submission of following:
1. Manufacturing method is incomplete. A detailed stepwise
method including precautions / controls required to produce
specified quantities of the drug and demonstration of
cleaning validation procedures. 2. The product has to be
formulated with an inner enteric coated (Delayed release)
tablet and an outer immediate release layer. Hence the
description, master formulation and manufacturing method
is required accordingly. Evidence of availability of requisite
manufacturing equipment is also required
Evaluation by PEC Firm has submitted following:
i. Master formulation & manufacturing method for
applied formulation describing the formulation as an
inner enteric coated (Delayed release) tablet of
Diclofenac sodium with an outer immediate release
layer Misoprostol.
ii. Firm has submitted copy of inspection report dated
13-08-2015, confirming the installation of double
compression machine.
iii. Firm has also referred to their already registered
product of similar formulation with different
strength. i.e. Samotec 50mg (Reg.# 036197)
Decision: Approved with USP psecifications
398. Name and address of manufacturer / M/s Jaens Pharmaceutical Industries (Pvt) Ltd., Sheikhupura
Applicant
Brand Name +Dosage Form + Strength Recon Capsule
Composition Each Capsule Contains: Itraconazole…….100mg
Diary No. Date of R& I & fee Dy. No. 634, dated 19-02-2014;Rs. 20,000/-
Type of Form Form 5
Finished product Specification Manufacturer specification
Pack size & Demanded Price 1x4’s blister / As fixed by Govt.
Approval status of product in ZEGERID (USFDA Approved)
Me-too status Rolac Capsule by M/s Sami.
GMP status Inspection Date 28-09-2016
GMP status:Submit compliance within 15 days time period,
so that follow up inspection could be carried out
Previous remarks of the Evaluator. Firm has submitted source of M/s Vision Pharmaceuticals
for itraconazole pellets and has submitted all relevant
documents.
Previous decision Deferred in 274th meeting of Registration Board for
submission of latest inspection report conducted within one
year by DRAP.
Evaluation by PEC Firm has submitted copy of GMP inspection report
conducted on 20-12-2017, concluding satisfactory GMP
compliant status.
399. Name and address of manufacturer / M/s. Jaens Pharmaceutical Industries (Pvt) Ltd, Sheikhupura
Applicant
Brand Name +Dosage Form + Strength Bepirox Capsule
Piroxicam…....20mg
Diary No. Date of R& I & fee Dy. No: 631 dated. 19-02-2014; Rs.20,000/- 19-02-2014
Pharmacological Group Nonsteroidal anti-inflam drug
Type of Form Form-5
Pack size & Demanded Price 1x10’s;As per SRO
Approval status of product in Feldene Capsules by Pfizer (UK)
Me-too status Pirobet capsules by Highnoon Labs.
GMP status:
Submit compliance within 15 days time period, so that
follow up inspection could be carried out.
Previous remarks of the Evaluator.  Following reference stated by firm has been verified:
“FELDENE 20mg CAPSULES approved by MHRA of
UK.”
 Firm has submitted revised master formulation
mentioning composition same as that of above cited
reference product.
 Revised composition submitted by firm is as under:
“Each capsule contains:-
Piroxicam …....20mg”
Previous decision Deferred in 273rd meeting of Registration Board for
submission of fee of Rs. 20,000 for application of revised
formulation of “Piroxicam 20mg capsules.”
Evaluation by PEC  Firm has submitted original fee challan of Fee
Rs.20,000/- (Challan No. 0526987) dated 19-09-2017.
 Firm has submitted copy of GMP inspection report
compliant status.
Decision: Approved.
400. Name and address of manufacturer / M/s. Jaens Pharmaceutical Industries (Pvt) Ltd, Sheikhupura
Applicant
Brand Name +Dosage Form + Strength Betaphos-N (Eye, Ear, Nose) Drops
Composition Each ml contains:-
Betamethasone sodium phosphate eq. to Betamethasone
…………….0.1%
Neomycin sulphate…………0.5%
Diary No. Date of R& I & fee Dy. No: 1129 dated. 28-04-2015; Rs.20,000/-
Pharmacological Group Corticosteroid/Antibiotic
Type of Form Form-5
Finished product Specification Manufacturer specifications
Pack size & Demanded Price 7.5 ml; As per SRO
Approval status of product in Betnesol-N drops approved by MHRA of UK
Me-too status Betatek-N by M/s Innvotek Pharmaceutical
GMP status:
Submit compliance within 15 days time period, so that
follow up inspection could be carried out.
Previous remarks of the Evaluator.  Firm has submitted revised master formulation
mentioning composition same as that of above cited
reference product.
 Revised composition submitted by firm is as under:
“Each ml contains:-
Betamethasone sodium phosphate eq. to Betamethasone
…....0.1%
Neomycin sulphate…………0.5%”
Previous decision Deferred in 273rd meeting of Registration Board for
submission of fee of Rs. 20,000 for application of revised
formulation.
Evaluation by PEC  Firm has submitted original fee challan of Fee
Rs.20,000/- (Challan No. 0526988) dated 19-09-2017.
 Firm has submitted copy of GMP inspection report
compliant status.
Case No. 03: Registration applications of newly granted DML or New section (Human)
a) New DML
Evaluator PEC-XII
Case No.01. M/s Pharmasol (Pvt) Ltd., Lahore. (New Licence).
The firm has been granted approval of new DML by way of formulation by Central Licensing Board in its
256th meeting for following sections:
1. Diluents and water for Injection (Human)
2. Tablet (Anti-Cancer) (Human)
3. Capsules (Anti-Cancer) (Human)
4. Liquid Injection (Anti-Cancer) (Human)
5. Tablets-1( General) (Human)
6. Capsules-1( General) (Human)
7. Syrup( General) (Human)
8. Liquid Injection (General) (Human)
9. Dry Powder Injection (General) (Human)
10. Liquid Ampoules (General) (Human)
11. Tablets-2 (General) (Human)
12. Capsules-2 (General) (Human)
13. Lotion (General) (Human)
14. Cream/Ointments/Gels (General) (Human)
15. Dry Powder Suspension (General) (Human)
16. Dry Powder Sachets (General) (Human)
17. Eye Drops (General) (Human)
18. Capsules (Cephalosporin) (Human)
19. Dry Powder Suspensions (Cephalosporin) (Human)
20. Dry Powder Injections (Cephalosporin) (Human)
21. Dry Powder Injections (Carbapenem) (Human)
22. Tablets (Hormone) (Human)
23. Capsules (Hormone) (Human)
24. Ampoules (Hormone) (Human)
25. Steroid Creams/Ointments/Gels (Human)
26. Liquid Vials and Ampoules (Steroid) (Human)
27. Dry Powder Vials (Steroid) (Human)
The following applications have been evaluated and presented before the Board
S. No. Section No. Products No. of Molecules
1 Diluents and water for Injection (Human) 07 05
2 Tablet (Anti-Cancer) (Human) - -
3 Capsules (Anti-Cancer) (Human) - -
4 Liquid Injection (Anti-Cancer) (Human) - -
5 Tablets-1( General) (Human) 14 10
6 Capsules-1( General) (Human) 16 10
7 Syrup( General) (Human) 10 10
8 Liquid Injection (General) (Human) 14 10
9 Dry Powder Injection (General) (Human) 13 10
10 Liquid Ampoules (General) (Human) 11 10
11 Tablets-2 (General) (Human) 22 10
12 Capsules-2 (General) (Human) 18 10
13 Lotion (General) (Human) 10 10
14 Cream/Ointments/Gels (General) (Human) 10 10
15 Dry Powder Suspension (General) (Human) - -
16 Dry Powder Sachets (General) (Human) - -
17 Eye Drops (General) (Human) - -
18 Capsules (Cephalosporin) (Human) - -
19 Dry Powder Suspensions (Cephalosporin) - -
(Human)
20 Dry Powder Injections (Cephalosporin) - -
(Human)
21 Dry Powder Injections (Carbapenem) (Human) 05 03
22 Tablets (Hormone) (Human) 10 10
23 Capsules (Hormone) (Human) 02 02
24 Ampoules (Hormone) (Human) 10 10
25 Steroid Creams/Ointments/Gels (Human) - -
26 Liquid Vials and Ampoules (Steroid) (Human) - -
27 Dry Powder Vials (Steroid) (Human) - -
Diluents and water for Injection (Human)

07 Products / 05 Molecules
401. Name and address of manufacturer / M/s Pharmasol (Pvt) Ltd. Plot No. 549, Sundar Industrial
Applicant Estate, Raiwind Road, Lahore.
Brand Name +Dosage Form + Strength PSOL Sterile water for injection 5ml
Diary No. Date of R& I & fee Diary No: 24154, 13-12-2017, Rs: 20,000/-
Composition Each Ampoule Contain
Sterile water for injection (as diluent)
Pharmacological Group Diluent/Solvent for Reconstitution
Type of Form Form-5
Pack size & Demanded Price 5ml ampoule/ As per SRO
Approval status of product in Reference Water for Injections by M/s Macarthys Laboratories
Regulatory Authorities. Limited (MHRA approved )
Me-too status Sterile water for injection 5ml by M/s Getz Pharma (Reg.
No. 053041)
GMP status 13-07-2017; Grant of new DML,
Panel recommends grant of new DML.
Decision: Deferred for confirmation whether manufacturing facility of “Diluents and water for
Injection (Human)” is approved for “Ampoules” or “Vials”.
Brand Name +Dosage Form + Strength PSOL Sterile water for injection 20ml
Diary No. Date of R& I & fee Diary No: 24155 ,13-12-2017 , Rs: 20,000/-
Composition Each Vial Contains:
Sterile water for injection….20ml
Type of Form Form-5
Pack size & Demanded Price 1’s vial x 20ml / As per SRO
Approval status of product in Reference Water for Injections BP by M/s Hameln Pharmaceuticals
Regulatory Authorities. Limited (MHRA Approved)
Me-too status Sterile water for injection by Mendoza pharma (Reg. No.
058646) 20ml
Brand Name +Dosage Form + Strength NSOL 0.9% W/V Solution for Injection
Diary No. Date of R& I & fee Diary No: 24156 , 13-12-2017 , Rs: 20,000/-
Sodium chloride…9mg
Type of Form Form-5
Pack size & Demanded Price 5ml ampoule/ As per SRO
Approval status of product in Reference Sodium Chloride Injection BP 0.9% w/v by M/s Hameln
Regulatory Authorities. pharmaceuticals limited (MHRA Approved)
Me-too status Sacro Injection (0.9%w/v) 5ml by M/s Macter
(Reg#079756)
Brand Name +Dosage Form + Strength Bensol(Bacteriostatic Water) for injection
Composition Each ml of sterile water contains:
Benzyl alcohol …….9mg
Type of Form Form-5
Pack size & Demanded Price 1’s ampoule x 7.8ml/ As per SRO
Approval status of product in Reference Bacteriostatic Water for Injections by M/s Pfizer Limited
Regulatory Authorities. (MHRA Approved) (1 ml pre-filled syringe)
Me-too status Bacteriostatic water 7.8ml by M/s Upjohn (Reg#031265)
Remarks of the Evaluator.  Applied pack size of 7.8ml ampoule not confirmed
from Reference Regulatory Authorities.
Registration Board also directed the firm to declare the Drug product for which this applied
diluent will be used.
Brand Name +Dosage Form + Strength SBSOL Diluent (Bacteriostatic saline)
Sodium chloride…9mg
Benzyl alcohol…9mg
Pharmacological Group Diluent
Type of Form Form-5
Pack size & Demanded Price 1ampoule x 5ml/ As per SRO
Approval status of product in ReferenceBacteriostatic sodium chloride solution
Regulatory Authorities. Hospira (USA/EU)
Me-too status Bacteriostatic Sodium chloride Injection by M/s Spencer
Pharma (Reg#042113)
Remarks of the Evaluator. Applied pack size of 5ml ampoule not confirmed from
Reference Regulatory Authorities. & me-too database.
Registration Board also directed the firm to declare the Drug product for which this applied
diluent will be used.
Brand Name +Dosage Form + Strength Diluent For Dotaxol 20mg
Ethanol 95%.…………..13%(V/V)
Water for Injection………..87%(V/V)
Type of Form Form-5
Finished Product Specification Innovator's specifications
Pack size & Demanded Price 1’sx1.5ml / As per SRO
Approval status of product in Reference Taxotere solvent by Sanofi-Aventis (Canada Approved)
Me-too status Diluent for Meberexel 20mg by M/s CCL
Pharmaceuticals 1.5ml (Reg#045609)
Brand Name +Dosage Form + Strength Diluent For Dotaxol 80mg
Ethanol 95%.BP…………..13%(V/V)
Water for Injection………..87%(V/V)
Type of Form Form-5
Pack size & Demanded Price 1’sx6ml / As per SRO
Approval status of product in Reference Taxotere solvent by Sanofi-Aventis (Canada Approved)
Me-too status Diluent for Meberexel 80mg by M/s CCL
Pharmaceuticals 6ml (Reg#045607)
Tablets-1(General) (Human)
14 products / 10 molecules
408. Name and address of manufacturer / M/s Pharmasol (Pvt) Ltd.Plot No. 549, Sundar
Applicant Industrial Estate, Raiwind Road, Lahore.
Brand Name +Dosage Form + Strength Diamin Tablet 50/500mg
Sitagliptin as phosphate monohydrate…50 mg
Pharmacological Group Ant diabetic (dipeptidyl peptidase-4 inhibitor (DPP-4)
and biguanide)
Type of Form Form-5
Finished Product Specification Innovator’s Specifications
Pack size & Demanded Price 10’s, 14’s, 30’s /As per SRO
Regulatory Authorities. (USFDA approved)
Me-too status Treviamet 50mg/500mg Tablets by M/s GETZ Pharma
Pakistan (Reg# 055443)
409. Name and address of manufacturer / M/s Pharmasol (Pvt) Ltd. Plot No. 549, Sundar
Brand Name +Dosage Form + Strength Diamin – M Tablet 50/1000mg
Sitagliptin as phosphate monohydrate…50 mg
Pharmacological Group Ant diabetic (dipeptidyl peptidase-4 inhibitor (DPP-4)
and biguanide)
Type of Form Form-5
Pack size & Demanded Price 10’s, 14’s, 30’s / As per SRO
Me-too status Treviamet 50mg/1000mg Tablets by M/s GETZ Pharma
Pakistan. (Reg# 055444)
Brand Name +Dosage Form + Strength Sitab Tablets 50mg
Pharmacological Group (Anti-hyperglycemic)
Dipeptidyl Peptidase-4 Inhibitor
Type of Form Form-5
Pack size & Demanded Price 10’s, 14’s, 30’s, / As per SRO
Approval status of product in Reference Ristaben 50 mg Film Coated Tablet by M/s Merck
Regulatory Authorities. Sharp and Dohme Limited (HPRA, Ireland Approved)
Me-too status Sitaglu 50mg tablets by Hilton Pharma (Reg. No.
055159)
Decision: Approved
Brand Name +Dosage Form + Strength Sitab Tablets 100mg
Pharmacological Group (Anti-hyperglycemic)Dipeptidyl Peptidase-4 Inhibitor
Type of Form Form-5
Pack size & Demanded Price 10’s, 14’s, 30’s, / As per SRO
Approval status of product in Reference Ristaben 50 mg Film Coated Tablet by M/s Merck
Regulatory Authorities. Sharp and Dohme Limited (HPRA, Ireland Approved)
Me-too status Sitaglu tablets by Hilton Pharma (Reg. No.055160)
Decision: Approved
Brand Name +Dosage Form + Strength Linzol Tablet 600mg
Diary No. Date of R& I & fee Diary No: 24099, 13-12-2017 , Rs: 20,000/-
Linezolid…600mg
Pharmacological Group Oxazolidone Antibiotic
Type of Form Form-5
Finished Product Specification Innovator’s specifications
Pack size & Demanded Price 12’s/ As per SRO
Approval status of product in Reference Zyvox 600 mg film-coated tablets by M/s Pharmacia
Regulatory Authorities. Limited, MHRA approved.
Me-too status Ecasil 600mg tablet by M/s Sami (Reg#066904)
Brand Name +Dosage Form + Strength Bandron Tablets 150mg
Ibandronate (as sodium monohydrate)…150mg
Pharmacological Group Bisphosphonates
Type of Form Form-5
Approval status of product in Reference Boniva 150mg film coated Tablets ByM/s Genentech
Regulatory Authorities. Inc. A Member Of Rosche Group South San Francisco
California, (USFDA Approved)
Me-too status Boonest 150mg Tablet by Barret Hodgson (Reg.
No.075856)
Brand Name +Dosage Form + Strength Febux Tablet 40mg
Febuxostat…40mg
Type of Form Form-5
Pack size & Demanded Price 20’s, 30’s/ As per SRO
Approval status of product in Reference Uloric 40mg film coated tablet by M/s Takeda
Regulatory Authorities. Pharmaceuticals America, Inc. (USFDA Approved)
Me-too status Febstat 40mg Table by Pharmatec Pak (Reg.
No.073775)
Brand Name +Dosage Form + Strength Febux Tablet 80mg
Febuxostat…80mg
Type of Form Form-5
Approval status of product in Reference Uloric 80mg film coated tablet by M/s Takeda
Regulatory Authorities. Pharmaceuticals America, Inc. (USFDA Approved)
Me-too status Febuxin 80mg Tablet by AGP Pvt. Ltd ( Reg. No.
081105)
Brand Name +Dosage Form + Strength Lonox Tablets 8mg
Lornoxicam...8mg
Type of Form Form-5
Pack size & Demanded Price 10’s / As per SRO
Approval status of product in Reference Xefo 8 mg Filmtabletten by M/s Takeda Pharma AG,
Regulatory Authorities. (Swiss Medic approved)
Me-too status Acabel 8mg Tablet by M/s Continental Pharma
(Reg No:061604)
GMP status 13-07-2017;
Grant of new DML,
Brand Name +Dosage Form + Strength Tramacet Tablets 37.5mg/325mg
Tramadol...37.5mg
Paracetamol ...325mg.
Pharmacological Group Opioids Analgesic, NSAID
Type of Form Form-5
Approval status of product in Reference Tramacet 37.5mg/325mg Film coated tablets by M/s
Regulatory Authorities. Grünenthal Ltd, (MHRA approved)
Me-too status Forgesil Tablet37.5mg/325mg by M/s Foray
(Reg#080874)
Decision: Approved
Brand Name +Dosage Form + Strength Piracet Tablets 800mg
Piracetam…800mg
Pharmacological Group Other psychostimulants and nootropics
Type of Form Form-5
Approval status of product in Reference Nootropil 800 mg film-coated Tablets By UCB Pharma
Regulatory Authorities. Ltd., (MHRA Approved)
Me-too status Troopil Tablets 800 mg by ParamountPharmaceuticals
(Reg. No.066666)
GMP status 13-07-2017
Grant of new DML,
Brand Name +Dosage Form + Strength Deston Tablets 8mg
Ondansetron as ( hydrochloride dihydrate)…8mg
Pharmacological Group Selective Serotonin 5-HT3 Receptor Antagonist
Type of Form Form-5
Approval status of product in Reference Ondansetron 8 mg film-coated tablets by M/s Pfizer
Regulatory Authorities. Limited (MHRA approved)
Me-too status Zofran 8mg tablet by M/s Novartis (Reg#084164).
Decision: Approved
Brand Name +Dosage Form + Strength Refaxol Tablet 200mg
Rifaximin…200mg
Pharmacological Group Intestinal Anti-infective
Type of Form Form-5
Approval status of product in Reference Xifaxanta 200 mg film-coated tablets by Norgine
Regulatory Authorities. Pharmaceuticals Limited (MHRA approved)
Me-too status Rifaxa 200mg Tablets by Ferozsons (Reg . No. 068205)
Brand Name +Dosage Form + Strength Refaxol Tablet 550mg
Rifaximin…550mg
Pharmacological Group Intestinal Anti-infective
Type of Form Form-5
Approval status of product in Reference REFERO 550 mg film-coated tablets by Alfa
Regulatory Authorities. Wassermann S.p.A. (MHRA approved)
Me-too status Rifaxa 550mg Tablets by Ferozsons (Reg . No. 071661)
Capsule-I (General) (Human)
Brand Name +Dosage Form + Strength Gabrix Capsules 25mg
Pregabalin…25mg
Pharmacological Group Anti-epileptic drug /GABA analogue.
Type of Form Form-5
Pack size & Demanded Price 14’s, 28’s /As per SRO
Approval status of product in Reference Lyrica 25mg Capsules M/s by PF Prism (USFDA
Me-too status Dygab 25mg Capsules by M/s Dyson (Reg#079155)
Grant of new DML,
Pregabalin…50mg
Type of Form Form-5
Approval status of product in Reference Lyrica 50mg Capsule by M/s PF Prism CV, (USFDA
Me-too status Gabica 50mg Capsule by M/s Getz Pharmaceuticals.
(Reg#048725)
Diary No. Date of R& I & fee Diary No:24111 , 13-12-2017 , Rs: 20,000/-
Pregabalin…75mg
Type of Form Form-5
Pack size & Demanded Price 14’s, 28’s / As per SRO
Approval status of product in Reference Lyrica 75mg Capsule by M/s PF Prism CV, (USFDA
Me-too status Lyrica 75mg Capsule by M/s Pfizer Pakistan Ltd.
(Reg#044817)
Brand Name +Dosage Form + Strength Corelex Capsule 4mg
Thiocolchicoside…4mg
Pharmacological Group Skeletal Muscle Relaxant
Type of Form Form-5
Pack size & Demanded Price 10’s, 20’s/As per SRO
Approval status of product in Reference Myoplege 4 mg capsule by Laboratories GENEVRIER
Regulatory Authorities. SA (ANSM approved)
Me-too status Muscor 4mg Capsule by M/s Genome Pharmaceuticals
Pvt. Ltd.(Reg#046466)
Grant of new DML,
426. Name and address of manufacturer / M/s Pharmasol (Pvt) Ltd.
Applicant Plot No. 549, Sundar Industrial Estate, Raiwind Road,
Lahore.
Brand Name +Dosage Form + Strength Dulox Capsules 30mg
Enteric `coated Pellets of Duloxetine hydrochloride
equivalent to Duloxetine…30 mg
Pharmacological Group Anti-depressants
Type of Form Form-5
Approval status of product in Reference Cymbalta (Duloxetine 30 mg capsule) by M/s Eli Lilly,
Regulatory Authorities. USFDA
Me-too status Dulan (Duloxetine 30 mg capsule) by M/s Hilton
Pharma.(Reg#055447)
Remarks of the Evaluator. 
Source of pellets Vision Pharmaceuticals,
Islamabad.
 Submitted source of pellets is not of USP grade.
otherwise.
Brand Name +Dosage Form + Strength Dulox Capsules 60mg
Enteric coated Pellets of Duloxetine hydrochloride
Pharmacological Group Anti-depressants
Type of Form Form-5
Approval status of product in Reference Cymbalta (Duloxetine 60 mg capsule) by M/s Eli Lilly,
Regulatory Authorities. USFDA
Pharma.(Reg#055448)
Remarks of the Evaluator.  Source of pellets Vision Pharmaceuticals,
Islamabad.
 Submitted source of pellets is not of USP grade.
otherwise.
Brand Name +Dosage Form + Strength Clindasol Capsules 300mg
Clindamycin (as hydrochloride)…300mg
Pharmacological Group Lincosamide Antibiotic
Type of Form Form-5
Pack size & Demanded Price 16’s, /As per SRO
Approval status of product in Reference Clindamycin 300 mg Capsules by M/s Brown & Burk
Regulatory Authorities. UK Limited (MHRA Approved)
Me-too status Uniclin 300mg Capsule by Kaizen Pharma (Reg.
No.076225)
Decision: Approved
Brand Name +Dosage Form + Strength Sporizol Capsules 100mg
Itraconazole (IR pellets)…100mg
Pharmacological Group Antimycotics for systemic use, triazole derivative
Type of Form Form-5
Pack size & Demanded Price 4’s /As per SRO
Approval status of product in Reference SPORANOX (itraconazole) 100mg Capsules by Janssen
Regulatory Authorities. Pharmaceuticals, Inc (USFDA Approved)
Me-too status Itraval Capsules 100mg by M/s Valor Pharmaceuticals (
Reg. No.65105)
Islamabad.
Brand Name +Dosage Form + Strength Inxamic Capsules 250mg
Tranexamic Acid....250mg
Pharmacological Group Antifibrinolytic
Type of Form Form-5
Approval status of product in Reference Hexatron capsule 250 mg by M/s Nippon Shinyaku Co.,
Regulatory Authorities. Ltd, PMDA Japan
Me-too status Trasamin 250mg Capsule by M/s Hilton Pharma
(Reg#006524)
Decision: Approved
Brand Name +Dosage Form + Strength Inxamic Capsules 500mg
Tranexamic Acid....500mg
Pharmacological Group Antifibrinolytic
Type of Form Form-5
Approval status of product in Reference Caprilon (Finland)/Hexatron (Japan) not confirmed.
(Reg#009730)
Remarks of the Evaluator.  Approval status of product in Reference Regulatory
Authorities not confirmed.
Brand Name +Dosage Form + Strength Tramax Capsule 50mg
Tramadol hydrochloride…50 mg
Pharmacological Group Opiate Analogue
Type of Form Form-5
Approval status of product in Reference Tramadol 50 mg capsules by M/s Milpharm Limited
Regulatory Authorities. (MHRA Approved)
Me-too status Tramal 50mg capsules by M/s Searle (Reg. No.
010170)
Grant of new DML,
Decision: Approved
Brand Name +Dosage Form + Strength Tramax Capsule SR 100mg
Tramadol hydrochloride…100mg
Pharmacological Group Opiate Analogue
Type of Form Form-5
Approval status of product in Reference Tramquel SR 100 mg prolonged-release hard capsules
Regulatory Authorities. by M/s Meda Pharmaceuticals Ltd (MHRA Approved)
Me-too status Zultra SR 100mg capsules by M/s Wilshire Laboratories
(Pvt) Ltd (Reg. No. 080714)
Remarks of the Evaluator.  Source of pellets not submitted by the firm.
Decision: Deferred for source of pellets, along with stability studies data, GMP certificate of
supplier and differential fee in case of import of pellets.
Brand Name +Dosage Form + Strength Luvastin Capsule 20mg
Fluvastatin (as sodium)…20mg
Pharmacological Group Lipid Modifying Agents, Plain (HMG CoA reductase
inhibitors)
Type of Form Form-5
Pack size & Demanded Price 10’s, 14’s, 28’s/ As per SRO
Approval status of product in Reference Fluvastatin 20 mg Hard Capsules by M/s Generics [UK]
Regulatory Authorities. Limited t/a Mylan (MHRA Approved)
Me-too status Lescol 20mg capsule by M/s Novartis (Reg. No.
014959)
Decision: Approved
Brand Name +Dosage Form + Strength Luvastin Capsule 40mg
Fluvastatin (as sodium)…40mg
Pharmacological Group Lipid Modifying Agents, Plain (HMG CoA reductase
inhibitors)
Type of Form Form-5
Approval status of product in Reference Fluvastatin 40 mg Hard Capsules by M/s Generics [UK]
Regulatory Authorities. Limited t/a Mylan (MHRA approved)
Me-too status Lescol 40mg capsule by M/s Novartis (Reg. No.
014960)
Decision: Approved
Brand Name +Dosage Form + Strength Uratim Capsule 0.4mg
Tamsulosin hydrochloride (SR Pellets 0.2%)…0.4 mg.
Pharmacological Group α1-Adrenergic blocking agent
Type of Form Form-5
Approval status of product in Reference Flomax 0.4mg capsule by M/s Boehringer Ingelheim
Regulatory Authorities. Pharmaceuticals (USFDA Approved)
Me-too status Tamflo 0.4mg SR Capsule by M/s Genome
Pharmaceutical (Reg#074562)
Islamabad.
Decision: Approved
Brand Name +Dosage Form + Strength Velna XR Capsules 75mg
Sustained release pellets (33%) of venlafaxine
hydrochloride equivalent to venlafaxine…75mg
Pharmacological Group Serotonin-norepinephrine reuptake inhibitors/ Atypical
Antidepressant.
Type of Form Form-5
Approval status of product in Reference Alventa XL 75mg Capsule by M/s Consilient Health
Regulatory Authorities. Ltd.(MHRA approved)
Me-too status Efexor XR 75mg Capsule by M/s Wyeth Pakistan Ltd.
(Reg#023658)
Remarks of the Evaluator.  Source of pellets Vision Pharmaceuticls, Islamabad.
 Submitted source of Pellets is not of USP grade.
Decision: Deferred for confirmation whether the pellets of Venlafaxine are of USP grade or
otherwise.
Syrup (General) (Human)
438. Name And Address Of Manufacturer / M/S Pharmasol (Pvt) Ltd. Plot No. 549, Sundar
Brand Name +Dosage Form + Strength Proval Syrup 250mg/5ml
Sodium valproate eq to valproic acid…250mg
Pharmacological Group Anti-epileptic / Anti-convulsant
Type of Form Form-5
Pack size & Demanded Price 120ml /As per SRO
Approval status of product in Reference DEPAKENE (valproic acid) oral solution by M/s
Regulatory Authorities. AbbVie Inc, USFDA approved.
Me-too status Epilax Syrup 250mg/5ml by M/s Vision
Decision: Approved
Brand Name +Dosage Form + Strength MANTIN Syrup 10mg/5ml
Memantine hydrochloride …10mg
Pharmacological Group Other anti-dementia drugs
Type of Form Form-5
Approval status of product in Reference NAMENDA (memantine HCl) solution 2mg/ml by M/s
Regulatory Authorities. Forest Pharmaceuticals, Inc (USFDA approved)
Me-too status Zexa 10mg/5ml syrup by English Pharmaceutical
Industries (Reg.No.071544)
Brand Name +Dosage Form + Strength Deston Syrup 4mg/5ml
Ondansetron (as hydrochloride dihydrate)…4mg
Pharmacological Group Selective Serotonin 5-HT3 antagonist.
Type of Form Form-5
Approval status of product in Reference Zofran 4mg/5ml syrup of M/s Aspen Bad Oldesloe
Regulatory Authorities. GmbH (MHRA approved).
Me-too status Dantron 4mg/5ml syrup by M/s Shrooq

Pharmaceuticals.(Reg# 77076)
Decision: Approved
Brand Name +Dosage Form + Strength CALCID oral drops 2mcg/ml
Diary No. Date of R& I & fee Diary No:23998, 13-12-2017 , Rs: 20,000/-
Composition Each ml Contains:
Alfacalcidol…2mcg
Pharmacological Group Vitamin D Analogue
Type of Form Form-5
Pack size & Demanded Price 20ml/As per SRO
Approval status of product in Reference One-Alpha 2 microgram/ml oral drops by M/s LEO
Regulatory Authorities. Laboratories Limited (MHRA Approved)
Me-too status Bioalfa 2mcg/1ml Drops by M/s Nabiqasim Industries
(Reg#044485)
Brand Name +Dosage Form + Strength Ketoresp Syrup 1mg/5ml
Ketotifen (as hydrogen fumarate)…1mg
Pharmacological Group Antihistamine
Type of Form Form-5
Approval status of product in Reference Zaditen 1 mg / 5 ml oral solution by M/s SIGMA TAU,
Regulatory Authorities. (ANSM approved)
Me-too status Zatofen 1mg/5ml Syrup by M/s Novartis (Reg#005804)
443. Name and address of manufacturer / M/S Pharmasol (Pvt) Ltd. Plot No. 549, Sundar
Brand Name +Dosage Form + Strength Pirasol Syrup 1g/5ml
Piracetam…1g
Pharmacological Group Other psychostimulants and nootropics
Type of Form Form-5
Approval status of product in Reference Nootropil 200 mg / ml oral solution by M/s UCB
Regulatory Authorities. Pharma, SA (Spanish Agency for Medicines and Health
Products Approved)
Me-too status Piractim 1g/5ml Syrup by M/s Global/Vision (Reg.
No.038406)
Brand Name +Dosage Form + Strength Freezak Syrup 20mg/5ml
Fluoxetine (as hydrochloride)…20mg
Pharmacological Group Anti-depressant (SSRI-selective serotonin reuptake
inhibitor)
Type of Form Form-5
Approval status of product in Reference Fluoxetine 20mg/5ml Oral Solution by M/s Chemidex
Regulatory Authorities. Pharma Limited (MHRA Approved)
Me-too status Depcure20mg/5ml Syrup by Medicraft (Reg. No.
036370)
Decision: Approved
Brand Name +Dosage Form + Strength Resp Syrup 1mg/ml
Risperidone…1mg
Type of Form Form-5
Pack size & Demanded Price 30ml, 60ml /As per SRO
Approval status of product in Reference Risperidone 1mg/ml Oral solution by Sandoz Limited
Regulatory Authorities. UK (MHRA Approved)
Me-too status Risperdal 1mg/ml syrup by M/s Janssen
(Reg.No.027396)
Decision: Approved
Brand Name +Dosage Form + Strength Neulorax Syrup 0.5mg/ml
Desloratadine…0.5mg
Pharmacological Group Histamine H1-Receptor blocker.
Type of Form Form-5
Approval status of product in Reference AERIUS FOR CHILDREN SYRUP desloratadine
Regulatory Authorities. 2.5mg/5mL oral liquid bottle by M/s Bayer Australia
Ltd (TGA approved)
Me-too status Desora 0.5mg/ml syrup by M/s Continental Pharma.
(Reg# 055192)
Brand Name +Dosage Form + Strength Lactisol syrup 10gm/15ml
Lactitol…10gm
Pharmacological Group Laxative
Type of Form Form-5
Approval status of product in Reference Lactitol Monohydrate by M/s Zambon Schweiz AG
Regulatory Authorities. (Swiss Medica) Switzerland Approved
Me-too status Lacasil By CCL Pharma (Reg. No.070552)
Remarks of the Evaluator.  Evidence of availability of HPLC with RI detector
submitted by firm.
Liquid Injection (General) (Human)
14 Products / 10 molecules
Brand Name +Dosage Form + Strength Typhoxcin Injection 200mg/100ml
Composition Each 100ml vial contains:
Ofloxacin (as hydrochloride)...200mg
Pharmacological Group Quinolone Antibacterial
Type of Form Form-5
Pack size & Demanded Price 1'sx100ml/As per SRO
Approval status of product in Reference Tarivid IV Infusion Solution 2mg/ml by M/s Sanofi,
Regulatory Authorities. MHRA approved
Me-too status Tariflox Infusion 200mg/100ml by M/s Bosch
(Reg#021506)
Remarks of the Evaluator.  Confirmed as glass vial
Decision: Deferred for confirmation whether manufacturing facility of L Liquid Injection
(General) (Human) is approved for “Small Volume Parenterals” or “Large Volume
Parenterals”
Brand Name +Dosage Form + Strength Ciproxol Infusion 200mg/100ml
Ciprofloxacin (as lactate)…200mg
Type of Form Form-5
Approval status of product in Reference Ciprofloxacin 2 mg/ml solution for infusion by M/s
Regulatory Authorities. Hikma Farmacêutica (Portugal), S.A.(MHRA
Approved)
Me-too status Qilox 200mg/100ml Infusion by M/s Bosch
(Reg#073417)
Parenterals”
Brand Name +Dosage Form + Strength Ciproxol Infusion 400mg/100ml
Ciprofloxacin (as lactate)…400mg
Type of Form Form-5
Approval status of product in Reference Cipro IV 400mg Bayer healthcare Pharmaceuticals Inc.
Regulatory Authorities. New Jersey, USA (not confirmed)
Me-too status Novidat DS Injection 400mg/100ml by M/s Sami
Phama (Reg#042270)
Parenterals”.
Brand Name +Dosage Form + Strength Levoxol Infusion 500mg/100ml
Composition Each 100ml vial contains: Levofloxacin (as
hemihydrate)…..500mg
Type of Form Form-5
Approval status of product in Reference Evoxil 5 mg/ml solution for infusion by M/s Beacon
Regulatory Authorities. Pharmaceuticals, (MHRA approved )
Me-too status Lorex Infusion 500mg/100ml by M/s Regal
Parenterals”
Brand Name +Dosage Form + Strength Levoxol Infusion 750mg/150ml
Composition Each 150ml of solution for infusion contains:
Levofloxacin (as hemihydrate)…750mg
Type of Form Form-5
Pack size & Demanded Price 1'sx150ml /As per SRO
Approval status of product in Reference Cravit IV by M/s Daiichi Sankyo, Japan (Pack size of
Regulatory Authorities. 150ml not confirmed from approved website of PMDA)
Me-too status Leflox 750mg/150ml Infusion By Getz Pharma
(Reg.No. 058590),
Remarks of the Evaluator.  Pack size of 150ml and packaging of applied
formulation in vials not confirmed from RRA.
Parenterals”
Brand Name +Dosage Form + Strength M-Flox Infusion 400mg/250ml
Moxifloxacin (as hydrochloride)…400mg
Type of Form Form-5
Pack size & Demanded Price 1'sx250ml /As per SRO
Approval status of product in Reference Avelox 400 mg/250 ml solution for infusion by M/s
Regulatory Authorities. Bayer plc, (MHRA approved)
Me-too status Mofest Infusion 400mg/250ml by M/s Sami
(Reg#053227)
Remarks of the Evaluator.  Confirmed as glass vial from MHRA
Parenterals”
Brand Name +Dosage Form + Strength Linzol Infusion 200mg/100ml
Composition Each 100ml solution for infusion contains:
Linezolid…200mg
Type of Form Form-5
Pack size & Demanded Price 1’sx100ml /As per SRO
Approval status of product in Reference ZYVOX linezolid 200mg/100mL injection infusion bag
Regulatory Authorities. by M/s Pfizer Australia Pty Ltd, (TGA approved.)
Me-too status Ecasil Infusion 200mg/100ml by M/s Sami
(Reg#067516)
Parenterals”
Linezolid…600mg
Type of Form Form-5
Approval status of product in Reference Linezolid 2 mg/ml solution for infusion by M/s Pfizer
Regulatory Authorities. Limited , MHRA approved
Me-too status Zolrest Infusion 600mg/300ml by M/s Bosch
(Reg#055916)

Parenterals”.
Linezolid…400mg
Type of Form Form-5
Approval status of product in Reference ZYVOX linezolid 400mg/200mL injection infusion bag
Regulatory Authorities. by M/s Pfizer Australia Pty Ltd, TGA approved.
Me-too status Linolid Infusion 400mg/200ml by M/s Bio-Labs
(Reg#073088)
Parenterals”.
Brand Name +Dosage Form + Strength Parasol Infusion 1g/100ml
Paracetamol…1000mg
Pharmacological Group Antipyretic/Analgesic
Type of Form Form-5
Pack size & Demanded Price 1's /As per SRO
Approval status of product in Reference PERFALGAN 10 mg/ml, solution for infusion by M/s
Regulatory Authorities. Bristol-Myers Squibb Pharmaceutical Limited, (MHRA
approved )
Me-too status Falgan Infusion 1000mg/100ml by M/s Bosch
(Reg#055540)
Parenterals”.
Brand Name +Dosage Form + Strength Konacane Infusion 200mg/100ml
Fluconazole…2mg
Pharmacological Group Anti-Fungal
Type of Form Form-5
Approval status of product in Reference Diflucan 2 mg/ml solution for infusion by M/s Pfizer
Regulatory Authorities. Limited (MHRA Approved)
Me-too status Diflucan 2mg/ml IV infusion 50ml by M/s Pfizer (Reg.
No.011830), (pack size not same as of applied
formulation.)
 Pack size of 100ml not confirmed from available
me-too database.
 Firm initially applied for 100ml pack size. When
communicated with shortcoming, firm replied that
they mistakenly wrote pack size 100ml instead of
50ml. Firm has submitted revised form-5 and
master formulation.
Parenterals”.
Registration Board also directed the firm to submit fee for revision of formulation.
Brand Name +Dosage Form + Strength Diazole Injection 500mg/100ml
Metronidazole…500mg
Pharmacological Group Imidazole derivatives/ Antibacterial
Type of Form Form-5
Approval status of product in Reference Metronidazole Braun 5 mg / ml solution for infusion b
Regulatory Authorities. M/s B. Braun Melsungen AG (Medical Products
Agency, Sweden Approved)
Me-too status Metrosol I.V Infusion 100ml by M/s Atlantic (Reg.No.
055042)
Parenterals”
Brand Name +Dosage Form + Strength Combifer Infusion 500mg/10ml
Composition Each 10ml vial contain:
Iron carboxymaltose complex eq.to Elemental Iron
…500mg
Type of Form Form-5
Approval status of product in Reference Ferinject 50 mg iron/mL solution for injection/infusion.
Regulatory Authorities. By M/s Vifor France (MHRA approved)
Me-too status Ferinject 500mg/10ml by M/s RG. Pharmaceuticals
(Reg#072548)
Remarks of the Evaluator.  Confirmed as 2ml, 10 ml and 20ml vial in MHRA,
UK.
Parenterals”
Brand Name +Dosage Form + Strength Tirosol Injection 12. 5mg/50ml
Composition Each ml contains
Tirofiban (as hydrochloride monohydrate)…0.25mg
Pharmacological Group Antithrombotic agents (Platelet aggregation inhibitors
excl. heparin)
Type of Form Form-5
Approval status of product in Reference AGGRASTAT (250 micrograms/ml) concentrate for
Regulatory Authorities. solution for infusion 50ml vial by M/s Correvio (UK)
Ltd (MHRA Approved)
Me-too status Aggrastat Injection 0.25mg/ml 50ml vial by M/s Atco
Labs (Reg#025299),
Grant of new DML,
Parenterals”
Dry Powder Injection (General) (Human)
Brand Name +Dosage Form + Strength Esol Injection 40mg
Esomeprazole (as sodium) powder for
reconstitution...40mg
Type of Form Form-5
Approval status of product in Reference Nexium I.V.40 mg Powder for solution for
Regulatory Authorities. injection/infusion by M/s Astra Zeneca Ltd. UK,
(MHRA approved)
Me-too status ES-Loprot 40mg Injection by M/s Nabiqasim Industries
(Reg#070679)
Grant of new DML,
Brand Name +Dosage Form + Strength Pantosol Injection 40mg
Pantoprazole (as sodium sesquihydrate) …40mg
Type of Form Form-5
Approval status of product in Reference Pantoprazole 40mg Powder for Solution for Injection or
Regulatory Authorities. Infusion b M/s TEVA UK Limited (MHRA Approved)
Me-too status Protonix Injection 40mg by M/s Wilshire Laboratories
Lahore. (Reg#071380)
Brand Name +Dosage Form + Strength Promiz Injection 40mg
Omeprazole (as sodium) powder for reconstitution
…40mg
Type of Form Form-5
Approval status of product in Reference Omeprazole 40 mg powder for solution for infusion by
Regulatory Authorities. M/s Mylan, (ANSM approved)
Me-too status Teph 40mg Injection by M/s Sami (Reg#057830)
Brand Name +Dosage Form + Strength Lanzofix Injection 30mg
Lansoprazole powder for reconstitution …30mg
Type of Form Form-5
Finished Product Specification Innovator’s specs
Approval status of product in Reference Prevacid IV Injection, Takeda Pharmaceuticals USA,
Me-too status Belenz Injection 30mg by M/s Wellborn Pharmachem
Hattar. (Reg#054894)
Remarks of the Evaluator.  In USFDA:
*Federal Register determination that product was
not discontinued or withdrawn for safety or efficacy
reasons*
Brand Name +Dosage Form + Strength Zithrocin Injection 500mg
Azithromycin (as dihydrate) powder for reconstitution
…500mg
Type of Form Form-5
Approval status of product in Reference Zedbac 500 mg powder for solution for infusion by M/s
Regulatory Authorities. Aspire Pharma Ltd ,( MHRA approved)
Me-too status Zezot Injection 500mg by M/s Bosch Karachi.
(Reg#055017)
Brand Name +Dosage Form + Strength Cyclovir Injection 250mg
Acyclovir powder for reconstitution …250mg
Pharmacological Group Anti-Viral
Type of Form Form-5
Approval status of product in Reference Aciclovir 250mg Powder For Solution For Infusion by
Regulatory Authorities. M/s GlaxoSmithKline UK (MHRA Approved)
Me-too status Aclovir 250mg Powder for Infusion by M/s Genix
(Reg#073690)
Remarks of the Evaluator.  Supplied as lyophilized powder for injection.
 Firm doesn’t have relevant section to manufacture
applied product.
Decision: Deferred for confirmation of manufacturing facility for Lyophilization.
Brand Name +Dosage Form + Strength Vancosol for Injection 500mg
Vancomycin (as hydrochloride) powder for
reconstitution …500mg
Pharmacological Group Glycopeptide antibacterial
Type of Form Form-5
Approval status of product in Reference Vancomycin 500mg Powder for Concentrate for
Regulatory Authorities. Solution for Infusion by M/s Actavis UK Ltd, (MHRA
approved)
Me-too status Vancomycin 500mg Vial by M/s Abbott (Reg#015015)
Decision: Approved
Brand Name +Dosage Form + Strength Vancosol Injection 1000mg
Vancomycin (as hydrochloride) powder for
reconstitution …1000mg
Pharmacological Group Glycopeptide antibacterial
Type of Form Form-5
Approval status of product in Reference Vancomycin 1000mg Powder for Concentrate for
Regulatory Authorities. Solution for Infusion by M/s Actavis UK Ltd, (MHRA
approved)
Me-too status Vancomycin 1gm Vial by M/s Abbott (Reg#015016)
Decision: Approved
Brand Name +Dosage Form + Strength Colistim Injection 150mg
Colistimethate (as sodium) powder for reconstitution
…150mg
Type of Form Form-5
Approval status of product in Reference Colistimethate for injection150mg/vial by M/s X-Gen
Regulatory Authorities. Pharmaceutical USA (USFDA Approved)
Me-too status Colistat by Medisure (Reg. No. 076160) (Formulation is
not same as for applied product)
Remarks of the Evaluator.  Me-too status not confirmed from available
database.
Decision: Deferred for evidence of applied formulation/drug already approved by DRAP
(generic / me-too status) alongwith registration number, brand name and name of firm
Brand Name +Dosage Form + Strength Colistim Injection 80mg
Colistimethate Sodium powder for reconstitution
…..80mg (1 Million IU)
Type of Form Form-5
Approval status of product in Reference Colistimethate sodium 1 MIU, powder for solution for
Regulatory Authorities. injection by M/s PANMEDICA (MHRA Approved)
Each vial contains 1 million International Units (IU)

which is approximately equivalent to 80 mg of
colistimethate sodium.
Me-too status Colistat powder for Injection 1MIU by M/s Medisure
Lab (Reg#076160)
Decision: Approved
Brand Name +Dosage Form + Strength Tigasol Injection 50mg
Tigecycline powder for reconstitution …50mg
Pharmacological Group Tetracycline
Type of Form Form-5
Approval status of product in Reference Tygacil 50mg powder for solution for infusion by M/s
Regulatory Authorities. Pfizer Limited (MHRA Approved)
Me-too status Tygacil 50mg Injection By M/s. Pfizer
Decision: Approved
Brand Name +Dosage Form + Strength Tiplasol Injection 200mg
Teicoplanin powder for reconstitution …200mg
Pharmacological Group Glycopeptide Antibiotic
Type of Form Form-5
Approval status of product in Reference Targocid 200mg powder for solution for
Regulatory Authorities. injection/infusion or oral solution by M/s Aventis
Pharma Limited (or trading as Marion Merrell or
Aventis Pharma) (MHRA Approved)
Me-too status Targocid 200mg powder for injection by M/s Sanofi-
Aventis (Reg#019503)
Decision: Deferred for confirmation of manufacturing in general filling area
Brand Name +Dosage Form + Strength Tiplasol Injection 400mg
Teicoplanin powder for reconstitution …400mg
Pharmacological Group Glycopeptide Antibiotic
Type of Form Form-5
Approval status of product in Reference Targocid 400mg powder for solution for
Regulatory Authorities. injection/infusion or oral solution by M/s Aventis
Pharma Limited (MHRA Approved)
Me-too status Targocid 400mg powder for injection by M/s Sanofi-
Aventis (Reg#019504)
Decision: Deferred for confirmation of manufacturing in general filling area.
Liquid Ampoules (General) (Human)

Brand Name +Dosage Form + Strength Mobicol Injection 500µg/ml
Mecobalamin…500mcg
Pharmacological Group (Vitamin B12)Antianemic Preparations
Type of Form Form-5
Pack size & Demanded Price 1mlx10’s /As per SRO
Approval status of product in Reference COMESGEN Injection 500 μg by M/s Tatsumi
Regulatory Authorities. Chemical Co, PMDA approved
Me-too status Mecoborn Injection 500mcg/ml by M/s Wellborne
(Reg#054885)
Grant of new DML,
Brand Name +Dosage Form + Strength Oraject-D Injection 5mg/ml
Cholecalciferol…5mg (eq. to 200,000IU of Vitamin D)
Pharmacological Group Vitamin D analogue
Type of Form Form-5
Pack size & Demanded Price 1ml x 1’s, 1ml x 5’s /As per SRO
Approval status of product in Reference VITAMIN D3 GOOD 200,000 IU / 1 ml IM solution
Regulatory Authorities. for injection ANSM, France approved
Me-too status D-Tres 5mg/ml Injectionby M/s Sami (Reg#076115)
Brand Name +Dosage Form + Strength Dboost Injection 1µg/ml
Calcitriol…1µg
Pharmacological Group Vitamin D Analogue
Type of Form Form-5
Pack size & Demanded Price 1mlx10’s /As per SRO
Approval status of product in Reference Calcitriol 1µg/ml Injection by M/s Akorn, Inc. (USFDA
Me-too status Aksobone Injection1µg/ml by M/s Akson
Pharmaceuticals Pvt Ltd (Reg#081638)
Brand Name +Dosage Form + Strength Ketrol Injection 30mg/ml
Ketorolac tromethamine…30mg
Type of Form Form-5
Pack size & Demanded Price 1mlx5’s/As per SRO
Approval status of product in Reference Ketorolac Tromethamine Injection 30mg/ml by M/s
Regulatory Authorities. Hospira Pharmaceuticals, USFDA approved.
Me-too status Toralac Injection 30mg/ml by M/s Vision
Decision: Approved
Brand Name +Dosage Form + Strength Tramax Injection 100mg/2ml
Tramadol hydrochloride…100mg
Pharmacological Group Opioid Analgesic
Type of Form Form-5
Pack size & Demanded Price 2mlx1’s, 2mlx 5’s, 2mlx 10’s, 2mlx 20’s, 2mlx 30’s,
2mlx 50’s /As per SRO
Approval status of product in Reference Tramadol 50 mg/ml solution for injection/infusion by
Regulatory Authorities. M/s AS KALCEKS (MHRA approved)
Me-too status Tramed 100mg Injection by M/s Cirin Pharmaceuticals
(Reg#081196)
Brand Name +Dosage Form + Strength Deston Injection 8mg/4ml
Diary No. Date of R& I & fee Diary No: 24062 ,13-12-2017 , Rs: 20,000/-
Ondansetron (as hydrochloride)…8mg
Pharmacological Group Serotonin (5HT3) antagonists (anti emetic)
Type of Form Form-5
Pack size & Demanded Price 4mlx1’s, 4mlx5’s /As per SRO
Approval status of product in Reference Ondansetron 2 mg/ml Solution for injection/ infusion by
Regulatory Authorities. M/s Mercury Pharmaceuticals Ltd., (MHRA approved)
Me-too status Doston Injection 8 mg/4ml by M/s Vision
Decision: Approved
Brand Name +Dosage Form + Strength Cerecolin Injection 250mg/2ml
Citicoline…250mg
Pharmacological Group Psychostimulants, Agents Used For ADHD And
Nootropics (Other psychostimulants and nootropics)
Type of Form Form-5
Pack size & Demanded Price 2mlx1’s , 2mlx10’s /As per SRO
Approval status of product in Reference CITICOLINE PANPHARMA 250 mg / 2 ml solution
Regulatory Authorities. for injection (IM, IV) ampoule by M/s PANPHARMA
(ANSM, France Approved)
Me-too status Cerebolin Injection 250mg/2ml by M/s Zam Zam
(Reg#021969)
Remarks of the Evaluator.  In ANSM France:
Approved with API Citicoline (as sodium)…250mg
 Firm initially applied for Citicoline…250mg. When
they mistakenly wrote Citicoline instead of
citicoline (as sodium). Firm has submitted revised
form-5 and master formulation.
Brand Name +Dosage Form + Strength Cerecolin Injection 500mg/4ml
Composition Each 4ml ampule contains:
Citicoline…500mg
Pharmacological Group Psychostimulants, Agents Used For ADHD And
Nootropics (Other psychostimulants and nootropics)
Type of Form Form-5
Pack size & Demanded Price 4mlx1’s, 4mlx10’s/As per SRO
Approval status of product in Reference CITICOLINE PANPHARMA 500 mg/ 4ml, solution
Regulatory Authorities. injectable (IM,IV) ampoule by M/s PANPHARMA
(ANSM, France Approved)
Me-too status SOMAZINA INJECTION 500 by Alina pharma (Reg.
No. 016975),
Remarks of the Evaluator.  In ANSM France:
Approved with API Citicoline (as sodium)…500mg
 Firm initially applied for Citicoline…500mg. When
they mistakenly wrote Citicoline instead of
citicoline (as sodium). Firm has submitted revised
form-5 and master formulation.
Brand Name +Dosage Form + Strength Inxamic Injection 250mg/5ml
Composition Each 5ml ampule contains:
Tranexamic acid…250mg (5%w/v)
Pharmacological Group Anti-Fibrinolytic Agent
Type of Form Form-5
Approval status of product in Reference Transcermin Note 5% Injection by M/s Daiichi Sankyo
Regulatory Authorities. Co., Ltd. (PMDA Japan Approved)
Me-too status Traxacid 250mg/5ml Injectionby M/s Asian Continental
(Reg#057865)
Decision: Approved
Brand Name +Dosage Form + Strength Isofer Injection 1000mg/10ml
Iron as (Iron (III) Isomaltoside)...1000mg
Pharmacological Group Hematinic
Type of Form Form-5
Approval status of product in Reference Monofer Injection 100mg/ml by Pharmacosmos UK,
Regulatory Authorities. (MHRA approved)
Me-too status Monofer Injection 100mg/ml by M/s Pharmacosmos
A/S Halbeak Denmark (Universal Karachi)
(Reg#072501) (1ml pack size approved)
Remarks of the Evaluator.  Applied pack size of 10ml from available Me-too
database not confirmed.
(generic / me-too status) in the applied pack size, alongwith registration number, brand name
and name of firm
Brand Name +Dosage Form + Strength Spasex Injection 40mg+0.04mg/4ml
Composition Each 4ml ampoule contains
Phloroglucinol Hydrate…40mg
Trimethyl phloroglucinol…0.04mg
Pharmacological Group Anti-Spasmodic Agent
Type of Form Form-5
Pack size & Demanded Price 4mlx1’s,4mlx6’s /As per SRO
Approval status of product in Reference SPASFON, solution for injection in ampoule 4ml by
Regulatory Authorities. M/s TEVA HEALTH, (ANSM Approved)
Me-too status Spasfon Injection 4ml by M/s Himont (Reg#018530)
Tablets-2 (General) (Human)
Brand Name +Dosage Form + Strength Statin-R Tablet 5mg
Pharmacological Group Lipid modifying agents, plain (HMG CoA reductase
inhibitors)
Type of Form Form-5
Approval status of product in Reference Crestor 5mg film-coated tablets by M/s AstraZeneca
Regulatory Authorities. UK Ltd (MHRA Approved)
Me-too status Easetec 5mg tablet by M/s Pharmatec (Reg#067563)
inhibitors)
Type of Form Form-5
inhibitors)
Type of Form Form-5
Brand Name +Dosage Form + Strength Qutin Tablet 100mg
Composition Each film-coated Tablet contains:
Quetiapine (as fumarate)…100mg
Pharmacological Group Antipsychotics (Diazepines, oxazepines, thiazepines and
oxepines)
Type of Form Form-5
Approval status of product in Reference SEROQUEL film coated tablets 100mg by M/s
Regulatory Authorities. Astrazeneca Pharmaceuticals Lp (USFDA Approved)
Me-too status Qupixan Tablet 100 mg by M/s Regal Pharmaceuticals
(Reg#081961)
Decision: Approved
oxepines)
Type of Form Form-5
Me-too status Pine Tablet 200mg by M/s Werrick Pharmaceuticals
(Reg#082046)
Decision: Approved
oxepines)
Type of Form Form-5
Me-too status Pine Tablet 300mg by M/s Werrick Pharmaceuticals
(Reg#082048)
Decision: Approved
oxepines)
Type of Form Form-5
Pack size & Demanded Price 10’s,14’s, 20’s, 30’s/As per SRO
Me-too status Quitrate by Shrooq Pharma (Reg. No. 067843) not
confirmed
Remarks of the Evaluator.  Me-too status of film coated tablet not confirmed
from available database.
Brand Name +Dosage Form + Strength Amloval Tablet 5mg/80mg
Amlodipine (as besylate)…5mg
Valsartan…80mg
Pharmacological Group Angiotensin II antagonists and calcium channel blockers
Type of Form Form-5
Approval status of product in Reference Asbima 5 mg / 80 mg film-coated tabletsby M/s
Regulatory Authorities. Winthrop Pharmaceuticals UK Limited (MHRA
Approved)
Me-too status Amlodine Tablet 5/80 by M/s Jupiter Pharma
(Reg#081931)
Decision: Approved
Valsartan…160mg
Type of Form Form-5
Approved)
(Reg#081932)
Decision: Approved
Valsartan…160mg
Type of Form Form-5
Approved)
(Reg#081933)
Decision: Approved.
Brand Name +Dosage Form + Strength Cartilex Tablet 500/400mg
Glucosamine sulphate…500mg
Chondroitin sulphate…400mg
Pharmacological Group Other antiinflammatory and antirheumatic agents, non-
steroids
Type of Form Form-5
Approval status of product in Reference Glucosamine 500mg + Chondroitin 400mg Tablet by
Regulatory Authorities. M/s Universal Nutrition & Beauty Care Pty Ltd (TGA
Approved)
Me-too status Gevolox CH Tablets by M/s Hilton Pharma
(Reg#039688)
Grant of new DML,
Remarks of the Evaluator.  Firm has applied as film-coated tablet but reference
in TGA provides evidence of uncoated tablet.
 When communicated with shortcoming, firm
replied that they mistakenly added coating material
in master formulation and have now removed it
from said document now. Firm has submitted
revised form-5 and master formulation.
Brand Name +Dosage Form + Strength Caldron Tablet 70mg/70mcg (2800IU)
Composition Each film coated Tablet contains:
Alendronic acid as alendronate sodium
trihydrate…70mg
Cholecalciferol…70mcg(2800IU)
Pharmacological Group Drugs affecting bone structure and mineralization
(Bisphosphonates, combinations)
Type of Form Form-5
Pack size & Demanded Price 4’s ,7’s /As per SRO
Approval status of product in Reference Apo-Alendronate Plus D3 Tablets by M/s Apotex Pty
Regulatory Authorities. Ltd (TGA Approved)
Alendronic Acid/Colecalciferol 70 mg/2800 IU tablets
by M/s Creo Pharma Limited (MHRA Approved)
Me-too status Drate Plus D Tablets70mg/70mcg by M/s S.J&G Fzul
Ellahie (Reg#047288)
Grant of new DML,
Remarks of the Evaluator.  Confirmed as plain tablet from TGA & MHRA
while firm has applied as film-coated tablet.
 When communicated with shortcoming, firm
replied that they mistakenly added coating material
in master formulation and have now removed it
from said document now. Firm has submitted
revised form-5 and master formulation.
Brand Name +Dosage Form + Strength Solap Tablet 50mg
Lacosamide…50 mg
Type of Form Form-5
Approval status of product in Reference Vimpat 50mg film coated tablet by M/s UCB Pharma
Regulatory Authorities. Ltd (USFDA approved)
Me-too status Atcomid 50mg Tablet by M/s Atco Lab (Reg#075947)
Lacosamide…100 mg
Type of Form Form-5
Approval status of product in Reference Vimpat 100mg film coated tablet by M/s UCB Pharma
Regulatory Authorities. Ltd (USFDA approved)
Lacosamide…150 mg
Type of Form Form-5
Approval status of product in Vimpat 150mg film coated tablet by M/s UCB Pharma Ltd
Reference Regulatory Authorities. (USFDA approved)
Me-too status Atcomid 150mg Tablet by M/s Atco Lab (Reg#075949).

Lacosamide…200 mg
Type of Form Form-5
Approval status of product in Vimpat 200mg film coated tablet by M/s UCB Pharma Ltd
Reference Regulatory Authorities. (USFDA approved)
Brand Name +Dosage Form + Strength Spasex Tablet 80mg/80mg
Phloroglucinol dihydrate…80mg
Trimethylphloroglucinol…80mg
Pharmacological Group Other drugs for functional gastrointestinal disorders
Type of Form Form-5
Approval status of product in SPASFON, coated tablet by M/s Teva Health (ANSM
Reference Regulatory Authorities. approved.)
Me-too status Anafortan Plus Tablet by M/s AGP Pharma (Reg#024504).
Remarks of the Evaluator.  Approved as sugar coated tablet in ANSM, France.
Decision: Deferred for clarification of applied formulation since reference product is available
as sugar coated tablet whereas firm has applied for film coated tablet
503. Name and address of manufacturer / M/s Pharmasol (Pvt) Ltd.Plot No. 549, Sundar Industrial
Brand Name +Dosage Form + Strength Neframin Tablet
α-keto analogue to isoleucine (calcium salt)…67mg.
α-keto analogue to leucine (calcium salt)……101mg
α-keto analogue to phenylalanine (calcium salt)..68mg
α-keto analogue to valine (calcium salt)…….86mg.
α-keto analogue to methionine (calcium salt)…59mg.
L-lysine acetate……………………….…105mg.
L-threonine……………………….…………..53mg.
L-tryptophan…………………………………23mg.
L-histidine………………………….…………38mg.
L-tyrosine………………………..………….30mg.
Total nitrogen content per tablet 36mg, calcium per tablet
0.05gm.
Pharmacological Group Calcium and analogue of essential amino acids.
Type of Form Form-5
Approval status of product in KETOSTERIL by Fresenius Kabi, Germany.(Bfarm
Reference Regulatory Authorities. approved)
Me-too status Ketoalfa Tablets by M/s Genome Pharmaceuticals (Pvt)
Ltd (Reg#076807)
Brand Name +Dosage Form + Strength Vildamet Tablet 50mg/500mg
Vildagliptin…50mg
Pharmacological Group Combinations of oral blood glucose lowering drugs
Type of Form Form-5
Approval status of product in Galvus Met 50mg/500mg film coated tablet b M/s Novartis
Reference Regulatory Authorities. Pharma Switzerland AG (Swissmedic, Switzerland
Approved)
Me-too status Galvus Met 50/500mg Tablets by M/s Novartis Pharma
(Pakistan) Limited (Reg#078106)
Brand Name +Dosage Form + Strength Vildamet Tablet 50mg/850mg
Vildagliptin…50mg
Pharmacological Group Combinations of oral blood glucose lowering drugs
Type of Form Form-5
Approval status of product in Galvus Met 50mg/850mg film coated tablet b M/s Novartis
Reference Regulatory Authorities. Pharma Switzerland AG (Swissmedic, Switzerland
Approved)
Me-too status Galvus Met 50/850mg Tablets by M/s Novartis Pharma
(Pakistan) Limited (Reg#066106)
Brand Name +Dosage Form + Strength Cinacalsol Tablets 30mg
Cinacalcet (as hydrochloride)…30mg
Pharmacological Group Other anti-parathyroid agents
Type of Form Form-5
Approval status of product in Cinacalcet 30 mg film-coated tablets by M/s Bristol
Reference Regulatory Authorities. Laboratories Ltd (MHRA Approved)
Me-too status Mimcipar tablet 30mg by M/s Genome Pharma
(Reg#082301)
Brand Name +Dosage Form + Strength Cinacalsol Tablets 60mg
Cinacalcet (as hydrochloride)…60mg
Pharmacological Group Other anti-parathyroid agents
Type of Form Form-5
Approval status of product in Cinacalcet 60 mg film-coated tablets by M/s Bristol
Reference Regulatory Authorities. Laboratories Ltd (MHRA Approved)
Me-too status Mimcipar tablet 60mg by M/s Genome Pharma
(Reg#082302)
Capsules-2 (General) (Human)
Brand Name +Dosage Form + Strength Ursolic Capsule 500mg
Ursodeoxycholic acid…500mg
Pharmacological Group Bile acids and derivatives
Type of Form Form-5
Approval status of product in Ursochol 500 mg capsules, hard byM/s Orifarm Generics
Reference Regulatory Authorities. A / S (Sweden Approved drug)
Me-too status Urso Capsules 500mg by AGP (Pvt)Ltd. (Reg#070853)
Decision: Approved
Brand Name +Dosage Form + Strength Ursolic Capsule 250mg
Ursodeoxycholic acid…250mg
Pharmacological Group Bile acids and derivatives
Type of Form Form-5
Approval status of product in Ursochol 250 mg capsules, hard byM/s Orifarm Generics
Reference Regulatory Authorities. A / S (Sweden Approved drug)
Me-too status Ursofalk Capsules 250mg by M/s Evron Ltd (Reg#007945)
Decision: Approved
Brand Name +Dosage Form + Strength Lowlip Capsule 67mg
Fenofibrate…67mg
Pharmacological Group Lipid modifying agents, plain (Fibrates)
Type of Form Form-5
Approval status of product in Fenofibrate 67 mg capsules by M/s Actavis UK Limited
Reference Regulatory Authorities. (MHRA Approved)
Me-too status Fenoget 67mg Capsules by M/s Getz Pharma (Reg.
No.047197)
Fenofibrate…200mg
Type of Form Form-5
Approval status of product in Fenofibrate 200 mg capsules by M/s Actavis UK Limited
Me-too status Fenoget 200mg Capsules by M/s Getz Pharma (Reg. No.
047198)
Fenofibrate…134mg
Type of Form Form-5
Approval status of product in Fenofibrate 134 mg Capsules by Mylan Pharmaceuticals,
Me-too status Fenoget 134mg Capsules by M/s Getz Pharma (Reg. No.
055692)
Brand Name +Dosage Form + Strength Coliver Capsule 200mg
Mebeverine hydrochloride (SR pellets 50%)…200 mg
Pharmacological Group Drugs for functional gastrointestinal disorders (Synthetic
anticholinergics, esters with tertiary amino group)
Type of Form Form-5
Approval status of product in Colofac MR. Modified release capsule 200mg by M/s
Reference Regulatory Authorities. Mylan Products Limited (MHRA approved)
Me-too status Mebever MR 200mg capsule by M/s Getz Pharma Pvt. Ltd.
(Reg#050754)
Grant of new DML,
Remarks of the Evaluator.  Source of pellets Vision Pharmaceuticals, Islamabad.
Brand Name +Dosage Form + Strength Freezak Capsule 20mg
Fluoxetine (as hydrochloride)…20mg
Pharmacological Group Selective serotonin reuptake inhibitor
Type of Form Form-5
Approval status of product in Prozac 20mg capsule by M/s Eli Lilly And Co, USFDA
Reference Regulatory Authorities. approved
Decision: Approved
Brand Name +Dosage Form + Strength Freezak-O Capsule 3mg/25mg
Olanzapine…3mg
Fluoxetine (as hydrochloride)….25mg.
Pharmacological Group Antidepressants in combination with psycholeptics
Type of Form Form-5
Pack size & Demanded Price 10’s, 14’s , 20’s, 30’s /As per SRO
Approval status of product in Symbyax 3mg/25mg capsule by Eli Lilly (USFDA
Me-too status Co-Depricap 3/25mg Capsule by M/s Nabi Qasim
Industries Pvt.Ltd. (Reg#076136)
Decision: Approved
Brand Name +Dosage Form + Strength Freezak-O Capsule 6mg/25mg
Olanzapine…6mg
Fluoxetine(as hydrochloride)...25mg.
Pharmacological Group Antidepressants in combination with psycholeptics
Type of Form Form-5
Pack size & Demanded Price 10’s, 14’s , 20’s, 30’s /As per SRO
Approval status of product in Symbyax 6mg/25mg capsule by Eli Lilly (USFDA
Me-too status Co-Depricap 6/25mg Capsule by M/s Nabi Qasim
Industries Pvt.Ltd. (Reg#076135)
Decision: Approved
Brand Name +Dosage Form + Strength Xecoc Capsules 200mg
Celecoxib...200mg
Type of Form Form-5
Approval status of product in Celebrex 200 mg capsules, hard. by Pfizer Limited
Me-too status Celbex 200 mg Capsule by M/s Getz (Reg#028693)
Brand Name +Dosage Form + Strength Xecoc Capsules 100mg
Diary No. Date of R& I & fee Diary No:-23987 , 13-12-2017 , Rs: 20,000/-
Celecoxib...100mg
Type of Form Form-5
Approval status of product in Celebrex 100 mg capsules, hard. By M/s Pfizer Limited
Me-too status Celbex by Getz Pharma(Reg. No. 028694)
Brand Name +Dosage Form + Strength Zithrocin Capsule 250mg
Azithromycin (as dihydrate)…250mg
Pharmacological Group Macrolide/Antibiotic.
Type of Form Form-5
Pack size & Demanded Price 10’s,14’s /As per SRO
Approval status of product in Zithromax 250mg capsule by M/s Pfizer Ltd.(MHRA
Me-too status Azomax 250mg capsule by M/s Sandoz
Pharmaceuticals.(Reg#022200)
Grant of new DML,
Decision: Approved
Brand Name +Dosage Form + Strength Lowcid Capsule 20mg
Omeprazole (as enteric coated pellets)…20mg
Type of Form Form-5
Approval status of product in Losec 20 mg hard gastro-resistant capsules by Astra Zeneca
Reference Regulatory Authorities. UK Ltd.(MHRA approved)
Me-too status Losec 20mg capsule by M/s Barrett Hodgson Pakistan Pvt.
Limited, (Reg# 010800)
Brand Name +Dosage Form + Strength Lowcid Capsule 40mg
Omeprazole (as enteric coated pellets)…40mg
Type of Form Form-5
Approval status of product in Losec 40 mg hard gastro-resistant capsules by Astra Zeneca
Reference Regulatory Authorities. UK Ltd.(MHRA approved)
Me-too status Risek 40mg capsule by M/s Getz Pharma Pvt.Ltd.
(Reg#022109)
Grant of new DML,
Brand Name +Dosage Form + Strength ESOL Capsule 20mg
Esomeprazole (as magnesium Trihydrate) enteric coated
pellets.....20mg
Type of Form Form-5
Approval status of product in Ventra 20 mg gastro-resistant capsules by M/s Ethypharm
Me-too status ESORID 20mg by M/s Hilton Pharma. Limited, (Reg#
032365 )
Remarks of the Evaluator. Source of pellets Vision Pharmaceuticals, Islamabad.
Brand Name +Dosage Form + Strength ESOL Capsule 40mg
pellets.....40mg
Type of Form Form-5
034227 )
Brand Name +Dosage Form + Strength Dexprazol Capsule 30mg
Dexlansoprazole dual delayed release pellets …30mg
Type of Form Form-5
Approval status of product in DEXILANT (dexlansoprazole) delayed release capsules
Reference Regulatory Authorities. 30mg by M/s Takeda Pharmaceuticals America, Inc.
(USFDA Approved)
Me-too status Dexilant by Helix Takeda Pakistan (Not confirmed)
Grant of new DML,
Remarks of the Evaluator.  Stability study data of finished product is not submitted
by the firm.
 Me-too status not confirmed from available database.
Decision: Deferred for applicationon form 5-D along with stability studies data as per format
decided in instant meeting.
Brand Name +Dosage Form + Strength Dexprazol Capsule 60mg
Dexlansoprazole dual delayed release pellets…60mg
Type of Form Form-5
Approval status of product in DEXILANT (dexlansoprazole) delayed release capsules
Reference Regulatory Authorities. 60mg by M/s Takeda Pharmaceuticals America, Inc.
(USFDA Approved)
Me-too status Dexilant by Helix Takeda Pakistan (Not confirmed)
Remarks of the Evaluator.  Stability study data of finished product is not submitted
by the firm.
Decision: Deferred for applicationon form 5-D along with stability studies data as per format
decided in instant meeting.
Lotion (General) (Human)
Brand Name +Dosage Form + Strength Methrix Lotion 5%w/w
Diary No. Date of R& I & fee Diary No: 24221 , 13-12-2017, Rs: 20,000/-
Permethrin…50mg (5% w/w)
Pharmacological Group Ectoparasiticides, incl. scabicides (Pyrethrines, incl.
synthetic compounds)
Type of Form Form-5
Pack size & Demanded Price 60ml / As per SRO
Approval status of product in Permethrin lotion 5% w/w by M/s GlaxoSmithKline
Reference Regulatory Authorities. Consumer Healthcare (UK) Trading Limited (MHRA
Approved )
Me-too status Plaveo Lotion by M/s Hiranis (Reg#076508)
Brand Name +Dosage Form + Strength Actil Lotion 16.7% w/w, 16.7% w/w
Composition Each gram contain:
Salicylic acid…167mg (16.7% w/w)
Lactic acid…167mg (16.7% w/w)
Pharmacological Group Emoliant/Antiinfective
Type of Form Form-5
Approval status of product in Salactol Collodion by M/s Diomed Developments Limited
Me-too status Duofilm by Stiefel (Reg#005032)
Remarks of the Evaluator. Internationally available as Collodion in the same strength
with following ingredients
 Proxylin
 Colophony
 Castor oil
 Industrial Methylated Spirit ‘66 OP1
 Ether.
Brand Name +Dosage Form + Strength Cleomin Lotion 1%w/v
Clindamycin (as phosphate)…10mg (1%w/v)
Pharmacological Group Antiinfectives for treatment of acne
Type of Form Form-5
Approval status of product in Dalacin T Topical Lotion 1%w/v by M/s Pfizer Limited
Me-too status Dalacin-T lotion by M/s Pfizer Pakistan (Reg#013582)
Decision: Approved.
Brand Name +Dosage Form + Strength Betam-S Lotion
Betamethasone Dipropionate…0.5mg (0.05%w/w)
Salicylic acid…20mg (2%w/w)
Pharmacological Group Corticosteroids, potent, combinations with antifungals for
topical use
Type of Form Form-5
Approval status of product in Diprosalic Scalp Application 0.05% w/w / 2% w/w,
Reference Regulatory Authorities. cutaneous solution by M/s Merck Sharp & Dohme Limited
(MHRA Approved)
Me-too status Betasaly lotion by Valor Pharmaceuticals (Reg# 065247)
Grant of new DML,
Decision: Approved
Brand Name +Dosage Form + Strength Betam Lotion 0.05% w/w
Betamethasone (as dipropionate)…0.5mg (0.05%w/w)
Pharmacological Group Steroid
Type of Form Form-5
Approval status of product in Diprosone 0.05 % w/w Lotion by M/s Merck Sharp &
Reference Regulatory Authorities. Dohme Limited (MHRA Approved)
Me-too status Procort Lotion by M/s Shrooq Pharmaceuticals (Pvt) Ltd
(Reg# 055223)
Grant of new DML,
Decision: Approved
Brand Name +Dosage Form + Strength Prednicarb Lotion 0.25%w/w
Prednicarbate…2.5mg (0.25%w/w)
Pharmacological Group Corticosteroids, potent (group III)
Type of Form Form-5
Pack size & Demanded Price 10gm, 20gm / As per SRO
Approval status of product in Prednitop 0.25%w/w Solution byM/s BGP Products
Reference Regulatory Authorities. GmbH (Swiss medic Switzerland Approved)
Me-too status Cabedin Lotion 0.25% by M/s Tabros Pharma
(Reg#055451)
Decision: Approved
Brand Name +Dosage Form + Strength Ketrazole Lotion 2%w/w
Ketoconazole…20mg (2%w/w)
Pharmacological Group Imidazole anti-fungal for topical use
Type of Form Form-5
Approval status of product in Nizora Anti-Dandruff Shampoo 2%w/w by M/s McNeil
Reference Regulatory Authorities. Products Limited (MHRA Approved)
Me-too status Ketonaz Lotion by M/s Sante (Reg#073453)
Decision: Approved
Brand Name +Dosage Form + Strength Minoxol Lotion 5%w/v
Minoxidil…50mg (5%w/v)
Pharmacological Group Other dermatologicals
Type of Form Form-5
Approval status of product in Regaine for Men Extra Strength Scalp Solution 5% w/v
Reference Regulatory Authorities. Cutaneous Solution by M/s McNeil Products Limited
(MHRA Approved)
Me-too status Minoxin Plus Solution5% by M/s Brooks Pharmaceuticals
(Reg#034492)
Decision: Approved.
Brand Name +Dosage Form + Strength Pirox Lotion 1.5%w/w
Diary No. Date of R& I & fee Diary No:24239 , 13-12-2017, Rs: 20,000/-
Ciclopirox olamine…15mg (1.5% w/w)
Pharmacological Group Other antifungals for topical use
Type of Form Form-5
Approval status of product in Stieprox 15mg/g Shampoo by M/s GlaxoSmithKline
Reference Regulatory Authorities. (Ireland) Limited (HPRA Ireland Approved
Me-too status Stieprox Topical Liquid by M/s GSK (Reg#026392)
Decision: Approved
Brand Name +Dosage Form + Strength Monozole Lotion 1%w/v
Composition Each ml contain:
Clotrimazole…10mg (1%w/v)
Pharmacological Group Antifungals for topical use (Imidazole and triazole
derivatives)
Type of Form Form-5
Approval status of product in Canesten Dermatological Spray 1% w/v by M/s Bayer
Reference Regulatory Authorities. plc(MHRA Approved)
Me-too status Stiemazole lotion by M/s Stiefel Pharma (GSK)
(Reg#024757)
Decision: Approved
Cream/Ointments/Gels (General) (Human)
10 Products / 10 molecules
Brand Name +Dosage Form + Strength Tinea Cream 1% w/w
Diary No. Date of R& I & fee Diary No:24229, 13-12-2017 , Rs: 20,000/-
Composition Each gram contains;
Terbinafine hydrochloride…10mg (1.0% w/w)
Type of Form Form-5
Pack size & Demanded Price 10gm /As per SRO
Approval status of product in LAMISIL 1% w/w Cream by M/s GlaxoSmithKline
Reference Regulatory Authorities. Consumer Healthcare (UK) Trading Limited. (MHRA
Approved)
Me-too status Onyfine Cream 1% by M/s Medisure (Reg#032811)
Grant of new DML,
Decision: Approved
Brand Name +Dosage Form + Strength Micona Gel 2%w/w
Miconazole nitrate…20mg (2%w/w)
Pharmacological Group Antiinfective
Type of Form Form-5
Finished Product Specification BP (as oromucosal gel)
Approval status of product in Daktarin 2% w/w oral gel by M/s J anssen-Cilag Limited
Me-too status Mogel 20mg/g Oral Gel by M/s Sigma Pharma (Reg no.
079910)
 In MHRA formulation is approved as oral gel which
contains Miconazole base while firm has applied as
Miconazole Nitrate.
 When communicated with shortcoming, firm replied
that they mistakenly wrote Miconazole nitrate instead
of miconazole base. Firm has submitted revised form-5
and master formulation.
Decision: Deferred for submission of fee forchange in formulation.
Brand Name +Dosage Form + Strength Raynox Gel 2%w/w
Composition Each 100 grams contain:
Diclofenac diethylamine ammonium salt as diclofenac
sodium…2gm (2%w/w)
Type of Form Form-5
Approval status of product in Voltarol Extra Strength Emulgel 2.32% Gel by M/s
Reference Regulatory Authorities. GlaxoSmithKline Consumer Healthcare (UK) Trading
Limited (MHRA Approved)
Me-too status Sofac Gel 2% by M/s Saffron Pharmaceuticals
(Reg#060356)
Decision: Approved
Brand Name +Dosage Form + Strength Fucyn-H Cream
Fusidic acid… 20 mg (2% w/w)
Hydrocortisone acetate…10 mg (1% w/w)
Pharmacological Group Corticosteroid/Antibacterial
Type of Form Form-5
Pack size & Demanded Price 5gm, 15gm /As per SRO
Approval status of product in Fucidin–H Cream by M/s Leo Laboratories Limited,
Reference Regulatory Authorities. (MHRA Approved.)
Me-too status Fosic-H Cream by M/s Metro Pharmaceuticals
(Reg#082039)
Decision: Approved
Brand Name +Dosage Form + Strength Sonoin Gel 0.05% w/w
Isotretinoin…0.5mg (0.05%w/w)
Type of Form Form-5
Approval status of product in Isotrex gel by M/s GlaxoSmithKline UK Limited (MHRA
Me-too status Isotrex Gel 0.05% by M/s GSK (Reg#015717)
Decision: Approved
Brand Name +Dosage Form + Strength Syner 10 mg/g + 50 mg/g Gel
Clindamycin (as phosphate)…10mg (1%w/w)
Anhydrous benzoyl peroxide (as hydrous benzoyl
peroxide)…50mg (5%w/w)
Pharmacological Group antibacterial + oxidizing agent with bacteriocidal and
keratolytic effects
Type of Form Form-5
Pack size & Demanded Price 10gm / As per SRO
Approval status of product in Duac Once Daily 10 mg/g + 50 mg/g Gel by M/s
Reference Regulatory Authorities. GlaxoSmithKline UK Limited (MHRA Approved)
Me-too status Hyclin Gel by M/s Hygeia Pharmaceuticals (Reg#080808)

Decision: Approved
Brand Name +Dosage Form + Strength Tretin Gel
Clindamycin Phosphate…12mg (1.2% w/w)
Tretinoin….0.25mg (0.025% w/w)
Pharmacological Group Antiinfective/Retinoid
Type of Form Form-5
Approval status of product in Reference ZIANA(clindamycin phosphate 1.2% and tretinoin 0.025%)
Regulatory Authorities. Gel by M/s Medicis, The Dermatology Company (USFDA
Approved)
Me-too status Acnicot Gel by M/s Nabiqasim (Reg#080660)
Decision:Approved
Brand Name +Dosage Form + Strength Proket Gel 2.5% w/w
Ketoprofen…25mg (2.5%w/w)
Pharmacological Group Antiinflammatory preparations, non-steroids for topical use
Type of Form Form-5
Approval status of product in Reference Fastum 2.5% gel by M/s A Menarini Industrie Fa
Regulatory Authorities. rmaceutiche Ruinite srl (MHRA Approved)
Me-too status Fastum gel by M/s Pharmatec (Reg# 018281)
Decision: Approved
Brand Name +Dosage Form + Strength Protolimit Cream 13.9% w/w
Eflornithine hydrochloride (as monohydrate)…139mg
(13.9%w/w)
Pharmacological Group Other dermatologicals
Type of Form Form-5
Approval status of product in Reference VANIQA (eflornithine hydrochloride) Cream, 13.9% by M/s
Regulatory Authorities. Bristol-Myers Squibb Company (USFDA Approved)
Me-too status Depilus Cream by M/s Atco Lab (Reg# 073869)
Decision: Approved
Brand Name +Dosage Form + Strength Sonoin E Gel 0.05%w/w +2% w/w
Isotretinoin…0.5mg (0.05%w/w)
Erythromycin…20mg (2%w/w)
Pharmacological Group Retinoid/Antibiotic
Type of Form Form-5
Approval status of product in Reference Isotrexin gel by M/s Stiefel Laboratories Ltd (MHRA
Me-too status Isotrexin gel by M/s Stiefel Laboratories (Reg#047552)
Decision: Approved
Evaluator PEC-VI
Dry Powder Injection Carbapenems
546. Name
2 and address of manufacturer / M/s Pharmasol (Pvt) Ltd. Plot No. 549, Sundar
Brand Name +Dosage Form + Strength Merosol Injection IV 500mg
Meropenem Trihydrate eq. to Meropenem..…500mg
Pharmacological Group Beta Lactam Antibiotics
Type of Form Form-5
Pack size & Demanded Price 1’s, 10’s/As per SRO
Approval status of product in Meropenem 500 mg Powder for Solution for Injection
Reference Regulatory Authorities. or Infusion by M/s Hospira UK Limited (MHRA
Approved)
Me-too status Meronem by ICI Pakistan (Reg. No. 018543),
GMP status New License (Inspection Date: 29-05- 2017, 30-05-
2017, 13-07-2017, 03-10-17 and 04-10-2017
Decision: Approved
547. Name
2 and address of manufacturer / M/s Pharmasol (Pvt) Ltd. Plot No. 549, Sundar Industrial
Brand Name +Dosage Form + Strength Merosol Injection IV 1g
Meropenem Trihydrate eq. to
Meropenem……………..………1g
Type of Form Form-5
Approval status of product in Meronem 1g by M/s Pfizer Limited (MHRA
Me-too status Meronem by ICI Pakistan (Reg. No. 018548)
GMP status New License (Inspection Date: 29-05- 2017, 30-05-2017,
13-07-2017, 03-10-17 and 04-10-2017
Decision: Approved
548. Name
Brand Name +Dosage Form + Strength Cilastipen Injection 250mg
Imipenem Monohydrate eq. to Imipenem .250mg
Cilastatin Sodium eq. to Cilastatin………250mg
Type of Form Form-5
Approval status of product in Imipenem/Cilastatin 250mg/250mg Powder for
Reference Regulatory Authorities. Solution for Infusion by M/s Actavis Group PTC ehf
(MHRA Approved)
Me-too status Cilapen by Bosch (Reg No. 048490)
13-07-2017, 03-10-17 and 04-10-2017
Decision: Approved
549. Name
Brand Name +Dosage Form + Strength Cilastipen Injection 500mg
Imipenem Monohydrate eq. to Imipenem………500mg
Cilastatin Sodium eq. to Cilastatin…………500mg
Type of Form Form-5
Approval status of product in Imipenem/Cilastatin 500 mg/500 mg, powder for solution
Reference Regulatory Authorities. for infusion b M/s Fresenius Kabi Ltd (MHRA Approved)
Me-too status Primaxin by Stallion (Reg No. 080839)
13-07-2017, 03-10-17 and 04-10-2017
Decision: Approved
550. Name
Brand Name +Dosage Form + Strength Eranem Injection 1g
Ertapenem sodium eq. to Ertapenem………………….1g
Type of Form Form-5
Approval status of product in MHRA approved; ERTAPENEM 1G POWDER FOR
Reference Regulatory Authorities. CONCENTRATE FOR SOLUTION FOR INFUSION
Me-too status Invanz by Muller & Phipps (Reg. No. 043051)
13-07-2017, 03-10-17 and 04-10-2017
Decision: Approved
Tablets (Hormones)
551. Name
Brand Name +Dosage Form + Strength Northon Tablet 5mg
Norethisterone ……….5mg
Pharmacological Group Progestogen
Type of Form Form-5
Pack size & Demanded Price 30`s/ As per SRO
Approval status of product in Reference Primolut-N by Bayer Pharma AG, Germany
Me-too status Primolut N by Bayer Health Care (Reg. No. 000677)
13-07-2017, 03-10-17 and 04-10-2017
Decision: The Board deferred product and advised te firm to get approval from Licensing
Division particularly for either Tablet (Steroidal Hormone) or Tablet (Non-steroidal
Horomone) for further processing by Registration Board.
552. Name
Brand Name +Dosage Form + Strength Stoviron Tablet 25 mg
Mesterolone ……….25mg.
Pharmacological Group Androgens, Dihydrotestosterone
Type of Form Form-5
Pack size & Demanded Price 20`s / As per SRO
Approval status of product in Reference Pro-Viron 25 Tablet by M/s Bayer plc, MHRA
Regulatory Authorities. Approved
Me-too status Proviron 25mg Tablet by M/s Bayer Health Care
(Reg. # 000697)
13-07-2017, 03-10-17 and 04-10-2017
Decision: The Board deferred product and advised the firm to get approval from Licensing
553. Name
Brand Name +Dosage Form + Strength Valedot Tablet 2 mg
Estradiol Valerate ……….2mg.
Pharmacological Group Estrogens.
Type of Form Form-5
Approval status of product in Reference TGA Approved
Me-too status Progynova by Bayer Health Care (Reg No. 017864)
13-07-2017, 03-10-17 and 04-10-2017
554. Name
Brand Name +Dosage Form + Strength Dinopros E-2 Tablet 3mg
Composition Each vaginal tablet contains
Dinoprostone ……….3mg.
Pharmacological Group Prostaglandin
Type of Form Form-5
Pack size & Demanded Price 1`s, 4’s / As per SRO
Approval status of product in Reference Prostin E2 Pharmacia & Upjohn Division of Pfizer USA.
Regulatory Authorities. MHRA approved Vaginal tablet
Me-too status Prostin E-2 by Pfizer vaginal tablets (Reg. No. 009821)
13-07-2017, 03-10-17 and 04-10-2017
555. Name
Brand Name +Dosage Form + Strength Estasol- D Tablets
Composition Each pink film coated tablet contains:
Ethinyl Estradiol …..........0.02mg
Each white film coated tablet (hormone free) contains:
Drospirenone ……………3.0mg
Pharmacological Group Estrogen/ Progestogens
Type of Form Form-5
Approval status of product in Reference Loryana By Sandoz Inc.USA
Me-too status YAZ by Bayer Health Care (Reg. No. 059087)
13-07-2017, 03-10-17 and 04-10-2017
556. Name
Brand Name +Dosage Form + Strength Stroges Tablet
Ethinyl Estradiol ……….0.02 mg
Gestodene ……………… 0.075 mg
Pharmacological Group Estrogen/progestogen
Type of Form Form-5
Approval status of product in Reference Millinette 20/75 microgm sugar coated tablets (MHRA
Me-too status Meliane by Bayer Health Care (Reg. No. 024076)
13-07-2017, 03-10-17 and 04-10-2017
Remarks of the Evaluator. MHRA Approved product is in sugar coating while
the firm applied in film coating.
Me-too product is in uncoated form.
557. Name
Brand Name +Dosage Form + Strength Bivol Tablet 2.5mg
Composition Each core tablet contains:
Tibolone ………...2.5 mg
Pharmacological Group Gonadomimetic
Type of Form Form-5
Approval status of product in Reference Tibelia 2.5 mg uncoated tablets by M/s Mithra
Regulatory Authorities. Pharmaceuticals S.A, (MHRA approved )
Me-too status TIBOPAUSE by Zafa (Reg. No.024213),
13-07-2017, 03-10-17 and 04-10-2017
558. Name
Brand Name +Dosage Form + Strength Promen Tablets
Composition Each white film coated tablet contains:
Estradiol valerate …………….2.0 mg
Each pink film coated tablet contains:
Estradiol valerate……………...2.0 mg
Cyproterone acetate……….......1.0 mg
Pharmacological Group Antiandrogens and estrogens
Type of Form Form-5
Approval status of product in Reference Climen by Bayer Schering Pharma AG Germany
Me-too status Climen by Bayer Health Care (Reg. No. 018207)
13-07-2017, 03-10-17 and 04-10-2017
Remarks of the Evaluator. In Reference country the applied product is coated, while
firm has applied film coating.
559. Name
Brand Name +Dosage Form + Strength Prodiol Tablets
Ethinyl Estradiol……………….0.035mg
Cyproterone Acetate…………….2mg
Pharmacological Group Anti-androgen/estrogen
Type of Form Form-5
Approval status of product in Reference Co-cyprindiol 2000/35 Tablets sugar coated by M/s
Regulatory Authorities. Fannin (UK) Ltd, MHRA approved
Me-too status DIANE-35 by Bayer Health care (Reg. No. 011467),
Eva-35 tablet by M/s Hansel (Reg#064796)
13-07-2017, 03-10-17 and 04-10-2017
Remarks of the Evaluator. In Reference country the applied product is sugar-coated,
while firm has applied film coating.
560. Name2 and address of manufacturer / M/s Pharmasol (Pvt) Ltd. Plot No. 549, Sundar Industrial
Brand Name +Dosage Form + Strength Dyrone Tablet 10mg
Dydrogesterone (trans- isomer) …….10mg
Type of Form Form-5
Approval status of product in Reference Duphaston by BGP Products (Swissmedic Approved)
Me-too status Duphaston by Abbott (Reg. No. 006654)
13-07-2017, 03-10-17 and 04-10-2017
Capsules (Hormones)
Brand Name +Dosage Form + Strength Danacare Capsule 200mg
Danazol….……………200mg
Pharmacological Group Antigonadotropins
Type of Form Form-5
Pack size & Demanded Price 30`s/ As per SRO
Approval status of product in Reference Danocrine by Sanofi Avents, UK
Me-too status Danzol by Platinum Pharma (Reg. No. 034832)
13-07-2017, 03-10-17 and 04-10-2017
Division particularly for either Capsule (Steroidal Hormone) or Capsule (Non-steroidal
562. Name
Brand Name +Dosage Form + Strength Klomin Capsule 50mg
Clomiphene citrate ….……………50mg
Pharmacological Group Estrogen Agonists-Antagonists
Type of Form Form-5
Pack size & Demanded Price 10`s , 30’s / As per SRO
Approval status of product in Reference Clomifene Citrate capsules by Penta Labs, Australia
Regulatory Authorities. (Could not be confirmed)
Me-too status Prolifen by Chiesi Pharma (Reg. No. 010250)
13-07-2017, 03-10-17 and 04-10-2017
Remarks of the Evaluator. International availability in RRA could not be confirmed.
Ampoules (Hormone) (Human)
Brand Name +Dosage Form + Strength Progesol Injection 250mg
Composition Each ml contains :
Hydroxyprogesterone caproate……………250mg
Pharmacological Group Progestogens
Type of Form Form-5
Pack size & Demanded Price 3’s(1ml) /As per SRO

Approval status of product in Reference Makena IM (1ml) Injection, Lumara Health, A Division
Regulatory Authorities. Of Amag Pharmaceuticals, Inc Waltham, MA. USA
Me-too status Hydroxy Progesterone Injection by ZAFA
250mg/ml(Reg. # 003531)
13-07-2017, 03-10-17 and 04-10-2017
Division particularly for either Ampoule (Steroidal Hormone-Human) or Ampoule (Non-
steroidal Horomone- Human) for further processing by Registration Board.
Brand Name +Dosage Form + Strength Steradol Injection IM
Composition Each ml contains :
Hydroxyprogesterone caproate …250mg
Estradiol Valerate……...5mg
Pharmacological Group Estrogen/progestogen
Type of Form Form-5
Pack size & Demanded Price 1’s(1ml) , / As per SRO
Approval status of product in Reference Gravibinian by Bayer Health Care Germany
Me-too status Gravibinian Inj (1ml) by Bayer Pakistan (oily
preparation)
13-07-2017, 03-10-17 and 04-10-2017
Brand Name +Dosage Form + Strength Tesfour Injection 250mg
Composition Each ml of the oily Solution contains:
Testosterone Propionate .....30 mg
Testosterone Phenyl propionate ........60mg
Testosterone Isocaproate ....................60mg
Testosterone Decanoate .....................100mg
Pharmacological Group Androgen
Type of Form Form-5
Pack size & Demanded Price 1’s(1ml) /As per SRO
Approval status of product in Reference Sustanon 250mg IM Injection vial
Me-too status Sustanon Injection By Organon(1ml) (Reg. No.002446)
13-07-2017, 03-10-17 and 04-10-2017
Remarks of the Evaluator. Reference product is in Vial form.
Brand Name +Dosage Form + Strength Tesviron Injection 250mg
Testosterone Enanthate .............250mg
Pharmacological Group Androgen
Type of Form Form-5
Pack size & Demanded Price 3’s, 1’s(1ml) /As per SRO
Approval status of product in Reference Primoteston Depot 250mg/ml Injection syringe 1ml
Me-too status Testofort Injection Reg # 025060 1ml ampoule
13-07-2017, 03-10-17 and 04-10-2017
Remarks of the Evaluator. Provided Reference is in Injection syringe.
Brand Name +Dosage Form + Strength Northon injection 200mg/ml
Norethisterone Enanthate …..200mg (in oily solution)
Type of Form Form-5
Finished Product Specification Innovator’s Specs
Pack size & Demanded Price 1’s(1ml) / As per SRO
Approval status of product in Reference Noristerat 200mg, Solution for Intramuscular Injection,in
Regulatory Authorities. oily solution(1ml) by Bayer PLC, UK
Me-too status Doryxas Injection in oily solution (1ml) Reg # 011082
13-07-2017, 03-10-17 and 04-10-2017
Brand Name +Dosage Form + Strength Medpro Injection 150mg/ml
Medroxyprogesterone acetate …….150mg
Pharmacological Group Synthetic progestogen
Type of Form Form-5
Pack size & Demanded Price 1’s (1ml) / As per SRO
Approval status of product in Reference Depo-Provera 150mg/ml Sterile Suspension for Injection
Regulatory Authorities. (1ml) Vial by Pfizer, UK
Me-too status Depo-Provera (1ml) Vial (Reg. No. 014862)
13-07-2017, 03-10-17 and 04-10-2017
Remarks of the Evaluator. Me-too & reference product is in vial 1ml form, while
firm has applied in 1ml ampoule.
Brand Name +Dosage Form + Strength Uterotonic Injection 0.2mg/ml
Diary No. Date of R& I & fee Diary No: -24167 , 13-12-2017 , Rs: 20,000/-
Methylergometrine maleate ……0.2mg
Pharmacological Group Synthetic analogue of ergonovine
Type of Form Form-5
Pack size & Demanded Price 50’s (1ml) / As per SRO
Approval status of product in Reference Methylergonovine Maleate Injection 0.2mg/ml (1ml) by
Regulatory Authorities. American Regent, Inc, USA
Methergine Injection by Novartis Pharma, USA
Me-too status Ergomin Injection 0.2 mg (1ml) Reg # 066614
13-07-2017, 03-10-17 and 04-10-2017
Brand Name +Dosage Form + Strength Dinopros Injection 5mg/ml
Dinoprost (as tromethamine)………... 5 mg
Pharmacological Group Prostaglandin
Type of Form Form-5
Pack size & Demanded Price 1`s (1ml) / As per SRO
Me-too status Prostin F2 ALPHA, Pfizer Pakistan 5mg/ml (1ml)
13-07-2017, 03-10-17 and 04-10-2017
Brand Name +Dosage Form + Strength Estol Injection 10mg/ml
Composition Each ml ampule contains:
Estradiol valerate ................10mg
Pharmacological Group Estrogen
Type of Form Form-5
Pack size & Demanded Price 3’s/As per SRO
Approval status of product in Reference Delestrogen 10mg/ml (5ml)by JHP Pharmaceuticals,
Regulatory Authorities. LLC, Michigan, USA
Me-too status Prognyore by Hansel Pharma (could not be confirmed)
13-07-2017, 03-10-17 and 04-10-2017
Remarks of the Evaluator. Me-too status could not be confirmed. Reference
Regulatory product pack size is in 5ml while firm has
provided pack size in 1ml
572. Name
Brand Name +Dosage Form + Strength Durasol Injection 50mg
Composition Each ml of the oily solution contains:
Nandrolone Decanoate……….50 mg
Pharmacological Group Anabolic Steroid
Type of Form Form-5
Pack size & Demanded Price 1`s (1ml) / As per SRO
Approval status of product in Reference Deca Duraboli, by MSD (1ml) USFDA Approved
Me-too status Deca-Durabolin by OBS Pharma (1ml) (Reg. No.
002443)
13-07-2017, 03-10-17 and 04-10-2017
Evaluator PEC-VIII
Previously considered Products/Molecules: Dry suspension(general):
Products:08, Molecules:06
Dry suspension(General):
Products: 05, Molecules :03
573. Name and address of Manufacturer / M/s Evolution Pharmaceuticals (Pvt.) Ltd. Plot #: 25 &
Applicant 26, Street No. S-3, RCCI, National Industrial Zone,
Rawat, Islamabad.
Brand Name+Dosage Form+Strength Fluva Dry Suspension 250 mg
Composition Each 5 ml (after reconstitution) contains:
Fosfomycin (as calcium) .......250 mg
Diary No. Date of R&I & fee DyNo.14219; 07-09-2017; Rs. 20,000/-
Pharmacological Group Antibiotics
Type of Form Form-5
Finished Product Specification Manufacturer Specifications
Pack Size & Demanded Price 60 ml ; As per SRO
Approval status of product in Fosfocina Suspension 250 mg/5ml of Laboratorios ERN,
Reference Regulatory Authorities S.A. Pedro IV, 499-08020 Barcelona, España,
Me-too status Cynfo Suspension 250 mg/5ml by Sami Pharma. (Pvt.)
Ltd.
GMP status New License (Inspection Date: 07th June 2017)
574. Name and address of Manufacturer / M/s Evolution Pharmaceuticals (Pvt.) Ltd. Plot#: 25 & 26,
Applicant St# S-3, RCCI, National Industrial Zone, Rawat, Islamabad
Brand Name+Dosage Form+Strength Lenox Dry Suspension 125 mg
Levofloxacin (as hemihydrate)......125 mg
Pharmacological Group Fluoroquinolone
Type of Form Form-5
Approval status of product in Allgram 125 mg/ml, Italy
Me-too status Quinocil suspension of Mediceena
reference agencies is required.
Brand Name+Dosage Form+Strength Lenox Dry Suspension 250 mg
Levofloxacin (as hemihydrate)......250 mg
Pharmacological Group Fluoroquinolone
Type of Form Form-5
Approval status of product in Allgram 250 mg/ml, Italy
Me-too status Quinocil suspension of Mediceena
Brand Name+Dosage Form+Strength Fluva Dry Suspension 500 mg
Fosfomycin (as calcium) .......500 mg
Pharmacological Group Antibiotics
Type of Form Form-5
Finished Product Specification As per Innovator’s Specs.
Approval status of product in Fosfocina Suspension 500 mg/5ml of Laboratorios ERN,
Reference Regulatory Authorities S.A. Pedro IV, 499-08020 Barcelona, España,
Me-too status Focin Suspension 500 mg/5ml by Tabros Pharma. (Pvt.)
Ltd.
Brand Name+Dosage Form+Strength Azirox Dry Suspension 200 mg
Azithromycin (as dihydrate) .......200 mg
Pharmacological Group Macrolide (Antibiotics)
Type of Form Form-5
Pack Size & Demanded Price 15 ml & 25 ml ; As per SRO
Approval status of product in Zithromax 200 mg in 5 ml Suspension of Pfizer Ltd., UK.
Reference Regulatory Authorities (MHRA)
Me-too status Rasthro 200mg/5ml suspension of Rasco pharma
Remarks of Evaluator  Firm has applied Azithromycin (as dihydrate) 200
mg/5ml suspension as granules but in reference
agencies it is found as powder for oral suspension.
Decision: Approved
Previously considered Products/Molecules:

Dry suspension(general): Products:32, Molecules:08
Dry Vial (Cephalosporin): Products: 02, Molecules: 01

Brand Name+Dosage Form+Strength Epirom Injection 500 mg
Composition Eaqch vial contains:
Cefpirome Sulphate ( with sodium carbonate).......500 mg
Pharmacological Group Cephalosporin (Antibiotics)
Type of Form Form-5
Approval status of product in Approved in ANSM
Me-too status Pirome Injection 500mg of Cirin Pharmaceuticals
Remarks of Evaluator The applied formulation is repealed in ANSM and
it is not found in other reference agencies.
Brand Name+Dosage Form+Strength Epirom Injection 1gm
Composition Eaqch vial contains:
Cefpirome Sulphate ( with sodium carbonate).......1gm
Pharmacological Group Cephalosporin (Antibiotics)
Type of Form Form-5
Approval status of product in Approved in ANSM
Me-too status Pirome Injection 1gm of Cirin Pharmaceuticals
Remarks of Evaluator The applied formulation is repealed in ANSM and
it is not found in other reference agencies.
Deferred for evidence of approval of applied formulation in reference regulatory
b) New section(s)
Previously considered Products/Molecules: Capsule section (Cephalosporin):
Products -3, Molecules-2
Capsule (General): Products; 04, Molecules :02
580. Name and address of manufacturer / M/s Aulton Pharmaceuticals, Plot # 84/1, Block A, Phase
Applicant 5, Industrial Estate, Hattar, NWFP.
Brand Name +Dosage Form + Strength Cefial Capsule 200mg
Diary No. Date of R& I & fee Dy No. 3218, 13-04-2017, Rs.20,000/-
Cefixime(as trihydrate)…200mg
Pharmacological Group Antibiotics ( Cephalosporin)
Type of Form Form-5
Finished Product Specification J.P Specifications
Pack size & Demanded Price 5’s ; As fixed by Govt.
Approval status of product in Reference Approved in Spain
Me-too status Soxime Capsule 200mg by Swat Pharmaceuticals.
GMP status On recommendation of panel of experts, CLB in its
252nd meeting held on 15th March, 2017 approved three
additional sections of M/s Aulton Pharmaceuticals.
Remarks of the Evaluator. i. Justification of addition of 3% overage in master
formulation.
ii. Two contradictory statements i.e.
Quantity/capsule…350.72mg and weight/capsule
…390.375mg are present in master formulation.
Clarification is required in this regard.
Decision: Deferred for clarification of following observations:
i. Justification of addition of 3% overage in master formulation.
ii. Two contradictory statements i.e. Quantity/capsule…350.72mg and weight/capsule
…390.375mg are present in master formulation. Clarification is required in this regard.
Evaluator PEC-XII
Case. No.1. M/s Fozan Pharmaceutical Industries (Pvt) Ltd. Peshawar. (New Section)
CLB in its 256th meeting held on 09-10th November, 2017 has considered and granted the following one
(01) additional section of M/ s Fozan Pharmaceutical Industries (PVT) Ltd.
Accordingly, firm has applied for following products for consideration by Drug Registration Board.
Sr. No Section No. of products No. of molecules
1 Tablet section (Psychotropic) 12 06
Tablet section (Psychotropic)
12 Products/ 06 Molecules
581. Name and Address of Manufacturer / M/s Fozan Pharmaceuticals (Pvt.) Ltd. 36A- Industrial
Applicant Estate, Hayatabad, Peshawar.
Brand Name + Dosage Form + Strength Alpezan Tablet 0.5mg
Diary No. Date of R & I & fee Diary No:26418, 28/12/2017, Rs: 20,000/-
Composition Each Tablet contains:
Alprazolam…0.5mg
Pharmacological Group Benzodiazepine derivatives
Type of Form Form-5
Pack Size & Demanded Price 3x10’s/ As per SRO
Approval Status of Product in Xanax 500 microgram Tablets by M/s Pfizer Limited
Me-too Status Alprazolam 0.5mg Tablets by M/s Heal Pharmaceuticals
(Reg#079391)
GMP Status 03-10-2017;
Panel Inspection renewal of DML and additional section.
Panel Recommends grant of additional sections.
Decision: Approved
582. Name and Address of Manufacturer / M/s Fozan Pharmaceuticals (Pvt.) Ltd.
Applicant 36A- Industrial Estate, Hayatabad, Peshawar.
Brand Name + Dosage Form + Strength Alpezan Tablet 1mg
Alprazolam…1 mg
Type of Form Form-5
Approval Status of Product in ALPRAZOLAM MYLAN 1 mg, scored tablet by M/s
Reference Regulatory Authorities. MYLAN SAS (ANSM France Approved)
Me-too Status Alprazolam 1 mg Tablets by M/s Heal Pharmaceuticals
(Reg#079392)
Decision: Approved
Brand Name + Dosage Form + Strength Alpezan Tablet 0.25mg
Alprazolam…0.25 mg
Type of Form Form-5
Approval Status of Product in Xanax 250 microgram Tablets by M/s Pfizer Limited
Me-too Status Alprazolam 0.25mg Tablets by M/s Heal Pharmaceuticals
(Reg#079390)
Decision: Approved
Brand Name + Dosage Form + Strength Bromezan Tablet 3mg
Bromazepam…3 mg
Type of Form Form-5
Approval Status of Product in Lexotan 3mg Tablets by M/s Roche Products Limited
Reference Regulatory Authorities. (HPRA Ireland Approved)
Me-too Status Bromota Tablet 3mg by M/s Orta Laboratories
(Reg#065938)
Remarks of the Evaluator.  Firm has claimed BP specification; however, product
monograph was not in available pharmacopeias.
Decision: Approved
Brand Name + Dosage Form + Strength Colonezan Tablet 0.5mg
Clonazepam…0.5 mg
Type of Form Form-5
Approval Status of Product in Clonazepam Auden 500mcg Tablets by M/s Auden
Reference Regulatory Authorities. Mckenzie (Pharma Division) Ltd (MHRA Approved)
Me-too Status Tovir 0.5mg Tablet by M/s Adamjee (Reg#080335)
Decision: Approved
Brand Name + Dosage Form + Strength Colonezan Tablet 1mg
Diary No. Date of R & I & fee Diary No:26415, 28/12/2017 , Rs: 20,000/-
Clonazepam…1 mg
Type of Form Form-5
Approval Status of Product in Klonopin Tablets 1mg by M/s Genetech USA, Inc
Me-too Status Curo 1mg Tablets by M/s Wilshire Laboratories (Pvt) Ltd
(Reg#065700)
Decision: Approved
Brand Name + Dosage Form + Strength Colonezan Tablet 2mg
Clonazepam…2 mg
Type of Form Form-5
Approval Status of Product in Clonazepam Auden 2mg Tablets by M/s Auden
Reference Regulatory Authorities. Mckenzie (Pharma Division) Ltd (MHRA Approved)
Me-too Status Tovir 2mg Tablet by M/s Adamjee (Reg#080336)
Decision: Approved
Brand Name + Dosage Form + Strength Diamezan Tablet 5mg
Diazepam …5mg
Type of Form Form-5
Approval Status of Product in Diazepam 5 mg Tablets by M/s TEVA UK Limited
Me-too Status Dipam tablet 5mg by M/s Leads Pharma Pvt Ltd
(Reg#065299)
Decision: Approved
Brand Name + Dosage Form + Strength Diamezan Tablet 10mg
Diazepam …10 mg
Type of Form Form-5
Approval Status of Product in Diazepam 10mg Tablets by M/s TEVA UK Limited
Me-too Status Dipam tablet 10mg by M/s Leads Pharma Pvt Ltd
(Reg#065300)
Decision: Approved
Brand Name + Dosage Form + Strength Lormezan Tablet 1mg
Lorazepam…1mg
Type of Form Form-5
Approval Status of Product in Lorazepam 1mg Tablets by M/s Genus Pharmaceuticals
Reference Regulatory Authorities. Holdings Limited (MHRA Approved)
Me-too Status Lorazepam 1 mg Tablets by M/s Heal Pharmaceuticals
(Reg#079396)
Decision: Approved
Brand Name + Dosage Form + Strength Lormezan Tablet 2mg
Lorazepam…2 mg
Type of Form Form-5
Approval Status of Product in Ativan Tablets 2mg by M/s Valeant Pharmaceuticals
Me-too Status Lorazepam 2 mg Tablets by M/s Heal Pharmaceuticals
(Reg#079397)
Decision: Approved
Brand Name + Dosage Form + Strength Phenomezan Tablet 30mg
Phenobarbitone …30 mg
Pharmacological Group Barbiturates and derivatives
Type of Form Form-5
Approval Status of Product in Phenobarbitone 30 mg Tablets by M/s Bristol
Reference Regulatory Authorities. Laboratories Limited (MHRA Approved)
Me-too Status ALEPTAL Tablet 30mg by M/s Bloom Pharmaceuticals
(Pvt) Ltd (Reg#080596)
Decision: Approved
Case. No.2. M/s Roryan Pharmaceutical Industries (PVT) Ltd. (New Section)
CLB in its 256th meeting held on 09-10th November, 2017 has considered and granted the following one
(01) additional section of M/s Roryan Pharmaceutical Industries (PVT) Ltd. Accordingly, firm has applied
for following products for consideration by Drug Registration Board.
Sr.No. Section No. of No. of

products molecules
1. Sachet section (General) 10 10
Sachet section (General)
10 Products/ 10 Molecules
593. Name and Address of Manufacturer / M/s Roryan Pharmaceutical Industries (PVT) Ltd.
Applicant 85/B, Industrial Estate, Hayatabad, Peshawar.
Brand Name + Dosage Form + Strength Sachet Anmol Insta
Diary No. Date of R & I & fee Diary No:26394 ,28/12/2017 , Rs: 20,000/-
Composition Each Sachet contains:
Omeprazole……….…40mg.
Sodium bicarbonate…1680mg.
Pharmacological Group Proton-pump inhibitor/Antacid
Type of Form Form-5
Pack Size & Demanded Price 10’s/ As per SRO
Approval Status of Product in Zegerid Sachet 40mg/1680mg powders by M/s
Reference Regulatory Authorities. SANTARUS INC (USFDA approved)
Me-too Status RULING+ 40mg/1680mg powders by M/s High-Q.
(Reg#070633)
GMP Status 25-09-17; Inspection of Additional Sections.
Brand Name + Dosage Form + Strength Unisoda Sachet 4g
Diary No. Date of R & I & fee Diary No:26395 , 28/12/2017, Rs: 20,000/-
Tartaric Acid…..0.215g
Sodium bicarbonate……0.429g
Citric acid…….0.176g
Sodium citrate……0.153g
Pharmacological Group Antacids & Antiflatulents
Type of Form Form-5
Pack Size & Demanded Price 20’s, 100’s/ As per SRO
Approval Status of Product in CitroSoda Sachet by M/s Abbott Laboratories (USFDA
Reference Regulatory Authorities. Approved) not confirmed.
Me-too Status Citrovel Sachet by M/s Well & Well pharma
(Reg#070071)
Remarks of the Evaluator.  In 276th meeting of Registration board, applied
formulation was approved with innovator’s
specification on the basis of me-too reference since
applied formulation is considered as OTC drug by
various reference regulatory authorities.
 Approval status of product in Reference Regulatory
 Firm has claimed BP specifications; however,
product monograph was not confirmed in available
pharmacopeias.
Decision: Approved with change of brand name and innovator specifications
Brand Name + Dosage Form + Strength ROLEKAST 4mg SACHET
Montelukast (as sodium)…4mg.
Pharmacological Group Leukotriene receptor antagonist.
Type of Form Form-5
Pack Size & Demanded Price 14’s/ As per SRO.
Approval Status of Product in Singulair Paediatric 4 Mg Granules by M/s Merck Sharp
Reference Regulatory Authorities. & Dohme Ltd.(MHRA approved)
Me-too Status Singulair 4mg powder by M/s OBS (Reg# 031377)
Remarks of the Evaluator.  Firm has claimed BP specifications; however,
product monograph was confirmed in USP.
Decision: Approved
Brand Name + Dosage Form + Strength MEBEGHULA SACHET
Mebeverine hydrochloride…135mg.
Ispaghula husk...3.5g.
Pharmacological Group Antispasmodic
Type of Form Form-5
Pack Size & Demanded Price 10’s/
As per SRO
Approval Status of Product in Fybogel Mebeverine effervescent granules by M/s
Reference Regulatory Authorities. Reckitt Benckiser Healthcare (UK) Ltd. (MHRA
approved)
Me-too Status Colospas Fibro 135mg/3.5g powder by M/s Nabiqasim.
(Reg# 058672)
pharmacopeias.
Decision: Approved
Brand Name + Dosage Form + Strength SMECTIT 3gm SACHET
Dioctahedral smectite…3gm
Pharmacological Group Anti-diarrheal
Type of Form Form-5
Approval Status of Product in Smecta 3 g powder for oral suspension in sachet by M/s
Reference Regulatory Authorities. Ipsen Pharma (ANSM approved)
Me-too Status Diosecta 3g sachet by M/s Woodwards Pharma. (Reg#
061111)
Decision: Approved with Innovator’s specification.
Brand Name + Dosage Form + Strength PAEDIA SAFE SACHET
Composition Each Sachet Contains:
Sodium chloride… 2.6gm
Potassium chloride…1.50gm
Trisodium citrate…2.90gm
Glucose Anhydrous…13.50gm
Pharmacological Group Electrolyte( Oral Rehydration Salts) O.R.S
Type of Form Form-5
Finished Product Specification International Pharmacopeia
Pack Size & Demanded Price 25’s, 20’s /As per SRO
Approval Status of Product in New formulation of Oral Rehydration Salts (ORS) with
Reference Regulatory Authorities. reduced osmolarity (WHO approved)
Me-too Status Orsol Sachet ORS by M/s Kaizen Pharmaceuticals
(Reg#073897)
Decision: Approved
Brand Name + Dosage Form + Strength DIGESTO SACHET 5g
Composition Each Sachet Contains:
Sodium bicarbonate…2.32 g
Citric acid…2.18 g
Anhydrous sodium carbonate…0.50 g
Pharmacological Group Antacid/Deflatulent
Type of Form Form-5
Pack Size & Demanded Price 72’s,12’s /As per SRO
Approval Status of Product in Eno (Sachet) by M/s GlaxoSmithKline Consumer
Reference Regulatory Authorities. Healthcare (UK) Trading Limited.(MHRA Approved)
Me-too Status PEDITRAL ORS SACHET by GLAXO SMITH
KLINE GSK.Pvt Ltd (Reg#016868) not confirmed
Remarks of the Evaluator.  Me-too Status not confirmed from available
database.
 Firm has claimed BP specifications; however,
pharmacopeias.
Brand Name + Dosage Form + Strength ROTIUM SACHET 2g
Strontium ranelate…2gm
Pharmacological Group Other drugs affecting bone structure and mineralization
Type of Form Form-5
Finished Product Specification Innovator’s specifications.
Approval Status of Product in Strontium ranelate 2 g granules for oral suspension by
Reference Regulatory Authorities. M/s Rivopharm UK Ltd. (MHRA approved)
Me-too Status Onita 2g powder by M/s PharmEvo. (Reg# 057746)
Decision: Approved
Brand Name + Dosage Form + Strength ROCETYL 200mg SACHET
Acetylcysteine…200mg.
Pharmacological Group Mucolytic
Type of Form Form-5
Pack Size & Demanded Price 30’s/ As per SRO.
Approval Status of Product in Acetylcysteine 200 mg Powder for Oral Solution by M/s
Reference Regulatory Authorities. NTC S.r.l. (MHRA approved)
Me-too Status Mucolator 200mg powders by M/s Abbott Laboratories.
(Reg# 017693)
pharmacopeias.
Decision: Approved
Brand Name + Dosage Form + Strength ROVICOL SACHET
Polyethylene Glycol 3350….13.125g
Sodium chloride……0.3507g
Sodium Bicarbonate…0.1785g
Potassium Chloride…0.0466g
Pharmacological Group Osmotic Lexative
Type of Form Form-5
Pack Size & Demanded Price 10’s/
As Per SRO
Approval Status of Product in Movicol 13.8g sachet, powder for oral solution by M/s
Reference Regulatory Authorities. Norgine Limited (MHRA Approved)
Me-too Status Movopeg Sachet by M/s Wns field Pharmaceutical
(Reg#078594)
pharmacopeias.
Decision: Approved
Case. No.3. M/s Treat Pharmaceutical Industry (Pvt.) Ltd. Bannu ( New Section)
CLB in its 256th meeting held on 09-10th November, 2017 has considered and granted the following one (07)
additional sections of M/s Treat Pharmaceutical Industry (Pvt.) Ltd.
Sr.no. Section No.of No. of
Products Molecules
1 Dry powder injection (Cephalosporin) 16 05
2 Oral dry suspension (Cephalosporin) 04 02
3 Capsule (Cephalosporin) 06 04
4 Capsule (General) 13 10
5 Tablet (Narcotic/ Psychotropic) - -
6 Liquid injectable (Narcotic/ Psychotropic) - -
7 Dry suspension (General) - -
Capsule (Cephalosporin)
603. Name and address of manufacturer / M/s Treat Pharmaceutical Industry (Pvt.) Ltd. A-37, Small
Applicant Industrial Estate Township Kohat Road Bannu.
Brand Name +Dosage Form + Strength CEFITEST 200mg CAPSULE
Cefixime (as trihydrate)…200 mg
Diary No. Date of R& I & fee Diary No: 26586, 29/12/2017, Rs: 20,000/-
Pharmacological Group Third-generation cephalosporins
Type of Form Form-5
Approval status of product in Approved by Spain.
Me-too status Soxime 200mg Capsule by M/s Swat Pharmaceuticals
(Reg#060127)
GMP status 05/10/2017
Grant of renewal of DML and additional sections.
Panel recommends DML renewal and additional sections
Decision: Approved
Brand Name +Dosage Form + Strength CEPTIL 100 mg Capsule
Cefpodoxime (as proxetil)…100mg
Type of Form Form-5
Pack size & Demanded Price 2 x 6’s / As per SRO
Approval status of product in Not confirmed.
Me-too status Ipod 100 mg Capsules by M/s Genome Pharmaceuticals
(Pvt,) Ltd (Reg#075529)
Brand Name +Dosage Form + Strength TILOCEF 250mg Capsule
Cefradine…250mg
Pharmacological Group First-generation cephalosporins
Type of Form Form-5
Approval status of product in Cefradine 250mg Capsules by M/s Athlone
Reference Regulatory Authorities. Pharmaceuticals Limited (MHRA Approved)
Me-too status Zasinol 250mg capsule byM/s Martin Dow (Reg#080643)
Decision: Approved
606. Name and address of manufacturer / M/s Treat Pharmaceutical Industry(Pvt.) Ltd. A-37, Small
Brand Name +Dosage Form + Strength TILOCEF 500mg Capsule
Cefradine…500mg
Type of Form Form-5
Approval status of product in Cefradine 500mg Capsules by M/s Athlone
Reference Regulatory Authorities. Pharmaceuticals Limited (MHRA Approved)
Me-too status Dinar 500mg capsule byM/s Baxter Pharma
(Reg#084548)
Decision: Approved
Brand Name +Dosage Form + Strength TRIXIL 250mg Capsule
Cefadroxil (as monohydrate)…250mg
Type of Form Form-5
Approval status of product in Not confirmed.
Me-too status Not confirmed.
 Evidence of applied formulation/drug already approved by DRAP (generic / me-too status)
alongwith registration number, brand name and name of firm.

Brand Name +Dosage Form + Strength TRIXIL 500mg Capsule
Cefadroxil (as monohydrate)…500mg
Type of Form Form-5
Approval status of product in Cefadroxil 500 mg capsules, hard by M/s Alkaloid-INT
Reference Regulatory Authorities. d.o.o. (MHRA Approved)
Me-too status Evacef 500mg Capsules by M/s Highnoon Laboratories,
(Reg#009141)
Decision: Approved
Dry powder injection (Cephalosporin)
16 products / 05molecules
Brand Name +Dosage Form + Strength CEFTA-500mg INJECTION (IM)
Composition Each vial contains:-
Ceftriaxone (as sodium)…500mg
Type of Form Form-5
Approval status of product in Rocephin IM 500 mg Powder and Solvent for Solution for
Reference Regulatory Authorities. Injection by M/s Roche Products Ltd (MHRA Approved)
Me-too status Rocimed 500mg Injection I.M by M/s Medicraft
Pharmaceuticals (Pvt) Ltd (Reg#082030)
Brand Name +Dosage Form + Strength CEFTA-500mg INJECTION (IV)
Ceftriaxone (as sodium)…500mg
Type of Form Form-5
Approval status of product in Rocephin IV 500 mg Powder and Solvent for Solution for
Reference Regulatory Authorities. Injection by M/s Roche Products Ltd (MHRA Approved)
Me-too status Signum 500 mg Injection I.V by M/s Cherwel
Brand Name +Dosage Form + Strength CEBACT-1gm INJECTION (IM/IV)
Cefoperazone (as sodium)....500mg
Sulbactam (as sodium)....500mg
Pharmacological Group Third-generation cephalosporin + Beta-lactamase
Inhibitor
Type of Form Form-5
Approval status of product in PMDA Japan Approved
Me-too status Cebac Injection 1gm by M/s Bosch (Reg#037630)
Brand Name +Dosage Form + Strength CEBACT-2gm INJECTION (IM/IV)
Cefoperazone (as sodium)…1 gram
Sulbactam (as sodium)…1 gram
Pharmacological Group Third-generation cephalosporins+ Beta-lactamase
Inhibitor
Type of Form Form-5
Approval status of product in Approved in Europe (Poland, Slovakia, Czech
Reference Regulatory Authorities. Republic) by EMA
Me-too status Cebac Injection 2gm by M/s Bosch (Reg#037631)
Brand Name +Dosage Form + Strength CEFTA-1g INJECTION (IV)
Ceftriaxone (as sodium)…1gm
Type of Form Form-5
Approval status of product in Rocephin IV 1 g powder and solvent for solution for
Reference Regulatory Authorities. injection by M/s Roche Products Ltd (MHRA Approved)
Me-too status Signum 1 gm Injection I.V. by M/s Cherwel
Brand Name +Dosage Form + Strength CEFTA-2g INJECTION (IV)
Ceftriaxone (as sodium)…2 gram
Type of Form Form-5
Approval status of product in Rocephin IV Injection 2gm By M/s Roche Products
Reference Regulatory Authorities. Limited (MHRA approved)
Me-too status Titan 2gm IV Injection by M/S Macter Pharma (Reg No.
075825)
Brand Name +Dosage Form + Strength CEFTA-250mg INJECTION (IV)
Ceftriaxone (as sodium).....250mg
Type of Form Form-5
Approval status of product in Ceftriaxone (as sodium) 250 mg powder for injection vial
Reference Regulatory Authorities. by M/s Alphapharm Pty Ltd, TGA confirmed)
Me-too status Antrix Injection 250mg IV by M/s Fynk (Reg#062723)
Brand Name +Dosage Form + Strength CEFTA-250mg INJECTION (IM)
Ceftriaxone (as sodium)....250mg
Type of Form Form-5
Approval status of product in Ceftriaxone (as sodium) 250 mg powder for injection vial
Reference Regulatory Authorities. by M/s Alphapharm Pty Ltd, TGA confirmed
Me-too status Antrix Injection 250mg IM by M/s Fynk
Brand Name +Dosage Form + Strength C-PIME-1g INJECTION (IM/IV)
Cefepime as hydrochloride…1 gm
With L-Ariginine
Pharmacological Group Fourth-generation cephalosporins
Type of Form Form-5
Approval status of product in Cefipime hydrochloride 1gm Injection by M/s Hospira,
Reference Regulatory Authorities. Inc. (USFDA approved).
Me-too status Uspime 500mg Injection by Usawa Pharmaceuicals (Reg#
060250)
Brand Name +Dosage Form + Strength C-PIME-500mg INJECTION (IM/IV)
Cefepime as hydrochloride…500mg
With L-Ariginine
Pharmacological Group Fourth-generation cephalosporins
Type of Form Form-5
Approval status of product in Cefipime hydrochloride 500mg Injection by M/s Hospira,
Reference Regulatory Authorities. Inc. (USFDA approved)
Me-too status Uspime 500mg Injection by Usawa Pharmaceuicals (Reg#
060251)
Brand Name +Dosage Form + Strength T-CEF-250mg INJECTION (IM/IV)
Cefotaxime (as sodium)....250mg
Type of Form Form-5
Approval status of product in Claforan Injection 250mg by M/s Aventis Pharma
Reference Regulatory Authorities. Limited (MHRA Approved)
Me-too status Getex Dry powder Injection 250mg by M/s Amarant from
Medicaid, Karachi (Reg#080277)
Decision: Approved
Brand Name +Dosage Form + Strength T-CEF-500mg INJECTION (IM/IV)
Cefotaxime (as sodium)....500mg
Type of Form Form-5
Approval status of product in Claforan Injection 500mg by M/s Aventis Pharma
Reference Regulatory Authorities. Limited (MHRA Approved)
Me-too status Getex Dry powder Injection 500mg by M/s Amarant from
Decision: Approved
Brand Name +Dosage Form + Strength T-CEF-1g INJECTION (IM/IV)
Cefotaxime (as sodium)....1gm
Type of Form Form-5
Approval status of product in Claforan Injection 1gm by M/s Aventis Pharma Limited
Me-too status Getex Dry powder Injection 1gm by M/s Amarant from
Decision: Approved
Brand Name +Dosage Form + Strength TILOCEF-500mg INJECTION (IM/IV)
Cephradine with L-Arginine….500mg
Type of Form Form-5
Approval status of product in USFDA discontinued
Reference Regulatory Authorities. ANSM France approved as IV only but archived on
07.05.2011
Me-too status Linadine 500mg Injection by M/s Alina (Reg#070736)
Remarks of the Evaluator.  Evidence of approval of applied formulation with
active status of in market in reference regulatory
authorities could not be confirmed.
 Evidence of L-Arginine in formulation not confirmed
in Reference Regulatory Authorities.
 Firm has not submitted master formulation of applied
product.
 Evidence of approval of applied formulation with active status of market in reference
regulatory authorities could not be confirmed.
 Evidence of L-Arginine in formulation not confirmed in Reference Regulatory Authorities.
 Master formulation of applied product.
Brand Name +Dosage Form + Strength TILOCEF-250mgINJECTION (IM/IV)
Type of Form Form-5
Me-too status Fostrum 250mg Injection by M/s Pulse Pharmaceuticals
(Reg#074171)
in Reference Regulatory Authorities.
product.
Brand Name +Dosage Form + Strength TILOCEF-1 g INJECTION(IM/IV)
Type of Form Form-5
Reference Regulatory Authorities. ANSM France approved separately as IV and IM but
archived on 26-04-2016
Me-too status Fostrum 1g Injection by M/s Pulse Pharmaceuticals
(Reg#074172)
from in Reference Regulatory Authorities.
product.
Oral dry suspension (Cephalosporin)
04products/ 02molecules
Brand Name +Dosage Form + Strength TILOCEF 125mg/5ml dry suspension 60 ml
Cephradine…125mg
Type of Form Form-5
Pack size & Demanded Price 60ml/ As per SRO
Approval status of product in CEPHRADINE 125mg/5ml powder for suspension by
Reference Regulatory Authorities. M/s TEVA (Discontinued in USFDA)
Me-too status Licef Dry Powder suspension 125mg/5ml by M/s Wisdom
Brand Name +Dosage Form + Strength TILOCEF 250mg/5ml dry suspension 60 ml
Cephradine…250mg
Type of Form Form-5
Approval status of product in Cefradine 250mg/5ml dry powder for syrup by M/s
Reference Regulatory Authorities. Strides Pharma UK Ltd (MHRA Approved)
Me-too status Licef Dry Powder suspension 250mg/5ml by M/s Wisdom
Decision: Approved
Brand Name +Dosage Form + Strength TRIXIL 125mg/5ml Dry suspension 60 ml
Composition Each5ml contains
Cefadroxil (as monohydrate)…. 125 mg
Type of Form Form-5
Approval status of product in DURICEF 125g/5ml for suspension by M/s Warner
Reference Regulatory Authorities. Chilcott Compant, Inc.(USFDA approved)
Me-too status Evacef Suspension 125mg/5ml by M/s Highnoon
Laboratories, Lahore (Reg#011213)
Decision: Approved
Brand Name +Dosage Form + Strength TRIXIL 250mg/5ml Dry suspension 60 ml
Composition Each5ml contains
Cefadroxil (as monohydrate)…. 250 mg
Type of Form Form-5
Approval status of product in DURICEF 250g/5ml for suspension by M/s Warner
Reference Regulatory Authorities. Chilcott Compant, Inc.(USFDA approved)
Me-too status Duricef 250mg/5ml Oral Suspension by GSK
(Reg. No. 010057)
Decision: Approved
Capsule (General)
13 products/ 10molecules
Brand Name +Dosage Form + Strength AZATE 250mg CAPSULE
Azithromycin (as dihydrate).....250mg
Pharmacological Group Macrolides
Type of Form Form-5
Pack size & Demanded Price 1x6’s/ As per SRO
Approval status of product in Zithromax 250mg capsule by M/s Pfizer Ltd.(MHRA
Me-too status Azomax 250mg capsule by M/s Sandoz
Pharmaceuticals.(Reg#022200)
Decision: Approved
Brand Name +Dosage Form + Strength DICER 50mg CAPSULES
Diacerein…50 mg
Pharmacological Group Other antiinflammatory and antirheumatic agents, non-
steroids
Type of Form Form-5
Approval status of product in Diacerein 50 mg hard capsule by M/s BIOGARAN
Reference Regulatory Authorities. (ANSM France Approved)
Me-too status Dibro 50mg Capsules by M/s Winbrain Research
Laboratories (Reg#071639)
Decision: Approved
Brand Name +Dosage Form + Strength DULTIN 20mg CAPSULE
Enteric coated Pellets (17%) of Duloxetine hydrochloride
Pharmacological Group Other antidepressants
Type of Form Form-5
Pack size & Demanded Price 1x10’s/As per SRO
Approval status of product in Cymbalta (Duloxetine 20 mg capsule) by M/s Eli Lilly,
Pharma.(Reg#055446)
Remarks of the Evaluator.  Source of Pellets: Vision Pharmaceuticals, Islamabad.
otherwise.
Brand Name +Dosage Form + Strength ETO 40mg CAPSULE
pellets (22.5%)...40mg
Type of Form Form-5
034227 )
GMP status GMP and Grant License Inspection
05/10/2017
Decision: Approved
Brand Name +Dosage Form + Strength ETO 20mg CAPSULE
pellets (22.5%)...20mg
Type of Form Form-5
Approval status of product in Esomperazole magnesium Capsule 20mg of Mylan
Reference Regulatory Authorities. Pharmaceuticals USFDA
Me-too status Esorid 20mg
Hilton Pharma
Decision: Approved
634. Name and address of manufacturer / M/s Treat Pharmaceutical Industry(Pvt.) Ltd. A-37,
Applicant Small Industrial Estate Township Kohat Road Bannu.
Brand Name +Dosage Form + Strength FLUZAN 150mg CAPSULE
Composition Each Capsule contains
Fluconazole…….150 mg
Pharmacological Group Triazole derivatives
Type of Form Form-5
Approval status of product in Reference Diflucan 150 mg capsule by M/s Pfizer, MHRA
Regulatory Authorities. Approved
Me-too status Diflucan 150 mg capsule by M/s Pfizer (Reg#011828)
Panel recommends DML renewal and additional
sections
Decision: Approved
Brand Name +Dosage Form + Strength Omcid 20mg CAPSULE
Omeprazole (enteric coated pellets 8.5%)…20mg
Type of Form Form-5
Approval status of product in Reference Losec 20 mg hard gastro-resistant capsules 20mg by
Regulatory Authorities. Astra Zeneca UK Ltd.(MHRA approved)
Me-too status Losec 20mg capsule by M/s Barrett Hodgson Pakistan
Pvt. Limited, (Reg# 010800)
sections
Remarks of the Evaluator.  Source of Pellets: Vision Pharmaceuticals,
Islamabad.
Decision: Approved.
Brand Name +Dosage Form + Strength OMCID 40mg CAPSULE
Omeprazole (enteric coated pellets 8.5%)…40mg
Type of Form Form-5
Approval status of product in Reference Losec 40 mg hard gastro-resistant capsules 20mg by
Regulatory Authorities. Astra Zeneca UK Ltd.(MHRA approved)
Me-too status Risek 40mg capsule by M/s Getz Pharma Pvt.Ltd.
(Reg#022109)
GMP status 05/10/2017. Grant of renewal of DML and additional
sections. Panel recommends DML renewal and
additional sections
Remarks of the Evaluator.  Source of Pellets: Vision Pharmaceuticals,
Islamabad.
Decision: Approved
Brand Name +Dosage Form + Strength REBETEK 20mg CAPSULE
Rabeprazole(as sodium) enteric coated pellets
8.5%…20mg
Type of Form Form-5
Approval status of product in Reference Not confirmed
Me-too status Rabecap Capsules 20mg by M/s Aries Pharmaceuticals
(Pvt.) Ltd (Reg#069725)
sections
 Source of Pellets: Vision Pharmaceuticals,
Islamabad.
Brand Name +Dosage Form + Strength TRANXAM 250mg CAPSULES
Tranexamic acid....250mg
Pharmacological Group Antifibrinolytics (Amino acids)
Type of Form Form-5
Approval status of product in Reference Hexatron capsule 250 mg by M/s Nippon Shinyaku Co.,
Regulatory Authorities. Ltd, PMDA Japan
(Reg#006524)
sections
Decision: Approved.
Brand Name +Dosage Form + Strength TRANXAM 500mg CAPSULES
Tranexamic acid…500mg
Pharmacological Group Antifibrinolytics (Amino acids)
Type of Form Form-5
Approval status of product in Reference Caprilon (Finland)/Hexatron (Japan) not confirmed.
(Reg#009730)
sections
Brand Name +Dosage Form + Strength TRAXECTIN 20mg CAPSULE
Fluoxetine as hydrochloride…20mg
Pharmacological Group Anti-depressant (Selective serotonin reuptake inhibitors)
Type of Form Form-5
Approval status of product in Reference Prozac 20 mg hard capsules by M/s Eli Lilly and
Regulatory Authorities. Company Limited (MHRA approved)
sections
Decision: Approved
Brand Name +Dosage Form + Strength TREAFEN SR 100mg CAPSULE
Diclofenac sodium sustained release pellets 32% Eq to
Diclofenac sodium…100 mg
Pharmacological Group Antiinflammatory and antirheumaticproducts, non-
steroids (Acetic acid derivatives and related substances)
Type of Form Form-5

Approval status of product in Reference Diclomax Retard Capsule by M/s Galen Ltd, (MHRA
Regulatory Authorities. approved )
Me-too status Mobikare by M/s Barrette Hodgson (Reg#029393)
sections
Remarks of the Evaluator.  Source of pellets: Vision Pharmaceuicals,
Islamabad.
Decision: Approved
Case. No.4. M/s Perfect Pharma (Pvt) Ltd. Lahore. (New Section)
CLB in its 251st meeting held on 06th December, 2017 has considered and granted the following one
(01) additional section of M/s Perfect Pharma (Pvt) Ltd.
Sr.No. Section No. of products No. of molecules
01 Liquid section (General) 10 10
Liquid section (General)
10Products / 10Molecules
642. Name and address of manufacturer / M/s Perfect Pharma (Pvt) Ltd. 5-km, Manga Road,
Applicant Riawind, Lahore.
Brand Name +Dosage Form + Strength Perfectin Syrup 40mg/15ml
Composition Each 15ml Contain:
Elemental iron (as iron protein succinylate)…40mg
Pharmacological Group Antianemic preparations
Type of Form Form-5
Pack size & Demanded Price 60 ml, 120ml / As per SRO
Me-too status Fero-slim Syrup by M/s Fynk Pharmaceuticals
(Reg#062725)
GMP status Last inspection report dated 06-10-2016 & 29-10-2016,
the panel recommended the resumption /renewal
/additional section for Liquid section (General), cream/
ointment section (general) and external preparation
section (repacking) but the panel did not recommend
resumption/renewal of tablet (general / psychotropic)
and capsule (general) section.
Remarks of the Evaluator.  GMP inspection report is older than 1 year.
Decision: Deferred for submission of latest GMP inspection report conducted within a period
of last 1 year by DRAP
643. Name and address of manufacturer / M/s Perfect Pharma (Pvt) Ltd.
Applicant 5-km, Manga Road, Riawind, Lahore.
Brand Name +Dosage Form + Strength Perfonol Syrup
Composition Each 5ml contains
Chlorpheniramine maleate……………….5mg
Terpin hydrate……………………………10mg
Potassium bicarbonate……………………0.1mg
Ammonium chloride……………………..25mg
Menthol…………………………………..1mg
Aminophylline……………………………32mg
Potassium guaiacol sulphonate…………...5mg
Potassium citrate………………………….0.1mg
Pharmacological Group Antihistamine/ Antitussive/ Demulcent/ Expectorant
Type of Form Form-5
Pack size & Demanded Price 120ml: Rs: 65.00/-
Approval status of product in Reference Chlor-Trimeton syrup by Schering USA (This drug only
Regulatory Authorities. contains chlorpheniramine)
Me-too status Pulmonol (for cough) syrup by M/s CCL (This drug
contains different active ingredients in different strength
than the applied drug)
Authorities not confirmed (The provided reference
of Chlor-Trimeton syrup by Schering USA only
contains chlopheniramine )
 Me-too status could not be confirmed from available
database
 GMP inspection report is older than 1 year.
 Submission of latest GMP inspection report conducted within a period of last 1 year by
DRAP.
Brand Name +Dosage Form + Strength Paranol Suspension 120mg/5ml
Paracetamol….120mg
Pharmacological Group Analgesic; antipyretic
Type of Form Form-5
Approval status of product in Reference Paracetamol 120 mg/5 ml Oral Suspension by M/s
Regulatory Authorities. Pinewood Laboratories Limited (MHRA approved)
Me-too status Fempol 120mg/5ml suspension by M/s Atlantic
Pharmaceuticals Pvt. Limited. (Reg# 062314)
Brand Name +Dosage Form + Strength Ulcode suspension 1gm/5ml
Composition Each 5ml Contains:
Sucralfate …… 1gm
Pharmacological Group Drugs for peptic ulcer and gastro-oesophageal reflux
disease (GORD)
Type of Form Form-5
120ml: Rs: 185.00/-
Approval status of product in Reference Antepsin 1g/5ml Oral Suspension by M/s Chugai
Regulatory Authorities. Pharma UK Limited, MHRA approved
Me-too status Ulsanic 1g/5ml Oral Suspension by M/s Highnoon
(Reg#010927)
Brand Name +Dosage Form + Strength Pemotose Syrup
Iron III hydroxide polymaltose complex eq. to elemental
iron…50mg
Folic acid…0.35mg
Pharmacological Group Antianemic preparations
Type of Form Form-5
Pack size & Demanded Price 60 ml: Rs: 80.00/- ; 120 ml: Rs: 120.00/-
Me-too status Renplex-F Syrup by M/s Reign Pharma (Reg#079694)
Brand Name +Dosage Form + Strength Nrufen Suspension 100mg/5ml
Ibuprofen…100mg
Pharmacological Group Antiinflammatory and antirheumatic products, non-
steroids (Propionic acid derivatives)
Type of Form Form-5
Pack size & Demanded Price 90 ml: Rs: 36.00/-
120 ml: Rs: 48.00/-
Approval status of product in Reference BRUFEN 100mg/5ml suspension by M/s y Abbvie
Me-too status BRUFEN 100mg/5ml suspension by M/s Abbott
Laboratories. (Reg# 004595)
Brand Name +Dosage Form + Strength Daviscon oral liquid
Sodium alginate…………..250mg
Calcium carbonate………..80mg
Sodium bicarbonate………133.5mg
Pharmacological Group Antacid
Type of Form Form-5
240 ml: Rs: 105.00/-
Approval status of product in Reference Gaviscon oral liquid peppermint bottle by M/s Reckitt
Regulatory Authorities. Benckiser Pty Ltd, (TGA approved)
Me-too status Ul-Nil Suspension by M/s Z-Jans. (Reg# 052470)
Brand Name +Dosage Form + Strength VeerVit Syrup
Thiamine hydrochloride..……..5mg
Riboflavin……………………..1.66mg
Pyridoxine……………………..1mg
Cyanocobalamin………………10mcg
Ascorbic acid……………………75mg
D-Pantothenol…………..……...2.5mg
Inositol………………………….5mg
Nicotinamide…………………...20mg
Lycine monohydrate (as HCl)….35mg
Pharmacological Group Vitamin preparation/ amino acid
Type of Form Form-5
Approval status of product in Reference Wellcosine by GSK Australia (The reference provided
Regulatory Authorities. by the firm could not be confirmed)
Me-too status Wellcosine Syruo by M/s GSK (Reg#006662)
 GMP inspection report is older than 1 year.
Brand Name +Dosage Form + Strength Aosegor Syrup 0.25mg/5ml
Pizotifen (as hydrogen malate)…0.25mg
Pharmacological Group Other antimigraine preparations
Type of Form Form-5
120ml: Rs: 86.00/-
Approval status of product in Reference Sanomigran Elixir 0.25mg/5ml by M/s Phoenix Labs,
Regulatory Authorities. MHRA approved.
Me-too status Zigor Syrup 0.25mg/5ml by M/s Onyx Pharma
(Reg#071674)
Brand Name +Dosage Form + Strength Trofol suspension 5mg/5ml
Composition Each 5ml Contains:
Domperidone…5mg
Pharmacological Group Drugs for functional gastrointestinal disorders
(Propulsives)
Type of Form Form-5
120 ml: Rs: 84.00/-
Approval status of product in Reference Domperidone 1mg/ml Oral Suspension by M/s
Regulatory Authorities. Wockhardt UK Ltd, MHRA approved
Me-too status Domel 1mg/ml Oral Suspension by M/s Barrett
Hodgson (Reg#028758)
b) Deferred cases
Evaluator PEC-III
652. Name and address of manufacturer / M/s Walt Danzay Pharmaceuticals, Plot No 35-A, Small
Applicant Industrial Estate, Taxila, Pakistan
Brand Name +Dosage Form + Strength DEPO-WALT 80mg/ml Injection
Diary No. Date of R& I & fee Dy No: 4103 : 26-05-2017 PKR 20,000/- : 26-05-2017
Composition Each vial contains
Methylprednisolone acetate …………….. 80 mg
Pharmacological Group Corticosteroid
Type of Form Form-5
Pack size & Demanded Price As Per SRO
Approval status of product in Reference DEPO MEDROL by Pfizer
GMP status Inspection report dated 15-02-2017, the panel
recommended the grant of drug manufacturing license
Remarks of the Evaluator.  Evidence of me-too status could not be confirmed
Decision of 271st meeting Deferred for evidence of me-too status.
Evaluation by PEC Firm has responded that the me-too status for this strength
does not exist but this product is internationally available
and registered in reference authorities, so it is requested to
grant registration on this basis.
Decision: Deferred for submission of application of Form 5-D along with differential fee of
Rs.30,000/- and stability data as per format decided in instant meeting.
Brand Name +Dosage Form + Strength Isowal 20 mg Capsule
Composition Each hard gelatin capsule contains
Isotretinoin………..20 mg
Pharmacological Group Retinoids for topical use
Type of Form Form-5
Finished Product Specification -
Pack size & Demanded Price 1 x 10’s: As Per SRO
Approval status of product in Reference Absorica capsule by Galephar Pharmaceuticals
Me-too status Daxar capsule by Weatherfolds Pharma
Remarks of the Evaluator. Firm has claimed in house specifications while the
product is present in both BP and USP
The FDA approved reference product contains following
excipients isotretinoin, stearoyl macrogolglycerides,
soybean oil, sorbitan monooleate and propyl gallate,
while the excipients mentioned by the firm in its
formulation only contains magnesium stearate, avicel and
aerosil.
st
Decision of 271 meeting Deferred for revision of formulation as per innovator
product according to the decision of 250th meeting of
Registration Board.
Evaluation by PEC Firm has provided the formulation of hard gelatin capsule
as per reference product approved by USFDA.
Brand Name +Dosage Form + Strength WALTOSPORIN Ear Drops.
Composition Each drop tainer dispenser contains:
Hydrocortisone……….. ……..1 mg
Neomycin sulphate ………….3400units/ml
Polymyxin B Sulphate ……….10000 units/ml
Pharmacological Group Corticosteroid and bactericidal
Type of Form Form 5
Finished Product Specification -
Pack size & Demanded Price 1 ×`1’s (5 ml Drop Tainer Dispenser)/As Per SRO
Me-too status OTOSPORIN EAR DROPS by GSK
Remarks of the Evaluator. Firm has claimed in house specification while the product
is present in USP as suspension
 The strength of hydrocortisone of applied formulation
is different from provided me-too status
Decision of 271st meeting Deferred for evidence of me-too status since the provided
me-too contains different strength of hydrocortisone.
Evaluation by PEC Firm has again submitted that there applied product
contains the same strength of hydrocortisone 1%w/v,
although the initially applied formulation contains
hydrocortisone 1mg which is equivalent to 0.1%,
moreover the me-too otosporin ear drops contains
hydrocortisone 10mg.
Decision: Deferred for evidence of me-too status since the provided me-too contains different
strength of hydrocortisone.
Brand Name +Dosage Form + Strength Tamsuwal 0.4mg Capsule
Tamsulosin Hydrochloride …..….0.4 mg
Pharmacological Group Selective alpha-1-Adrenergic Blocking Agents
Type of Form Form-5
Approval status of product in Reference Flomax capsule by Boehringer
Me-too status Tamsolin 0.4 mg cap Getz Pharma
recommended the grant of drug manufacturing license.
Remarks of the Evaluator. The reference product approved by FDA do not specify
whether it is delayed release/prolonged release, while the
product approved in MHRA is available as prolonged
release capsule. The USP monograph is for tamsulosin
capsule but the dissolution time is stated upto 8 and 12
hours with both acid and buffer as dissolution medium.
Firm has claimed tamsulosin immediate release powder.
Decision of 271st meeting Deferred for clarification of formulation since the
reference product is available as prolonged release
capsule.
Evaluation by PEC Firm has submitted revised formulation containing
Tamsulosin HCl SR pellets 0.2% from M/s Vision
Pharmaceuticals. Moreover firm has also provided COA,
stability study data of 3 batches of pellets and GMP of
M/s Vision Pharma.
Decision: Deferred for submission of fee for revised formulation.
Brand Name +Dosage Form + Strength Walgesdiol Tablet
Dydrogesterone … ……………..10mg
Estradiol valerate………….. 2mg
Pharmacological Group Progestogen and synthetic steroid
Type of Form Form-5
Finished product Specifications -
Approval status of product in Reference Femoston by BGP products
Me-too status Femoston by Abbott
Remarks of the Evaluator i. Clarification regarding cis or trans isomer is
required.
ii. Firm has claimed USP specifications while the
formulation is not present in BP and USP
iii. Firm has applied for estradiol valerate tablets while
internationally the salt is available as estradiol as
hemihydrate
Decision of previous meeting Registration Board deferred all the applications applied for
Tablet (Hormone) section for clarification from the firm
whether it specifies/retains the section for steroidal
preparations or for non-steroidal preparations. Registration
Board further deferred this case for following
clarifications:
 Whether applied formulation contains “cis” or “trans”
isomer.
 Product approved in reference regulatory authorities as
“estradiol as hemihydrate” while the applied product is
“Estradiol valerate”
 Submission of finished product specification. (M-271).
Evaluation by PEC  Firm has stated that they want to specify the tablet
hormone section for steroidal hormonal preparations
 Firm has stated that they will use “Cis” isomer of
Dydrogesterone
 Firm has submitted that they will use “estradiol as
hemihydrate” instead of “estradiol valerate”
 The Firm has submitted finished product specification
claiming in house specification
Decision of 275st meeting Deferred for further deliberation regarding cis and trans
isomer
Evaluation by PEC Firm has further submitted that they will use cis isomer of
dydrogesterone
 Further deliberation regarding cis and trans isomer.
 Submission of fee for change of formulation.
 Approval from Licensing Division particularly for Tablet (Steroidal Hormone)
Brand Name +Dosage Form + Strength Walgestron 10mg Tablet
Dydrogesterone … ……………..10 mg
Pharmacological Group Progestogens
Type of Form Form-5
Approval status of product in Reference Duphaston by BGP Products
Regulatory Authorities (Swissmedic Approved)
Me-too status Duphaston by Abbott
Remarks of the Evaluator Clarification regarding cis or trans isomer is required.
Decision of previous meeting Registration Board deferred all the applications applied for
Tablet (Hormone) section for clarification from the firm
whether it specifies/retains the section for steroidal
preparations or for non-steroidal preparations. Registration
Board Further deferred this application for clarification of
formulation whether it contains “cis” or “trans” isomer.
(M-271)
Evaluation by PEC  Firm has stated that they want to specify the tablet
hormone section for steroidal hormonal preparations
 Firm has stated that they will use “Cis” isomer of
Dydrogesterone
st
Decision of 275 meeting Deferred for further deliberation regarding cis and trans
isomer.
Evaluation by PEC Firm has further submitted that they will use cis isomer of
dydrogesterone
 Further deliberation regarding cis and trans isomer.
 Approval from Licensing Division particularly for Tablet (Steroidal Hormone)
Brand Name +Dosage Form + Strength WALTVIR 250mg Injection
Composition Each vial Contains
Acyclovir Sodium equivalent to Acyclovir….. 250mg
(Lyophilized Powder)
Type of Form Form-5
Approval status of product in Reference Zovirax Injection by GSK
Regulatory Authorities (USFDA Approved) but discontinued for reasons other
than safety and efficacy
Me-too status Cycloz by Highnoon
Decision of previous meeting Deferred for clarification of formulation since the
reference product is available as lyophilized injection. (M-
271)
Evaluation by PEC Firm has provided master formulation of acyclovir in
which lyophilized powder of acyclovir is used. Firm has
not provided any clarification regarding the use of
lyophilized powder and that the reference product is
available as lyophilized injection.
st
Decision of 275 meeting Deferred as firm has not provided reply to last query as
reference product is available as lyophilized injection
Evaluation by PEC Firm has submitted the formulation of lyophilized injection
containing acyclovir. Moreover firm has also submitted in
method of manufacturing that “Acyclovir lyophilized
injection is first prepared as a solution and then
lyophilisation process is carried out in a lyophilizer to
obtain powder ready for reconstitution for intravenous
administration.” The firm do not have lyophilized section,
and the approved section is “Dry powder injection Vial
(General)”
Decision: Deferred for confirmation of approved manufacturing facility for Dry powder
Lyophilized Injectable’ section.
Brand Name +Dosage Form + Strength CIPRO-DEX Eye Drops
Composition Each Drop Tainer Dispenser Contains:
Ciprofloxacin as hydrochloride….. 0.3%
Dexamethasone……….. 0.1%
Pharmacological Group Quinolone Antibiotic and Corticosteroid
Type of Form Form-5
Pack size & Demanded Price 7.5ml per pack
As Per SRO
Approval status of product in Reference CIPRODEX by Novartis
Me-too status Metadex by Optx Pharma
Remarks of the Evaluator Firm has claimed in house specifications while the product
is present in USP
Firm has provided formulation of ophthalmic solution
while the FDA approved product is available as
ophthalmic suspension
Decision of previous meeting Deferred for following:
 Clarification of formulation whether it is ophthalmic
solution or suspension.
 Clarification of drop tainer dispenser. (M-271)
Evaluation by PEC Firm has submitted that the applied formulation is
ophthalmic suspension, the previously submitted
formulation was ophthalmic solution and the firm has not
submitted fee for change in formulation.
Firm has submitted that drop tainer dispenser is
potentially compatible with dispensed formulations
containing benzalkonium chloride and other excipients.
The composition of drop tainer dispenser is
o Low density polyethylene bottle
o Dropper nozzle
o Tamper evident high density polyethylene cap
Decision of 275st meeting Deferred for submission of fee of Rs. 20,000/- for change
of formulation.
Evaluation by PEC Firm has submitted fee PKR 20,000/- along with original
fee chalan (Chalan #: 0726015) along with attestation of
statistical officer DRAP.
Decision: Approved
Brand Name +Dosage Form + Strength TOP-DEX Eye Drops
Dexamethasone………… 0.1%
Tobramycin ………………0.3%
Pharmacological Group Corticosteroids and Aminoglycoside antibiotic
Type of Form Form-5
Pack size & Demanded Price 1 ×`1’s(5 ml Drop Tainer Dispenser) / As Per SRO
Approval status of product in Reference TOBRADEX by Novartis
Me-too status TOBRADEX by Novartis
Remarks of the Evaluator Firm has claimed in house specification while the product
is present in USP
 Firm has provided formulation of ophthalmic solution
o Dropper nozzle
of formulation.
Decision: Approved
Brand Name +Dosage Form + Strength TOP-PRED Eye Drops
Loteprednol etabonate……….. 0.5 %
Tobramycin………… 0.3 %
Pharmacological Group Corticosteroid and aminoglycoside antibiotic
Type of Form Form-5
Pack size & Demanded Price 5ml × 1’s / As Per SRO
Approval status of product in Reference ZYLET by bausch & lomb
Me-too status LOTEPRED-T by Sante
Remarks of the Evaluator Firm has claimed in house specification without providing
documents as per 267th RB meeting
Firm has provided formulation of ophthalmic solution
o Dropper nozzle
of formulation.
Decision: Approved
Brand Name +Dosage Form + Strength Waltdul Capsule 30 mg
Enteric coated pellets of Duloxetine hydrochloride
(17.5%) equivalent to Duloxetine……………30mg
Pharmacological Group Selective Serotonin Reuptake Inhibitor (SSRI)
Type of Form Form 5
Pack size & Demanded Price 14’s/As Per SRO
Approval status of product in Reference Cymbalta by Lilly
Me-too status Dulan by Hilton Pharma
is present in USP
 Firm has not provided source, GMP, COA and stability
data of pellets
Decision of previous meeting Deferred for following submissions
 Real time and accelerated stability study data of 3
batches of pellets
 Differential fee (if pellets are imported)
 Submission of same brand name for all strengths
(M-271)
Evaluation by PEC Firm has submitted COA, GMP certificate and stability
study data of 3 batches of 17% pellets of M/s Vision
Pharmaceuticals Islamabad
Firm has not submitted same brand name for both
strengths
Decision of 275st meeting Registration Board deferred for clarification as submitted
source of pellets is not of USP grade.
Evaluation by PEC Firm has requested to change the source of pellets
(22.5%) to M/s Murli Krishna Pharma (Pvt) Ltd., along
with fee PKR 100,000/- (Chalan # 0726014).
Firm has also submitted COA and stability study data and
copy of GMP certificate
The real time stability study data of pellets is conducted at
25oC ± 2oC and 60% ± 5% RH which is not as per the
requirement of Zone IV-A
The USP has specified the pellets to be tested at buffer
stage of either 20% or 32%, while the pellets of M/s Murli
Krishna is 22.5%.
The dissolution range of pellets in USP is NLT 75% of Q
in 60 mins, while that provided in COA is NLT 70% of Q
in 45 min.
Decision: Registratio Board deferred the case since submitted source of pellets is not of USP
grade.
Brand Name +Dosage Form + Strength DULAXWALT 60 mg Capsule
Enteric coated pellets of Duloxetine hydrochloride (22.5%)
equivalent to Duloxetine……………60mg
Pharmacological Group Selective Serotonin Reuptake Inhibitor (SSRI)
Type of Form Form-5
Pack size & Demanded Price 1 x 10’s: As Per SRO
Approval status of product in Reference Cymbalta by Lilly
Me-too status Dulan by Hilton Pharma
is present in USP
Firm has not provided source, GMP, COA and stability
data of pellets
Firm has applied for different brand name for 30mg
strength of same drug
Decision of previous meeting Deferred for following submissions
 Real time and accelerated stability study data of 3
batches of pellets
 Differential fee (if pellets are imported)
 Submission of same brand name for all strengths
(M-271)
Evaluation by PEC Firm has submitted COA, GMP certificate and stability
study data of 3 batches of 17% pellets of M/s Vision
Pharmaceuticals Islamabad
Firm has not submitted same brand name for both
strengths
Decision of 275st meeting Registration Board deferred for clarification as submitted
source of pellets is not of USP grade.
Evaluation by PEC Firm has requested to change the source of pellets
(22.5%) to M/s Murli Krishna Pharma (Pvt) Ltd., along
with fee PKR 100,000/- (Chalan # 0726014).
Firm has also submitted COA and stability study data and
copy of GMP certificate
The real time stability study data of pellets is conducted at
25oC ± 2oC and 60% ± 5% RH which is not as per the
requirement of Zone IV-A
The USP has specified the pellets to be tested at buffer
stage of either 20% or 32%, while the pellets of M/s Murli
Krishna is 22.5%.
The dissolution range of pellets in USP is NLT 75% of Q
in 60 mins, while that provided in COA is NLT 70% of Q
in 45 min.
Decision: Registratio Board deferred the case since submitted source of pellets is not of USP
grade.
Evaluator PEC-VIII
664. Name and address of manufacturer / M/s. Farm Aid Group, Plot No. 3/2, Phase I & II, Hattar
Applicant Industrial Estate, Haripur.
Brand Name +Dosage Form + Strength Diclofarm 100mg Capsule
Diclofenac Sodium (as SR Pellets) ……………. 100mg
Diary No. Date of R& I & fee DiaryNo:10074; 26-07-2017, 20,000/-
Pharmacological Group Non-steroidalanti-inflammatory drug (NSAID) with
analgesic, antipyretic and anti-inflammatory activity.
Type of Form Form-5
Finished Product Specification As per Innovator’s Specifications
Pack size & Demanded Price 10’s, 20’s, 30’s ; As Per SRO
Approval status of product in Reference Rhumalgan XL 100 mg modified-release capsules approved
Regulatory Authorities. by MHRA of UK
Me-too status Durum 100mg SR capsules of M/s Pride Pharmaceutricals
(Reg.0.39543)
GMP status On recommendation of panel of experts, The CLB in its
253rd meeting held on May 15th-16th , 2017 has considered
and approved the grant of following two additional sections
to M/s. Farm Aid group:
 Dry Penicillin Powder section(vet)
 Capsule Section(general)
Remarks of the Evaluator.  Evidence of approval status of applied formulation in
reference agencies.
 Justification on scientific basis for addition of 3% overage in
master formulation.
 Mistake in stability studies in dissolution test.
Previous Decision: Registration Board in its 275th Meeting deferred the case for
the following reason:
 COA of diclofenac sodium pellets state time limit of
8 hrs in dissolution test for buffer stage whereas in stability
data sheet time limit of 7 hrs is mentioned for the same test.
Evaluation by PEC Vision Pharmaceuticals has submitted its statement that
specifications for Diclofenac sodium SR pellet’s dissolution
is 1 hour in 0.1N HCl, 3rd hour and 8th hour in buffer medium
(including acid stage), whereas on stability data it was
mentioned 1 hour in 0.1N HCl,2nd hour and 7th hour in buffer
medium (excluding acid stage). It’s actually the same pattern
1 hour in 0.1N HCl plus 2 hours in buffer medium
(correspond to 3rd hour in specification) and 1 hour in 0.1N
HCl plus 7 hours in buffer medium (correspond to 8th hour in
specification). It is mistakenly done due to difference in
interpretation on stability data.
Decision: Deferred for further deliberation
Case No. 04: Registration applications for local manufacturing of (veterinary) drugs.
a) Routine Applications:
Evaluator PEC-XIV
665. Name and address of manufacturer / M/s. S.J.&G. Fazul Ellahie (Pvt.) Ltd., E/46, SITE,
Applicant Karachi
Brand Name +Dosage Form + Strength Brolex Injection
Buparvaquone…………….50mg
Pharmacological Group Hydroxynaphthoquinone anti-theileriotic
Type of Form Form-5
Pack size & Demanded Price 50ml ; Decontrolled
Approval status of product in Reference N/A
Me-too status Bupralex Injection of star laboratories (Reg # 033264)
GMP status Last GMP Inspection of S.J &G. Fazul Ellahie
conducted on 12-07-2017 with conclusive remarks of
good cGMP compliance.
Remarks of the Evaluator.  The firm has provided Sterile Liquid inj. VET (Non-
antibiotic/antibiotic) section.
Decision: Approved with innovator’s specifications.
666. Name and address of manufacturer / M/s. Bio-Labs (Pvt.) Ltd, Plot # 145, Industrial
Applicant Triangle, Kahuta Road, Islamabad
Brand Name +Dosage Form + Strength Elite-50 Water soluble powder
Colistin Sulphate………………...5000,000IU
Pharmacological Group Polypeptide antibiotic
Type of Form Form-5
Pack size & Demanded Price 100gm, 500gm, 1000gm, 2Kg, 3kg, 5kg ; Decontrolled
Me-too status Col plus Powder of A & K Pharma (Reg # 043560)
GMP status The panel inspection conducted on 28-08-2017 & 29-
08-2017 unanimously recommends the issuance of GMP
certificate.
667. Name and address of manufacturer / M/s. Nawan Laboratories (Pvt) Ltd., 136, sector 15,
Brand Name +Dosage Form + Strength Marbowan Injection
Marbofloxacin………………..100mg
Type of Form Form-5
Pack size & Demanded Price 50ml; Decontrolled
Approval status of product in Reference Actimarbo 100 mg/ml Solution for Injection of
Regulatory Authorities. Mcuphar, Belgium (UK)
Me-too status Marbostar 10% of Huzaifa International (Reg # 074054)
GMP status Routine GMP inspection conducted on 26-09-2017, the
firm was found to be operating at a satisfactory level of
GMP compliance.
668. Name and address of manufacturer / M/s. Nawan Laboratories (Pvt) Ltd., 136, sector 15,
Brand Name +Dosage Form + Strength Torxin Injection
Tulathromycin………………..100mg
Type of Form Form-5
Pack size & Demanded Price 50ml; Decontrolled
Approval status of product in Reference Draxxin 100 mg/ml Solution for Injection of Zoetis
Regulatory Authorities. Belgium, VMD, UK
Me-too status Tulat Injection of M/s. Hilton Pharma (Reg # 044908)
GMP status Routine GMP inspection conducted on 26-09-2017, the
firm was found to be operating at a satisfactory level of
GMP compliance.
669. Name and address of manufacturer / M/s. Moreno Iglisias Research Laboratories (Pvt) Ltd.,
Applicant 21-Km, Ferozpur Road, Lahore.
Brand Name +Dosage Form + Strength Oxazide Suspension
Oxyclozanide ….……….6.250gm
Oxfendazole ……..……..2.265gm
Diary No. Date of R& I & fee 198, 26-08-2015, 20,000/-25-08-2016
Pharmacological Group Anthelmintic/Dewormer
Type of Form Form-5
Finished Product Specification In-house specifications
Pack size & Demanded Price 10ml, 30ml, 50ml, 100ml, 250ml, 500ml, 1Liter, 5Liter;
Decontrolled
Me-too status Oxarex Drench of M/s. Star Laboratories (Reg #
031454)
GMP status GMP inspection on 12-12-2017 concluded that at the
time of visit, the different areas of the premises found
clean and maintained. HVAC was also installed in the
sections and functional. No production activity was
observed at the time of visit.
Brand Name +Dosage Form + Strength Floramor Solution
Florfenicol……………….200gm
Pharmacological Group Antibiotic/Antibacterial
Type of Form Form-5
Decontrolled
Me-too status FLUROTIN Liquid of M/s. Elegance Pharma (Reg #
075751)
Brand Name +Dosage Form + Strength Morenodox Liquid
Tylosin Tartrate ……….10gm
Doxycycline HCl …………..20gm
Colistine Sulphate………..…500,000 IU (26.32gm)
Pharmacological Group Antibiotic/Antibacterial
Type of Form Form-5
Decontrolled
Me-too status Target CRD of Leads Pharma
Remarks of the Evaluator.  The submitted me-too reference could not be
verified.
Decision: Deferred for confirmation of generic/me-too status as submitted reference is of
different strength/dosage form.
Evaluator PEC-XIII
672. Name and address of manufacturer / M/s Star Laboratories (Pvt) limited, 23km, Multan
Applicant Road, Lahore.
Brand Name +Dosage Form +Strength Diclostar-10 Injection (1%) 50ml, 100ml
Meloxicam ……………….10mg
Diary No. Date of R& I & fee Dy.434, R&I 28-10-2015, (Rs.20,000/-) (22-10-2015)
Pharmacological Group Cyclo-oxygenase inhibitor; analgesic; anti-
inflammatory
Type of Form Form -5
Pack size & Demanded Price Vial of 50ml & 100ml & Decontrolled
Me-too status Loxicon Injection of M/s Vetcon Pharma (Reg.#
057187)
report concludes good level of GMP for grant of GMP
certificate for export purpose.
Remarks of the Evaluator.  Latest inspection report.
 Species: cattle & buffaloes; horses & camels;
sheep & goats; Dogs & Cats.
 Section needs to be verified.
 Two pack sizes were applied on one injection.
Now, the firm asks to consider only one pack
size i.e.50ml.
 Firm has submitted the reply after being issued
letter and reminder dated 13th Nov, 2017 & 4th
Jan, 2018 respectively but is incomplete as the
“latest” GMP is not yet submitted.
673. Name and address of manufacturer / M/s Star Laboratories, 23km, Multan Road, Lahore.
Applicant
Brand Name +Dosage Form +Strength Diclostar-20 Injection (2%) 50ml, 100ml
Meloxicam ……………….20mg
Diary No. Date of R& I & fee Dy.435, R&I 28-10-2015, (Rs.20,000/-) (22-10-2015)
Pharmacological Group Cyclo-oxygenase inhibitor; analgesic; anti-
inflammatory
Pack size & Demanded Price Vial of 50ml & 100ml & Decontrolled
Me-too status Meloxi-20 Injection of M/s Selmore Pharma (Reg.#
057007)
report concludes good level of GMP for grant of GMP
certificate for export purpose.
 Species: cattle & buffaloes; horses & camels;
sheep & goats; Dogs & Cats.
 Two pack sizes were applied on one injection.
Now, the firm asks to consider only one pack
size i.e.50ml.
 Firm has submitted the reply after being issued
letter and reminder dated 13th Nov, 2017 & 4th
Jan, 2018 respectively but is incomplete as the
“latest” GMP is not yet submitted.
period of last 1 year by DRAP.
674. Name and address of manufacturer / M/s Delux Chemical Industries, LT 26 A/1 Landhi
Applicant Industrial Area, Karachi-22
Brand Name +Dosage Form +Strength Reoflor 25% liquid (Oral Solution)
Florfenicol ……………….25% w/v
Diary No. Date of R& I & fee Dy. No.512, R&I Dated 20-06-2016, (Rs.20,000/-) (20-
06-2016)
Pharmacological Group Anti-bacterial in poultry
Pack size & Demanded Price 100ml, 500 ml, 1000ml, 2.5 litre, 5 litre bottle &
Decontrolled
Me-too status Nobiflor 25% of M/s Noble Pharma Mirpur AK
report concludes renewal of DML by way of
formulation.
 Species: Cattles; Sheep & Goats; Poultry.
 Provide specs.
 Firm has not submitted the reply even after
being issued letter and reminder dated 13th Nov,
2017 & 4th Jan, 2018 respectively.
675. Name and address of manufacturer / M/s Delux Chemical Industries, LT 26 A/1 Landhi
Applicant Industrial Area, Karachi-22
Brand Name +Dosage Form +Strength Reoflox-C oral solution
Composition Each 100ml solution contains:
Enrofloxacin ……………….25% w/v
Colistin Sulphate……………50 M.I.U.
06-2016)
Pharmacological Group Anti-bacterial
Pack size & Demanded Price 100ml, 500 ml, 1000ml, 2.5 litre, 5 litre bottle &
Decontrolled
Me-too status Vitaflox-C 25% liquid of M/s Vetz Pharma
report concludes renewal of DML by way of
formulation.
 Species: Poultry & Ruminants
 Provide specs.
676. Name and address of manufacturer / M/s Mallard Pharmaceuticals (Pvt) Limited, 23 km ,
Applicant Lahore Road, Multan
Brand Name +Dosage Form + Strength Florotril Plus W.S.P powder1kg
Composition Each 1g powder contains:
Florfenicol ……………….100mg
Erythromycin ……………...100mg
Diary No. Date of R& I & fee Dy. No.626, R&I Dated 18-06-2012, (Rs.12,000/-+
Rs.8000/-) (30-07-2013)
Pack size & Demanded Price 100g, 250g, 500g, 1kg, 2.5kg & Decontrolled price
Me-too status Not available
report concludes “the firm is advised to appoint one
more technical person as QA officer which they agreed
to do that immediately.
 Me-too couldn’t be searched.
 Species: poultry

Section needs to be verified.

Provide specs.

Firm has not submitted the reply even after
Brand Name +Dosage Form +Strength Enromax W.S.P. Powder
Composition Each 1kg powder contains:
Enrofloxacin HCl……………….100g
Colistin Sulphate………………..100g
Amantadine………………………40g
Rs.8000/-) (30-07-2013)
Pharmacological Group Antibiotic/Antiviral
Pack size & Demanded Price 10g, 25g, 50g, 100g, 250g, 500g, 1kg & Decontrolled
price
Me-too status Colamin of M/s Attabak Pharmaceuticals, Rawalpindi
 Provide specs.
 Mention the strength on the fee-challan.
Brand Name +Dosage Form +Strength Seloquine WSP
Composition Each 1g contains:
Flumiquine HCl……………….500g
Lactose ……….………………..100g
Colistin sulphate…………….1M.I.U.
Rs.8000/-) (30-07-2013)
Approval status of product in Reference Seloquine 500 of M/s Selovet M.49, Madrid (SPAIN)
 Provide specs.
 Mention the strength on the fee-challan as well
as on form-5.
Brand Name +Dosage Form + Strength Floxy-Neo Liquid
Composition Each 1litre contains:
Florfenicol ………………..200g
Oxytetracycline …………....150g
Neomycin…………………..100g
Rs.8000/-) (30-07-2013)
Approval status of product in Reference Florochem of M/s Pharmachem Bio (Belgium)
 Me-too couldn’t be searched.
 Provide specs.
 Mention the strength on the fee-challan.
Brand Name +Dosage Form + Strength Doxycam Liquid
Tylosin tartarate……………….200g
Doxycycline HCl ……………...250g
Colistin sulphate…………...500MIU
Bromhexine HCl…………….......12g
05-2015)
Pharmacological Group Antibiotic/Expectorant
Pack size & Demanded Price 30ml, 100ml, 200ml, 500ml, 1000ml, 2.5 litre &
Decontrolled price
Me-too status Synergistic Forte of M/s Westmount Pharmaceuticals
(Rawalpindi)
 Species: poultry & Calves
 Provide specs.
 The brand name is Doxycam FORT in fee –
challan while applied one is simple Doxycam.
Brand Name +Dosage Form + Strength Fastrim-48 Liquid
Sulphadiazine ……………….400mg
Trimethoprim ……………........80mg
05-2015)
Pack size & Demanded Price 30ml, 100ml, 200ml, 500ml, 1000ml, 2.5litre &
Decontrolled price
Me-too status Sulprim suspension of M/s Hilton Pharma
report concludes “detailed report shall be forwarded to
concerned quarter of DRAP, Islamabad.”
 Provide specs.
b) Deferred cases (Veterinary Drugs)

Evaluator PEC-XIV
M/s. Vantage Pharmaceutical, Plot No. 54-RB Sarhali, 6-Km, Sangla Hill, Shahkot Road
District, Faisalabad
Application received against letter No.F.1-3/2017-Reg-I (Vet).

Registration Board in its 260th & 264th meetings considered various registration applications of
M/s. Vantage Pharmaceutical, Faisalabad. The decision of the board is summarized as under:
Section Approved Deferred New Request of the firm

Applications
Oral Powder 09 01 01 The firm has requested that the
(Veterinary) deferred application, namely
Tylostin oral powder be
withdrawn and the new
registration application may be
considered instead.
Now, the firm has submitted following application as a replacement of deferred product that has
been withdrawn.
682. Name and address of manufacturer / M/s. Vantage Pharmaceutical, Plot No. 54-RB Sarhali,
Applicant 6-Km, Sangla Hill, Shahkot Road District, Faisalabad
Brand Name +Dosage Form + Strength Amantage oral powder
Composition Each 100gm contains:
Amantadine HCl………………..10gm
Type of Form Form-5
Pack size & Demanded Price 500g, 1Kg; Decontrolled
Me-too status Antamits WSP of M/s. Wimits Pharma (Reg #078316)
GMP status CLB in its 247th meeting held on 29-04-2016 approved
the grant of Drug Manufacturing License (DML) to M/s.
Vantage pharmaceutical.
Previous Decision  Deferred in 277th meeting for confirmation of reason
for already deferred product against which
replacement has been claimed.
Evaluation by PEC  Registration Board deferred already applied product
in 260th meeting for confirmation of approval status
of same formulation in Pakistan and reference
regulatory authorities as already approved
formulation are in liquid form while firm has applied
for dry powder.
 Already applied formulation is as under:
 TYLOSTIN Oral Powder
Each 1000 gm contains:
Tylosin Tartrate…………..100gm
Doxycycline HCl…………200gm
Colistin Sulphate…………480 MIU
Bromhexine HCl………….3gm
 Now the firm has requested that the already deferred
application be withdrawn and new registration
application be considered instead.
M/s. Biorific Pharma, Plot No. 143, Industrial Triangle Kahuta Road, Islamabad
The CLB in 250th meeting held on 27th October 2016 has considered and approved the grant of
Drug Manufacturing License (by way of formulation) vide letter No. F.1-48/2003-lic with
following sections:
 Dry powder Section (Veterinary)
 Liquid Syrup Section (Veterinary)
The details of already approved and deferred products in various meetings of Registration Board
are as under:
Sr. Name of section No. of molecules Deferred Remaining
No. already approved molecules molecules
Dry powder Section
1. 6 4 -
(Veterinary)
Liquid Syrup Section
2. 4 4 2
(Veterinary)
Now, the firm wants to withdraw dossier of Encof Powder Deferred in 266th Registration Board
meeting and has applied Amrific Powder (Amantadine 10%) Vet Powder instead for priority
consideration.
683. Name and address of manufacturer / M/s. Biorific Pharma, Plot No.143, Industrial Triangle
Applicant Kahuta Road, Islamabad.
Brand Name +Dosage Form + Strength Amrific (Vet) Dry Powder
Composition Each gm powder contains:
Amantadine HCl……….………10%
Type of Form Form-5
Pack size & Demanded Price 100g, 200g, 500g, 1Kg; Decontrolled
Me-too status Antamits WSP of M/s. Wimits Pharma (Reg #078316)
GMP status The firm was granted new DML based on inspection
conducted on 21-10-2016.
Previous Decision Deferred for confirmation of reason for already deferred
product against which replacement has been claimed.
Evaluation by PEC Registration Board deferred already applied product in
266th meeting for evidence of me-too status as stated
reference is not correct.
 Already applied formulation is as under:
ENCOF Dry Powder
Each 100g powder contains:-
Enramycin………….4% (w/w)
 Now the firm has requested that the already deferred
application be withdrawn and new registration
application be considered instead.
Case No. 05: Registration applications of newly granted DML or New section (Veterinary)
Evaluator PEC-XIV
M/s. Bio-Labs (Pvt) Ltd., Plot # 145, Industrial Triangle, Kahuta Road, Islamabad.
The firm was granted new sections against vide letter No. F. 1-12/89-Lic (Vol-III) on the
recommendation of panel of experts in 256th meeting of Central Licensing Board held on 9th &
10th November, 2017.
Accordingly, firm has applied registration application the section wise details are as follows
 Liquid injection General (Vet) (10 molecules / 23 products)
 Liquid Injection Penicillin (Vet) (8 molecules / 18 products)
 Dry Powder Injection Penicillin (Vet) (5 molecules / 12 products )
Liquid injection General (10 molecules / 23 products)
684. Name and address of manufacturer / M/s. Bio-Labs (Pvt) Ltd., Plot # 145, Industrial Triangle,
Brand Name +Dosage Form + Strength Animectin 1.2% Injection
Diary No. Date of R& I& fee 25497, 21-12-2017, 20,000/-
Ivermectin………....12mg
Pharmacological Group Anthelmintic agent
Type of Form Form-5
Finished Product Specification BP Specifications
Pack size& Demanded Price 100ml; Decontrolled
Approval status of product in N/A
Me-too status Mectogen Injection of M/s. Biogen Pharmaceuticals
(Pvt) Ltd. (Reg # 075623)
GMP status The panel inspection conducted on 28-08-2017 & 29-08-
2017 unanimously recommends the issuance of GMP
certificate.
Decision: Approved
Brand Name +Dosage Form + Strength Animectin 1.2% Injection
Ivermectin………...12mg
Pharmacological Group Anthelminitc agent
Type of Form Form-5
Me-too status Mectogen Injection of M/s. Biogen Pharmaceuticals
(Pvt) Ltd. (Reg # 075623)
certificate.
Decision: Approved
Brand Name +Dosage Form + Strength Animectin 1% Injection
Ivermectin……………..10mg
Type of Form Form-5
Approval status of product in Ivomec 1% injection of Merial Inc. USFDA
Me-too status Ivermex Injection of M/s. Wimits Pharma (Reg #
078309)
certificate.
Decision: Approved.
Brand Name +Dosage Form + Strength Kerry T.S Injection
Sulfadiazine …………… 200mg
Trimethoprim ………….40mg
Pharmacological Group Sulfadiazine is Sulfonamide antibacterial.
Trimethoprim is a pyrimidine inhibitor of dihydrofolate
reductase
Type of Form Form-5
Me-too status Altrim injection of M/s. Alina Combine (Reg # 048269)
certificate.
Decision: Approved
Brand Name +Dosage Form + Strength Kerry T.S Plus Injection
Sulfadiazine …………… 400mg
Trimethoprim ………….80mg
Pharmacological Group Sulfadiazine: Sulfonamide antibacterial.
Trimethoprim: Dihydrofolate reductase inhibitor
Type of Form Form-5
Approval status of product in Tribrissen 48%® Intervet/schering-plough animal
Reference Regulatory Authorities. health, 19966-0318, USFDA
Me-too status Santrim-50 Injection of Sanna laboratories (Reg #
027421)
certificate.
Decision: Approved
Brand Name +Dosage Form + Strength Tylomix 20% Injection
Composition Each ml Contains:
Tylosin tartrate ………….... 200mg
Type of Form Form-5
Me-too status Tylosin 20% Injection of U.M.Enterprises (Reg#017988)
certificate.
Decision: Approved
Brand Name +Dosage Form + Strength Keto-10 Injection (50ml)
Composition Each ml contains: Ketoprofen…..……100 mg
Type of Form Form-5
Finished Product Specification In-house Specifications
Approval status of product in Comforion Vet 100 mg/ml Solution for Injection of
Reference Regulatory Authorities. Orion Corporation, Finland (UK)
Me-too status Fenak Injection of A&K Pharma (Reg # 075796)
certificate.
Brand Name +Dosage Form + Strength Keto-10 Injection (100ml)
Composition Each ml contains
Ketoprofen……………100 mg
Type of Form Form-5
Approval status of product in Comforion Vet 100 mg/ml Solution for Injection of
Reference Regulatory Authorities. Orion Corporation, Finland (UK)
Me-too status Fenak Injection of A&K Pharma (Reg # 075796)
certificate.
Brand Name +Dosage Form + Strength WORMIDEC 7.5% INJECTION 50ml
Diary No. Date of R& I& fee 24550, 14-12-2017,Rs.20,000/-
Levamisole as HCl……..….75mg
Type of Form Form-5
Finished Product Specification The firm has claimed BP Specifications
Me-too status Vernil of M/s. Star Laboratories (PVT) LTD
certificate.
verified from available database of DRAP.
Decision: Deferred for confirmation of generic/me-too status.
Brand Name +Dosage Form + Strength WORMIDEC 1.5% INJECTION
Diary No. Date of R& I& fee 24551,14-12-2017, Rs.20,000/-
Levamisole as (HCL)……….15mg
Type of Form Form-5
Me-too status Sanamisol of M/s. Sanna Laboratories (Pvt) Ltd
certificate
Brand Name +Dosage Form + Strength WORMIDEC 1.5% INJECTION
Levamisole as (HCL)……….15mg
Type of Form Form-5
Me-too status Sanamisol of M/s. Sanna Laboratories (Pvt) Ltd
certificate
Brand Name +Dosage Form + Strength Wormidec 7.5% injection 100ml
Diary No. Date of R&I & fee 24542,14-Dec-2017,Rs.20,000/-
Levamisole as (HCL) …….75mg
Type of Form Form-5
Pack size& Demanded Price 100ml vial: Decontrolled
Me-too status Vernil Injection by Star Laboratories (Pvt) Ltd
the panel recommends renewal of DML and grant of
additional section
Brand Name +Dosage Form + Strength Wormidec 10% injection 100ml
Diary No. Date of R& I& fee 24543,14-Dec-2017,Rs.20,000/-
Levamisole as HCl …….100mg
Type of Form Form-5
Pack size& Demanded Price 100ml vial: Decontrolled
Me-too status Levavet-100 Injection of Vetcon Pharma (Reg # 063711)
additional section
Decision: Approved.
Brand Name +Dosage Form + Strength Bio-Oxyne 5% INJECTION 100ml
Oxytetracycline……....50mg
Pharmacological Group Tetracycline antibiotic
Type of Form Form-5
Approval status of product in Liquamycin Injectable solution of Zoetis inc. USFDA
Me-too status Oxycare-50 Injection of M/s. Leads Pharma
(Reg#025318)
certificate
Decision: Approved.
Brand Name +Dosage Form + Strength Bio-Oxyne 20% injection
Oxytetracycline…………… 200mg
Pharmacological Group Tetracycline antibiotic agent
Type of Form Form-5
Me-too status Oxycare L.A. 200 injection of M/s. Leads Pharma
(Reg # 026579)
certificate
Decision: Approved.
Brand Name +Dosage Form + Strength Bio-oxyne 30% injection
Oxytetracycline ………….300mg
Pharmacological Group Tetracycline antibiotic agent
Type of Form Form-5
Pack size& Demanded Price 50ml: Decontrolled
Me-too status Duramycin 300 LA Injectable solution by Mustafa
Brothers (Reg #053950)
additional section
Decision: Approved.
Brand Name +Dosage Form + Strength Bio-E- Floxacin 10% Injection 100ml
Enrofloxacin…………… 100mg
Pharmacological Group Fluoroquinolone Antibiotic
Type of Form Form-5
Approval status of product in Baytril® 100 Injectable Solution of Bayer Healthcare,
Me-too status Vety-Enrox 10% Injection of M/s. Leads Pharma (Reg #
025322)
certificate
Brand Name +Dosage Form + Strength Bio-E-Floxacin 5% injection 100ml
Diary No. Date of R& I& fee 24553, 14-12-2017, Rs.20,000/-
Enrofloxacin ……………50mg
Pharmacological Group Fluoroquinolone Antibiotic
Type of Form Form-5
Pack size& Demanded Price 100ml; Decontrolled:
Me-too status Enflox 5% injection by Alina Combine (Reg # 048287)
certificate.
Brand Name +Dosage Form + Strength Bio-Oxicam 0.75% injection
Meloxicam……….7.5mg
Pharmacological Group Non-steroidal Anti-Inflammatory Drug (NSAID)
Type of Form Form-5
Pack size& Demanded Price 100 vial: Decontrolled
Me-too status Melox 7.5mg Injection of Alina Combine (Reg #
053995)
GMP status  The panel inspection conducted on 28-08-2017
& 29-08-2017 unanimously recommends the issuance of
GMP certificate.
 Last inspection report dated 28-08-2017 & 29-
08-2017, the panel recommends renewal of DML and
grant of additional section
Decision: Approved
Brand Name +Dosage Form + Strength Tylocol injection
Diary No. Date of R& I& fee 24558, 14-12-2017, Rs.20,000/-
Tylosin Tartrate…..…50mg
Colistin Sulfate …….10mg
Pharmacological Group Tylosin is a member of the macrolide group of
antibiotics.
Colistin is an antibiotic from the group of polymyxins.
Type of Form Form-5
Me-too status Colitylo Injection of Alina Combine (Reg # 048275)
GMP status  The panel inspection conducted on 28-08-2017
& 29-08-2017 unanimously recommends the issuance of
GMP certificate.
 Last inspection report dated 28-08-2017 & 29-
08-2017, the panel recommends renewal of DML and
grant of additional section
Decision: Approved
Brand Name +Dosage Form + Strength Pet-Tetrafin Injection
Oxytetracycline (as Dihydrate)…..… 200mg
Diclofenac sodium…………………..10mg
Pharmacological Group Tetracycline antibiotic/ NSAID
Type of Form Form-5
Me-too status Rosamycin-LA of M/s. STAR Laboratories
certificate.
Remarks of the Evaluator. The submitted me-too reference could not be verified
from available database of DRAP.
Decision: Registration Board rejected the case as applied formulation contains diclofenac
sodium which isa banned in veterinary practice.
Type of Form Form-5
certificate.
Type of Form Form-5
certificate.
Liquid Injection Penicillin vet (molecules 8/ products 18)

Brand Name +Dosage Form + Strength Distrepen-G Injection
Procaine Penicillin G.……………….…...200mg
Dihydrostreptomycin Sulphate…………..250mg
Pharmacological Group Penicillin (Antibiotic)/ Aminoglycoside
Type of Form Form-5
Me-too status Strepcin Injection of M/s. Breeze Pharma (Reg # 059176)
certificate.
Remarks of the Evaluator.  The me-too reference contains streptomycin
sulphate while applied formulation contains
dihydrostreptomycin.
Decision: Deferred for confirmation of me-too status.
Brand Name +Dosage Form + Strength Distrepen-G Injection
Procaine Penicillin G.……………….…...200mg
Dihydrostreptomycin Sulphate…………..250mg
Pharmacological Group Penicillin ( Antibiotic)/ Aminoglycoside
Type of Form Form-5
Pack size& Demanded Price 100ml ; Decontrolled
Me-too status Strepcillin Injection of M/s ICI Pakistan.
certificate.
Remarks of the Evaluator.  The me-too reference contains streptomycin
sulphate while applied formulation contains
dihydrostreptomycin.
Decision: Deferred for confirmation of me-too status.
Brand Name +Dosage Form + Strength Probenzacin Injection
Benzathine Penicillin G.…………...100,000IU
Procaine Penicillin G…………………150,000IU
Dihydrostreptomycin Sulphate………...200mg
Type of Form Form-5
Me-too status B.G Probenz Injection of M/s Biogen Pharma (Reg #
072699)
certificate.
Brand Name +Dosage Form + Strength Probenzacin Injection
Type of Form Form-5
072699)
certificate.
Brand Name +Dosage Form + Strength Probenzacin Injection (30ml)
Type of Form Form-5
072699)
certificate.
Brand Name +Dosage Form + Strength Probenzacin Injection (10ml)
Pharmacological Group Penicillin (Antibiotics)/ Aminoglycoside
Type of Form Form-5
072699)
certificate.
Brand Name +Dosage Form + Strength Bioampet 20% Injection (50ml)
Ampicillin Trihydrate ……….200mg
Pharmacological Group Penicillin Antibiotics
Type of Form Form-5
Finished Product Specification USP Specifications.
Me-too status Ampi-vee Injection of Venus Pharma (Reg # 016238)
certificate.
Decision: Approved.
Brand Name +Dosage Form + Strength Bio-ampet 20% Injection (100ml)
Type of Form Form-5
Finished Product Specification USP Specifications.
Me-too status Ampi-vee Injection of Venus Pharma (Reg # 016238)
GMP status The panel inspection conducted on 28 & 29th August,
certificate.
Decision: Approved.
Brand Name +Dosage Form + Strength Bioampet 10% Injection
Type of Form Form-5
Me-too status Ampicon Injection of Vetcon Pharma (Reg # 012873)
th
| 331
GMP status The panel inspection conducted on 28 & 29th August,
certificate.
Decision: Approved.
Brand Name +Dosage Form + Strength Bioampet 10% Injection
Pharmacological Group Penicillin (Antibiotics)
Type of Form Form-5
Me-too status Ampicon Injection of Vetcon Pharma (Reg # 012873)
certificate.
Decision: Approved.
Brand Name +Dosage Form + Strength Vetamocol Injection (100ml)
Amoxycillin Trihydrate.…………...100mg
Colistin Sulphate……………….…..25MIU
Pharmacological Group Amoxycillin is an antibiotic useful for the treatment of a
number of bacterial infections.
Type of Form Form-5
Me-too status Amoxyvet L.A Injection of M/s. EPLA Labs (Reg #
023456)
certificate.
Remarks of the Evaluator. The submitted me-too reference is of different strength.
Brand Name +Dosage Form + Strength Vetamocol Injection (50ml)
Colistin Sulphate……………….…..25MIU
Pharmacological Group Amoxycillin is an antibiotic useful for the treatment of a
number of bacterial infections.
Type of Form Form-5
Finished Product Specification The firm has claimed
Me-too status Amoxyvet L.A Injection of M/s. EPLA Labs (Reg #
023456)
certificate.
Remarks of the Evaluator. The submitted me-too reference is of different strength.
Brand Name +Dosage Form + Strength Bioprocil 300mg Injection
Procaine Penicillin ………… 300mg
Pharmacological Group Penicillin (Antibiotic)
Type of Form Form-5
Me-too status Nawapen-30 Injection of M/s. Nawan Lab (Reg # 053996)
certificate.
Remarks of the Evaluator.  The label claim of submitted me-too reference in
database is
Each vial contains:
Procaine penicillin……………300mg
Brand Name +Dosage Form + Strength Bioprocil 300mg Injection
Procaine Penicillin ………… 300mg
Pharmacological Group Penicillin (Antibiotic)
Type of Form Form-5
certificate.
Remarks of the Evaluator.  The label claim of submitted me-too reference in
database is
Each vial contains:
Procaine penicillin……………300mg
Brand Name +Dosage Form + Strength Bioampet-G Injection
Gentamicin Sulphate……………….40mg
Pharmacological Group Penicillin antibiotic, Aminoglycoside
Type of Form Form-5
Me-too status Dufamox-G Injection of M/s. NB Sons (Pvt) Ltd
certificate.
Brand Name +Dosage Form + Strength Bioampet-G Injection
Gentamicin Sulphate……………….40mg
Pharmacological Group Penicillin antibiotic, Aminoglycoside
Type of Form Form-5
Me-too status Dufamox-G Injection of M/s. NB Sons (Pvt) Ltd
certificate.
Brand Name +Dosage Form + Strength Bioxicillin 15% injection
Amoxycillin as Trihydrate.…………...150mg
Pharmacological Group Penicillin
Type of Form Form-5
Me-too status Amovet LA Injection of M/s. Nawan Labs (Reg #
021305)
certificate.
Brand Name +Dosage Form + Strength Bioxicillin 15% injection
Amoxycillin as Trihydrate.…………...150mg
Pharmacological Group Penicillin
Type of Form Form-5
Me-too status Amovet LA Injection of M/s. Nawan Labs (Reg #
021305)
certificate.
Dry Powder Injection Penicillin (5 molecules/12 products)
Brand Name+Dosage Form+ Strength Proben Dry Powder Injection
Procaine Penicillin ……….…. 3,000,000 IU
Benzyl Penicillin ……………... 1,000,000 IU
Pharmacological Group Penicillins
Type of Form Form-5
Pack size& Demanded Price 1x1 40 lac units ; Decontrolled
certificate.
Brand Name+Dosage Form+ Strength Proben-S 5 Dry Powder Injection (5g)
Benzyl Penicillin ……………..300.00 mg
Procaine Penicillin …………… 1500.00 mg
Streptomycin Sulphate……….. 5000.00 mg
Pharmacological Group Penicillins/aminoglycosides
Type of Form Form-5
Pack size& Demanded Price 5g ; Decontrolled
Me-too status Penivet-5 of M/s Star Laboratories Pvt Ltd
certificate.
Brand Name+Dosage Form+ Strength Proben-S 5 Dry Powder Injection (2.5g)
Benzyl Penicillin ……………..300.00mg
Procaine Penicillin …………… 1500.00mg
Streptomycin Sulphate……….. 5000.00mg
Pharmacological Group Penicillins/aminoglycosides
Type of Form Form-5
Pack size& Demanded Price 2.5g ; Decontrolled
Me-too status Penivet-5 of M/s Star Laboratories Pvt Ltd
certificate.
Brand Name+Dosage Form+ Strength Proben-S 2.5 Dry Powder Injection (5g)
Benzyl Penicillin ……………..300 mg
Procaine Penicillin …………… 1500 mg
Streptomycin Sulphate……….. 2500 mg
Pharmacological Group Penicillins/ Aminoglycosides
Type of Form Form-5
Pack size& Demanded Price 5g vial ; Decontrolled
Me-too status Penivet-2.5 of M/s Star Laboratories Pvt Ltd
certificate.
Brand Name+Dosage Form+ Strength Proben-S 2.5 Dry Powder Injection (2.5g)
Benzyl Penicillin ………………300mg
Procaine Penicillin …………….1500 mg
Streptomycin Sulphate………….2500 mg
Pharmacological Group Penicillins/ Aminoglycosides
Type of Form Form-5
Pack size& Demanded Price 2.5g ; Decontrolled
Me-too status Penivet-2.5 of M/s Star Laboratories Pvt Ltd
certificate.
Brand Name+Dosage Form+ Strength Proben-S Forte Dry Powder Injection
Penicillin G Procaine............... 3000.00mg
Penicillin G Sodium….........600.00mg
Dihydrostreptomycin Sulphate......5000.00mg
Pharmacological Group Penicillin/ Aminoglycosides
Type of Form Form-5
Pack size& Demanded Price 1x1 50ml Vail with diluent; Decontrolled
Me-too status Penivet Forte Injection Of M/S. Star Laboratories Pvt Ltd
certificate.
Brand Name+Dosage Form+ Strength Amclovet Dry Powder Injection (2g)
Composition Each 2 gm vial contains:
Ampicillin Trihydrate…………..1000 mg
Cloxacillin Sodium…………..…1000 mg
Type of Form Form-5
Finished Product Specification The firm has claimed BP (Vet) Specifications
Pack size& Demanded Price 2g ; Decontrolled
Me-too status Biocin Injection of M/s Concept Pharma Pvt Ltd
certificate.
 The firm has claimed BP specification but the
product is not present in available British Pharmacopoeia
(Vet).
Brand Name+Dosage Form+ Strength Amclovet Dry Powder Injection (2.5g)
Composition Each 2.5 gm vial contains:
Ampicillin Trihydrate……………1250 mg
Cloxacillin Sodium………….…1250 mg
Type of Form Form-5
Pack size& Demanded Price 2.5g vial ; Decontrolled
Me-too status Binocin Injection of M/s Concept Pharma Pvt Ltd
certificate.
Remarks of the Evaluator.  The submitted me-too reference could not be verified
 The firm has claimed BP specification but the product
is not present in available British Pharmacopoeia (Vet).
Brand Name+Dosage Form+ Strength Amclovet Dry Powder Injection (4g)
Composition Each 4 gm vial contains:
Ampicilin Trihydrate…..……2 gm
Cloxacilin Sodium…………..2 gm
Type of Form Form-5
Pack size& Demanded Price 4g vial; Decontrolled
Me-too status Binocin Injection of M/s Concept Pharma Pvt Ltd
certificate.
 The firm has claimed BP specification but the
product is not present in available British Pharmacopoeia
(Vet).
Brand Name+Dosage Form+ Strength Ampcil Injection
Ampicillin trihydrate……………..1000mg
Pharmacological Group Penicillin antibiotic
Type of Form Form-5
Pack size& Demanded Price 1×1 vial of 1g; Decontrolled
Me-too status Conampi injection of concept pharma
certificate.
 The stated label claim is ambiguous, it should be
written correctly as “Each vial contains”.
Composition Each 2gram vial contains:
Type of Form Form-5
Pack size& Demanded Price 1×1 vial of 2g; Decontrolled
certificate.
 The firm has claimed USP specifications but the
product is not present in available USP.
Composition Each 2.5gram vial contains:
Type of Form Form-5
Pack size& Demanded Price 1×1 vial of 2.5g; Decontrolled
certificate.
 The firm has claimed USP specifications but the
product is not present in available USP.
Case No. 06: Registration applications of categories to be considered on priority
a) Local Manufacture
Evaluator PEC-VI
737. Name and address of manufacturer / M/s Magns Pharmaceutical, Faisalabad
Applicant
Brand Name +Dosage Form + Strength Letoz 2.5mg tablet
Letrozole….2.5mg
Pharmacological Group Non Steroidal aromatase inhibitor
Type of Form Form-5
Approval status of product in Reference FEMARA letrozole 2.5mg coated tablet by Novartis
Regulatory Authorities. Pharmaceuticals Australia Pty Ltd (TGA Approved)
Me-too status Femara 2.5mg Tablet by Novartis (Reg. No. 021129)
GMP status Last inspection report 7th dec 2017. “Firm was
considered to be operating at good level of compliance
with GMP guidelines as per Drug Act, 1976 and rules
framed there under.”
738. Name and address of manufacturer / M/s Aulton Pharmaceutical, Hattar
Applicant
Brand Name +Dosage Form + Strength Myco 500mg tablet
Mycophenolate mofetil……500mg
Pharmacological Group Immunosuppressive agent
Type of Form Form-5
Me-too status Mypheno 500mg Tablets of M/s WelMark
Pharmaceutical (Reg.# 068328)
GMP status Last GMP inspection report dated 11-01-2017 confirms
739. Name and address of manufacturer / M/s Aulton Pharmaceutical, Hattar
Applicant
Brand Name +Dosage Form + Strength Myco 250mg tablet
Mycophenolate mofetil……250mg
Type of Form Form-5
Approval status of product in Reference CellCept USFDA Approved
Me-too status MY-REPT CAPSULES 250MG Reg # 78108
GMP status Last GMP inspection report dated 11-01-2017 confirms
740. Name and address of manufacturer / M/s Regal Pharmceuticals, Islamabad

Applicant
Brand Name +Dosage Form + Strength Tenox 300mg tablet
Tenofovir Disproxil Fumarate…..300mg
Pharmacological Group Nucleoside Reverse Transcriptase inhibitor
Type of Form Form 5
Finished product Specification IP
Me-too status Hilten 300mg Tablet of M/s Hilton Karachi (Reg.#
073735)
GMP status Last inspection report 20-11-2017 firm is operating at a
fair level of cGMP as of today.
Decision: Approved
741. Name and address of manufacturer / M/s Fozan Pharmaceuticals, Peshawar
Applicant
Brand Name +Dosage Form + Strength Tenofoz 300mg tablet
Tenofovir Disproxil fumarate….300mg
Eq to 245mg of tenofovir disproxil
Type of Form Form-5
Me-too status Hilten 300mg Tablet of M/s Hilton Karachi. (Reg.#
073735)
GMP status Last Inspection report 24-08-2017 firm is working under
satisfactory level of GMP.
Decision: Approved
742. Name and address of manufacturer / M/s Jenner Pharmaceuticals, sheikhupura
Applicant
Brand Name +Dosage Form + Strength Tacromus capsules 0.5mg
Tacrolimus(as monohydrate)…..0.5mg
Pharmacological Group Immunosupressant
Type of Form Form-5
Approval status of product in Reference Prograf by Astellas
Me-too status Inograf by Platinum
Routine GMP inspection
Overall condition of firm is satisfactory
743. Name and address of manufacturer / M/s Nabiqasim Industries, Karachi
Applicant
Brand Name +Dosage Form + Strength Fovirox 300mg tablet
Tenofovir desproxil fumarate…..300mg
Pharmacological Group Antiretroviral
Type of Form Form-5
073735)
GMP status Last inspection report 3-8-2017firm is considered to be
operating at an acceptable level of compliance of GMP
requirements at the time of inspection.
Decision: Approved
744. Name and address of manufacturer / M/s Aspin Pharma, Karachi
Applicant
Brand Name +Dosage Form + Strength Axovir 5% cream
Aciclovir…..50mg (5%w/w)
Type of Form Form-5
Pack size & Demanded Price 10gm, 2gm, As per SRO
Approval status of product in Reference USFDA Approved 5% cream
Me-too status Clovirex Cream 5% Reg # 39740
GMP status Last inspection report 18.08.2017
745. Name and address of manufacturer / M/s Sigma Pharma International, Karachi
Applicant
Brand Name +Dosage Form + Strength NOrtis tablet 100mg
Lamivudine …..100mg
Type of Form Form-5
Pack size & Demanded Price 10’s, 14’s, As per Drap Policy
Me-too status Path Tablets Reg # 49194
GMP status Issued certificate of GMP on 21-9-2017
Decision: Approved
746. Name and address of manufacturer / Zeta Pharmaceuticals, Lahore
Applicant
Brand Name +Dosage Form + Strength Ribazet 40mg tablet
Ribavirin…..400mg
Type of Form Form-5
Approval status of product in Reference Copegus by Roche
Me-too status Ribavil by Genix
GMP status Issued Certificate of GMP based on evaluation
conducted on 3-1-2017
Decision: Approved
747. Name and address of manufacturer / Crystolite Pharmaceuticals, Islamabad
Applicant
Brand Name +Dosage Form + Strength Romlus 0.5mg capsule
Tacrolimus…..(as monohydrate)….0.5mg
Pharmacological Group Immunosuprressive agent
Type of Form Form-5
Pack size & Demanded Price 10’s, 30’s As per SRO
good level of cGMP as of today.
Applicant
Brand Name +Dosage Form + Strength Heb-HIV 200mg tablet
Tenofovir disoproxil fumarate…..200mg
Type of Form Form-5
Approval status of product in Reference Viread USFDA Approved
Me-too status TENOF TABLETS TENOFOVIR 200MG Reg # 41118
Decision: Approved
Applicant
Brand Name +Dosage Form + Strength Tacromus capsules 1mg
Tacrolimus(as monohydrate)…..1mg
Pharmacological Group Calcineurin inhibitor
Type of Form Form-5
GMP status 06-11-2017; Routine GMP inspection
Applicant
Brand Name +Dosage Form + Strength Azaprine 50mg tablet
Composition Each fim coated tablet contains:
Azathioprine….50mg
Type of Form Form-5
Approval status of product in Reference Imuran tablets by Aspen
Me-too status Azoprine tablets by Global
Applicant
Brand Name +Dosage Form + Strength Mycolate tablet 500mg
Mycophenolate Mofetil…..500mg
Type of Form Form-5
Applicant
Brand Name +Dosage Form + Strength Avir tablet 0.5mg
Entecavir as monohydrate…..0.5mg
Type of Form Form-5
Approval status of product in Reference Baraclude tablets by Bristol Myers
Me-too status Livose-C tablets by Wilson
Decision: Approved
753. Name and address of manufacturer / M/s Don Valley Pharmaceuticals, Lahore
Applicant
Brand Name +Dosage Form + Strength Lowvir-C capsule 600mg
Ribavirin…600mg
Diary No. Date of R& I & fee Dy. No 351; 12-8-2015 ; Rs.20,000/- (12-8-2015)
Type of Form Form-5
GMP status Last inspection report 19.05.2017 panel recommended
grant of GMP.
Remarks of the Evaluator. International evidence in RRA and me-too status could
not be confirmed.
754. Name and address of manufacturer / M/s Noa Hemis Pharmaceuticals, Karachi
Applicant
Brand Name +Dosage Form + Strength Tenohep-B tablets 300mg
Composition Each fim coated tablet contains:
Tenofovir Disoproxil fumarate…..300mg
Type of Form Form-5
073735)
remarks of cGMP compliance.
Decision: Approved
755. Name and address of manufacturer / M/s Crystolite Pharmaceuticals, Islamabad
Applicant
Brand Name +Dosage Form + Strength Virosone cream 5%
Acyclovir…..5%
Type of Form Form-5
Pack size & Demanded Price 10gm, As per SRO
Approval status of product in Reference USFDA Approved 5% cream
Me-too status Clovirex Cream 5% Reg # 39740
Remarks of the Evaluator. Firm has cream/ointment (general) section
Applicant
Brand Name +Dosage Form + Strength Sino 0.5mg tablets
Entecavir as monohydrate….0.5mg
Type of Form Form-5
Decision: Approved
757. Name and address of manufacturer / Crystolite Pharmaceuticals, Islamabad
Applicant
Brand Name +Dosage Form + Strength Romlus 1mg capsule
Tacrolimus…..(as monohydrate)….1mg
Type of Form Form-5
Applicant
Brand Name +Dosage Form + Strength Troximate 2.5mg tablet
Methotrexate sodium eq. to 2.5mg of methotrexate
Pharmacological Group Folic acid antagonist
Type of Form Form-5
Me-too status METHOTREXATE TABLET 2.5M by PAK CHINA
INTERNATIONAL KARACHI Reg# 066008
Decision: Registration Board deferred the case for further deliberation regarding
manufacturing facility for Cytotoxic drugs
Applicant
Brand Name +Dosage Form + Strength Mycotil 500mg tablet
Mycophenolate mofetil….500mg
Type of Form Form-5
in close handling of these drugs
Applicant
Brand Name +Dosage Form + Strength Silomus 0.25mg tablet
Everolimus….0.25mg
Pharmacological Group Protein kinase inhibitor
Type of Form Form-5
Regulatory Authorities. Afinitor - Novartis
Me-too status Certican Tablet
Applicant
Brand Name +Dosage Form + Strength Silomus 0.75mg tablet
Composition Each tablet contains: Everolimus….0.75mg
Type of Form Form-5
Regulatory Authorities. Afinitor - Novartis
Me-too status Certican Tablet
762. Name and address of manufacturer / M/s Fynk Pharmaceuticals, Lahore
Applicant
Brand Name +Dosage Form + Strength Virtec tablet 0.5mg
Entecavir……0.5mg
Pharmacological Group Anti viral
Type of Form Form-5
Pack size & Demanded Price 1x10’s, 3x10’s,, As per SRO
GMP status GMP inspection conducted on 20-09-2017 concluding
Decision: Approved
763. Name and address of manufacturer / M/s Fynk Pharmaceuticals, Lahore
Applicant
Brand Name +Dosage Form + Strength Zolret tablet 2.5mg
Composition Each film coated table contains:
Letrozole….2.5mg
Pharmacological Group Romatase inhibitor
Type of Form Form-5
Approval status of product in Reference Femara 2.5 mg Tablet by M/s Novartis Pharmaceuticals
Regulatory Authorities. UK Ltd (MHRA approved)
Me-too status Femara (Novartis)
(R.No: 021129)
GMP status GMP inspection conducted on 20-09-2017 concluding
Decision: Registration Board approved registration of product in general manufacturing
areas with condition that manufacturer shall provide safety and protective measures for
workers and personnel which remain in direct contact or are involved in close handling of
these drugs.
Applicant
Brand Name +Dosage Form + Strength Carnib capsules 50mg
Sunitinib maleate eq to sunitinib…..50mg
Type of Form Form-5
Approval status of product in Reference Sutent 50 mg capsules (Sunitinib as Malate) by Pfizer
Regulatory Authorities. Ltd Ramsgate Road Sandwich, Kent CT13 9NJ United
Kingdom (USFDA Approved)
Me-too status Sutent 50mg Capsule by M/s Pfizer (Reg. No. 052227)
Decisioin: Registration Board deferred the case for further deliberation regarding
manufacturing facility for Cytotoxic drugs
Applicant
Brand Name +Dosage Form + Strength Carnib capsules 12.5mg
Sunitinib maleate eq to sunitinib…..12.5mg
Type of Form Form-5
Me-too status SUTENT 12.5MG CAPSULE Reg # 052225
Decisioin: Registration Board deferred the case for further deliberation regarding
manufacturing facility for Cytotoxic drugs.
766. Name and address of manufacturer / M/s Rotex Pharma, Islamabad

Applicant
Brand Name +Dosage Form + Strength Primus 5mg dispersible tablet
Composition Each dispersible tablet contains:
Everolimus….5mg
Pharmacological Group Protein Kinase inhibitor
Type of Form Form-5
Finished product Specification Mfg
Pack size & Demanded Price 10’s, 30’s, 50’s, 60’s, 90’s, As per SRO
Approval status of product in Reference AFINITOR DISPERZ TABLET FOR ORAL
Regulatory Authorities. SUSPENSION. USFDA Approved
GMP status Last Inspection report 17-3-2017
The panel concluded that the company is following GMP
guidelines
Remarks of the Evaluator. Me-too status could not be confirmed.
(generic / me-too status) alongwith registration number, brand name and name of firm and
confirmation of pharmacological group
767. Name and address of manufacturer / M/s Rotex Pharma, Islamabad
Applicant
Brand Name +Dosage Form + Strength Primus 10mg tablet
Everolimus….10mg
Pharmacological Group Protein Kinase inhibitor
Type of Form Form-5
Finished product Specification Mfg
Pack size & Demanded Price 10’s, 30’s, 50’s, 60’s, 90’s, As per SRO
Me-too status AFINITOR 10MG TABLETS. by NOVARTIS
PHARMA (PAKISTAN) LIMITED, Reg #069520
GMP status Last Inspection report 17-3-2017
The panel concluded that the company is following GMP
guidelines
these drugs.
768. Name and address of manufacturer / M/s Kaizen Pharmaceuticals, Karachi
Applicant
Brand Name +Dosage Form + Strength Grafles 2.5mg tablet
Everolimus…..2.5mg
Pharmacological Group Immunosuppressant)
Type of Form Form-5
Pack size & Demanded Price 10’s, 20’s, 30’s, As per SRO
Me-too status AFINITOR 2.5MG TABLETS Reg # 78105
GMP status Copy of GMP inspection report dated 18 & 31st July,
2017 recommending renewal of DML.
these drugs.
Applicant
Brand Name +Dosage Form + Strength Grafin 250mg capsule
Mycophenolate mofetil…..250mg
Type of Form Form-5
Approval status of product in Reference CellCept USFDA Approved
Me-too status MY-REPT CAPSULES 250MG Reg # 78108
Decision: Approved
Applicant
Brand Name +Dosage Form + Strength Valganvir 450mg tablet
Valganciclovir HCl eq to valganiciclor…..450mg
Type of Form Form-5
Approval status of product in Reference USFDA Approved film coated tablet
Me-too status Reg #052253 Valcyte 450mg tablet imported from
Canada by Roche Pakistan
Decision: Approved.
771. Name and address of manufacturer / M/s Epharm Laboratories, Karachi

Applicant
Brand Name +Dosage Form + Strength Ribapharm tablet 500mg
Ribavirin…..500mg
Pharmacological Group Anti-cytomegalovirus agent
Type of Form Form-5
Me-too status Alcorib 500mg tablets by M/s Searle Pak, Karachi
(Reg#047386)
GMP status Last inspection report 27 April 2017, the panel
recommend the firm for grant of GMP certificate.
Decision: Approved
772. Name and address of manufacturer / M/s Epharm Laboratories, Karachi
Applicant
Brand Name +Dosage Form + Strength Ribapharm tablet 600mg
Ribavirin…..600mg
Pharmacological Group Anti-cytomegalovirus agent
Type of Form Form-5
Approval status of product in Reference Ribavirin tablet by Sandoz
Me-too status Ribuvir tablet by Martin Dow
GMP status Last inspection report 27 april 2017, the panel
recommend the firm for grant of GMP certificate.
Decision: Approved
773. Name and address of manufacturer / M/s The Searle company limited, Karachi
Applicant
Brand Name +Dosage Form + Strength Lifovir 300mg tablets
Tenofovir Disoproxil Fumarate…….300mg
eq to 245mg of Tenofovir disoproxil
Type of Form Form-5
073735)
GMP status Last inspection report 08.03.2017, Compliance from
firm.
Decision: Approved
774. Name and address of manufacturer / M/s The Searle company, Karachi
Applicant
Brand Name +Dosage Form + Strength Hepaovir tablet 0.5mg
Entecavir….0.5mg
Type of Form Form-5
GMP status Certificate of cGMP based on inspection conducted on
12-06-2017 is provided.
Decision: Approved
775. Name and address of manufacturer / M/s Global Pharmaceuticals, Islamabad
Applicant
Brand Name +Dosage Form + Strength Viro-B tablets 300mg
Tenofovir Disoproxil Fumarate…….300mg
eq to 245mg of Tenofovir disoproxil
Type of Form Form-5
073735)
GMP status GMP compliant dated 12-07-2017
Decision: Approved
776. Name and address of manufacturer / M/s Welwink Pharmaceuticals, Gujranwala
Applicant
Brand Name +Dosage Form + Strength Zitral 2.5mg tablets
Letrozole……2.5mg
Pharmacological Group Aromatase Inhibitor
Type of Form Form-5
Pack size & Demanded Price 3x10’s As per SRO
GMP status Last inspection report 20-12-2017 the panel concluded
that the firm was operating at a satisfactory level of GMP
compliance for all sections except liquid injectable
section for which firm was advised to provide Liquid
particle counter and TOC.
777. Name and address of manufacturer / M/s Olive laboratories, Rawalpindi

Applicant
Brand Name +Dosage Form + Strength Loverex tablet 500mg
Valganciclovir HCl eq to valaciclovir……500mg
Type of Form Form-5
GMP status Last inspection report 1-8-2017 firm is operating at
good level of GMP as of today.
Remarks of the Evaluator. International availability in RRA and me-too status could
not be confirmed.
b) Export Facilitation
Evaluator PEC-VI
Export Facilitation:
Application was received through letter No.F.8-6/2013-Reg-V stated as under “The firm claimed three
molecules to be considered on priority against USD 441565, duly verified from submitted documents
(Form E, GD form and shipment/invoices) as per decision of registration board.”
778. Name and address of manufacturer / M/s Highnoon Labs, Lahore
Applicant
Brand Name +Dosage Form + Strength Hirix 200mg tablet
Rifaximin….200mg
(Duplicate)
Type of Form Form-5
Pack size & Demanded Price 10’s, 14’s, 20’s, 30’s, As per SRO
Approval status of product in Reference Approved by MHRA
Me-too status Normix Tablets by M/s Sanital Pharmaceutical
Rawalpindi. (Reg#022656)
GMP status Last inspection report 6-7-2017 panel recommends
considering the firm for grant of cGMP certificate for
export purpose for all sections.
Remarks of the Evaluator. Fee challan photocopy is attached.
Decision: Approved with innovator’s specifications. Reference will be sent to Budget &
Applicant
Brand Name +Dosage Form + Strength Hirix 550mg tablet
Rifaximin….550mg
(Duplicate)
Type of Form Form-5
Approval status of product in Reference Approved by MHRA
Me-too status Rixago 550mg Tablet by M/s OBS Pharma Karachi
(Reg#081073)
Decision: Approved with innovator’s specifications. Reference will be sent to Budget &
Applicant
Brand Name +Dosage Form + Strength Viforge 160mg tablet
Valsartan….160mg
(Duplicate)
Pharmacological Group Angiotension II antagonist
Type of Form Form-5
Approval status of product in ReferenceValsartan tablets by Mylan
Me-too status Diovan tablet by Novartis
Decision: Approved with change of brand name. Reference will be sent to Budget & Accounts
Division for verification of challan and Board authorized its Chairman for the issuance of
registration letter.
Applicant
Brand Name +Dosage Form + Strength Viforge 320mg tablet
Valsartan….320mg
(Duplicate)
Pharmacological Group Angiotension II antagonist
Type of Form Form-5
Me-too status Diovan tablet by Novartis
Decision: Approved. Reference will be sent to Budget & Accounts Division for verification of
Applicant
Brand Name +Dosage Form + Strength Bifprge 10/160mg tablet
Amlodipine (as besylate)……10mg
Valsartan….160mg
(Duplicate)
Pharmacological Group Angiotension II antagonist and calcium channel blocker
Type of Form Form-5
Approval status of product in Reference Exforge by Novartis
Regulatory Authorities. (MHRA)
Me-too status Exforge by Novartis

Applicant
Brand Name +Dosage Form + Strength Biforge 5/320mg tablet
Amlodipine(as besylate)……5mg
Valsartan….320mg
Diary No. Date of R& I & fee Dy.1913 (15-1-2018); Rs.20,000/-(15-2-2017)
(Duplicate)
Pharmacological Group Angiotension II antagonist and calcium channel blocker
Type of Form Form-5
Approval status of product in Reference Exforge Tablets of M/s Novartis Europharm limited
Me-too status Newday Tablets of M/s Werrick Pharmaceuticals
Export Facilitation:
Application was received through letter No.F.8-6/2013-Reg-V stated as under “The firm claimed two
molecules to be considered on priority against USD 218589, duly verified from submitted documents
(Form E, GD form and shipment/invoices) as per decision of registration board.”
784. Name and address of manufacturer / M/s Novamed Pharmaceuticals, Lahore
Applicant
Brand Name +Dosage Form + Strength Linzod infusion 600mg/300ml
Linezolid…..2mg
Pharmacological Group Oxazolidinone
Type of Form Form-5
Pack size & Demanded Price 1’s(300ml), As per SRO
(Reg#055916)
GMP status Last inspection report 8-2-2017firm was considered to
be operating at good level of compliance with GMP
guidelines.
Remarks of the Evaluator. Firm has liquid injectable(ampoule & vial section)
Decision: Registration Board approved the applied formulation with innovator’s
specifications in the light of decision taken in 271st meeting, stated as under:
“In order to ensure, safety, efficacy and quality of Linezolid infusion, Registration Board
decided as under;
i) All the Manufacturers of Linezolid Infusion shall follow the packaging instructions of the
innovator of the product i.e M/s Pfizer which has clearly mention the storage precautions in
its Product Information Leaflet (PIL). They will also make sure that the solution is kept
correctly in its box and foil wrapping in order to protect from light.
Applicant
Brand Name +Dosage Form + Strength Linzod tablet 600mg
Linezolid…..600mg
Type of Form Form-5
Approval status of product in Reference Zyvox 600 mg tablet by Pharmacia and Upjohn Pharma
Me-too status Ecasil by Sami
guidelines.
Applicant
Brand Name +Dosage Form + Strength Linzod for oral suspension
Linezolid…….100mg
Type of Form Form-5
Linezolid 100 mg/5 ml granules for oral suspension by
Regulatory Authorities. M/s Pfizer Limited, MHRA approved.
Me-too status Barizold Dry Suspension by M/s Barret Hodgson
(Reg#076343)
guidelines.
Remarks of the Evaluator. Firm has dry powder for oral suspension section.
Applicant
Linzolid……2mg
Type of Form Form-5
(Reg#055914)
guidelines.
decided as under;
correctly in its box and foil wrapping in order to protect from light.”
Applicant
Linezolid….2mg
Type of Form Form-5
Pack size & Demanded Price 1’s, (200ml), As per SRO
Me-too status Linzol Infusion 400mg/200ml by M/s Regal
guidelines.
decided as under;
correctly in its box and foil wrapping in order to protect from light.
Applicant
Brand Name +Dosage Form + Strength Novaterafine tablet 125mg
Terbinafine as (terbinafine HCl)…..125mg
Type of Form Form-5
Pack size & Demanded Price 1x10’s, 7’s, 2x7’s, As per SRO
Approval status of product in Reference Terbinafine 125 mg tablets by M/s Genus
Me-too status Onyfine 125mg Tablet by M/s Medisure
guidelines.
Decision: Approved
Applicant
Brand Name +Dosage Form + Strength Novaterafine tablet 250mg
Terbinafine as (terbinafine HCl)…..250mg
Type of Form Form-5
Pack size & Demanded Price 1x10’s, 7’s, 2x7’s, 3x10’s, 3x7’s, 10x10’s, As per SRO
Me-too status Neoterbin Tablets 250mg of Neomedix
guidelines.
Decision: Approved
Applicant
Brand Name +Dosage Form + Strength Novaterafine topical cream 1%
Terbinafine HCl….1%
Type of Form Form-5
Finished product Specification JP
Pack size & Demanded Price 10gm, 15gm, 30gm, As per SRO
Approval status of product in Reference LAMISIL 1% w/w Cream by M/s Novartis Consumer
Regulatory Authorities. Health, USFDA Approved.
Me-too status Terbiderm Cream 1% by M/s Atco Laboratories
Limited (Reg#032004)
guidelines.
Decision: Approved
c) Finished Import
Evaluator PEC-X
792. Name and address of Applicant M/s Pharmatech Pakistan (PVT) Limited, D-86/A, Mangophir
Road, SITE, Karachi.
Detail of Drug Sale License Address: Pharmatech Pakistan (Pvt.) Ltd. Pharmatech
Pakistan (Pvt.) Ltd.
Validity: 22/06/2019
Status: Drug sale license by the way of wholesale
Name and address of M/s A. Menarini Manufacturing logistics and services
manufacturer SRLCampo di Pile-67100 L’Aquila
(site responsible for all cycles except for analytical controls)
M/s A. Menarini Manufacturing Logistics and Services SRL
Sette Santi, 3-50131 Firenz, Italy.
(Site responsible for Analytical control)
Name and address of marketing M/s Menarini International Operations Luxembourg, S.A. 1,
authorization holder Avenue de la Gare Lxembourg L-1611 Luxembourg
Name of exporting country Italy
Type of Form Form 5-A
Diary No. & Date of R& I Dy. No.17270 Dated 06/10/2017
Fee including differential fee Rs. 300,000/- Dated 05/10/2017
Brand Name +Dosage Form + KETESSE 25mg film coated Tablet
Strength
Composition Each film tablet contains:
Dexketoprofen trometamol…….. 36.9mg
(Eq. to Dexketoprofen………….. 25mg)
Finished Product Specification In House
Pharmacological Group NSAIDS
Shelf life 36 months
Demanded Price For 25’s pack Rs. 2250/-
For 20’s pack Rs. 1800/-
Pack size 15’s, 20’s
International availability Available in Italy as per CoPP
Me-too status N/A
Detail of certificates attached  Original legalized CoPP (certificate No.
NoCPP/2016/823)) certified by AIFA, Italy issued on
30/03/2016 confirms the free sale of the product in
exporting country. The facilities and operations conform
to WHO-GMP (GMP status has been confirmed from
CoPP the plants which are present in Italy)
 GMP certificate issued by AIFA on 02/10/2016 for M/s.
A. Menarini Manufacturing logistics and services
SRLCampo di Pile-67100 L’Aquila
Remarks of the Evaluator:
 The firm has claimed In House specifications and the product is not present in USP/BP.
Description of the product:
The drug is indicated for symtomatic treatment of pain of mild to moderate intensity, such as
musculo-skeletal pain, dysmonerrhoea, dentalpain.
Decision: Approved as per Imort Policy for Finished Pharmaceutuical Products.
793. Name and address of Applicant M/s Pharmatech Pakistan (PVT) Limited, D-86/A, Mangophir
Road, SITE, Karachi.
Detail of Drug Sale License Address: Pharmatech Pakistan (Pvt.) Ltd. Pharmatech
Pakistan (Pvt.) Ltd.
Name and address of M/s A. Menarini Manufacturing Logistics and Services SRL
manufacturer Sette Santi, 3-50131 Firenz, Italy.
(Site responsible for Bulk production, Primary and secondary
packaging, analytical controls and Batch release)
Name and address of marketing M/s Menarini International Operations Luxembourg, S.A. 1,
authorization holder Avenue de la Gare Lxembourg L-1611 Luxembourg
Brand Name +Dosage Form + KETESSE 50mg/2ml Infusion
Strength Concentrate for solution for Infusion
Composition Each ampoule (2ml) contains:
Dexketoprofen trometamol…….. 73.80mg
(Eq. to Dexketoprofen………….. 50mg)
Shelf life 05 years
Demanded Price Fro 1’s Pack Rs. 320/-
For 100’s pack Rs. 32,000/-
Pack size 15’s, 20’s
International availability Available in Italy as per CoPP
Me-too status N/A
o
N CPP/2015/2980)) certified by AIFA, Italy issued on
exporting country. The facilities and operations conform
to WHO-GMP (GMP status has been confirmed from
CoPP the plants which are present in Italy)
 GMP certificate issued by AIFA on 02/10/2016 for M/s.
A. Menarini Manufacturing logistics and services
SRLCampo di Pile-67100 L’Aquila
Description of the product:
The drug is indicated for symtomatic treatment of pain of mild to moderate intensity, such as
musculo-skeletal pain, dysmonerrhoea, dentalpain.
794. Name and address of Applicant M/s Novartis Pharma (Pakistan) Limited 15, West Wharf,
Karachi.
Detail of Drug Sale License Adress: Novartis Pharma Pakistan Ltd. 15, West Wharf,
Karachi.
Status: By the way of wholesale
The Firm has applied for renewal of the license on
16/05/2017.
Name and address of M/s SA Alcon-Courveur N V, Rijksweg 14, B-2870 Puurs,
manufacturer Belgium
Name and address of marketing M/s Novartis Europharm Limited, Frimley Business Park,
authorization holder Camberley GU16 7SR, United Kingdom
Name of exporting country Belgium
Brand Name +Dosage Form + ILEVRO Eye drops (suspension)
Strength
Composition Each ml of suspension contains:
Nepafenac………. 3mg
Demanded Price 5.5 USD
Pack size 1’s
International availability Nevanac 3mg/ml by M/s Novartis UK (MHRA Approved)
Available in Belgium (EU states) as per CoPP
Me-too status N/A
Detail of certificates attached  Original legalized CoPP (certificate No. 11/17/112330)
certified by EMA issued on 31/08/2017 confirms the
free sale of the product in exporting region. The
facilities and operations conform to WHO-GMP.
 GMP certificate issued by Federal Agency for
Medicines and Health Products on 27/05/2016
 The firm has claimed in House specifications and the product is not present in USP/BP.
Description:
 It is used for prevention and treatment of postoperative pain and inflammation and for reducing
the risk of post-operative macular oedema associated with cataract surgery.

Decision: Approved as per Imort Policy for Finished Pharmaceutuical Products
795. Name and address of Applicant M/s Punjab Medical Services, 793-D, Block C, Faisal Town
Lahore.
Detail of Drug Sale License Adress: Punjab Medical Services Pharmacy, Office No. 4,5
Jalal Centre 2nd Dfloor Opposite O.P.D gate Sir Ganga Ram
Hospital Lahore
Status: License to sell drug s in Pharmacy
Name and address of M/s Aizant Drug Research Solutions Pvt Ltd Sy No.
manufacturer 172&173, Apparel Park Road, Dulapallay village,
Quthbullapur mandal, Ranga Reddy district Hyderabad-500
100, Telangana state, India.
Name and address of marketing M/s Aizant Drug Research Solutions Pvt Ltd Sy No.
authorization holder 172&173, Apparel Park Road, Dulapallay village,
Quthbullapur mandal, Ranga Reddy district Hyderabad-500
100, Telangana state, India.
Name of exporting country India
Brand Name +Dosage Form + ABIRATERONE ACETATE tablet 250 mg
Strength
Abiraterone acetate…… 250mg
Pharmacological Group Anticancer/steroidal enzyme CYP17A1 Inhibitor
Shelf life 2 years
Demanded Price As per SRO
Pack size 120 tablet in HDPE bottle
International availability ZYTIGA 250 mg tablets by M/s JANSSEN BIOTECH,
USFDA Approved
Me-too status N/A
Detail of certificates attached  Original legalized CoPP (certificate no. 12390/A3/2017-1 )
certified by Drugs Control Administration Vengalraonagar,
Hyderabad 500 038, TS, India Valid up to 10/03/2018
confirms the free sale of the product in exporting country.
The facilities and operations conform to WHO-GMP.
Followings are he short comings
Description:
Abiraterone acetate inhibitor of steroidal enzymes and it is indicated for use in combination with
prednisone for the treatment of patients with metastatic castration-resistant prostate cancer who
have received prior chemotherapy containing docetaxel.

796. Name and address of Applicant M/s Punjab Medical Services, 793-D, Block C, Faisal town
Lahore
Detail of Drug Sale License Adress: Punjab Medical Services Pharmacy, Office No. 4,5
Jalal Centre 2nd Dfloor Opposite O.P.D gate Sir Ganga Ram
Hospital Lahore
Status: License to sell drug s in Pharmacy
Name and address of M/s Actavis Italy SPA, via Pasteur, 10, 20014, nerbiano
manufacturer Milano Italy
Name and address of marketing M/s Actavis Group PTC ehf., Reykjavikurvegur 76-78, 220
authorization holder Haafnarfjorour, Iceland
Brand Name +Dosage Form + HIMZOL 4mg/5ml
Strength Concentrate for solution for IV infusion
Composition Each vial (5ml) contains:
Zoledronic acid (as monohydrate)……… 4mg
Pharmacological Group Biophosphonate
Shelf life 3 years
Pack size 1’s
International availability Pms-Zoledronic Acid By Pharmascience Inc, Health Canada
Me-too status Zoledronic acid by Scotmann
Detail of certificates attached  Original legalized CoPP (certificate No. 04/17/111074)
certified by EMA issued on 21/07/2017 confirms the
free sale of the product in exporting region. The
facilities and operations conform to WHO-GMP.
 Legalized GMP certificate issued by AIFA Italy on
11/21/2016
The firm has claimed in House specifications and the product is not present in USP/BP.

797. Name and address of Applicant M/s Shamco Traders, 17-a Ahmed block, New garden town
Lahore.
Detail of Drug Sale License Address: M/s Shamco Traders, 17-a Ahmed block, New garden
town Lahore.
Status: License to sell drugs as a Distributor
Name and address of M/s Mefar Ilac Sanayii A.S. Ramazanoglu Mah. Ensar Cad.
manufacturer No:20 Kurkoy Pendik/Istanbul, Turkey.
Name and address of marketing M/s Pharmada Ilac San Ve Tic A.S. Dem Plaza Inonu Mah.
authorization holder Kayisdagi Cad No:172 34755 Atasehir-Istanbul, Turkey.
Name of exporting country Turkey
Diary No. & Date of R& I Dy. No. 7829 Dated 07/07/2017
Brand Name +Dosage Form + PARICITOL IV Injection 10mcg/2ml
Strength Solution for injection
Paricalcitol……. 5mcg
Pharmacological Group Anti-parathyroid agent
Shelf life 3 years
Demanded Price 7 USD
Pack size A pack of 5 Ampoules (2ml Ampoule)
International availability Zemplar injection by M/s Abvie, USFDA Approved.
Me-too status N/A
Detail of certificates attached Original legalized CoPP (certificate No. 2017/1005 certified by
Ministry of Health Turkey valid up to 03/04/2019 confirms the
free sale of the product in exporting country. The facilities and
operations conform to GMP as recommended by WHO as per
CoPP.
 The firm has claimed for in House manufacturing specifications while the product is present in
USP.
 In response to letter of short comings, the firm has submitted long term stability studies of 09
months. However, the firm has claimed a shelf life of 36 months. The batch manufacturing date
is 15/12/2016.
Description:
It is an analog of active form of Vit D2 and is indicated in adults for the prevention and treatment
of secondary hyperparathyroidism in patients with chronic renal failure who are undergoing
haemodialysis.

798. Name and address of Applicant M/s Mukhtar Enterprises, 55 Block B, Faisal town Lahore
Detail of Drug Sale License Address: M/s Mukhtar Enterprises, 1st floor 55B, Faisal town
Lahore
Status: License to sell drugs as a distributor
Name and address of M/s Xellia Pharmaceuticals APS Dalslandsgade11, 2300
manufacturer Copenhagen S Denmark
Name and address of marketing M/s Xellia Pharmaceuticals APS Dalslandsgade11, 2300
authorization holder Copenhagen S Denmark
Name of exporting country Denmark
Brand Name +Dosage Form + COLISTIMETHATE SODIUM powder for solution for
Strength IVinjection/infusion
Colistimethate Sodium…….. 2MIU
Pharmacological Group Antibacterial.
Demanded Price Rs. 2250/- per vial
Pack size 10’s
International availability Available in Denmark as per CoPP
Me-too status N/A
Detail of certificates attached  Original legalized CoPP (certificate No. 2017073239)
certified by Danish Medicines Agency issued on
exporting country. The facilities and operations
conform to WHO-GMP.
Remarks of the Evaluator The firm has claimed In House specifications while the
product is present in USP and B.P.
Decision: Approved
799. Name and address of Applicant M/s Novartis Pharma (Pakistan) Ltd, 15 West Wharf Karachi.
Karachi.
The Firm has applied for renewal of the license on
16/05/2017.
Name and address of M/s Catalemt Germany Eberbach GmbH, Gammelsbacher
manufacturer Str. 2, 69412 Eberbach, Baden wuerttemberg, Germany
Name and address of marketing M/s Novartis Europharm Limited, Frimley Business Park,
authorization holder Camerley GU16 7SR, United Kingdom
Name of exporting country Germany
Brand Name +Dosage Form + RYDAPT soft capsule 25mg/
Strength
Composition Each Soft Capsule contains:
Midostaurin…….. 25mg
Pharmacological Group Anti-cancer
Demanded Price Rs. 450,000/- per pack of 28’s (Rs. 16,071/- per capsule)
Rs. 800,000/- per pack of 56’s (Rs. 14,285/- per Capsule)
Rs. 1,600,000/- per pack of 112’s (Rs. 14,285/- per Capsule)
Pack size 28’s, 56’s, 112’s
International availability EMA approved as per COPP
Me-too status N/A
Detail of certificates attached Original legalized CoPP (certificate No. 12/17/115066)
issued by EMA on 01/12/2017 confirms the free sale of the
product in exporting region. The facilities and operation
conform to GMP as recommended by WHO.
Remarks of the Evaluator.  The firm has claimed In House specifications and the
product is not present in USP/BP.
 Chemical tests (Assay of active ingredient and
degradation products) of long term stability are
performed till 18 months while the firm has claimed a
life of 36 months.
Decision: Deferred for submission of stability data of long term till claimed shelf life of 36
months.
800. Name and address of Applicant M/s AJ Mirza Pharma (Pvt.) Ltd., 7-Ground Floor, Shafi
Court, Merewether Road, Civil Lines, Karachi.
Detail of Drug Sale License Adress:, A. J. Mirza Pharma (pvt) Ltd., 1st floor shafi court
Merewether road, civil lines, Karachi.
Status: by the way of wholesale
Name and address of M/s Cipla limited Plot No. A-2, A-33 & A-37/2/2, M.I.D.C.,
manufacturer Patalganga, Raigad 410220 Maharashtra State, India
Name and address of marketing M/s Cipla limited Plot No. A-2, A-33 & A-37/2/2, M.I.D.C.,
authorization holder Patalganga, Raigad 410220 Maharashtra State, India
Brand Name +Dosage Form + VALGILOR 450 tablet
Strength Film Coated Tablet
Valganciclovir (as hydrochloride)……… 450mg
Demanded Price Not proposed
Pack size 60 tablets in HDPE
International availability Valcyte 450 mg film-coated tablets M/s Roche Products
Limited, MHRA Approved
Me-too status Valcyte 450mg film coated tablet M/s Roche Pakistan limited
(Reg # 052253)
Detail of certificates attached  Original legalized CoPP (certificate
No.COPP/CERT/KD/47308/2016/11/15789/80968)) certified
by Food and Drug Administration M.S Bandra (E), Mumbai,
India Valid up to 12/06/2018 confirms the free sale of the
product in exporting country. The facilities and operations
conform to WHO-GMP.
 GMP certificate issued by Food and Drug
Administration M.s Bandra (E), Mumbai, India
Decision: Deferred for confirmation regarding importability from India as per IPO.
Name and address of M/s Cipla Ltd., M-61 to M-63, Verna Industrial Estate,
manufacturer Verna, Goa, India.
Name and address of marketing M/s Cipla Ltd., M-61 to M-63, Verna Industrial Estate,
authorization holder Verna, Goa, India.
Brand Name +Dosage Form + CASPOGIN 50
Strength Lyophilized powder for concentrate for solution for IV
infusion
Caspofungin acetate Eq. to Caspofungin…… 50mg
Pack size 1’s
International availability Caspofungin 50 mg powder for concentrate for solution for
infusion M/s Sun Pharmaceutical Industries Europe B.V,
MHRA Approved.
Me-too status N/A
831/MFG/WHO-GMP/DFDA/2017/30 (3)) certified by
Directorate of Food and Drug Administration Govt. of Goa,
conform to WHO-GMP.
Storage conditions: 2-8oC
 The firm has claimed for In House manufacturing specifications and the product is not
present in USP/BP.
 A significant change (more than 5%) has been observed in assay value of long term
stability studies of batch No. GI50309 between initial and final (24 months) time points.
 Status of antifungal drugs whether they can be imported from India or otherwise is not
clear yet.
Description:
Caspofungin is a lipopeptide antifungal drug.
Treatment of invasive candidiasis in adult or paediatric patients.
Treatment of invasive aspergillosis in adult or paediatric patients who are refractory to or
intolerant of amphotericin B, lipid formulations of amphotericin B and/or itraconazole.
Refractoriness is defined as progression of infection or failure to improve after a minimum of 7
days of prior therapeutic doses of effective antifungal therapy.
Empirical therapy for presumed fungal infections (such as Candida or Aspergillus) in febrile,
neutropaenic adult or paediatric patients.
Name and address of M/s Cipla Ltd., M-61 to M-63, Verna Industrial Estate,
manufacturer Verna, Goa, India.
Name and address of marketing M/s Cipla Ltd., M-61 to M-63, Verna Industrial Estate,
authorization holder Verna, Goa, India.
Brand Name +Dosage Form + CASPOGIN 70
Strength Lyophilized powder for concentrate for solution for IV
infusion
Caspofungin acetate Eq. to Caspofungin…… 70mg
Pack size 1’s
International availability Caspofungin 70 mg powder for concentrate for solution for
infusion M/s Sun Pharmaceutical Industries Europe B.V,
MHRA Approved.
Me-too status N/A
831/MFG/WHO-GMP/DFDA/2017/30 (3)) certified by
Directorate of Food and Drug Administration Govt. of Goa,
conform to WHO-GMP.
 The firm has claimed for In House manufacturing specifications and the product is not
present in USP/BP.
 Status of antifungal drugs whether they can be imported from India or otherwise is not
clear yet.
Description:
Caspofungin is a lipopeptide antifungal drug.
Treatment of invasive candidiasis in adult or paediatric patients.
Treatment of invasive aspergillosis in adult or paediatric patients who are refractory to or
intolerant of amphotericin B, lipid formulations of amphotericin B and/or itraconazole.
Refractoriness is defined as progression of infection or failure to improve after a minimum of 7
days of prior therapeutic doses of effective antifungal therapy.
Empirical therapy for presumed fungal infections (such as Candida or Aspergillus) in febrile,
neutropaenic adult or paediatric patients.
Case No. 07: Registration applications of import cases
a) Import routine cases (Human)
Evaluator PEC-X
803. Name and address of Applicant M/s Mukhtar Enterprises, 55 block B, Faisal town Lahore.
Detail of Drug Sale License Address: M/s Mukhtar Enterprises, 1st floor 55 block B, Faisal
town Lahore.
Name and address of M/s Ilsung Pharmaceuticals Co. Ltd. 9,, Wonhyo-ro 84-gil,
manufacturer Yongsan-gu, Seoul Korea, Republic of Korea.
Name and address of marketing M/s Ilsung Pharmaceuticals Co. Ltd. 9,, Wonhyo-ro 84-gil,
authorization holder Yongsan-gu, Seoul Korea, Republic of Korea.
Name of exporting country Korea
Brand Name +Dosage Form + SEVOPRANE Inhalation Solution 250ml
Strength
Composition Each bottle contains:
Sevoflurane…… 250ml
Pharmacological Group General anesthetic
Demanded Price Rs. 9800/- per bottle
Pack size 250 ml bottle
International availability Sevoflurane 100% Inhalation Vapour, liquid by M/s Piramal
Healthcare UK Limited, MHRA Approved
Me-too status Sevoflurane inhalational solution by M/s Abbot Labs (Reg #
018556) (Imported)
Detail of certificates attached  Original legalized CoPP (certificate No. 2015-DI-0858)
certified by Gyeongin Regional Food & Drg
administration, Korea valid till 31/03/2015 confirms the
free sale of the product in exporting country. The facilities
and operations conform to WHO-GMP as per CoPP.
Remarks of the Evaluator.  The firm has claimed for In House manufacturing
specifications and the product is not present in USP/BP.
 The firm has applied for Sevoflurane inhalation solution
with filled volume of 250ml while CoPP does not clarify
the filled volume of the product. Only composition of the
product in CoPP is mentioned.
Decision: Deferred for clarification of fill volume on CoPP.
804. Name and address of Applicant M/s Mehran International, 498D Hume Road Quiadeen
Colony Karachi
Detail of Drug Sale License Address: Mehran International, 98-C, Feroz Shah Mehta
Road, Karachi
Name and address of M/s Jiangsu Pengyao Pharmaceuticla Co., Ltd., No. Chaquan
manufacturer road, Yixing city, Jiangsu, 214205, China
Name and address of marketing M/s Jiangsu Pengyao Pharmaceuticla Co., Ltd., No. Chaquan
authorization holder road, Yixing city, Jiangsu, 214205, China
Exported by: M/s Ninhua Group Cp., Ltd., 21 Jiangxia street,
Ningbo, P.R. China
Name of exporting country China
Brand Name +Dosage Form + PARACETAMOL 1g.100ml IV infusion
Strength Solution for IV infusion
Composition Each vial (100ml) contains:
Paracetamol…….. 1000mg
Pharmacological Group Analgesic, antipyretic
Shelf life 3 years
Demanded Price Rs. 80/- per Bottle
Pack size 1’s
International availability ACETAMINOPHEN IV infusion 1g/100ml by M/s
CUSTOPHARM INC, USFDA pproved
Me-too status Paedal Infusion 1g/100ml by M/s Regal Pharma (Reg #
082000)
Detail of certificates attached  Original legalized CoPP (certificate No. YI-
20150331) certified by Jiangsu province Yixing Food and
Drug Administration of the People’s Republic of China issued
on 31/03/2015 confirms the free sale of the product in
exporting country. The facilities and operations conform to
WHO-GMP.
Remarks of the Evaluator.  The firm has claimed In House specifications and the
805. Name and address of Applicant M/s S.K. Enterprises, Office No. 701, 7th floor KS trade tower,
Shahrah e Liaquat Karachi.
Detail of Drug Sale License Address: S.K. Enterprises, Shop No. 11 Marriot Road, Kutchi
Gali Karachi.
Status: Drug License by way of Wholesale
Name and address of M/s Shijiazhuang No. 4 Pharmaceutical Co., Ltd., No. 288,
manufacturer Zhujiang Road, High Tech Industrial Development Zone,
Shijiazhunang, Hebei, China
Name and address of marketing M/s Shijiazhuang No. 4 Pharmaceutical Co., Ltd., No. 288,
authorization holder Zhujiang Road, High Tech Industrial Development Zone,
Brand Name +Dosage Form + SK+METROSIM Infusion
Strength Solution for IV infusion
Metronidazole…….. 500mg
Finished Product Specification B.P
Pharmacological Group ANTIPROTOZOALS
Shelf life 3 years
Demanded Price As per DRAP policy
Pack size As per DRAP policy
International availability Metronidazole 500 mg / 100 ml Intravenous Infusion by M/s
Baxter Healthcare Ltd. (MHRA Approved)
Me-too status Fygin 500mg/100ml by Regal Pharma (Reg # 081994)
certified by Hebei Food and Drug Administration, China
Valid till 28/12/2019 confirms the free sale of the product
in exporting country. The facilities and operations conform
to WHO-GMP.
 Gmp certificate valid till 09/02/2020
Gali Karachi.
Name and address of M/s Shijiazhuang No. 4 Pharmaceutical Co., Ltd., No. 288,
manufacturer Zhujiang Road, High & New Tech Development Zone,
authorization holder Zhujiang Road, High Tech Industrial Development Zone,
Shijiazhunang, Hebei, China (CoPP manu Plus MA)
Brand Name +Dosage Form + SK+CIPROSIM Injection
Strength Solution for IV Injection
Ciprofloxacin (as lactate)……. 200mg
Pharmacological Group Quinolones
Shelf life 3 years
International availability Ciprofloxacin 2 mg/ml solution for infusion by M/s Hikma
Farmacêutica (Portugal), S.A. (MHRA Approved)
Me-too status Reflox infusion by M/s Regal Pharma (Reg # 081993)
to WHO-GMP
Gali Karachi.
Name and address of M/s Shijiazhuang No. 4 Pharmaceutical Co., Ltd., Yangzi
manufacturer Road, Economic & TechnologicalDevelopment zone,
Shijiazhuang City, Hebei Province. (MA Holder Plus Manu
acc. To COPP)
authorization holder Zhujiang Road, High & New Tech Development Zone,
Brand Name +Dosage Form + SK+RINGERSIM Infusion
Strength Solution for IV Infusion
Sodium lactate…………..…….… 1.6g
Potassium chloride…………….... 0.2g
Calcium chloride dihydrate…….. 0.135g
Sodium chloride………………… 3g
Pharmacological Group electrolytes
Shelf life 3 years
International availability Compound Sodium Lactate Solution for Infusion BP by M/s
Bater helath care, MHRA Approved
Me-too status Sterifluid RLInfusion by M/s Frontier Dextroseltd (Reg #
052739)
to WHO-GMP
 Original legalized Free Sale certificate (certificate No.
20170793) certified by Hebei Food and Drug
Administration, China issued in 28/12/2017 confirms the
free sale of the product in exporting country and WHO-
GMP.
Detail of Drug Sale License Address: A.J Mirza Pharma (PVT) Ltd. 1st floor Shafi Court
Merewether road civil line Karachi.
Status: Drug license by way of wholesale
Name and address of M/s Cipla ltd, S-103 to S-105, S-107 to S-112, L-138, L-147
manufacturer to L-147-1, L-147/3, L-147/A, Verna Industrial Estate, Verna,
Goa. India.
Name and address of marketing M/s Cipla ltd, S-103 to S-105, S-107 to S-112, L-138, L-147
authorization holder to L-147-1, L-147/3, L-147/A, Verna Industrial Estate, Verna,
Goa. India.
Fee including differential fee Rs. 100,000/- Dated
Brand Name +Dosage Form + IMATIB Capsules 100mg
Strength
Imatinib (as mesylate)….. 100mg
Pharmacological Group Antineoplastic
Pack size 10’s
International availability Imatinib Dr. Reddy's 100 mg Capsules, Hard by Dr. Reddy's
Laboratories (UK) Ltd,( MHRA Approved)
Me-too status Glivec Capsules 100mg by Novartis Pharma, (imported)
Detail of certificates attached Original Legalized CoPP (certificate NO. 789/MFG/WHO-
GMP/DFDA/2017/234(03)) issued by Food & Drug
Administration Bambolim, Goa, India valid up to 15/12/2018
Confirms the free sale of drug in country of origin. The
facilities and operations conform to GMP as recommended by
WHO.
Remarks of the Evaluator.  The firm has claimed In House manufacturing
specifications and the product is not available in USP/BP.
809. Name and address of Applicant M/s Novartis Pharma (Pakistan) Limited, 15 west Wharf Road
P.O box 100 & 7247, Karachi
Details of Drug sale License Adress: Novartis Pharma Pakistan Ltd. 15, West Wharf,
Karachi.
The Firm has applied for renewal of the license on 16/05/2017.
Name and address of M/s Hetero Labs Ltd (Unit-VI), TSIIC Formulation SEZ, S.No
manufacturer 410 & 411, Polepally Village, Jadcheria (mandal) Mahaboob
Nagar (district) Pin-509301, Telangana, India
Name and address of Marketing M/s Sandoz GmbH Biochmiestrabe 10 AT-6250 Kundi Austria.
authorization holder
Name of exporting country Austria
Brand Name+Dosage Form + CAPECITABIN SANDOZ 150mg
Composition Each Film Coated Tablet contains:
Capecitabine…..150mg
Finished product Specification In House
Shelf life 2 years
Fee including differential fee (Rs. 50,000/- Dated 30/09/2013) + (Rs. 50,000/- Dated
22/01/2018)
Pack size 60’s
Demanded Price Rs. 4118/- per 60’s
International Availability Capecitabine by Actavis, MHRA
Me-too status N/A
New strength
Detail of certificates attached  Notarized copy of GMP certificate issued by
Norwegian Medicines Agency of Unit VI of M/s
Heterolabs Limited.
 Legalzied (embassy attested) Copy of GMP certificate
issued by Licensing & controlling Authority, Drugs
Control Administration, Government of Telangana,
India.
 Original legalized CoPP (certificate No.9934859)
issued by Bundesamt fur Sicherheit im
Gesundheitswesen, Austria on 13/04/2017 confirms
the free sale of the product in exporting country.
Remarks of the Evaluator.  The firm has claimed In House specifications while the
product is available in USP and BP. In House specifications are
more stringent.
810. Name and address of Applicant M/s Medi Mark Pharmaceuticals, Liaqat chowk, sahiwal,
Pakistan
Detail of Drug Sale License Address: Medi Mark Oharmaceuticals 588-Karbala Road
Liaqat Chowk (Inside Al-Javaid children Clinic Sahiwal)
Status: drug sale license by the way of wholesale
Name and address of M/s Sinopharm A-Think Pharmaceutical Co., Ltd., No.1, A-
manufacturer think Road Economic Development Zone Shuangyang
District Changchun Jilin Province, China.
Name and address of marketing M/s Sinopharm A-Think Pharmaceutical Co., Ltd., No.1, A-
authorization holder think Road Economic Development Zone Shuangyang
District Changchun Jilin Province, China.
Brand Name +Dosage Form + OCTFIN IV/SC Injection
Strength Solution for injection
Octreotide acetate…… 0.1mg
Pharmacological Group Pituitary hormaone release inhibitor
Pack size 1’s
International availability Octreotide 100 micrograms/ml solution for injection by M/s
Ranbaxy UK limited, MHRA Approved
Me-too status Sandotide injection 0.1mg/ml by M/s CCL Pharma, (Reg #
052284)
certified by Jilin Provincial Food and Drug
Administration on 25/11/2017 confirms the free sale of
the product in exporting country. The facilities and
operations conform to GMP as recommended by WHO as
per CoPP. (expired)
 Storage condition: 2-8oC
The firm has claimed In House specifications and the product is not present in USP/BP.
 The product is approved in reference countires as “Octreotide as Acetate 0.1mg/ml” in
contrary, The applied formulation in CoPP is mentioned as “Octreotide Acetate 0.1mg/ml).
However a letter of explanation in response to the query from the manufacturer has been
submitted by the applicant. According to the letter of explanation the amount of base
(Octreotide) is 0.1mg/1ml and the salt form of API is Octreotide Acetate.
 Confirmation of origin of source of API whether synthetic or natural.
 Submission of CoPP with composition stated as per reference product.
811. Name and address of Applicant M/s Mukhtar Enterprises, 55 block B, Faisal town Lahore.
town Lahore.
Name and address of M/s Xellia Pharmaceutical ApS Dalslandsgade 11, 2300
Name and address of marketing M/s Xellia Pharmaceutical ApS Dalslandsgade 11, 2300
Brand Name +Dosage Form + VANCOMYCIN Injection 500mg
Strength Powder for concentrate for solution for IV infusion
Vancomycin (as hydrochloride)……… 500mg
Pack size 1’s (10ml vial)
International availability MHRA approved
Approved in Denmark as per CoPP
Me-too status Vanzay powder for solution (500mg and 1g) by M/s Vision
Pharma (Reg No. 081901)
certified by Danish Health and Medicines Authority, Denmark
issued on 13th July, 2016 confirms the free sale of the product.
Remarks of the Evaluator.  The firm has claimed for In House specifications while
the product is present in USP and BP..
812. Name and address of Applicant M/s Mukhtar Enterprises,55 block B, Faisal town Lahore.
town Lahore.
Name and address of M/s Xellia Pharmaceutical ApS Dalslandsgade 11, 2300
Name and address of marketing M/s Xellia Pharmaceutical ApS Dalslandsgade 11, 2300
Brand Name +Dosage Form + VANCOMYCIN Injection 1000mg
Strength Powder for concentrate for solution for IV infusion
Vancomycin (as hydrochloride)……… 1000mg
Pack size 1’s (20ml vial)
International availability MHRA approved
Approved in Denmark as per CoPP
Me-too status Vanzay powder for solution (500mg and 1g) by M/s Vision
Pharma (Reg No. 081902)
certified by Danish Health and Medicines Authority, Denmark
issued on 13th July, 2016 confirms the free sale of the product.
Remarks of the Evaluator.  The firm has claimed for In House specifications while
the product is present in USP and BP.
b) Import routine cases (Veterinary)
813. Name and address of Applicant M/s U.M Enterprises, Plot No. 12, Sector 15, Korangi
Industrial Area, Karachi.
Detail of Drug Sale License Address: U.M. Enterprises, 18 C 3rd Floor Dolmen Estate
Block-7, Shaheed e Millat Road, Karachi.
Name and address of M/s Qilu Animal Health Products Co., Ltd., No. 243 Gongye
manufacturer North Road, Jinan, 250100, Shandong, China
Name and address of marketing M/s Qilu Animal Health Products Co., Ltd., No. 243 Gongye
authorization holder North Road, Jinan, 250100, Shandong, China
Brand Name +Dosage Form + FEQUNOME LC.
Strength (Pre filled Syringe for intramamary Infusion)
Composition Each 8g of pre filled syringe contains:
Cefquinome (as sulfate)…… 75mg
Target species (for use for cattles)
Pharmacological Group Beta Lactam Antibiotic
Demanded Price Rs. 550/- per syringe
Pack size 1’s
International availability Cobactan MC Intramammary Suspension 75 mg Milking Cow
by M/s Intervet UK Ltd. Walton Manor Walton Milton Keynes
Buckinghamshire MK7 7AJ, VMD, UK Approved
Detail of certificates attached  Original legalized CoPP (certificate No. Vet. Drug No.
(2014)15025450) certified by Bureau of Animal Husbandry
& Veterinary of Shandong Province, P.R. China issued on
GMP as recommended by WHO as per CoPP.
 GMP certificate
Remarks of the Evaluator. Withdrawal Period:
Meat and Offal……. 4days
Milk………………... 5days
 The firm has claimed for In House specifications and the
814. Name and address of Applicant M/s U.M Enterprises, Plot No. 12, Sector 15, Korangi
Industrial Area, Karachi.
Detail of Drug Sale License Address: U.M. Enterprises, 18 C 3rd Floor Dolmen Estate
Block-7, Shaheed e Millat Road, Karachi.
Name and address of M/s Qilu Animal Health Products Co., Ltd., No. 243 Gongye
manufacturer North Road, Jinan, 250100, Shandong, China
Name and address of marketing M/s Qilu Animal Health Products Co., Ltd., No. 243 Gongye
authorization holder North Road, Jinan, 250100, Shandong, China
Brand Name +Dosage Form + CEFENT DC
Strength (Pre filled Syringe for intramamary Infusion)
Composition Each pre filled syringe of 8ml contains:
Ceftiofur (as Hydrochloride)……. 500mg
Target Species (for cattle use)
Pharmacological Group Beta lactam antibiotic
Demanded Price Rs. 550/- per syringe
Pack size 1’s
International availability Spectramast DC sterile suspension by M/s Zoitis INC.
(USFDA Approved) 500mg/10ml prefilled syringe
Me-too status Could not be confirmed.
Detail of certificates attached  Original legalized CoPP (certificate No. Vet. Drug
No. (2014)150252457) certified by Bureau of Animal
Husbandry & Veterinary of Shandong Province, P.R.
China on issued 27/01/2015 confirms the free sale of the
conform to GMP as recommended by WHO as per CoPP.
 GMP certificate
Remarks of the Evaluator. Withdrawal Period:
Meat and Offal……. 0days
Milk………………... 0 hours
 The firm has claimed for In House specifications and the
 Clarification is required since the applied product is
approved in USFDA as 500mg/10ml single used syringe
while you have applied for 500mg/8ml single use syringe.
However the product is for single use and all the contents
in the pre filled syringe will be administered at once.
c) Import Deferred Cases
I. Human Cases
815. Name and address of Applicant M/s Novartis Pharma (Pakistan) Limited, 15 west Wharf Road
P.O box 100 & 7247, Karachi
Details of Drug sale License Adress: Novartis Pharma Pakistan Ltd. 15, West Wharf,
Karachi.
Name and address of M/s Hetero Labs Ltd (Unit-VI), TSIIC Formulation SEZ, S.No
manufacturer 410 & 411, Polepally Village, Jadcheria (mandal) Mahaboob
Nagar (district) Pin-509301, Telangana, India
Name and address of Marketing M/s Sandoz GmbH Biochmiestrabe 10 AT-6250 Kundi Austria.
authorization holder
Name of exporting country Austria
Brand Name+Dosage Form + CAPECITABIN SANDOZ 500mg
Composition Each Film Coated Tablet contains:
Capecitabine…..500mg
Shelf life 2 years
Fee including differential fee (Rs. 50,000/- Dated 30/09/2013) + (Rs. 50,000/- Dated
01/04/2016)
Pack size 120’s
Demanded Price Rs. 25000/- per 120’s
International Availability Capecitabine by Actavis, MHRA
Me-too status Xeloda by Roche
Detail of certificates attached Original legalized CoPP (certificate No.9935122) issued by
Bundesamt fur Sicherheit im Gesundheitswesen, Austria on
13/04/2017 confirms the free sale of the product in exporting
country. Copy of GMP certificate GMP certificate
product is available in USP and BP.
 GMP certificate provided by the firm could not be
traced from the official site. The GMP status of the
manufacturing site from Unit I to Unit V has been verified.
However the applied product is being manufactured in Unit VI.
Decision: Registration Board deferred the case for valid GMP certificate of Unit-VI of the
manufacturing site as web data does not support document submitted by the firm.
Fresh Evaluation:
The firm has submitted following documents:
 Notarized copy of GMP certificate issued by Norwegian Medicines Agency of Unit VI of
M/s Heterolabs Limited.
 Legalzied (embassy attested) Copy of GMP certificate issued by Licensing & controlling
Authority, Drugs Control Administration, Government of Telangana, India.
Decision: The Registration Board deferred the case for valid GMP certificate of Unit-VI of the
manufacturing site from Drug Control Administration, India.
816. Name and address of Applicant M/s The Searle Company Limited, 1st floor, N.I.C.L building
Abbasi Shaheed Road, Karachi
Detail of Drug Sale License Address: The Searl company Ltd, F-319, S.I.T.E., Karachi
Name and address of M/s Reyoung Pharmaceutical Co., Ltd., No.6 Erlangshan Road,
manufacturer Yiyuan County, Shandong Province, China
Name & address of Marketing M/s Reyoung Pharmaceutical Co., Ltd., No.6 Erlangshan Road,
authorization holder Yiyuan County, Shandong Province, China
Exporting country China
Brand Name+Dosage Form + EZIUM INJECTION 40mg (IV injection)
Strength Dry powder Injection (Lyophilized)
Composition Each ml after reconstitution contains:
Esomeprazole Sodium….. 42.6mg (Eq. to 40mg Esomeprazole)
Pharmacological Group Proton Pump inhibitor
Shelf life 3 years
Fee including differential fee Rs. 100,000/- Dated31/03/2015
Pack size 1’s
Demanded Price As per DPC
International Availability Esomeprazole injection by Sun Pharmaceutical Industries,
MHRA
Me-too status Esasia injection by Med asia Pharmaceuticals
Detail of certificates attached Original legalized CoPP (certificate NO. 201706001) issued by
Yiyuan Food and Drug Administration China on 02/06/2017
confirms free sale of the product in exporting country. The
facilities and operations conform to GMP as recommended by
WHO.
Remarks of the Evaluator.  The product will be imported in the form of Bulk
Labeled Vial and then the applicant will add registered solvent
(0.9% Sodium chloride) and repack it in finished form. The
solvent will be purchased from local market.
 The firm has claimed In House manufacturing
specifications and the product is not present in USP/BP.
Decision: Deferred in 272nd meeting of Registration Board for following:
 Evidence of facility of repacking where bulk vials will be re-packed with solvent into finished
form.
 Address of applicant and address mentioned on DSL are different.
Evaluation by PEC:
The firm has stated that the Re-Packing activity would be performed in the GMP compliant facility
located at F-319, S.I.T.E., Sindh industrial trading estate, Karachi.
The DML of the firm has been renewed on 31/03/2015, (License No No000016).
Decision of 274th meeting: Registration Board deferred for confirmation of quality control release
of product after packing.
Fresh Evaluation: The firm has stated that the product in the form of bulk finished seal vials from
China, where all tests according to certificate of analysis will be performed in QC lab of
manufacturer. After that the physical testing of the product in the quality control lab of GMP
compliant facility t F-319, S.I.T.E Sindh industrial estate Karachi and will reconfirm critical
parameters prior to repack.
Decision of 276th meeting: Registration Board deferred the case for clarification for final quality
control release after secondary repacking with diluent.
Fresh Evaluation:
1. The firm has submitted letter of authorization stating that M/s Seale Company Limited will
import bulk labelled vials from M/s Reyoung Pharmaceutical Co., Ltd., and will add solvent in
their own facility, repack and release the final product.
2. The firm has elaborated complete details of import , re-packing & batch release of finished
product
Step # 1: Bulk labeled vials of Esomeprazole injection will be imported from M/s Reyoung
Pharmaceutical Co., Ltd. China
Step # 2: Purchase of registered solvent (0.9% Sodium Chloride)
Step # 3: Complete testing will be performed on the vials of esomeprazole and solvent.
Step # 4: Bulk labeled vials of Esomperazole injection and solvent will be re-packed in final
unit dose carton. This re-packing activity will be performed in GMP compliant facility located
at F-319, S.I.T.E, Karachi
Step #5 QC release & batch release of the final dosage form will be done by the Searle
Company limited.
Decision: Approved as per Imort Policy for Finished Pharmaceutuical Products. Labelled
vials will be imported and packed alongwith diluent and for final quality control release at
M/s Searle F-319, S.I.T.E, Karachi.
817. Name and address of Applicant M/s The Searle Company Limited, 1st floor, N.I.C.L building
Abbasi Shaheed Road, Karachi
Detail of Drug Sale License Address: The Searle company limited, F-319, S.I.T.E.,
Karachi
Name and address of manufacturer Manufacturer of vials:
M/s Biolab co., Ltd., 625 SOI 7A Bangpoo Industrial Estate,
Sukhumvit Road, Moo, PRAKASA, Muhang, Samutparakarn
10280, Thailand
Repacking and addition of solvent:
The Searle Company Limited, F-319, S.I.T.E, Karachi
Name and address of marketing M/s Biolab co., Ltd., 625 SOI 7A Bangpoo Industrial Estate,
authorization holder Sukhumvit Road, Moo , PRAKASA, Muhang,
Samutparakarn 10280, Thailand
Name of exporting country Thailand
Brand Name +Dosage Form + MEROMAX Injection IV 1g
Strength (Powder for solution for injection)
Meropenem (as trihydrate)………… 1g
Pharmacological Group Antibiotic (carbapenem)
Shelf life 36 mojths
Demanded Price As per DPC
Pack size A pack of 01 vial and 2 sterile water for injection ampoules of
10ml
International availability Meronem IV powder for solution for injection (500mg &
1gm) By M/s AstraZeneca UK Ltd, MHRA Approved (As
trihydrate)
Me-too status Xepime powder for solution for injection (500mg & 1gm) by
M/s Macter International (Reg # 055844)
Detail of certificates attached Original legalized CoPP (certificate No. 4-2-10-03-16-00273)
certified by Bureau of Drug Control, Food and Drug
Administration, Ministry of Public Health, Thailand issue don
country, The facilities and operations conform to WHO-
GMP.
Remarks of the Evaluator. The Searle company limited, F-319, S.I.T.E., Karachi, will be
responsible for Complete testing and QC release of the
product.
Decision: Registration board deferred the case for deliberation regarding the Complete
Testing and QC release of the product after repacking. The Board advised the firm to submit
the auhtoirty letter from the manufacturer mentioning the details of the ampoules to be
imported for repacking.
Fresh Evaluation:
1. The firm has submitted letter of authorization stating that M/s Seale Company Limited will
import bulk labelled vials from M/s Biolab Co. Ltd. Thailand, and will add solvent in their
own facility, repack and release the final product.
2. The firm has elaborated complete details of import , re-packing & batch release of finished
product
Step # 1: Bulk labeled vials of Meropenem injection will be imported from M/s Biolab Co.
Ltd. Thailand
Step # 2: Purchase of registered solvent (Sterile water for injection 2 ampoules of 10ml)
Step # 3: Complete testing will be performed on the vials of esomeprazole and solvent.
Step # 4: Bulk labeled vials of Meropenem injection and solvent will be re-packed in final
unit dose carton. This re-packing activity will be performed in GMP compliant facility
located at F-319, S.I.T.E, Karachi
Step #5 QC release & batch release of the final dosage form will be done by the Searle
Company limited.
Decision: Approved as per Imort Policy for Finished Pharmaceutuical Products. Labelled
vials will be imported and packed alongwith diluent and for final quality control release at
M/s Searle F-319, S.I.T.E, Karachi.
818. Name and address of Applicant M/s Pharmatec Pakistan Pvt Ltd. D-86/A. Manghopir Road,
SITE, Karachi, Pakistan
Detail of Drug Sale License Address: M/s Pharmatec Pakistan Pvt Ltd. D-86/A. Manghopir
Road, SITE, Karachi, Pakistan
Status: Drug sale license by the way of whole sale
Name and address of M/s A.Menarini Manfacturing Logistics and Services S.R.L.-
manufacturer Via Sette Santi, 3-50131 Firenze-Italy
Name and address of marketing M/s A. Menarini Industrie Farmacetuiche Riunite S.R.L. Via
authorization holder Sette Santi, 3-50131 Firenze-Italy
Brand Name +Dosage Form + FASTUM 2.5% Topical Gel
Strength
Ketoprofen……2.5gm
Pharmacological Group Non-steroid anti-inflammatroy drug
Demanded Price Rs. 600/- for 50gm tube
Pack size 1×1’s
International availability Ketoprofen 2.5% w/w Gel by M/s Pinewood Laboratories
Limited, MHRA approved
Me-too status Toprofin 2.5% gel by M/s Ciba Pharmaceuticals (Reg #
081511)
Detail of certificates attached  Original legalized CoPP (Certificate No. N
CPP/2014/2780) certified by AIFA, Italy on 16/12/2014
confirms that the product is authorized to be marketed and
sold in Italy. The Manufacturing plants where the medicinal
products (to be marketed in Italy) are manufactured are
inspected periodically in order to verify the compliance
with the principles and guidelines of GMP and quality
control recommendation by WHO and commission
directive N 2003/94/EC.
Remarks of the Evaluator.  The firm has claimed in House manufacturing
specifications while the product is present in BP.`
 Address of marketing authorization holder in Sole agency
agreement is different from the address mentioned in
CoPP, Clarification is required with documented evidence.
 CoPP describes the pack size as 50gm tube while the in
registration application another pack size of 100gm is
mentioned.
 Most of the part of CoPP is in Italian language and the firm
has submitted copy of translation.
Decision of 274th meeting:
Deferred for the following reasons;
 Address of marketing authorization holder in Sole agency agreement is different from the
address mentioned in CoPP, Clarification is required with documented evidence.
 CoPP describes the pack size as 50gm tube while the in registration application another
pack size of 100gm is mentioned.
 Translation of CoPP (in original).
Fresh Evaluation:
The firm has claimed in House manufacturing specifications while the product is present in BP.
However the stability testing has been performed according to In House standards and In House
specifications are more stringent than the B.P specifications.
The firm has provided following documents;

 A clarification letter from the principal stating that A.Menarini Manfacturing Logistics and
Services S.R.L. was acquired by Menarini Group in 2006.
 The firm has requested for grant of registration for 50g tube as per CoPP.
 Translated copy of CoPP endorsed by department of translation and interpretation,
NUML.
819. Name and address of Applicant M/s Graton Pharma, Office # 102, First Floor, The Plaza, block-
9 Clifton, Karachi.
Detail of Drug Sale License Address: Graton Pharma, Suit No.102 A, the plaza Block-9
Clifton, Karachi.
Status: Drug license by the way of wholesale
Name and address of M/s Jewim Pharmaceutical (shandong) Co., Ltd., Chuangye
manufacturer street Taian Hi-Tech Industrial Development Zone. Shandong,
China
Name and address of marketing M/s Jewim Pharmaceutical (shandong) Co., Ltd., Chuangye
authorization holder street Taian Hi-Tech Industrial Development Zone. Shandong,
China
Fee including differential fee Rs.50,000/- dt:15/8/2016 + 50,000/- dt: 19/12/2016
Brand Name +Dosage Form + MINORISE Spray 2%
Strength (solution for topical use)
Composition Each ml contains;
Minoxidil…….. 0.02g
(1.2g per 60ml of bottle)
Pharmacological Group Misc. Skin and mucous membrane agents/Potassium channel
opener (ATC code: D11AX01)
Demanded Price As per Policy
Pack size 1’s (1.2g/60ml with spray applicator)
International availability APO-GAIN LIQ 20MG/ML By M/s APOTEX INC (Health
Canada Approved)
Me-too status Hair max 2% by M/s Sante pharma (Reg # 020254)
Detail of certificates attached  Originallegalized CoPP (certificate No. 20160009(cpp))
certified by Shandong Food and Drug Administration, China
valid till 18/12/2016 confirms the free sale of the product in
GMP as recommended by WHO.
product is present in USP and BP.`
Deferred for the submission of Legalized and Valid CoPP.
Fresh Evaluation:
The firm has submitted original, legalized and valid CoPP (certificate No. 2017004) issued by
Shandong Food and Drug Administration, China on 15/03/2017 confirms the free sale of the
product in exporting country. The facilities and operations conform to WHO-GMP.
9 Clifton, Karachi.
Detail of Drug Sale License Address: Graton Pharma, suit no. 102 A the plaza Block-9
Clifton, Karachi.
Name and address of M/s Jewim Pharmaceutical (shandong) Co., Ltd., Chuangye
manufacturer street Taian Hi-Tech Industrial Development Zone. Shandong,
China
Name and address of marketing M/s Jewim Pharmaceutical (shandong) Co., Ltd., Chuangye
authorization holder street Taian Hi-Tech Industrial Development Zone. Shandong,
China
Fee including differential fee Rs. (50,000/- Dated 15/08/2016 + 50,000/- Dated 19/12/2016)
Brand Name +Dosage Form + MINORISE Spray 5%
Strength (solution for topical use)
Composition Each ml contains;
Minoxidil…….. 0.05g
(3g per 60ml bottle)
Pharmacological Group MISC. SKIN AND MUCOUS MEMBRANE
AGENTS/Potassium channel opener (ATC code: D11AX01)
Pack size 1’s (3g/60ml with spray applicator)
International availability Regain 5% solution by M/s McNeil Products Limited (MHRA
Approved)
Me-too status Hair max 5% by M/s Sante pharma (Reg # 027592)
Detail of certificates attached  Originallegalized CoPP (certificate No. 20160011 (cpp))
certified by Shandong Food and Drug Administration, China
valid till 18/12/2016 confirms the free sale of the product in
GMP as recommended by WHO.
product is present in USP and BP.
Deferred for the submission of Legalized and Valid CoPP.
Fresh Evaluation:
The firm has submitted original, legalized and valid CoPP (certificate No. 2017005) issued by
Shandong Food and Drug Administration, China on 15/03/2017 confirms the free sale of the
product in exporting country. The facilities and operations conform to WHO-GMP.
821. Name and address of Applicant M/s Graton Pharma Office # 102, First Floor, The Plaza, block-
9 Clifton, Karachi.
Detail of Drug Sale License Address: Graton Pharma, suit no. 102 A, the plaza Block-9
Clifton, Karachi.
Name and address of M/s Jewim Pharmaceutical (shandong) Co., Ltd., west of
manufacturer Peitianmen street Taian Hi-Tech Industrial Development Zone.
Shandong, China
Name and address of marketing M/s Jewim Pharmaceutical (shandong) Co., Ltd., west of
authorization holder Peitianmen street Taian Hi-Tech Industrial Development Zone.
Shandong, China
Brand Name +Dosage Form + GRAFIN Dermal Spray 1% (0.01g/ml)
Strength (for topical use only)
Terbinafine hydrochloride………. 0.01g
Pharmacological Group Anti fungal
Pack size 1’s (0.3g/30ml spray pump)
International availability Lamisil® AT 1% Spray by M/s GSK UK (MHRA Approved)
Me-too status Lamisil spray by M/s Sandoz (Reg # 021173)
Detail of certificates attached  Originallegalized CoPP (certificate No. 2015-13) certified by
Shandong Food and Drug Administration, China valid till
country. The facilities and operations conform to GMP as
recommended by WHO.
product is present in JP.
Deferred for the submission of valid and legalized CoPP.
Fresh Evaluation:
The firm has submitted original, legalized and valid CoPP (certificate No. SD20170059) issued by
Shandong Food and Drug Administration, China on Nov, 2017 confirms the free sale of the product
in exporting country. The facilities and operations conform to WHO-GMP.
9 Clifton, Karachi.
Detail of Drug Sale License Address: Graton Pharma, suit no. 102 A the plaza Block-9
Clifton, Karachi.
Name and address of M/s Jewim Pharmaceutical (shandong) Co., Ltd., Taian Hi-Tech
manufacturer Industrial Development Zone. Shandong, China
Name and address of marketing M/s Jewim Pharmaceutical (shandong) Co., Ltd., Taian Hi-Tech
authorization holder Industrial Development Zone. Shandong, China
Brand Name+Dosage Form BECLOTRON Nasal Spray 50mcg/dose
+Strength
Composition Each dose contains:
Beclometasone dipropionate (Anhydrous)…… 50mcg
Finished Product Specification B.P.
Pharmacological Group Synthetic halogenated glucocorticoid/ antiasthmatic
Pack size 1’s (200 doses)
International availability ClenilR ModuliteR 50 micrograms per actuation pressurised
inhalation solution by M/s Chiesi Limited (MHRA Approved)
Me-too status Gnadian Nasal spray by M/s Mehran traders (Reg # 016826)
Detail of certificates attached  Originallegalized CoPP (certificate No. 2015-09) certified by
Shandong Food and Drug Administration, China valid till
country. The facilities and operations conform to GMP as
recommended by WHO.
Remarks of the Evaluator. CoPP is expired but it was valid at the time of submission of
dossier.
Deferred for the submission of legalized and valid CoPP.
Fresh Evaluation:
The firm has submitted original, legalized and valid CoPP (certificate No. SD20170060) issued by
Shandong Food and Drug Administration, China on Nov, 2017 confirms the free sale of the product
in exporting country. The facilities and operations conform to WHO-GMP.
Karachi.
Karachi.
Name and address of M/s Glaxosmithkline manufacturing S.p.A, Starda provincial
manufacturer Asolana, 90, 43056 San polo di Torrile, Parma, Italy.
Name and address of marketing M/s Novartis Europharm Limited, Frimley Bussiness Park,
authorization holder camberley GU166 7SR, United Kingdom
Brand Name +Dosage Form + MEKINIST tablet 2mg
Trametinib (as dimethyl sulfoxide)……… 2mg
Demanded Price Rs. 164,888.00/- per 7 FC tablets
Rs. 706,667.00/- per 30 FC tablets
Rs. 23,555.56/- per tablet
Pack size 7’s & 30’s
International availability Mekinist film coated tablet (0.5mg & 2mg) By M/s Novartis,
USFDA Approved.
Me-too status New Molecule
Detail of certificates attached Original legalized CoPP (certificate No. 04/15/91219) certified
by EMA issued on 21/08/2015 confirms that the facilities and
operations conform to GMP as recommended by WHO.
The CoPP describes 03 strengths of tablets that is 0.5mg, 1mg
and 2mg.
 The product is not available for free sale in exporting region. However, the same product is
approved by USFDA.
 The firm has claimed in House manufacturing specifications and the product is not present in
USP/BP.
Description:
The product is a prescription medicine used to treat people with a type of skin cancer called
melanoma that has spread to other parts of the body or cannot be removed by surgery and that has a
certain type of abnormal “BRAF” gene (BRAF is a protein that is involved in sending the signals
for increasing the growth of the cells). The applied product should not be used to treat people who
have received a BRAF inhibitor 439 for treatment of their melanoma.
Registration Board was apprised that EMA CoPP does not confirm availability of product in the
region. Although firm has stated that product is approved by USFDA but manufacturing site could
not be confirmed. Thus the Board advised firm to provide any reference to ensure availability of
product in a reference country.
Fresh Evaluation:
The firm has submitted original, legalized and valid CoPP (certificate No. 07/17/113373) issued by
EMA on 29/09/2017 confirms the free sale of the product in exporting country. The facilities and
The CoPP describes 02 strengths of Mekinist film coated tablets i.e 0.5mg and 2mg.
Karachi.
Karachi.
Name and address of M/s Glaxosmithkline manufacturing S.p.A, Starda provincial
manufacturer Asolana, 90, 43056 San polo di Torrile, Parma, Italy.
Name and address of marketing M/s Novartis Europharm Limited, Frimley Bussiness Park,
authorization holder camberley GU166 7SR, United Kingdom
Brand Name +Dosage Form + MEKINIST tablet 0.5mg
Trametinib (as dimethyl sulfoxide )……… 0.5mg
Demanded Price Rs. 53515.70/- per 7 FC tablets
Rs. 229,353.00/- per 30 FC tablets
Rs. 7,645.00/- per tablet
Pack size 7’s & 30’s
International availability Mekinist film coated tablet (0.5mg & 2mg) By M/s Novartis,
USFDA Approved.
Me-too status New Molecule
Detail of certificates attached Original legalized CoPP (certificate No. 04/15/91219) certified
by EMA issued on 21/08/2015 confirms that the facilities and
The CoPP describes 03 strengths of tablets that is 0.5mg, 1mg
and 2mg.
 The product is not available for free sale in exporting region. However the same product is
approved by USFDA.
 The firm has claimed In House manufacture ng specifications and the product is no tpresent in
USP/BP.
Description:
The product is a prescription medicine used to treat people with a type of skin cancer called
melanoma that has spread to other parts of the body or cannot be removed by surgery and that has a
certain type of abnormal “BRAF” gene (BRAF is a protein that is involved in sending the signals
for increasing the growth of the cells). The applied product should not be used to treat people who
have received a BRAF inhibitor 439 for treatment of their melanoma.
Registration Board was apprised that EMA CoPP does not confirm availability of product in the
region. Although firm has stated that product is approved by USFDA but manufacturing site could
not be confirmed. Thus the Board advised firm to provide any reference to ensure availability of
product in a reference country.
Fresh Evaluation:
The firm has submitted original, legalized and valid CoPP (certificate No. 07/17/113373) issued by
EMA on 29/09/2017 confirms the free sale of the product in exporting country. The facilities and
The CoPP describes 02 strengths of Mekinist film coated tablets i.e 0.5mg and 2mg.
II. Veterinary
Evaluator PEC-X
825. Name and address of Applicant M/s Forward Solutions, 67 west wood society, Main canal
Road, Lahore
Detail of Drug Sale License Address: M/s Genome Pharma, House No. 593-B, Street No.
10, Chaklala Scheme-III, Rawalpindi
Name and address of M/s Indutrial Veterinaria S.A., Esmeralda 19 08950 Esplugues
manufacturer De Llobregat Barcelona, Spain
Name and address of marketing M/s Indutrial Veterinaria S.A., Esmeralda 19 08950 Esplugues
authorization holder De Llobregat Barcelona, Spain
Name of exporting country Spain
Diary No. & Date of R& I 14-06-2011vide diary # 121 R&I,
Fee including differential fee Rs.15000/ & 26-05-2014 vide diary # 488 R&I,
Rs.85,000.26/05/2014
Brand Name +Dosage Form + DOXINYL Oral Solution 100mg/ml
Strength To be used with drinking water
Doxycycline (as hyclate)…….. 100mg
Target Species Poultry
Demanded Price Rs. 5000/-
Pack size 1 litre and 5 litre
International availability Available in Spain as per Free Sale Certificate
Detail of certificates attached  Free sale certificate certified by Agenicia Espanola
Medicamentos Y Productos Sanitarios, Spain on 09/12/2016
confirms the free sale of the product in exporting country. It
also confirms the GMP status of the manufacturing facility.
 Copy of GMP certificate issued by Agencia Espanola
Medicamentos Y Productos Sanitarios, Spain on 20/04/2017
Decision:
Registration Board in 255th meeting deferred the case for the following reasons,
1.Sole agency agreement is not attached.
2. Address at serial no. 1of form 5A is not provided.
3. Free sale is issued on 16-07-2009, in Madrid and legalized by the Arif Khan Attache Consular
Affairs, Embassy of Pakistan, Madrid dated 27-07-2009.
4. GMP issued 0n 11-10-2012 and is valid up to 17-07-2015 legalized by Imran Haider on 24-03-
2014 by the
Embassy of Pakistan in Madrid.
5. The firm has provided the stability data at following conditions:-
i. Conducted at 25±2 temperature with 60±5% Relative humidity for the period of 36 months there
is a variation of more than 5% .
ii. conducted at 30±2 temperature with 60±5% relative humidity for the period of 09 months there
is a variation of more than 5%.
iii. conducted at 40±2 temperature with 75±5% relative humidity for the period of 03 months there
is a variation of more than 5%.
iv. The firm in the conclusions have mentioned that the results showed a chemical
instability of the medicinal product when it was stored at 30ºC during 9 month as well as a
physical & chemical linstability when it was kept at 40ºC during 3 months and claimed that the
product is stable if it is stored in its original package at a temperature not above 25ºC.
6. Furthermore firm has not submitted the stability studies for real time storage conditions i.e
conducted at 30ºC ±2 temperature and 65±5% RH.
7. Batch sizes are 1900 Liters for all the three batches V-017, V-025 & V-074.
Fresh Evaluation:
The firm has provided following documents;
 Original Legalized free sale certificate issued by Agencia espanola de madicomentos y
productos sanitorios department de medicomentos Veterinarios, Spain on 24th November,
2016.
 Letter of authorization of authorization
 GMP certificate issued by Agencia espanola de madicomentos y productos sanitorios on
20/02/2017.
 Form 5-A with correct address of manufacturer.
826. Name and address of Applicant M/s Huzaifa International, Commercial area, Aziz Bhatti,
Town Sargodha Pakistan.
Detail of Drug Sale License Address: Huzaifa International, A-E Commercial Area Aziz
Bhatti Ton Sargodha
Status: License to sell drugs in pharmacy
Name and address of M/s KOMIPHARM International Co. Ltd., 17, Gyeongje-RO,
manufacturer Siheung-SI, Gyeonggi-DO, The Republic of Korea.
Name and address of marketing M/s KOMIPHARM International Co. Ltd., 17, Gyeongje-RO,
authorization holder Siheung-SI, Gyeonggi-DO, The Republic of Korea.
Name of exporting country Korea
Brand Name +Dosage Form + FLOSTAR Solution 10%
Strength (Oral Solution)
Composition Each 1 litre contains:
Florfenicol……. 100 g
Target species (For poultry)
Pharmacological Group Phenicols antibiotics
Shelf life 3 years
Demanded Price Decontrolled
Pack size Pack of 100ml, 500ml, 1 litre, 5 litre, 10 litre
International availability Nefincol 100mg/ml oral solution by M/s Vetpharma Animal
Health, S.L., Netherlands Approved
Me-too status Naflor oral solution 100mg/ml by M/s Nawan Pharaceuticals
(Reg # 049514)
Detail of certificates attached  Original legalized free sale certificate certified by
Animal and Plant Quarantine Agency of the Ministry for
Agriculture food and Rural affairs, Korea.
 GMP certificate
Remarks of the Evaluator.  The firm has claimed for In House manufacturing
specifications and the product is not present in BP/USP.
Decision: The Registration Board in 274th deferred the case for the submission of original
legalized and valid free sale certificate confirming the free sale status of the applied product in the
exporting country.
Fresh Evaluation:
The free sale certificate submitted by the firm confirms the free sale of the product in Republic of
Korea. The certificate is issued by Animal and plant Quarantine Agency of Ministry for
Agriculture food and rural Affairs, Korea on 11/09/2015.
827. Name and address of Applicant M/s Eli Lilly Pakistan (Private) Limited 5-A, 5th floor, Al-
Tijarah Centre, 32-1-A, Block 6, PECHs, Main Shahra-e-
Faisal, Karachi.
Detail of Drug Sale License Address: Eli lilly Pakistan (PVT) LTD. 5-A, 5th floor 10th
building floor, Al-Tijarah centre 32-1-A Block 6 PECHS
Karachi
Status: Drug license by way of whole sale
Name and address of M/s Elanco Animal Health, a division of Eli Lilly and
manufacturer Company, 10500 S. state Road 63, Clinton, Indiana (IN)
47842, United States (USA)
Name and address of marketing M/s Elanco Animal Health, a division of Eli Lilly and
authorization holder Company, 2500 Innovation way, Greenfield, Indiana 46140
Name of exporting country USA
Brand Name +Dosage Form + RUMENSIN 200 Medicated Feed
Strength (for Cattles/dairy cows)
Composition Each kg contains:
Monensin (as sodium)…… 200 g
Pharmacological Group Anticoccidial and usereducesd severity of ketosis syndrome
Shelf life 2 years
Pack size 25 kg pack
International availability Rumensin™ 90 by M/s Elanco US INC., USFDA Approved
Me-too status Elancoban 200kg premix by M/s Eastern Agencies (Reg #
013729)
Detail of certificates attached Original legalized CoPP (certificate No. V2015-1014) certified
by USFDA valid till 28/07/2017 confirms the free sale of the
conform to GMP as recommended by WHO as per CoPP.
Decision: Deferred for submission of valid legalized CoPP.
Fresh Evaluation:
The firm has submitted original, legalized and valid CoPP (Certificate No. V2018-172) issued by
USFDA on 12/12/2017 which confirms the free sale of the product in exporting country. The
facilities and operations conform to GMP as recommended by WHO.
Decision: Deferred for confirmation of intended use of applied formulation.
828. Name and address of M/s Prix Pharmaceutica, 26-Abbot Road, Lahore.
Applicant
Name and address of M/s Fatro S.p.A, Via Emilia, 285-40064 Ozzano, Emilia
manufacturer (Bologna), Italy.
Name and address of M/s Fatro S.p.A, Via Emilia, 285-40064 Ozzano, Emilia
Product license holder (Bologna), Italy.
Exporting country Italy
Brand Name+Dosage Form Tirsan 200 Oral Solution
+ Strength
Composition Each ml contains:-
Thiamphenicol…….……200mg
Pharmacological Group Antimicrobial agent for systemic use
Finished product
Manufacturer’s Specifications.
Specification
Shelf Life 2years
Fee including differential fee Rs. 50,000/-
Pack size Bottle of 1 1iter, 5 liter, 10 liter
International Availability Tirsan 200 oral solution, Mexico;
Tirsan 200, Italy
Me-too status Cannot be confirmed
Detail of certificates 1. Free sale issued dated 31-OCT-2012.
attached 2. GMP issued dated 20-02-2009.later firm has submitted 20-03-
2014.
Remarks of the Evaluator. 1. Free sale certificate describes the composition as:
“1gm contains 200mg Thiamphenicol”
2. The approval status in reference regulatory authorities and
Pakistan cannot be confirmed.
Previous Decision:
Registration Board in its 259th Meeting held on 30-31st May, 2016 deferred the case for expert
opinion, toxicity data and stability requirements of Head pharmacology, UVAS, Arid and UAF.
The comments of the experts are as under:
Prof. Dr. Muhammad Ashraf (T.I),
Professor of Emeritus,
(Department of Pharmacology and Toxicology, University of Veterinary Animal Sciences,
Lahore).
1. Thiamphenicol is an analogue chloramphenicol in which P-nitro group of

Chloramphenicol has been replaced with Methyl Sulphonyl group.
2. Thiamphenicol is a broad spectrum antibiotic having similar properties as
chloramphenicol.
3. Chloramphenicol is banned for use in veterinary practice due to association of aplastic
anemia which is not linked with thiamphenicol.
4. Thiamphenicol was introduced in veterinary practice as a replacement of
chloramphenicol.
5. Thiamphenicol toxicity profile resembles with chloramphenicol without its association to
lethal idiosyncratic aplastic anemia.
6. Chloramphenicol and thiamphenicol cause bone marrow depression leading to reversible
anemia which is time and dose depended and is reversed with the cessation of therapy.
7. Chloramphenicol also cause another type of bone marrow depression which is
idiosyncratic in nature (not dose and time depended) and is irreversible leading to lethal aplastic
anemia in human. Such type of toxicity is not associated with thiamphenicol.
8. Chloramphenicol is mainly metabolized by Liver (about 90%) while thiamphenicol is
mainly eliminated (70%) unchanged by renal excretion.
9. Tirsan 200 oral solution contains thiamphenicol 200mg/ml which has good bioavailability
and stability.
Recommendations:
Product “TIRSAN 200 ORAL SOLUTION” may be approved for therapeutic use only in
veterinary practice.
Dr. Mazhar ul Haq
Assistant Professor (Pharmacology),
(Arid Agricultural University Rawalpindi, Department of Biomedical Sciences, Faculty of
Veterinary and Animal Sciences, Rawalpindi).
1. I am interested to ask whether this product (drug; Thiamphenicol) is registered already

with the Registration Board in Pakistan?
2. In order to review the toxicity and stability of the formulation, the information of the
product with the pharmaceutics detail (e.g. excipients/vehicles used) what the firm has submitted
with the application for registration, is required, please.
3. You are therefore requested to furnish the above said information to accomplish the
report, please.
Dr. Faqir Muhammad
Associate Professor,
(University of Agriculture, Faisalabad, Pakistan Institute of Pharmacy, Physiology, and
Pharmacology).
1. The product under consideration contains thiamphenicol as active ingredient with

antibacterial activity. The available international published literature on thiamphenicol’s stability
suggest a shelf life of 5 to 6 years, but no specific statements or recommendations are made by the
sponsor, other than a statement that the product is stable if stored in closed containers, and
protected from humidity and excessive heat.
2. The available literature on the toxicity of thiamphenicol particularly residues in food
animals indicated that thiamphenicol concentrations were present above the limit of quantification
(LOQ) in the plasma of cattle at 34 hours post the last dose. While in sheep, the thiamphenicol
concentrations in all body fluids declined to below the limit of detection (LOD) by 24 hours after
the cessation of doing. In chickens, by 56 hours after the completion of dosing, the birds on the
highest dose have plasma levels below the LOQ. When killed 5 days after dosing, less than 1%
thiamphenicol remained in the carcase. Results indicate that during the first 120 hours after
dosing, 92% of the administered dose was excreted in feces. Tissues containing the highest levels
were the liver, kidney and gizzard. Skeletal muscle showed low levels at six hours post dose.
3. Tissues residue depletion studies in cattle indicate that liver, lung and spleen have
appreciable concentrations for longer than other tissues, but all were below the LOQ eight
cessation of dosing. In lactating cows, on the first day after cessation after treatment mean
thiamphenicol concentrations were 764±133 µg/L, on the next day levels in six of the eight cows
were below the LOQ (20 µg/L), and on the following day levels in seven cows were below the
LOQ. All milk samples were below the LOQ on the fourth day of dosing was completed. In
chicken, seven days after the cessation of dosing, levels of thiamphenicol in the eggs from 7/15
birds where below LOQ. The following day, the drug was detected in 1 egg only and on the 9th
day after dosing ceased, no eggs were positive for thiamphenicol residues.
4. Based upon these available studies, it may be recommended for veterinary use
provided the recommended drug withdrawal times are observed strictly to avoid
objectionable residues in milk, meat or eggs. It is worth mentioning over here that above studies
are conducted and withdrawal times are established in foreign countries in their animal species.
The same drug withdrawal times might not be applicable to our local animal species because of
differences in genetics, nutrition and environment. Thus there is need to validate these drug
withdrawal in our local food animal species in order to validate drug withdrawal times for
avoiding violative residues in animal derived foods. It is therefore suggested to make this
mandatory for manufacturers/importers to get this type of studies done in Pakistan for
establishing/validating drug withdrawal times in local species of food animals.
Decision of 275th meeting: Registration Board endorsed the decision of the experts. However the
Registration Board deferred the case for the submission of:
 Original, legalized and valid Free Sales Certificate with correct composition
 Valid copy of GMP certificate
Fresh Evaluation:
The firm has submitted following documents;
 Valid copy of GMP certificate issued by Director General, Ministry of Health, on
03/04/2017.
 Original legalized CoPP (certificate No. 254/2017/C) issued by Director General, Ministry
of Health on 12/12/2017 confirms the free sale of the product in exporting country.
The applied dosage form is Oral Solution while composition describes as follows;
1 gram of product contains : Thiamphenicol 200mg

Registration Board directed to place warning of withdrawal period on label.
Case No. 08: Registration applications of drugs for which stability study data is required to
be verified
a. New cases
Evaluator PEC-II
Sr. Name & Brand Name Type of Form, International Availability / Local
No. Address of (Proprietary Name + Dosage Initial Diary & Availability
Manufacturer Form + Strength), Date, Fee
/ Applicant Composition, (including GMP Inspection Report Date &
Pharmacological Group, differential fee), Remarks
Finished Product Demanded Price /
Specification Pack size
829. M/s Barrett Hepgard Plus Form 5-D Harvoni, FDA.
Hodgson Tablet Dairy No. 5335 Harvoni, Ferozsons, Pakistan.
Pakistan (Pvt) Each film coated tablet dated 21-08-2015
Ltd. Karachi. contains:- Rs.50,000/- GMP inspection report dated 08-
Sofosbuvir……400mg 7’s,10’s,14’s,20’s 08-2017 concluding satisfactory
Ledipasvir……90mg , 28’s,30’s GMP status
(Direct-acting antiviral agent Rs.24,500/-
against the hepatitis C virus) Rs.35,000/-
(Mnf Specs) Rs.49,000/-
Rs.70,000/-
Rs.1,05,000/-
Previous Remarks:
 Stability studies not submitted.
 Last Inspection report required.
 Undertaking as per new format
Previous Decision:
Registration Board in its 260th meeting deferred for rectification of mentioned deficiencies and
submission of stability data
Evaluation by PEC:
Firm has submitted stability data, details of which is as under:
STABILITY STUDY DATA
Drug Hepgard Plus Tablet
Name of
M/s Barrett Hodgson Pakistan (Pvt) Ltd. Karachi.
Manufacturer
Manufacturer of API Sofosbuvir: M/s Nantong Chanyoo Pharmatech. Co. ltd.
Ledipasvir –Co-povidone: Bengbu BBCA Tushan Pharmaceutical Co., Ltd, Anhui
, China
API Lot No. Sofosbuvir: RD-SFB (Form VI) -201606141
Ledipasvir –Co-povidone: 160502
Description of Pack
(Container closure HDPE bottle packed in unit carton
system)
Stability Storage Real time : 30°C ± 2°C / 65% ± 5%RH
Condition Accelerated: 40°C ± 2°C / 75% ± 5%RH
Time Period Real time: 26 weeks
Accelerated: 26 weeks
Frequency Accelerated: 0,4,12,26 (Week)
Real Time: 0,4,12,26 (Week)
Batch No. EXP-T-841 PLT-T-041 PLT-T-042
Batch Size 400 tablets 800 tablets 800 tablets
Manufacturing Date 11-2016 01-2017 01-2017
Date of Initiation 11-2016 01-2017` 01-2017
No. of Batches 03
Date of Submission 24-11-2017 (Dy. No. 22108)
DOCUMENTS / DATA PROVIDED BY THE APPLICANT
Sr. Documents To Be Provided Status
No.
1. COA of API Yes
2. Approval of API by regulatory authority of Sofosbuvir: Copy of Certificate of GMP compliance
country of origin or GMP certificate of API issued to M/s Nantong Chanyoo Pharmatech by
manufacturer issued by regulatory authority of Agency for medicinal products and medical devices
country of origin. of the Republic of Solvenia. (verified from EU GMP
database)
Ledipasvir –Co-povidone: Copy of GMP certificate
issued by “Bengbu Food & Drug Administration of
the peoples Republic of China” in the name of
“Bengbu BBCA Tushan Pharmaceutical Co., Ltd,
Anhui , China”, valid upto 17-06-2018. The relevant
provincial regulatory body for issuance of GMP
certificate is “Anhui Food & Drug Administration.”
3. Protocols followed for conduction of stability
Yes
study and details of tests.
4. Data of 03 batches will be supported by
attested respective documents like Raw data sheets and lab reports have not been
chromatograms, laboratory reports, data sheets submitted with stability studies data.
etc.
5. Documents confirming import of API etc. Sofosbuvir: Copy of commercial invoice for
Sofosbuvir (Batch No. RD-SFB (Form VI) -
201606141) has been submitted. The said invoice is
attested by ADC, DRAP Karachi. The quantity of
sofosbuvir mentioned on invoice is 900gm.
Ledipasvir –Co-povidone: Copy of Form 6
(License to Import Drugs for Clinical trial
examination, Test analysis) has been submitted,
issued by ADC, Karachi, DRAP. The quantity of
Ledipasvir –Co-povidone mentioned on invoice is
405gm.
6. All provided documents will be attested
(name, sign and stamp) for ensuring Yes
authenticity of data / documents.
7. Commitment to continue real time stability
Yes
study till assigned shelf life of the product.
8. Commitment to follow Drug Specification
Yes
Rules, 1978.
REMARKS OF EVALUATOR
 The firm has submitted 26 weeks of Accelerated and Real time Stability Study Data for 03 Batches.
 The Dissolution conditions mentioned in Test method for Hepgard Plus tablet, submitted along with
stability studies data, are different from that recommended buy USFDA as detailed below:
Dissolution parameter USFDA Recommendations Hepgard Plus Test method

Dissolution medium 1.5% Polysorbate 80 in 10 mM 1.5% Tween 80 in 0.1N HCl
Potassium Phosphate Buffer with
0.0075 mg/mL Butylated
Hydroxytoluene (BHT), pH 6.0
Speed (RPMs) 75 100
Sampling time 60 45
 Above observation was communicated to firm vide letter no. F.1-1/2017/PEC-DRAP (AD PES-II)
DATED 26-12-2017, to which firm has replied as under:
“Please note it is clearly mentioned in FDA website that dissolution methods contained in FDA website
that dissolution methods contained in the FDA database are recommended methods only that are not
binding on FDA or to others. FDA also recognizes that the database contains a large amount of
material and methods and specifications that may change over time. Although composition of
dissolution media given for “Ledipasvir + Sofosbuvir Tablet” in FDA database is different but we have
also used surfactant containing dissolution media for dissolution studies.
The complete disclaimer available on USFDA website for dissolution methods database is as under:
(Ref. https://www.accessdata.fda.gov/scripts/cder/dissolution/disclaimer.cfm) accessed on 09-01-2018
“The Dissolution Methods Database has been prepared by the Division of Bioequivalence, Office of
Generic Drugs, Center for Drug Evaluation and Research, Food and Drug Administration. The
dissolution methods contained in the database are recommended methods that are not binding on FDA
or others. We will consider alternate methods when supported by appropriate data. We recognize that
the database contains a large amount of material, and methods and specifications may change over time.
We welcome comments or suggested changes to the database. We plan to revise the web site on an
ongoing basis.”
Decision: Registration Board decided to constitute the following panel for onsite investigation to
confirm genuineness/ authenticity of stability data and associated documents, import of API, quality,
specification, test analysis, facilities etc. Moreover, Registration Board also directed the firm to
perform Dissolution analysis for al three stability batches as per USFDA recommended method and
submit data before the visit of panel. The same data of dissolutionanalysis shall also be verified by the
panel.
 Dr. Rafeeq Alam Khan, Meritorious Professor (Member Registration Board)

 Dr. Saif ur Rehman Khattak, FGA, CDL, Karachi
 Mr. Affan Ali Qureshi (Assistant Director, CDL, Karachi )
Evaluator PEC-II
b. Deferred cases
Following cases were discussed in 273rd meeting of Registration Board details of which are as
under:
830. Name and address of manufacturer / M/s Hilton Pharma (Pvt.) Ltd., Karachi.
Applicant
Brand Name +Dosage Form + Strength Sitaglu Met XR 50/500 mg tablet
Diary No. Date of R& I & fee Dy. No. 1206 (06-07-2012)
Rs: 15,000 (06-07-2012), Rs: 35,000 (24-06-2014)
Sitagliptin phosphate monohydrate eq. to Sitagliptin..50 mg
Metformin hydrochloride (extended release)….500 mg
Type of Form Form 5-D
Finished Product Specification Manufacturer’s specifications.
Pack size & Demanded Price 10’s, 14’s, 20’s, 28’s / As per DPC
Approval status of product in Janumet XR –USFDA approved
Me-too status Not applicable
GMP status Last GMP Inspection of conducted on 17-10-2016 with
conclusive remarks of cGMP compliant.
Remarks of the Evaluator.  Master formulation submitted does not state quantities of
excipients.
 Manufacturing method is general outline and does not
describe stepwise process of manufacturing for applied
formulation.
 Firm has claimed manufacturer’s specifications.
 Dissolution parameters stated in finished product testing
method is not as per USFDA recommendations.
Drug Sitaglu Met XR 50/500 mg tablet
Name of Manufacturer M/s Hilton Pharma (Pvt.) Ltd., Karachi.
Sitagliptin phosphate monohydrate: M/s Ruyuan HEC Pharm Co., Ltd.,
China
Manufacturer of API
Metformin hydrochloride: M/s Abhilash Chemicals & Pharmaceuticals Pvt.
Ltd., India
Sitagliptin phosphate monohydrate: STP-RD201603101B
API Lot No.
Metformoin hydrochloride: MET/01/15050727
Description of Pack
Alu-Alu foil in printed unit carton
(Container closure system)
Accelerated: 40°C ± 2°C & 75%±5%RH
Stability Storage Condition
Real Time: 30°C ± 2°C & 65%±5%RH
Accelerated: 6 Months
Time Period
Real Time: 6 Months
Accelerated: 0,3,6 (months)
Frequency
Real Time: 0,3,6 (months)
Batch No. SIM-232601-1 SIM-230012-2 SIM-230012-3
Batch Size 3000 Tablets 3000 Tablets 3000 Tablets
Manufacturing Date 13-12-2016 14-12-2016 15-12-2016
Date of Initiation 09-01-2017 09-01-2017 09-01-2017
No. of Batches 03
Sr.
Documents To Be Provided Status
No.
1. COA of API Yes
Copy of GMP certificate issued by
Shaoguan food and Drug Administration
has been submitted for M/s Ruyuan HEC
Pharm Co., Ltd. The certificate is valid
Approval of API by regulatory authority of country upto 14-12-2017
2. of origin or GMP certificate of API manufacturer Copy of GMP certificate issued by
issued by regulatory authority of country of origin. Department of Food safety and Drugs
Control administration, Govt. of Tamil
Nadu has been submitted for M/s Abhilash
chemicals & pharmaceuticals Pvt. Ltd.
The certificate is valid upto 31-12-2018
Protocols followed for conduction of stability study
3. Yes
and details of tests.
Data of 03 batches will be supported by attested
4. respective documents like chromatograms, Yes
laboratory reports, data sheets etc.
Copy of ADC (Karachi) attested invoice
5. Documents confirming import of API etc.
provided.
All provided documents will be attested (name, sign
6. and stamp) for ensuring authenticity of data / Yes
documents.
Commitment to continue real time stability study till
7. Yes
assigned shelf life of the product.
Commitment to follow Drug Specification Rules,
8. Yes
1978.
(AD PEC-II)
i. Finished product specifications state description as Oblong biconvex coated bilayer tablet, where as
ii. Firm has submitted revised Form 5-D.
iii. Firm has submitted revised manufacturing method.
iv. Revised manufacturing method submitted for Sitaglu Met range tablets state the manufacturing of
bilayer compressed tablets where Sitagliptin core and Metformin hydrochloride core are
compressed together to form bilayer tablet. The stated method is not as per reference product where
a matrix release tablet core of Metformin hydrochloride is covered with Sitagliptin active coating to
provide immediate release of Sitagliptin.
v. Firm has submitted revised finished product testing method along with stability studies data.
vi. Dissolution parameters stated in finished product testing method, submitted along with stability
studies data are not as per recommended by USFDA.
Decision: Registration Board deliberated the case and decided to call firm’s representative in next
Board meeting for clarification/justification of following points:
i. In contrary to approved by the reference agencies/authorities wherein the innovator’s
product contains a matrix release tablet core of Metformin hydrochloride is covered with
Sitagliptin active coating to provide immediate release of Sitagliptin, while firm has
manufactured bilayer compressed tablets where Sitagliptin core and Metformin
hydrochloride core are compressed together to form bilayer tablet.
ii. Dissolution parameters stated in finished product testing method, submitted along with
stability studies data are not as per recommended by USFDA.
Applicant
Rs: 15,000 (06-07-2012), Rs: 35,000 (24-06-2014)
Sitagliptin phosphate monohydrate eq. to Sitagliptin
…………….100 mg
Pack size & Demanded Price 10’s, 14’s, 20’s, 28’s

As per DPC
excipients.
formulation.
Sitagliptin phosphate monohydrate: M/s Ruyuan HEC Pharm Co., Ltd.,
China
Manufacturer of API
Metformin hydrochloride: M/s Abhilash Chemicals & Pharmaceuticals Pvt.
Ltd., India
API Lot No.
Description of Pack
Stability Storage Accelerated: 40°C ± 2°C & 75%±5%RH
Condition Real Time: 30°C ± 2°C & 65%±5%RH
Time Period Accelerated: 6 Months
Real Time: 6 Months
Frequency
No. of Batches 03
Sr.
No.
1. COA of API Yes
upto 14-12-2017
Approval of API by regulatory authority of country of
2. origin or GMP certificate of API manufacturer issued
Department of Food safety and Drugs
by regulatory authority of country of origin.
Nadu has been submitted for M/s
Abhilash chemicals & pharmaceuticals
Pvt. Ltd. The certificate is valid upto 31-
12-2018
Protocols followed for conduction of stability study
3. Yes
and details of tests.
4. respective documents like chromatograms, laboratory Yes
reports, data sheets etc.
provided.
All provided documents will be attested (name, sign
6. and stamp) for ensuring authenticity of data / Yes
documents.
7. Yes
Commitment to follow Drug Specification Rules,
8. Yes
1978.
(AD PEC-II)
i. In contrary to approved by the reference agencies/authorities wherein the innovator’s product
contains a matrix release tablet core of Metformin hydrochloride is covered with Sitagliptin
active coating to provide immediate release of Sitagliptin, while firm has manufactured bilayer
compressed tablets where Sitagliptin core and Metformin hydrochloride core are compressed
together to form bilayer tablet.
stability studies data are not as per recommended by USFDA
Applicant
Rs: 15,000 (06-07-2012), Rs: 35,000 (24-06-2014)
Sitagliptin phosphate monohydrate eq. to Sitagliptin..50mg
Pack size & Demanded Price 10’s, 14’s, 20’s, 28’s / As per DPC
excipients.
formulation.
Sitagliptin phosphate monohydrate: M/s Ruyuan HEC Pharm Co., Ltd., China
Manufacturer of API Metformin hydrochloride: M/s Abhilash Chemicals & Pharmaceuticals Pvt.
Ltd., India
API Lot No.
Description of Pack
Stability Storage Accelerated: 40°C ± 2°C & 75%±5%RH
Condition Real Time: 30°C ± 2°C & 65%±5%RH
Time Period
Real Time: 6 Months
Frequency
No. of Batches 03
Sr.
No.
1. COA of API Yes
upto 14-12-2017
Approval of API by regulatory authority of country of
2. origin or GMP certificate of API manufacturer issued by
Department of Food safety and Drugs
regulatory authority of country of origin.
Nadu has been submitted for M/s
Abhilash chemicals & pharmaceuticals
Pvt. Ltd. The certificate is valid upto 31-
12-2018
Protocols followed for conduction of stability study and
3. Yes
details of tests.
4. respective documents like chromatograms, laboratory Yes
provided.
All provided documents will be attested (name, sign and
6. Yes
stamp) for ensuring authenticity of data / documents.
7. Yes
8. Commitment to follow Drug Specification Rules, 1978. Yes
(AD PEC-II)
i. In contrary to approved by the reference agencies/authorities wherein the innovator’s
product contains a matrix release tablet core of Metformin hydrochloride is covered with
Sitagliptin active coating to provide immediate release of Sitagliptin, while firm has
manufactured bilayer compressed tablets where Sitagliptin core and Metformin
hydrochloride core are compressed together to form bilayer tablet.
stability studies data are not as per recommended by USFDA.
In this regard literature of reference product Janumet XR (approved by USFDA) is presented
below for deliberation of Board.
Reference USFDA
Decision of 273rd meeting: Mr. Tahir Nabi Mirza, Director Technical appeared before the
Board, for clarification regarding variation in manufacturing technology and
dissolution conditions from that of reference innovator product i.e. Janumet XR
(USFDA approved). The representative emphasized the bilayered manufacturing
technology used by firm gave a comparable dissolution profile to as that of
reference innovator product. He also stated that a comparative dissolution study
has been performed which concluded comparable results of applied and reference
product and can be confirmed by onsite inspection.
Registration Board deferred the case for further deliberation.
 Now the Firm has submitted Comparative dissolution study protocol & results. The details of
reference product & Sample product are as follows:
Feature Reference product Product of Hilton

Brand name JanuMet XR 100- SitagluMet XR 100-
1000mg tablet 1000mg tablet
Sitagliptin (pH 1.2) 67
Metformin (pH 1.2) 88
Similarity Sitagliptin (pH 4.5) 87
factor Metformin (pH 4.5) 89
Sitagliptin (pH 6.8) 68
Metformin (pH 6.8) 75
Decision: Registration Board advised the PEC to evaluate the case in light of guidelines
and reference literature shared by firm during, and place the case in agenda of
next Board meeting for further deliberation.
 Following cases of M/s Ferozsons Laboratories limited, were presented in 275th meeting of
Registration Board along with stability data. The details of the cases & decision of the Board
are reproduced as under:
Sr. Name & Address of Brand Name Type of Form, International Previous DRB
No. Manufacturer / (Proprietary Name + Initial Diary & Availability / Decision / Remarks
Applicant Dosage Form + Date, Fee Local (if any)
Strength), (including Availability
Composition, differential
Pharmacological fee), GMP
Group, Demanded Inspection
Finished Product Price / Pack Report Date &
Specification size Remarks
833. M/s Ferozsons Carveda XR Form-5 Coreg CR 20 The case was deferred
Laboratories Ltd, 20mg Capsule 21-06-2011 mg capsules of in 265th meeting of
P.O Ferozsons, Each capsule contains: Diary No 222. M/s Smithkline Registration Board for
Amangarh, Carvedilol Phosphate Beecham submission of
Nowshera, KPK SR Form-5D approved by stability data as per
pellets (20% w/w) eq. (20-06-2016) USFDA guidelines of 251st
to Copy of challan DRB meeting and
Carvedilol 20mg. of Rs. 15000/- verification of fee
Beta-adrenergic dated challan.
blocking drug 21-06-2011
Copy of challan
Source of pellets:- of Rs. 85000/-
M/s Alphamed Dated
formulations (Pvt.) Ltd. 27-2-2014
India
Drug Carveda XR 20mg Capsule
Name of Manufacturer M/s Ferozsons Laboratories limited, Nowshera, KPK
Manufacturer of M/s Alphamed formulations (Pvt.) Ltd. India
API/pellets
API Lot No. AF050-011
Description of Pack Extended release Carvedilol Phosphate (pellets 20% w/w) are filled in empty hard
(Container closure gelatin capsules soize#2 and such 7 capsules are packed in a blister made up of
system) unprinted aluminium foil & alu-silver film. Such two blisters packed in unit carton
Stability Storage Accelerated: 40°C ± 2°C & 75±5%RH
Condition Real Time: 30°C ± 2°C & 65±5%RH
Time Period Accelerated: 26 weeks
Real Time: 26 weeks
Frequency Accelerated: 0,1st,2nd, 3rd,4th,6th,8th, 12th,16th,20th,24th,26th (Week)
Real Time: 0,1st,2nd, 3rd,4th,6th,8th, 12th,16th,20th,24th,26th (Week)
Batch No. PD16-73A PD16-73B PD16-73C
Batch Size 2,500 capsules 2,500 capsules 2,500 capsules
No. of Batches 03
1. COAs of API Copy of COA for Carvedilol phosphate ER pellets (20%
w/w) from M/s Alphamed Formulations Pvt. Ltd has
been submitted.
2. Approval of API by regulatory authority of Copy of GMP Certificate for M/s Alphamed formulations
country of origin or GMP certificate of API (Pvt.) Ltd. India issued by DCA, Government of
manufacturer issued by regulatory authority of Telangana valid upto 13-12-2018.
country of origin.
3. Protocols followed for conduction of stability Finished product testing method has not been submitted.
4. Data of 03 batches will be supported by Yes
attested respective documents like
chromatograms, laboratory reports, data
sheets etc.
5. Documents confirming import of API etc. Copy of Form 6 for Carvediolol Phosphate Extended
release pellets 20% w/w attested by ADC (Peshawar) has
been submitted.
6. All provided documents will be attested Yes
(name, sign and stamp) for ensuring
7. Commitment to continue real time stability Yes
8. Commitment to follow Drug Specification Yes
Rules, 1978.
REMARKS OF EVALUATOR2
 The firm has provided 26 Weeks Accelerated and 26 Weeks Real Time Stability Data for 03 batches.
 Firm has also submitted data of analytical method validation & Comparative dissolution profile for applied
formulation.
 Label of reference product Coreg CR capsules states as under:
“COREG CR is available for once-a-day administration as controlled-release oral capsules containing 10,
20, 40, or 80 mg carvedilol phosphate. COREG CR hard gelatin capsules are filled with carvedilol
phosphate immediate-release and controlled-release microparticles that are drug-layered and then coated
with methacrylic acid copolymers. Inactive ingredients include crospovidone, hydrogenated castor oil,
hydrogenated vegetable oil, magnesium stearate, methacrylic acid copolymers, microcrystalline cellulose,
and povidone.”
 No such details have been provided along with stability studies data which declares that applied
formulation consists of immediate-release and controlled-release microparticles.
Decision: Registration Board deferred the case for clarification of description of product in comparison
to reference product in light of above cited observation.
834. M/s Ferozsons Carveda XR Form-5 Coreg CR 40 The case was deferred
Laboratories Ltd, 40mg Capsule 21-06-2011 mg capsules of in 265th meeting of
P.O Ferozsons, Each capsule contains:- diary No 220. M/s Smithkline Registration Board for
Amangarh, Carvedilol Phosphate Form 5-D Beecham submission of
Nowshera, KPK SR (20-06-2016) approved by stability data as per
pellets (20% w/w ) eq. Copy of challan USFDA guidelines of 251st
to of Rs. 15000/- DRB meeting and
Carvedilol ….40mg. dated verification of fee
Beta-adrenergic 21-06-2011 challan.
blocking drug Copy of challan
Source of of Rs. 85000/-
pellets:- M/s Alphamed dated
formulations (Pvt.) Ltd. 26-2-2014
India.
Rs.40 per
Capsule
API/pellets
Real Time: 26 weeks
No. of Batches 03
been submitted.
country of origin.
sheets etc.
been submitted.
Rules, 1978.
formulation.
and povidone.”
835. M/s Ferozsons Carveda XR 80mg Form-5 Coreg CR 80 The case was deferred
Laboratories Ltd. Capsule 21-06-2011 mg capsules of in 265th meeting of
P.O Ferozsons, Each capsule contains: diary No 219. M/s Smithkline Registration Board for
Nowshera, KPK SR pellets (20% w/w) (20-06-2016) approved by stability data as per
eq. to Carvedilol 80mg. Copy of challan USFDA guidelines of 251st
Beta-adrenergic of Rs. 15000/- DRB meeting and
blocking drug dated verification of fee
21-06-2011 challan.
Source of Copy of challan
pellets:- M/s Alphamed of Rs. 85000/-
formulations (Pvt.) Ltd. dated
India. 27-2-2014
Rs.79 per
capsule
API/pellets
th
| 415
Real Time: 26 weeks
No. of Batches 03
been submitted.
country of origin.
sheets etc.
been submitted.
Rules, 1978.
formulation.
and povidone.”
Decision: Registeration Board deferred the case for clarification of description of product in comparison
Sr. Name & Address Brand Name Type of Form, International Previous DRB
No. of Manufacturer (Proprietary Name + Initial Diary & Availability / Decision / Remarks
/ Applicant Dosage Form + Date, Fee Local (if any)
836. M/s Ferozsons Carveda XR 10mg Form-5 Coreg CR 10 The case was deferred
Laboratories Ltd. Capsule 21-06-2011 mg capsules of in 265th meeting of
P.O Ferozsons, Each capsule contains:- diary No 221. M/s Smithkline Registration Board for
Nowshera, KPK SR pellets (20% w/w) (20-06-2016) approved by stability data as per
eq. to Carvedilol 10mg. Copy of challan USFDA guidelines of 251st
Beta-adrenergic of Rs. 15000/- DRB meeting and
blocking drug dated21-6-2011 verification of fee
Copy of challan challan.
Source of of Rs. 85000/-
pellets:- M/s Alphamed dated27-2-2014
formulations (Pvt.) Ltd. Rs.79 per
India capsule
API/pellets
Real Time: 26 weeks
No. of Batches 03
been submitted.
country of origin.
sheets etc.
been submitted.
Rules, 1978.
formulation.
and povidone.”
Evaluation by PEC:
 Firm has submitted a note from the M/s Alphamed Formulations Pvt. Ltd. India, (supplier of Carvedilol
Phosphate SR pellets (20% w/w) ) which states as under;
“We wish to bring your kind notice that we are supplying carvediolol Phosphate ER pellets as a
mixture of immediate release and controlled release (i.e. sustained release) pellet. These pellets differ
in their dissolution profiles. Immediate release pellets start releasing the product within 30 minutes of
time and the controlled release (i.e. sustained release) pellets start releasing the product over a period
of 24 hours’ time. The design of product I s identical to the one marketed in US (Coreg CR capsules
manufactured by M/s GSK).”
 The details of composition & manufacturing process of both immediate release and controlled release
pellets have been submitted which shows that the product is made up of three types of pellets i.e.
Immediate release pellets, Enteric coating Type A pellets & Enteric coating Type B pellets.
 Final blend composition is as under:
i. Immediate release pellets = 12.5% w/w
ii. Enteric coating Type A pellets = 37.5% w/w
iii. Enteric coating Type B pellets = 50.0% w/w
Decision: Registration Board decided to constitute the following panel for onsite investigation of all the
above cited strengths of Craved XR capsules, to confirm genuineness/ authenticity of stability data and
associated documents, import of API, quality, specification, test analysis, facilities etc. Moreover
Registration Board also directed the panel to confirm that whether the firm has verified the claim of
supplier regaring different types of pellets in final boend, through any analysis or not.
 Director DTL Peshawar (Member Registration Board)
 Mr. Syed Adnan Ali Shah (Assistant Director, PE&R Islamabad)
 Mr. Farhadullah (Assistant Director E&M, DRAP Peshawar)
c. Verification of Stability Study Data
VERIFICATOIN OF GENUINENESS / AUTHENTICITY OF STABILITY DATA AND ASSOCIATED

DOCUMENTS
M/s GlaxoSmithKline Pakistan, F-268 Karachi – 01 Product
S. No Molecule Name Product Brand Name

837. Paracetamol & Phenylephrine Panadol Sinus
Investigation Date and Time: 18th January, 2018

Investigation Site: Factory premises of M/s GlaxoSmithKline Pakistan F-268.
Background:
Registration Board in its 267th Meeting decided to constitute the following panel for onsite investigation to
confirm genuineness/ authenticity of stability data and associated documents, import of API, quality,
specification, test analysis, facilities etc. of above 01 Product of M/s. GlaxoSmithKline Pakistan Limited,
Karachi.
–Chairman, Committee/Member, Reg. Board DRAP/Director DTL, Quetta

- Member Registration Board, DRAP
–Area FID
Details of Investigation as discussed in 273rd Meeting:

During the inspection it was revealed that the firm has not carried out stability study as per registration Board
protocol. The firm has carried out 6th month accelerated stability study and 6 th month real time study only. The
real time samples were withdrawn from the stability chamber without any scientific justification. The panel
could not further carried-out inspection in the present scenario as there was no justification for the panel to
proceed further due to incomplete stability study. The case is submitted for the information and further guidance
of the Board.
Decision 273rd RB Meeting: Registration Board opined the same panel for investigation to confirm genuineness /
authenticity of 6 months accelerated stability study and 6 months’ real time study data and associated
documents, import of API, quality, specification, test analysis, facilities etc.
Details of Investigation:
Sr. Description Observation by panel
No.
1. Do you have documents confirming the Firm has shown required invoices where ADC clearance
import of (Panadol Sinus) API including required.
approval from DRAP?
2. What was the rationale behind selecting There is proper vendor evaluation process being implemented
the manufacturer of API by the firm and the rationale behind the vendor selection is
vendor GMP approval by competent authority. Furthermore,
the API Phenylephrine issued by the manufacturer M/S
DIVIs laboratories limited office 7-1-77-EF/1/303 divi
towers Dharm karam road Ameerpret, Hyderabad-irm GMP
certificate has been issued by Joint director and licensing
authority drug control administration Visakhapatnam india.
Dated 8th July 2014 and total quantity of received was25 Kg,
verification of invoice is carried out by assistant drug
controller dated 28th of August 2014.
The other API Paracetamol is manufactured by Zafa Chemie
Pakistan Karachi dated 26th of August 2015. Total quantity
received 240 Kg. the GMP certificate for API Paracetamol
was not available.
The Vendor audit report of the Zafa Chemi dated 26th
November 2014 record number 235266 was available for
Paracetamol API which was carried out Global Gsk.
SOP tittle SOP Number

New material/Supplier approval and QA/GEN-F-
control for material (API, Excipient, 161/07-F
packaging component and raw material
3. Do you have documents confirming the The firm has imported reference standard and impurity
import of (Panadol Sinus) reference standard from globally centralized unit of M/S
standard and impurity standards? GlaxoSmithKline.
(Reference Standards Unit, MS GlaxoSmithKline, Harmire
road, Barnard Castle, CO.Durham, DL 12 8DT,UK.)
Dated 16th May 2014 for Phenylephrine hydrochloride, dated
22nd Jan 2013 for Paracetamol dated 20th Sept 2013.
4. Do you have certificate of Analysis of The firm has certificates of analysis for API, reference
the API, reference standards and standards & impurity standards.
impurity standards?
5. Do you have GMP certificate of API Firm has provided copy of GMP certificate issued by
manufacturer issued by regulatory Government of ANDHRA PRADESH, DRUG Control
authority of country of origin? Administration, Office of the joint director licencing and
approving authority, Visakhapatnam region, Visakhapatnam
region-53003 for Phenylephrine and Government of Pakistan
Drug regulatory authority of Pakistan Ministry of national
health services, regulation and co-ordination second floor
building No4 block B S.M.C.H.S, Karachi for Paracetamol.
6. Do you have API, manufacturer method The API manufacturer for Phenylephrine hydrochloride used
of testing for testing API? USP method of testing, which include testing of API,
reference standard and impurity.
The API manufacturer for Paracetamol used BP method for
testing, it is further to clear that API manufacturer used BP
method for Assay Analysis which is titration method
however the firm (Gsk) used Isocratic HPLC method for
Assay testing of Paracetamol, furthermore the related
impurities for paracetamol were carried out by using BP
method.
7. Do have stability studies reports on The stability reports of the APIs manufacturer were available.
API?
8. If Yes, Weather the stability testing has The manufacturer of APIs has performed the stability testing
ben performed as per SIM method and method of APIs as per SIM method and degradation products
degradation product have been have been quantified by the APIs manufacturer.
quantified?
9. Do you have method for quantifying the The APIs manufacturer has method for quantifying the
impurities in the API? impurities in the API.
10. Do you have some remaining quantities The firm has some remaining quantities of reference
of the API its reference standard and standard, API and impurity standard.
impurity standard?
11. Have you used Pharmaceutical grade The firm has used the following Pharmaceutical grade
excipients? excipients in manufacturing:
Maize starch dry mix
Povidone K25
Potassium Sorbate
Sodium lauryl sulphate
Microcrystalline cellulose PH102
Stearic acid
Pre-gelatinize starch.
12. Do you have documents confirming the The firm has necessary documents confirming the import of
import of the used excipients? excipients however few of the excipient were purchased
locally from the Approved vendor.
13. Do you have test reports and other The firm has testing reports for all excipients used in the
records on the excipients used? manufacture of the product.
14. Do you have written & authorized The firm has written and authorized protocols for the
protocols for the development of development of Panadol Sinus.
Panadol Sinus?
15. Have you performed Drug-excipient The firm has not performed drug-excipient compatibility
compatibility studies? studies because already the product is manufactured globally
by Gsk Australia.
16. Have you performed comparative The firm has not performed comparative dissolution studies
dissolution studies? because already the product is manufactured globally by Gsk
Australia.
The product is non-pharmacopeial and it is manufactured by
using Gsk Specs.
17. Do you have product development (R & The firm has not established R & D section however,
D section)? manufacturing area and quality control area were used for the
manufacturing and testing of Panadol Sinus.
18. Do you have necessary equipment The firm has necessary equipment’s for the manufacturing of
available in manufacturing section for Panadol Sinus.
Panadol Sinus?
19. Are the equipment in Manufacturing The equipment’s in the manufacturing area were qualified.
section qualified?
20. Do you have proper The firm has proper maintenance/calibration/requalification
maintenance/calibration/requalification program for the equipment used in manufacturing and quality
program for the equipment used in control area.
manufacturing section?
21. Do you have qualified staff in product As the firm, has not established product development section
development section with proper however the product is developed globally by Gsk Australia.
knowledge and training in product
development?
22. Have you manufactured 3 stability The firm has manufactured 3 stability batches.
batches for the stability studies of Batch No. Mfg. Date Quantity
(Panadol Sinus)? PSR 01 10/2015 184881 Tab
PSR 02 10/2015 186141 Tab
PSR 03 10/2015 187223 Tab
23. Do you any criteria for fixing the batch The firm has criteria for fixing the batch size as per testing
size of stability batches? requirement.
24. Do you have complete record of The firm has complete record of production of stability
production of stability batches? batches.
25. Do you have protocols for stability The firm has protocols for stability testing of stability
testing of stability batches? batches.
26. Do you have developed and validated The firm has validated method of testing for products.
the method for testing of stability
batches?
27. Do you have method transfer studies in The firm has no method transfer studies.
case when the method of testing being
used by your firm is given by any other
lab?
28. Do you have documents confirming the The firm has proper documents confirming the qualification
qualification of equipment/instruments of equipment/instruments being used in the test and analysis
being used in the test and analysis of of Panadol Sinus finished product.
Panadol Sinus finished drug?
29. Do your method of analysis stability Yes, the method of analysis is stability indicating.
indicating?
30. Do your HPLC software 21CFR The HPLC software 21CFR is Compliant.
Compliant?
31. Can you show audit trial reports on Yes, audit trial reports on the testing is available.
Panadol Sinus testing?
32. Do you have some remaining quantities The degradation quantities of product were not available as
of degradation products and stability the product was developed globally by Gsk Australia.
batches?
33. Do you have stability batches kept on The firm has completed six months accelerated studies and
stability testing? six months’ real time study however after the completion of
six month studies the samples from real time study was
withdrawn.
34. Do you have valid calibration status for The firm has valid calibration status for the equipment used
the equipment used in (Panadol Sinus) for product.
production and analysis?
35. Do proper and continuous monitoring The firm has continuous monitoring and control system for
and control are available for stability the stability chambers, the stability chambers were supported
chamber? by data logger furthermore the UPS and backup generators
were also available.
36. Do related manufacturing area, The related manufacturing area, equipment, personal and
equipment, personal and utilities be utilities were found GMP compliant.
rated GMP compliant?
CONCLUSION:
On the basis of risk based approach, the genuineness/authenticity of the stability data submitted by the firm for
registration of Panadol Sinus Caplets is verifiable. Related manufacturing area, equipment, personnel and
utilities are rated as GMP compliant to satisfactory level.
Further to conclude that as per decision of registration board 273rd meeting dated August 28-29, 2017 the
facility of Gsk for the Panadol Sinus was re inspected for the authenticity and geniuses of 6 months accelerated
stability study and 6 months’ real time study along with the associated documents, import of API, quality,
specification, test analysis, facilities etc.
As mentioned the data is verifiable however as product is withdrawn after six months’ real time the firm is
advised to keep first three batches on real time study.
Decision: Registration Board decided to approve registration of “Panadol Sinus Tablets
(Paracetamol/Phenylepherine)” by M/s GlaxoSmithKline Pakistan, F-268 Karachi. Manufacturer will
place first three production batches on long term stability studies throughout proposed shelf life and on
accelerated studies for six months.
M/s. Sami Pharmaceutical (Pvt.) Ltd., F-95, S.I.T.E, Karachi – 01 Product
838. Report on Investigation of Authenticity / Genuineness of data submitted for registration of
TONOFLEX-P FORTE 75mg / 650mg (Tramadol HCl + Paracetamol) Tablets by M/s. Sami
Pharmaceutical (Pvt.) Ltd., F-95, S.I.T.E, Karachi.
Investigation Date and Time: 08th January, 2018 (Morning)

Investigation Site: Factory premises of M/S. Sami Pharmaceutical (Pvt.) Ltd., F-95, S.I.T.E, Karachi.
Background:
Registration Board in 275th meeting considered the applications of M/s. Sami Pharmaceutical (Pvt.)
Ltd., F-95, S.I.T.E, Karachi for registration of Tonoflex-P Forte 75mg / 650mg Tablets. Registration Board
considered scientifically rational laboratory scale data submitted by the firm as pre-requisite of registration being
new formulation and constituted a three member panel to investigate the authenticity / genuineness of data
(import of raw material and stability data). Panel was advised to conduct inspection of the firm as per decision of
Registration Board and to submit report for further consideration.
Composition of Panel:
1. Prof. Dr. Rafeeq Alam Khan, Meritorious Professor and Chairman, Faculty of Pharmacy, University of
Karachi, Karachi. (Member Registration Board).
2. Mr. Muzaffar Hussain Jaffari, Director DTL, Govt. of Sindh, Karachi
3. Dr. Saif-ur-Rehman Khattak, Director / FGA, CDL, DRAP, Karachi.
Scope of investigation:
Investigation of the authenticity / genuineness of data (import of raw material and stability data),
manufacturing of stability batches and stability studies on these batches.
Tools for Investigation:
The investigation was conducted by using a structured questionnaire of DRAP. For objective evidence
physical inspection of the facilities for manufacturing and quality control, material used and retained, personnel
involved, ongoing studies, printed data and integrity and security of data in respective databases were also
audited. The details of investigation may be summarized as under:
Detail of Investigation:
Sr.
Questions Remarks
No.
1. Do you have documents confirming the Firm has imported Tramadol HCl API from M/s. Supriya
import APIs including approval from Life Sciences, India Batch No. SLL/TDM/0216007-A Qty.
DRAP? received 500Kg as per invoice no. SLL/EXP/373-16-17, for
the development of Tonoflex-P Forte Tablets and material
is cleared by ADC.
Since, Paracetamol purchased locally so ADC clearance not
required having invoice number CP15-2148 and batch
number PGS16-083
2. What was the rationale behind selecting Firm has informed that they have selected both API’s
the particular manufacturer of APIs? suppliers on the basis of GMP compliance and quantifying
all test of COA.
Suppliers are GMP certified.
COA meets all requirement of pharmacopeia.
3. Do you have documents confirming the Firm has imported pharmacopeia reference standard and
import of APIs reference standard and impurities standard of both APIs.
impurity standards?
4. Do you have certificate of Analysis of Firm have certificates of analysis for APIs, reference
the APIs, reference standards and standards and impurities standards.
impurity standards?
5. Do you have GMP certificate of APIs Firm provided copy of GMP certificate of M/s. Supriya Life
manufacturer issued by regulatory Science issued by Commissioner Food and Drugs
authority of country of origin? Administration.
GMP certificate of M/s Citi Pharma Pvt Ltd issued by Drug
Regulatory Authority Of Pakistan
6. Do you use APIs manufacturer method Both APIs are pharmacopeial and testing of APIs are
of testing for testing APIs? according to pharmacopeial monograph.
7. Do you have stability studies reports on Firm has stability study reports of both APIs.
APIs?
8. If yes, whether the stability testing has Stability testing has been performed as per SIM method and
been performed as per SIM method and degradation products have been quantified.
degradation products have been
quantified?
9. Do you have method for quantifying the Firm have pharmacopeial method for quantifying the
impurities in the APIs? impurities in the API.
10. Do you have some remaining quantities Firm has some remaining quantities of the working
of the APIs, its reference standard and reference standard and APIs.
impurities standards?
11. Have you used pharmaceutical grade Firm has used pharmaceuticals grade excipients.
excipients? Pharmacopeial monograph of excipients has been attached
COA’s of all excipients is also available
12. Do you have documents confirming the Firm has necessary documents confirming the import of the
import of the used excipients? used excipients.
13. Do you have test reports and other Firm has complete test reports and other records of the
records on the excipients used? excipients used.
14. Do you have written and authorized Firm has written and authorized protocol, for the
protocols for the development of development of Tonoflex-P Forte Tablets.
Tonoflex-P Forte Tablets?
15. Have you performed Drug-excipients Yes, drug-excipients compatibility studies have been
compatibility studies? performed.
16. Have you performed comparative Firm has performed comparative dissolution studies with
dissolution studies? reference product i.e. Tramadol/Paracetamol 75mg+650mg
Tablets of M/s. KrKa, Spain.
Firm tablets have comparable dissolution profile with the
reference tablets.
17. Do you have product development Firm has dedicated area for product development (R&D)
(R&D) section section.
18. Do you have necessary equipment Firm has dedicated manufacturing and testing equipment in
available in product development section product development section for the development of
for development of Tonoflex-P Forte Tonoflex-P Forte Tablets.
Tablets?
19. Are the equipments in product The available equipments in product development section
development section qualified? are qualified.
20. Do you have proper maintenance / Firm has proper maintenance / calibration / re-qualification
calibration / re-qualification program for program for the equipment used in Product Development
the equipment used in PD section? section.
21. Do you have qualified staff in product Firm has trained & qualified staff in product development
development section with proper section with proper knowledge and training in product
knowledge and training in product development.
development?
22. Have you manufactured three stability Three stability batches have been manufactured for the
batches for the stability studies of stability studies of Tonoflex-P Forte Tablets with batch
Tonoflex-P Forte Tablets as required? numbers Lab-01, Lab-02 and Lab-03.
The batch sizes for all these batches are 2000 tablets each.
The pack size is 1x10s Alu-Alu blister.
23. Do you have any criteria for fixing the Firm has informed that for fixing the batch size of stability
batch size of stability batches? batches is the number of tablets per testing frequency and
number of testing frequencies.
24. Do you have complete record of Firm has complete record of stability batches.
production of stability batches?
25. Do you have protocols for stability Firm has detailed protocols for stability testing of stability
testing of stability batches? batches.
26. Do you have developed and validated Firm has adopted USP finished good monograph and also
the method for testing of stability validate the method.
batches?
27. Do you have method transfer studies in USP testing method has been adopted.
case when the method of testing being
lab?
28. Do you have documents confirming the Firm has proper documents confirming the qualification of
qualification of equipments / instruments equipment / instruments being used in the test and analysis
being used in the test and analysis of of both APIs and the finished drugs.
APIs and the finished drug?
29. Does your method of analysis stability The firm method of analysis is stability Indicating
indicate? evidenced by force degradation studies. USP also provided
test method for impurity analysis.
30. Do your HPLC software 21CFR The HPLC software is 21CFR Compliant.
Compliant?
31. Can you show Audit trail reports? Firm has shown all Audit trail reports.
32. Do you have some remaining quantities Firm has remaining quantities of stability batches only.
of degradation products and stability
batches?
33. Do you have stability batches kept on The firm has three stability batches kept on real time
stability testing? stability testing. Currently 09 months studies have been
completed.
34. Do you have valid calibration status for The firm has Valid calibration status for the equipment used
the equipments used in Tonoflex-P Forte in Tonoflex-P Forte tablets production and analysis.
Tablets production and analysis?
35. Do proper and continuous monitoring Adequate monitoring and control are available for stability
and control are available for stability chambers. Data Loggers are also placed in stability
chamber? chambers for monitoring.
36. Do related manufacturing area, Firm has dedicated area for manufacturing of products
equipment, personnel and utilities be including Tonoflex-P Forte tablets. All manufacturing area,
rated as GMP compliant? equipment, personnel and utilities are as per cGMP
compliance.
Conclusions:
1. On the basis of risk based approach the genuineness / authenticity of stability data submitted by the firm for
registration of Tonoflex-P Forte 75mg/650mg Tablets (Tramadol HCl + Paracetamol) is verifiable to highly
satisfactory level.
2. The related manufacturing area, equipments, personnel and utilities are GMP compliant and well suited for
the manufacturing of Tonoflex-P Forte Tablets.
Decision: Registration Board decided to approve registration of “Tonoflex-P Forte 75mg/650mg Tablets
(Tramadol HCl + Paracetamol)” by M/s. Sami Pharmaceutical (Pvt.) Ltd., F-95, S.I.T.E, Karachi.
Manufacturer will place first three production batches on long term stability studies throughout proposed
shelf life and on accelerated studies for six months.
M/s Searle IV Solutions (Pvt.) Ltd. Lahore – 01 Product
839. Report on Investigation of Authenticity / Genuineness of data submitted for registration of IX
IV Infusion (Ibuprofen 4mg) by M/s Searle IV Solutions (Pvt.) Ltd. Lahore.
Investigation Date and Time: 23-01-2018.
Investigation Site: Factory premises of M/s Searle IV Solutions (Pvt.) Ltd. Lahore.
Background:
Registration Board in 277th meeting considered the application of M/s Searle IV Solutions (Pvt.) Ltd. Lahore for
registration of IX IV Infusion (Ibuprofen 4mg) and decided to constitute the following panel for onsite
investigation to confirm genuineness / authenticity of stability data and associated documents, import of API,
quality, specification, test analysis, facilities etc.
1. Mr. Asim Rauf, Additional Director, DRAP, Lahore.
2. Ms. Ufaq Tanveer Butt, Area FID, DRAP, Lahore.
3. Mr. Muhammad Tahir Waqas, Assistant Director (PEC) DRAP, Islamabad.
Sr. Question Observation by Panel
No.
1. Whether the firm has documents Yes. Import of API was confirmed from copies of ADC
confirming import of API? attested invoice No. 2016APE40646 dated Nov 11, 2016.
2. What was the rationale behind selecting the The manufacturer is GMP compliant and it was
particular manufacturer of API? recommended by the innovator as informed by the firm.
3. Whether documents confirm the import of Yes. Documents were present.
API reference standard and impurity
standards?
4. Whether the firm has certificate of Yes. Certificates of analysis were provided by the firm.
Analysis of the API, reference standards
and impurity standards from exporter?
5. Whether the firm has any approval of API Yes. The manufacturer has GMP certificate of China.
or GMP certificate of API manufacturer Certification No. was SD20140251.
issued by regulatory authority of country of
origin?
6. Whether firm use API manufacturer Yes. The firm used manufacturer’s method of testing.
method of testing?
7. Whether firm has stability studies reports No. The firm informed that stability studies report on API
on API? will be provided after commercial import of API by the firm.
8. If yes, whether the stability testing has N/A
been performed as per SIM method and
degradation products have been quantified.
9. Whether firm has method for quantifying No. Quantification of impurities was not done. However, the
the impurities in the API? firm informed that they will be performing it in future.
10. Whether firm has some remaining Yes. The remaining quantities were present.
quantities of the API, its reference standard
and impurities standard?
11. Whether firm has used pharmaceutical Yes. The firm has used pharmaceutical grade excipients.
grade excipients?
12. Whether firm has documents confirming Yes. ADC attested invoices were provided by the firm. L-
the import of the used excipients? Arginine Invoice No. HN15313 dated 12-11-2015. Sodium
Chloride Invoice No. 1410003868 dated 28-02-2017, tris
was purchased locally.
13. Whether firm has test reports and other Yes. Reports were present.
records on the excipients used?
14. Whether firm has written and authorized Yes. SOP’s for development of drug product were present.
protocols for the development of product?
15. Whether firm has performed Drug- No. The firm informed that they are following the formula of
excipient compatibility studies? innovator. However, they would demand the same data from
innovator.
16. Whether firm has performed comparative No. However, the firm informed that they will be doing it in
dissolution studies? future.
17. Whether firm has product development Yes. R&D Section was present.
(R&D) section?
18. Whether firm has necessary equipment No. Equipment of production and quality control were used
available in product development section for development of drug product.
for development of product?
19. Are the equipment in product development No equipment in product development department.
section qualified?
20. Whether firm has proper maintenance / Yes. Calibration certificate of the equipment were provided.
calibration / re-qualification program for
the equipment used in PD section?
21. Whether firm has qualified staff in product Yes. 1 manager and 1 pharmacist were working in product
development section with proper development. However, training was not conducted till date.
knowledge and training in product
development?
22. Whether firm has manufactured three Yes. Batch No. RD17002, RD17003 and RD17004 were
stability batches for the stability studies of manufactured in May 2017.
API tablets as required?
23. What was the criteria for fixing the batch The firm informed that they are following DRAP’s Policy
size of stability batches? for selecting batch size i.e. 1/10th of commercial batch size.
24. Whether firm has complete record of Yes. BMR’s were present.
production of stability batches?
25. Whether firm has protocols for stability Yes. Stability study protocols were present.
testing of stability batches?
26. Whether firm has developed validated the Yes. The firm had performed validation studies including
method for testing of stability batches? accuracy, precision, linearity, specificity, robustness etc.
27. Whether firm has method transfer studies N/A
in case when the method of testing being
lab?
28. Whether firm has documents confirming Yes. Calibration certificate of all the used equipment were
the qualification of equipment / instruments present.
being used in the test and analysis of API
and the finished drug?
29. Whether firm has stability indicating Yes. However, no impurities were detected as mentioned in
method of analysis? test reports provided by the firm.
30. Whether firm has HPLC software 21CFR Yes. Only 3 persons of Quality Control had their ID’s to use
compliant? HPLC. The software installed was “Lab solution BB”.
31. Whether firm could you show Audit Trail Yes. Audit trail reports were present from July onwards. The
reports on API testing? data of May and June was available, but did not appear in
audit trail.
32. Whether firm has some remaining Stability batches for real time studies were present. The
quantities of degradation products and batches for accelerated studies were consumed as informed
stability batches? by the firm.
33. Whether firm has batches kept on stability Yes. For real time stability studies.
testing?
34. Whether firm has valid calibration status Yes. Calibration was valid and performed by AIMS.
for the equipment used in API tablets
35. Do proper and continuous monitoring and Yes. Data logger was installed.
control are available for stability chamber?
36. Do related manufacturing area, equipment, Yes. The firm was found GMP compliant.
personnel and utilities be rated as GMP
compliant?
Conclusions:
On the basis of risk based approach, the genuineness / authenticity of stability data submitted for registration of
IX IV infusion (Ibuprofen 4mg) is verifiable to satisfactory level and it seems that firm had performed stability
studies.
Related manufacturing area, equipment, personnel and utilities are also rated as GMP compliant to satisfactory
level.
Decision: Registration Board decided to approve registration of “IX IV Infusion (Ibuprofen 4mg) by M/s
Searle IV Solutions (Pvt.) Ltd. Lahore. Manufacturer will place first three production batches on long
term stability studies throughout proposed shelf life and on accelerated studies for six months.
M/s. Aspin Pharma (Pvt.) Ltd., Plot No. 10&25, Sector 20, Korangi Industrial Area, Karachi. – 01
Product
840. Report on Investigation of Authenticity / Genuineness of data submitted for registration of
DASAVIR 60mg (Daclatasvir) Tablets by M/s. Aspin Pharma (Pvt.) Ltd., Plot No. 10 & 25, Sector 20,
Korangi Industrial Area, Karachi.
Investigation Date and Time: 11th January, 2018 (Morning)

Investigation Site: Aspin Pharma (Pvt.) Ltd., Plot No. 10 & 25, Sector 20, K.I.A, Karachi.
Background:
Registration Board in 275th meeting considered the applications of M/s. Aspin Pharma (Pvt.) Ltd.,
Korangi Industrial Area, Karachi for registration of DASAVIR 60mg Tablets. Registration Board considered
scientifically rational laboratory scale data submitted by the firm as pre-requisite of registration being new
formulation and constituted a three member panel to investigate the authenticity / genuineness of data (import of
raw material and stability data). Panel was advised to conduct inspection of the firm as per decision of
Registration Board and to submit report for further consideration.
1. Prof. Dr. Rafeeq Alam Khan, Meritorious Professor and Chairman, Department of Pharmacology, Faculty of
Pharmacy, University of Karachi, Karachi. (Member Registration Board).
2. Prof. Dr. Ghulam Sarwar, Dean, Faculty of Pharmacy, Jinnah University for Women, Karachi.
3. Dr. Saif-ur-Rehman Khattak, Director / FGA, CDL, DRAP, Karachi.
Scope of investigation:
Investigation of the authenticity / genuineness of data (import of raw material and stability data),
manufacturing of stability batches and stability studies on these batches.

The investigation was conducted by using a structured questionnaire of DRAP. For objective evidence
physical inspection of the facilities for manufacturing and quality control, material used and retained, personnel
involved, ongoing studies, printed data and integrity and security of data in respective databases were also
audited. The details of investigation may be summarized as under:
Sr.
Question Observation by panel
No.
1. Do you have documents confirming the Firm has imported 1.5Kg of Daclatasvir from M/S. Ruyan
import of API including approval from HEC China vide Invoice letter No. QC16M1005 dated Nov.
DRAP? 15 2016, and has proper approval for its import vide Lice.
No. 4010 dated 24.11.2016 from DRAP Karachi. The 1.5Kg
API has been used in manufacturing 3 batches each for
30mg, 60mg and 90mg tablets of Daclatasvir.
2. What was the rationale behind selecting the Selection of the manufacturer has been based upon its GMP
particular manufacturer of API? Certification and availability of DMF (open part) & adequate
sample for initial testing for prequalification.
3. Do you have documents confirming the The firm imported working standards of the API and the
import of Daclatasvir reference standard major impurity and vide proper import documents.
and impurity standards?
4. Do you have certificate of Analysis of the The firm has certificates of analysis for the API, working
API, reference standards and impurity standard of API and major impurity.
standards?
5. Do you have any approval of API or GMP The firm has GMP certificate of API manufacturer issued by
certificate of API manufacturer issued by regularity authority of country of Origin (China).
regulatory authority of country of origin?
6. Do you use API manufacturer method of The firm is using API manufacturer method of testing.
testing?
7. Do you have stability studies reports on The firm has accelerated stability studies reports of six
API? months and real time stability studies report on the API
conducted by the API manufacturer.
8. If yes, whether the stability testing has The stability testing has been performed as per SIM method
been performed as per SIM method and and degradation products have been quantified.
degradation products have been quantified?
9. Do you have method for quantifying the The firm has method for quantifying the impurities in the
impurities in the API? API.
10. Do you have some remaining quantities of The firm has remaining quantities of the API, working
the API, its reference standard and standard of API and the major impurity. All these material
impurities standards? have been checked physically and found in order.
11. Have you used pharmaceutical grade The firm has used pharmaceutical grade excipients.
excipients?
12. Do you have documents confirming the The firm has imported all the excipients vide proper import
import of the used excipients? documents.
13. Do you have test reports and other records The firm has test reports and other records on the excipients
on the excipients used? used.
14. Do you have written and authorized The firm has written and authorized protocols for the
protocols for the development of development of Daclatasvir Dasavir 60mg tablets.
Daclatasvir tablets?
15. Have you performed Drug-excipients The firm has not performed Drug-excipients compatibility
compatibility studies? studies as their formulation is similar to that of the innovator
formulation (Daklinza Tablets).
16. Have you performed comparative The firm has performed comparative dissolution studies in
dissolution studies? three media including pH 1.2, pH 4.5 and pH 6.8 buffers
with MyDacla 60mg tablets manufactured by M/S. Mylan,
India. The firm‘s product results are comparable to that of
the comparator product.
17. Do you have product development (R&D) The firm has dedicated area for manufacturing of trial
section batches. The QC part is conducted in dedicated equipments
in routine QC lab.
18. Do you have necessary equipment’s The firm has necessary equipment for production of trial
available in product development section batches in product development section, however, the
for development of Daclatasvir tablets? analytical part has been performed via dedicated equipment
in routine quality control laboratory.
19. Are the equipments in product The equipment used in production and analysis of trial
development section qualified? batches are qualified.
20. Do you have proper maintenance / The firm has proper maintenance / calibration / re-
calibration / re-qualification program for qualification program for the equipment used in production
the equipment used in PD section? and QC of trial batches of tablets dosage form.
21. Do you have qualified staff in product The firm has a team of 2 pharmacists for production and 2
development section with proper chemists for Quality Control of trial batches with a machine
knowledge and training in product operator with suitable knowledge and training in product
development? development.
22. Have you manufactured three stability The firm has manufactured three stability batches for the
batches for the stability studies of stability studies of Dasavir 60mg tablet with batch number
Daclatasvir tablets as required? 023/2017, 024/2017 and 025/2017 with batch size of 1600
tablets each. It is further submitted that the firm has
manufactured three trial batches each of 30mg and 90mg
also. All necessary studies have been conducted on 30mg
and 90mg tablets also, except comparative dissolution
studies.
23. Do you have any criteria for fixing the As per statement of the firm the criteria for fixing the batch
batch size of stability batches? size of stability batches is the number of tablets per testing
frequency and number of testing frequencies.
24. Do you have complete record of production The firm has complete record of production of stability
of stability batches? batches. Necessary log books of equipment used has been
available with the firm, assuring the traceability of
manufacturing and analysis of stability batches.
25. Do you have protocols for stability testing The firm has detailed protocol for stability testing of stability
of stability batches? batches.
26. Do you have developed and validated the The firm has used method of testing of API manufacturer for
method for testing of stability batches? related substances for stability testing of their finished
product (Tablets).The method is gradient mode and stability
indicating and has properly validated while using the
working standard of API, impurities and forced degradation
studies.
27. Do you have method transfer studies in The firm has not conducted method transfer studies,
case when the method of testing being used however, they have validated their method properly.
by your firm is given by any other lab?
28. Do you have documents confirming the The firm has proper documents confirming the qualification
qualification of equipments / instruments of equipment / instruments being used in the test and
being used in the test and analysis of analysis of Daclatasvir API and the finished drug.
Daclatasvir API and the finished drug?
29. Do your method of analysis stability The firm method of testing is stability indicating for stability
indicating? testing of their finished product, as supported by forced
degradation studies.
30. Do your HPLC software is 21CFR Firm has used two HPLC systems for stability studies of
compliant? Dasavir 60mg tablets. The HPLC used upto 06 months
studies has software not 21CFR compliant whereas, the
second HPLC used for 09 months studies and scheduled to
be used for further studies has software 21CFR compliant.
31. Can you show Audit Trail reports on Audit trail on the testing reports can be made from 09
Daclatasvir testing? months studies.
32. Do you have some remaining quantities of The firm has remaining quantities of stability batches, some
degradation products and stability batches? quantities of working standard of the API and one major
impurity.
33. Do you have stability batches kept on The firm has completed the accelerated stability testing on
stability testing? the three stability batches of 30mg, 60mg and 90mg tablets,
however, the real time stability testing is in progress on all
the three stability batches of each potency. Currently 09
months study has been completed with satisfactory results.
34. Do you have valid calibration status for the The firm has valid calibration status for the equipment used
equipment’s used in Daclatasvir tablets in Dasavir 60mg tablets production and analysis.
production in analysis?
35. Do proper and continuous monitoring and Continuous power supply and monitoring are available for
control are available for stability chamber? stability chamber.
36. Do related manufacturing area, equipment, The related manufacturing area, equipment, personnel and
personnel and utilities be rated as GMP utilities are rated as GMP compliant.
compliant?
Conclusions & Recommendations:
1. On the basis of risk based approach the genuineness / authenticity of stability data submitted by the firm for
registration of Dasavir 60mg Tablets (Daclatasvir) is verifiable to satisfactory level.
2. The related manufacturing area, equipments, personnel and utilities are GMP compliant and well suited for
the manufacturing of Dasavir 60mg Tablets, therefore, the panel recommends the registration of Dasavir
60mg tablets in the name of the manufacturer.
3. Since comparative dissolution profile studies have not been conducted by the firm on Dasavir 30mg and
90mg tablet yet therefore, the recommendation for registration of these two potencies is differed till
comparative dissolution profile studies of Dasavir 30mg and 90mg tablets with the comparator products.
Decision: Registration Board deliberated that since Comparative Dissolution Profile Study has not been
considered as mandatory requirement and Board has previously approved cases in which Comparative
Dissolution Profile Study was not performed, so the Board decided to approve registration of “Dasavir
30mg Tablets (Daclatasvir 30 mg), Dasavir 60mg Tablets (Daclatasvir 60 mg) & Dasavir 90mg Tablets
(Daclatasvir 90 mg) by M/s. Aspin Pharma (Pvt.) Ltd. Manufacturer will place first three production
batches of al three approved strengths on long term stability studies throughout proposed shelf life and on
Following case of M/s. Wilson Pharmaceuticals, Islamabad was presented in 269th meeting of registration Board
along with inspection report of submitted stability data of Saferon (Sofosbuvir 400mg) Tablets. Details of
inspection report and decision of Board are reproduced under:
Sr. Name &Address Brand Name Type of Form, International Previous DRB
No. of Manufacturer / (Proprietary Name + Initial Diary& Availability / Decision /
Applicant Dosage Form + ate, Fee Local Remarks (if
Strength), (including Availability any)
Composition, differential fee),
Pharmacological Demanded Price/ GMP Inspection
Group, Pack size Report Date &
Finished Product Remarks
Specification
841. M/S Wilson Saferon Tablets Form 5 Sovaldi – Gilead
Pharmaceuticals, I- Each film coated tablet Dy no1616 USFDA
9 Industrial Area, contains 30-11-2016
Islamabad Safosbovir…..400mg Sovaldi-
Rs 20,000 Ferozsons
Anti –viral 30-11-2016 Last inspection
Pack size 14’s, report 4-11-2015
28’s GMP was
Price as per SRO compliant
Investigation Date and Time: 19th April, 2017(Forenoon)
Investigation Site: Factory premises of M/s. Wilson Pharmaceuticals Islamabad.
Background:
M/s. Wilson Pharmaceutical, Islamabad applied for grant of registration of Saferon (Sofosbuvir 400mg) Tablets.
Firm has submitted laboratory scale data as pre-requisite of registration of generic version of new formulation.
Data was considered by Registration Board in its 265th meeting held on 24-25th January, 2017. The Board
constituted a three-member panel to investigate the authenticity / genuineness of data (import of raw material
and stability data). Panel was advised to conduct inspection of these firms as per decision of Registration Board
and to submit reports for further consideration.
1. Dr. Rafeeq Alam Khan, Meritorious Professor, University of Karachi, Karachi; (Member Registration
Board).
2. Dr. Obaidullah, Additional Director (Registration-1), DRAP Islamabad.
3. Mr. Manzoor Ali Bozdar, Additional Director (Licensing), DRAP Islamabad.
Management of firm informed that during inspection conducted on 10th December, 2015, M/s. Wilson
Pharmaceuticals was not able to comprehensively present their whole process and related documents for
traceability of record pertaining to import of raw material, manufacturing and quality control facilities and
stability data. It was because of the fact that this kind of audit was carried out for the first time by DRAP.
However, now they have compiled all the related documents in a comprehensive form for presentation before
the panel. The panel decided to proceed / confirm only with those short comings / observations, which were
pointed out by the panel inspection conducted on 10th December, 2015 and were reasons for rejection of
registration application of the firm. The decision was taken because on rest of the points, there was no need of
cross verification.
Point wise observations of previous panel and their confirmation status is as follows:
Q. Observations of panel conducted on Observations of panel conducted on 19-04-2017
No. 10.12.2015
1. The firm has imported 600g sofosbuvir API Firm provided invoice bearing No.
through M/s Morgan Karachi. However no VPPL/EXP/016/16-16 dated 11.11.2014 for import
invoice for M/s Werrick and approval from of sofosbuvir from M/s. Virupaksha Organic Ltd,
DRAP could be shown to the panel. India
2. Import documents for some of the excipients are Stance of the management was same as in the
available however some excipients are lacking previous inspection as some of the excipients were
for the import documents i.e. they are purchased purchased from the local market (magnesium citrate,
from the local markets colloidal silicon, mannitol and titanium dioxide) and
were not only used in the formulation of Hepalid
Tablets containing Sofosbuvir but were also used in
other products
3. The firm has test reports on certain quality Certificate of analysis of all the excipients, including
parameters of the some of the excipients used the ones for which the reports were not available
during the previous inspection, were presented
4. The firm has performed comparative dissolution Firm presented registers showing calculations related
studies and their product show comparable to performance of comparative dissolution studies.
acceptable dissolution profile. The method for Performance has not been done in standardized
analysis was spectrophotometric; therefore, manner i.e. different dissolution apparatuses were
system traceability could not be made. used and at different intervals. However,
Moreover, respective entries in log book for documented results show comparable dissolution
dissolution apparatus and spectrophotometer profile
were not traceable
5. The firm does not have proper dedicated Development of separate R&D/Product development
product development (R&D) section and used section is under process. Management informed that
general area for manufacturing of stability procedure for entries in log book have been re-
batches. However entries in respective area log examined after the observations of the panel
books were partially available but without any inspection on 10-12-2015. This happened due to the
serial indexing fact that such type of detailed inspection was
conducted for the first time by the DRAP and the
firm was not expecting suchqueries. Now the firm
has developed procedure for manufacturing of trial
batches for product development.
6. The firm has complete record of production of
stability batches as per their batch
manufacturing record. Although firm has used
manufacturing equipment of commercial area
but separate log books for trial batches
(compression only) were prepared instead of
using general log books. For rest of processes,
log books of general areas are used but without
any serial indexing
7. The firm has three commitment batches kept on Firm presented test results of trial batches conducted
stability testing for real time stability testing. at various time intervals (0, 3, 6 for both real time
Panel observed that stability chamber for real and accelerated stability testing) and real time testing
time stability was set at 25C, 60%RH, which is at 9, 12, 18 and 24 months, which showed that trial
not as per Zone IVA and thus real time stability batches were of standard quality during
data is not reliable aforementioned test intervals. Moreover, both
chambers have been provided with digital data
loggers with record of test period since January,
2016.
8. The firm informed that chromatograph used for Software of HPLC present in the firm is 21CFR
the analysis of stability batches is out of order compliant and audit trail on the testing reports was
and therefore no data in the chromatograph available and confirmed. Panel reviewed
could be shown to the panel chromatograms for testing of API and trial batches at
0, 3 and 6 months for real time and accelerated
stability testing.
9. Do related manufacturing area, equipment, Firm is in phase of renovating tablet section
personnel and utilities be rated as GMP including machines, HVAC, thus panel could not
compliant? evaluate GMP status of tablet section
Conclusion: On the basis of risk based approach the genuineness / authenticity of stability data submitted by
the firm for registration of Saferon (Sofosbuvir 400mg) Tablets by M/s. Wilson Pharmaceutical, Islamabad is
verifiable to satisfactory level. However, GMP assessment may be done after renovation of tablet section of
firm.
Decision: Registration Board decided to defer above case for GMP assessment after renovation of
tablet section. Two members of previous panel will evaluate GMP status of tablet section
after information by the firm.
Evaluation by PEC:
Following two-member panel has conducted inspection of tablet section of M/s. Wilson Pharmaceuticals,
Islamabad on 20-01-2018 for GMP assessment after renovation. The observations of inspection are mentioned
hereafter.
1. Mr. Abdullah (Additional Director PE & R), DRAP Islamabad.
2. Mr. Manzoor Ali Bozdar, Additional Director (Licensing), DRAP Islamabad.
Observations of panel:
Panel has observed that firm has improved as follows:
 Floor has been renovated and painted with epoxy paint (anti-bacterial).
 Old windows were replaced with double glazed windows.
 Special Aluminium fixtures with rounded edges were installed.
 Upgraded HVAC with pressure differentials was provided.
 Firm has 06 tablet compression machines with capability of producing double layered tablets.
Keeping in view improvements made by the firm as identified in the previous inspection, panel recommends the
facilities of the firm for manufacturing of Saferon (Sofosbuvir 400mg) tablets and give rating of very Good.
 The case is submitted for consideration of Registration Board.
Decision: Registration Board decided to approve registration of “Saferon (Sofosbuvir 400mg) tablets by
M/s Wilson Pharmaceuticals, I-9 Industrial Area, Islamabad. Manufacturer will place first
three production batches on long term stability studies throughout proposed shelf life and on
The following cases were presented in 277th meeting of Registration Board along with submitted data as per
checklist approved in 276th meeting of Registration Board for exemption from “On site investigation of
submitted stability data”. Details of submitted data and decision of Board are reproduced under:
Sr. Name & Address of Brand Name Type of Form, International Availability / Local
No. Manufacturer / (Proprietary Name + Initial Diary & Availability
Applicant Dosage Form + Date, Fee
Strength), (including GMP Inspection Report Date &
Composition, differential fee), Remarks
Pharmacological Demanded Price /
Group, Pack size
Finished Product
Specification
842. M/s Novamed DASVIR Tablets 90mg Form-5 DAKLINZA by M/s Bristol
Pharmaceuticals (Pvt.) Each film coated tablet Diary No. 11539 Myers Squibb, USA.
Ltd. 28 km Ferozepur contains: dated 09-08-2017 CLAVIR by M/s Hilton Pharma,
Road, Lahore. Daclatasvir (as Rs. 20,000/- Karachi.
dihydrochloride) dated 09-08-2017 GMP compliant dated 08-2-2017
…..…90mg Rs. 30,000/-
(Anti-viral) dated 18-08-2017
As per SRO.
Previous Decision:
The case was presented in 275th meeting of Registration Board alongwith stability studies data, and
Registration Board decided as under:
Registration Board deliberated that it has been decided that onsite inspection for verification of data will
be exempted as decided in instant meeting. Thus the Board decided as follows:
Onsite inspection by following panel to confirm genuineness/ authenticity of stability data and associated
documents, import of API, quality, specification, test analysis, facilities etc
 Dr. Rafeeq Alam Khan, Merotorious Professor/Chairman, Faculty of Pharmacy, University of
Karachi.
 Dr. Obaidullah, Additional Director (PE&R), DRAP, Islamabad.
 Additional Director, DRAP, Lahore.
OR
Firm can submit requisite documents as decided in instant meeting in Case No. 02 (On site investigation of
submitted data).
Evaluation by PEC:
Now the firm has submitted data as per checklist approved in 276th meeting of Registration Board for
exemption from “On site investigation of submitted stability data”. Details of submitted data are as under:
(Dy.# 24967 dated 18-12-2017)
Administrative Portion
1. Reference of last onsite panel Firm has referred to onsite inspection report of their product
inspection for instant dosage form “Sofonil 400mg (Sofosbuvir) Tablets”, which was conducted on
conducted during last two years. 06th March, 2017 and was presented in 268th meeting of
Registration board held on 20-21st March, 2017. Registration
Board decided to approve registration of Sofonil Tablets
(Sofosbuvir 400mg) by M/s. NovaMed Pharmaceutical (Pvt.) Ltd.,
Lahore.
2. Documents for the procurement of Firm has submitted copy of commercial invoice for Daclatasvir
API with approval from DRAP (in dihydrochloride, attested by AD (I&E), DRAP Lahore on 05-10-
case of import). 2016.
3. Documents for the procurement of Firm has submitted DHL receipts of date 10-10-2016, with
reference standard and impurity contents mentioned as “Daclatasvir dihydrochloride & weight of
standards. shipment as 0.5Kg.
4. Approval of API/ DML/GMP Firm has submitted following:

certificate of API manufacturer issued i. Copy of GMP certificate issued to M/s Nantong Chanyoo
by regulatory authority of country of Pharmatech by by Nantong Food & Drug Administration,
origin. valid upto 07-09-2020.
ii. Copy of Certificate of GMP compliance issued to M/s
Nantong Chanyoo Pharmatech by Agency for medicinal
products and medical devices of the Republic of Solvenia.
5. Mechanism for Vendor pre- Firm has submitted following:
qualification i. SOP for Vendor Evaluation
ii. Check list of “Supplier Quality Evaluation” filled for M/s
Nantong Chanyoo Pharmatech.
6. Certificate of analysis of the API, Firm has submitted following:
reference standards and impurity i. COA of Daclatasvir dihydrochloride (Batch.# RD-DCL-
standards 201608261) from M/s Nantong Chanyoo Pharmatech.
ii. COA of working standard for Daclatasvir dihydrochloride
(Batch.# WS201603001) from M/s Nantong Chanyoo
Pharmatech.
iii. COA of all the related substances mentioned in the
Certificate of analysis of Daclatasvir dihydrochloride.
7. Documents for the procurement of Firm has submitted commercial invoices for all the excipients used
excipients used in product in the applied formulation, details of which are as under:
development? Name of Excipient Name of Manufacturer
Crosscarmellose sodium M/s Accent Microcell Pvt. Ltd.,
(USP/NF/JP/BP) Gujarat, India.
Microcrystalline cellulose M/s Microcellulose Weibenborn
GmbH+Co. KG.
Magnesium stearate (USP M/s Anhui Sunhere Pharmaceutical
32) excipients Co., Ltd.
Aerosil 200 M/s Evonik Degussa, Belgium
Lactose (USP-NF,JP) M/s Fonterra Excipients GmbH &
Co. KG
Tabcoat TC film coating M/s Colorcon, China.
powder
8. List of qualified staff involved in Firm has submitted R&D staff list comprising of 6 members.
product development with relevant
experience.
Production Data
9. Authorized Protocols/SOP for the Firm has submitted following:
development & stability testing of i. Copy of SOP for Dasvir tablet 90mg Development issued
trial batches. on 18-01-2017.
ii. Stability study protocol for Dasvir tablet 90mg issued on
18-01-2017.
10. Complete batch manufacturing record Firm has Batch Manufacturing Record, including Pre-formulation
of three stability batches. data, Dispensing sheets, Master formulation & Standard
Manufacturing procedure, for all the three batches of Dasvir 90mg
tablet i.e.
TP/80/-T1/S1, TP/80/-T1/S2 & TP/80/-T1/S3.
11. Record of remaining quantities of Firm has submitted reconciliation sheet for use of Daclatasvir
stability batches. dihydrochloride for all the three stability batches.
QA/QC DATA
12. Record of Digital data logger for Firm has submitted following:
temperature and humidity monitoring i. Copy of stability chambers validation report. (dt: 01-12-2016)
of stability chambers (real time and Instrument ID: QA/INS/008 for Real time conditions
accelerated) Instrument ID: QA/INS/009 for accelerated conditions.
ii. Copy of stability chambers qualification report(dt:30-11-2017)
iii. Copy of Certificate of calibration for stability chambers. (dated
10-05-2017)
iv. Manually filled sheets for temperature & humidity record of
Accelerated & real time conditions for the time period of
02-01-2017 to 15-12-2017.
13. Method used for analysis of API along Firm has submitted Method of analysis & COA for Daclatasvir
with COA. dihydrochloride from M/s Nantong Chanyoo Pharmatech Co., Ltd.
14. Method used for analysis of FPP & Firm has submitted following for both accelerated & real time
complete record of testing of stability stability studies of all three stability batches:
batches (i.e. chromatograms, lab i. Method of analysis.
reports, raw data sheets etc.) ii. Lab reports
iii. Raw data sheets
iv. HPLC Chromatograms (for Assay analysis) & UV
Spectrums (for Dissolution analysis)
15. Reports of stability studies of API Firm has submitted both accelerated (40°C ± 2°C & 75±5%RH)
from manufacturer. stability studies & long term (25°C ± 2°C & 60±5%RH) stability
studies reports of three batches of Daclatasvir dihydrochloride
from M/s Nantong Chanyoo Pharmatech Co., Ltd.
Submitted stability reports are of three months only.
16. Analysis reports for excipients used. Firm has submitted analysis reports for all the excipients used in
17. Drug-excipients compatibility studies. Firm has stated that since formulation of Dasvir tablet is same as
per Innovator Daklinza tablet so no need for drug excipient
compatibility.
18. Record of comparative dissolution  Firm has submitted Comparative dissolution study protocol &
data. results. The details of reference product & Sample product are
as follows:
Feature Reference product Product of Novamed
Brand name Mydekla tablets 90mg Dasvir tablets 90mg
Batch No. 8055708 TP/81-T1/S1
Mfg. date 09-2016 02-2016
Expiry date 05-2018 02-2018

Comparative study dissolution study has been performed in
following mediums:
i. pH 1.2 HCl buffer.
ii. pH 4.5 Acetate buffer.
iii. pH 6.8 Phosphate buffer with 0.75% Brij 35.
 UV spectrums for Comparative dissolution study have been
submitted.
 Both sample and reference product has shown more than 85%
dissolution within 15 minutes in all three mediums.
19. Compliance Record of HPLC Firm has submitted audit trail reports for HPLC analysis of both
software 21CFR & audit trail reports stability studies.
on product testing.
Sr. Name & Address of Brand Name Type of Form, International Availability / Local
No. Manufacturer / (Proprietary Name + Initial Diary & Availability
Strength), (including GMP Inspection Report Date &
Composition, differential fee), Remarks
Pharmacological Demanded Price /
Group, Pack size
Finished Product
Specification
843. M/s Novamed DASVIR Tablets Form 5 DAKLINZA by M/s Bristol
Pharmaceuticals (Pvt.) 60mg Diary No. 11542 Myers Squibb, USA.
Ltd. 28 km Ferozepur Each film coated dated 09-08-2017 CLAVIR by M/s Hilton Pharma,
Road, Lahore. tablet contains: Rs. 20,000/- Karachi.
Daclatasvir (as dated 09-08-2017 GMP compliant dated 08-2-2017
dihydrochloride).60mg Rs. 30,000/-
(Anti-viral) dated 18-08-2017
As per SRO.
Previous Decision:
The case was presented in 275th meeting of Registration Board alongwith stability studies data, and
Registration Board decided as under:
Registration Board deliberated that it has been decided that onsite inspection for verification of data will
be exempted as decided in instant meeting. Thus the Board decided as follows:
Onsite inspection by following panel to confirm genuineness/ authenticity of stability data and associated
documents, import of API, quality, specification, test analysis, facilities etc
Prof. Dr. Rafeeq Alam Khan, Merotorious professor and Chairman Faculty of Pharmacy, University of
Karachi, Karachi.
 Dr. Obaidullah, Additional Director (PE&R), DRAP, Islamabad.
 Additional Director, DRAP, Lahore
OR
Firm can submit requisite documents as decided in instant meeting in Case No. 02 (On site investigation of
submitted data)
Evaluation by PEC:
Now the firm has submitted data as per checklist approved in 276th meeting of Registration Board for
exemption from “On site investigation of submitted stability data”. Detailsof submitted data are as under:
(Dy.# 24967 dated 18-12-2017)
1. Reference of last onsite panel Firm has referred to onsite inspection report of their product
inspection for instant dosage form “Sofonil 400mg (Sofosbuvir) Tablets”, which was conducted on
conducted during last two years. 06th March, 2017 and was presented in 268th meeting of
Registration board held on 20-21st March, 2017. Registration
Board decided to approve registration of Sofonil Tablets
(Sofosbuvir 400mg) by M/s. NovaMed Pharmaceutical (Pvt.) Ltd.,
Lahore.
2. Documents for the procurement of Firm has submitted copy of commercial invoice for Daclatasvir
API with approval from DRAP (in dihydrochloride, attested by AD (I&E), DRAP Lahore on 05-10-
case of import). 2016.
3. Documents for the procurement of Firm has submitted DHL receipts of date 10-10-2016, with
reference standard and impurity contents mentioned as “Daclatasvir dihydrochloride & weight of
standards. shipment as 0.5Kg.
4. Approval of API/ DML/GMP Firm has submitted following:
certificate of API manufacturer issued i. Copy of GMP certificate issued to M/s Nantong Chanyoo
by regulatory authority of country of Pharmatech by by Nantong Food & Drug Administration,
origin. valid upto 07-09-2020.
ii. Copy of Certificate of GMP compliance issued to M/s
Nantong Chanyoo Pharmatech by Agency for medicinal
products and medical devices of the Republic of Solvenia.
qualification i. SOP for Vendor Evaluation
ii. Check list of “Supplier Quality Evaluation” filled for M/s
Nantong Chanyoo Pharmatech.
reference standards and impurity i. COA of Daclatasvir dihydrochloride (Batch.# RD-DCL-
standards 201608261) from M/s Nantong Chanyoo Pharmatech.
ii. COA of working standard for Daclatasvir dihydrochloride
(Batch.# WS201603001) from M/s Nantong Chanyoo
Pharmatech.
iii. COA of all the related substances mentioned in the
Certificate of analysis of Daclatasvir dihydrochloride.
7. Documents for the procurement of Firm has submitted commercial invoices for all the excipients used
excipients used in product in the applied formulation, details of which are as under:
development? Name of Excipient Name of Manufacturer
Crosscarmellose sodium M/s Accent Microcell Pvt. Ltd.,
(USP/NF/JP/BP) Gujarat, India.
Microcrystalline cellulose M/s Microcellulose Weibenborn
GmbH+Co. KG.
Magnesium stearate (USP 32) M/s Anhui Sunhere Pharmaceutical
excipients Co., Ltd.
Aerosil 200 M/s Evonik Degussa, Belgium
Lactose (USP-NF,JP) M/s Fonterra Excipients GmbH &
Co. KG
Tabcoat TC film coating M/s Colorcon, China.
powder
8. List of qualified staff involved in Firm has submitted R&D staff list comprising of 6 members.
product development with relevant
experience.
Production Data
9. Authorized Protocols/SOP for the Firm has submitted following:
development & stability testing of i. Copy of SOP for Dasvir tablet 90mg Development issued
trial batches. on 18-01-2017.
ii. Stability study protocol for Dasvir tablet 90mg issued on
18-01-2017.
10. Complete batch manufacturing record Firm has Batch Manufacturing Record, including Pre-formulation
of three stability batches. data, Dispensing sheets, Master formulation & Standard
Manufacturing procedure, for all the three batches of Dasvir 90mg
tablet i.e.
TP/81/-T1/S1, TP/81/-T1/S2 & TP/81/-T1/S3.
11. Record of remaining quantities of Firm has submitted reconciliation sheet for use of Daclatasvir
stability batches. dihydrochloride for all the three stability batches.
QA/QC DATA
temperature and humidity monitoring i. Copy of stability chambers validation report. (dated 01-12-
of stability chambers (real time and 2016)
accelerated) Instrument ID: QA/INS/008 for Real time conditions
Instrument ID: QA/INS/009 for accelerated conditions.
ii. Copy of stability chambers qualification report. (dated 30-
11-2017)
iii. Copy of Certificate of calibration for stability chambers.
(dated 10-05-2017)
iv. Manually filled sheets for temperature & humidity record
of Accelerated & real time conditions for the time period
of 02-01-2017 to 15-12-2017.
13. Method used for analysis of API along Firm has submitted Method of analysis & COA for Daclatasvir
with COA. dihydrochloride from M/s Nantong Chanyoo Pharmatech Co., Ltd.
14. Method used for analysis of FPP & Firm has submitted following for both accelerated & real time
complete record of testing of stability stability studies of all three stability batches:
iv. HPLC Chromatograms (for Assay analysis) & UV
Spectrums (for Dissolution analysis)
15. Reports of stability studies of API Firm has submitted both accelerated (40°C ± 2°C & 75±5%RH)
from manufacturer. stability studies & long term (25°C ± 2°C & 60±5%RH) stability
studies reports of three batches of Daclatasvir dihydrochloride
from M/s Nantong Chanyoo Pharmatech Co., Ltd.
Submitted stability reports are of three months only.
16. Analysis reports for excipients used. Firm has submitted analysis reports for all the excipients used in
17. Drug-excipients compatibility studies. Firm has stated that since formulation of Dasvir tablet is same as
per Innovator Daklinza tablet so no need for drug excipient
compatibility.
18. Record of comparative dissolution  Firm has submitted Comparative dissolution study protocol &
data. results. The details of reference product & Sample product are
as follows:
Feature Reference product Product of Novamed
Brand name Mydekla tablets 90mg Dasvir tablets 60mg
Batch No. 8055727 TP/81-T1/S1
Mfg. date 10-2016 02-2017
Expiry date 06-2018 02-2019
Comparative study dissolution study has been performed in
following mediums:
i. pH 1.2 HCl buffer.
ii. pH 4.5 Acetate buffer.
iii. pH 6.8 Phosphate buffer with 0.75% Brij 35.
 UV spectrums for Comparative dissolution study have been
submitted.
 Both sample and reference product has shown more than 85%
dissolution within 15 minutes in all three mediums.
19. Compliance Record of HPLC Firm has submitted audit trail reports for HPLC analysis of both
software 21CFR & audit trail reports stability studies.
on product testing.
 When observation regarding manually filled sheets for temperature & humidity record of
Accelerated & Real time conditions were communicated to firm the firm has replied as
under:
“It is stated that we have already got the registration of Sofonil (Sofosbuvir) 400mg tablets
registration no. 084570 after onsite inspection of our facility by panel of inspectors by
DRAP. The same stability chambers were used for stability study of Dasvir (Daclatasvir)
tablets 60 mg & 90 mg.
The already installed stability chambers have digital display of temperature & humidity & we
maintain manual record of temperature & humidity. Since now you have added the
requirement of digital data logger for temperature & humidity, we have already installed a
new stability chamber having digital data logger from WiseCube Korea (Capacity 800 ltr.)
From now onwards the stability studies will be conducted in this new chamber & digital data
of temperature & humidity will be provided to your good office. You are therefore requested
to kindly accept manual data of temperature & humidity for this time as were accepted in our
previous on-site inspection for Sofosbuvir 400mg tablets.
Decision 277th meeting: Registration Board deferred the case for confirmation of data
logging of stability chambers by Area FID.
 Now, the Inspection report has been received from Hafiz Jawad Ali (Area FID) vide letter
No. 1292/2018-DRAP (L-V) dated 24-01-2018. The inspection was conducted on 22-01-
2018 for the Verification of data of Stability Chamber. The observations & conclusion of
inspection are as under:
Observations:
 The scope/ ranges of the Stability Chambers was as under:
i. 25°C & 60% RH
ii. 30°C & 65% RH
iii. 40°C & 75% RH
 Temperature & Humidity record of the chambers was available at the time of inspection and
was being recorded twice a day.
 The firm also had provided automatic electric supply by the Generator & USP system as
back-up arrangement, along with continuous alarm system for monitoring.
 Both stability chambers were calibrated, their performance qualification was also being
performed.
Conclusion:
Keeping in view of above, the genuineness / authenticity of stability data submitted by the firm
for registration of Dasvir tablets (Daclatasvir as dihydrochloride 60mg & 90mg) has been
verified.
 The case is submitted for consideration of Registration Board.
Decision: Registration Board decided to approve registration of “Dasvir tablets 60 mg
(Daclatasvir as dihydrochloride 60mg) & Dasvir tablets 90 mg (Daclatasvir as
dihydrochloride 90mg) by M/s Novamed Pharmaceuticals Lahore.
Manufacturer will place first three production batches on long term stability
studies throughout proposed shelf life and on accelerated studies for six months.
Case No. 09: Miscellaneous Cases
844. Withdrawl of Registration application of Cefamezin 2 gm injection by M/s Barrett

Hodgson Pakistan (Pvt) Ltd
M/s Barrett Hodgson Pakistan (Pvt) Ltd, Karachi has requested through a letter dated 10 th
January 2018, to withdraw their registration application for Cefamezin 2 gm injection. The
details of the above mentioned application is provided as under:
Product detail Application Current status

Detail
CEFAMEZIN Injection 2g Form 5-D The product was discussed in 277th
Each vial contains 22-07-2016 meeting of Registration Board and
Cefazolin sodium eq to cefazolin……2g Fee 50,000/- Board decided to constitute panel
(First generation cephalosporin) (22-07-2016) for on-site investigation to confirm
genuineness of stability data
Decision: Registration Board acceded with firms request and declared the application
of CEFAMEZIN Injection 2gm (Cefazolin sodium eq. to cefazolin……2gm)
as disposed off.
845. Data requirement for stability study
Registration Board in its 251st meeting advised for provision of scientifically rational lab
scale stability study data. Registration Board in its 276th meeting revised the assessment
frequencies for both accelerated and real time stability study data. The final recommendations of
the both meetings are provided under for consideration by the Board.
Stability Study Data Sheet
1.0 Product details:
Product name ABCD 100mg tablets Batch No.
/Generic
name/Dosage form
Description of pack e.g: 300mg uncoated 10mm off white round tablet
(container closure
blistered in 250mn PVC, 25mm aluminum foil in Batch Size.
system) a 10x 1 printed unit carton, 100 u/c further packed
in a master shipper.
Parameters and tests As per Product Specifications Mfg. Date
mentioned
Recommended  Short term conditions (Accelerated) 40+ Exp Date
storage conditions 2C, 75 +5RH
 Long term conditions (Real time) 30+
2C, 65 +5 RH
Date of initiation & (API) lot no.
implementation
Stability No.
Approval by: Sample taken for physical tests =

Sample taken for Chemical tests =
QC Manager:--------------------- Sample taken for Microbiological tests =
QA Manager:--------------------- Extra samples (if needed) =
Total Sample size (approx) =
Poduction Manager:---------- R&D Manager:-------------------
Accelerated Stability study data:
Assessment frequency (Months) Initial 1 2 3 4 6

Date of Testing
Tests Acceptance Storage conditions
(Physical, Criteria (Accelerated)
Chemical,
Microbiological)
40oC + 2oC & 75%RH

+ 5% RH
40oC + 2oC & 75%RH

+ 5% RH
40oC + 2oC & 75%RH

+ 5% RH
40oC + 2oC & 75%RH

+ 5% RH
40oC + 2oC & 75%RH

+ 5% RH
Analyst signature (after completion of every time line)
Conclusion by QA (after completion of the study):
Real time stability study data:
Assessment frequency (Months) Initial 3 6 9 12 18 24

Date of Testing
Tests Acceptance Storage conditions
(Physical, Criteria (Real time)
Chemical,
Microbiological)
30oC + 2oC & 65%RH + 5%

RH
30oC + 2oC & 65%RH + 5%

RH
30oC + 2oC & 65%RH + 5%

RH
30oC + 2oC & 65%RH + 5%

RH
30oC + 2oC & 65%RH + 5%

RH
Analyst signature (after completion of every time line)

Conclusion by QA (after completion of the study):
Documents / Data to be provided by the applicants.
 Certificate of Analysis of API.
 Approval of API by regulatory authority of country of origin or GMP certificate of
API manufacturer issued by regulatory authority of country of origin.
 Manufacturer will follow Drug Specification Rules, 1986.
 Protocols followed for conduction of stability study and details of tests.
 Data of 03 batches will be supported by attested respective documents like
chromatograms, laboratory reports, data sheets etc.
 Documents confirming import of API etc.
 All provided documents will be attested (name, sign and stamp) for ensuring
 Shelf life of two years shall be granted based upon the results 06 month accelerated
and real time stability study data.
 Commitment to continue real time stability study till assigned shelf life of the
product.
On Site Investigation of Submitted Data.

In 254th meeting Registration Board, Registration Board considered recommendations /
directions of Ministry of National Health Services, Regulation & Coordination and decided for
onsite investigation for the genuineness of submitted data should be adopted in future, for all
applications of generics of NCEs (New Chemical entities / New drugs generic versions) where
local long term data and experience is not available, to ascertain quality, safety and efficacy
profile of such drugs, in the larger public interest.
A structured questionnaire was adopted as a tool for investigation against which objective
evidence was done via physical inspection of the facilities for manufacturing and quality control,
material used and retained, personnel involved, ongoing studies, printed data and integrity and
security of data in respective databases.
In 275th meeting of Registration Board again deliberated the matter of “On site investigation of
submitted stability data” & decided as follows:
 Firms can submit product development data including stability study data along
with related documents after completion of 3 months. These shall be evaluated
and shortcomings (if any) will be communicated to the applicant. The case will be
presented before the Board upon the submission of 6 months stability study data
after its necessary evaluation.
 Exemptions from verification of authenticity of submitted stability data shall be
granted to those firms which have already been granted approval of one (01)
similar dosage form by Registration Board on the basis of panel inspection reports
with no observation related to quality and integrity of data and these applicants
possesses following systems:
i. 21 CFR compliant system and complete audit trail report for test/
analysis performed on HPLC, confirmed/reported by panel which has
specifically inspected the pharmaceutical unit for this purpose.
ii. Digital data logger for temperature and humidity monitoring of
stability chambers (real time and accelerated).
 Registration Board can constitute panel for product specific inspection for
verification of authenticity of submitted stability study data if it deems necessary
to confirm any inconsistency in data etc.
Now, the case is presented here before the Board to decide about requisite documents which
shall be submitted by firms claiming exemption from On-site investigation of submitted stability
data. In this regard the Questionnaire which has been previously adopted as a tool for on-site
investigation of submitted stability data is reproduced here for consideration of Board.
 Moreover, Registration Board in its 251st meeting recommended “Assessment frequency” at
Initial,1,2,4,6,8,12,16,20,24 & 26 weeks for both Accelerated & Real time stability
conditions.
Now the case is again presented before the Board for re-consideration of assessment
frequency of Stability studies batches.
Decision: Registration Board deliberated the matter in detail and decided that firms
can claim exemption from “On site investigation of submitted stability data”
for two years since the last onsite panel inspection for applied dosage form,
by submitting documets as per following checklist, for considertaion of
Registration Board.
1. Reference of last onsite panel inspection for instant dosage form conducted during last two years.
2. Documents for the procurement of API with approval from DRAP (in case of import).
3. Documents for the procurement of reference standard and impurity standards.
4. Approval of API/ DML/GMP certificate of API manufacturer issued by regulatory authority of
country of origin.
5. Mechanism for Vendor pre-qualification
6. Certificate of analysis of the API, reference standards and impurity standards
7. Documents for the procurement of excipients used in product development?

8. List of qualified staff involved in product development with relevant experience.
Production Data
9. Authorized Protocols/SOP for the development & stability testing of trial batches.
10. Complete batch manufacturing record of three stability batches.
11. Record of remaining quantities of stability batches.
QA/QC DATA
12. Record of Digital data logger for temperature and humidity monitoring of stability chambers (real
time and accelerated)
13. Method used for analysis of API along with COA.
14. Method used for analysis of FPP & complete record of testing of stability batches (i.e.
chromatograms, lab reports, raw data sheets etc.)
15. Reports of stability studies of API from manufacturer.
16. Analysis reports for excipients used.
17. Drug-excipients compatibility studies.
18. Record of comparative dissolution data.
19. Compliance Record of HPLC software 21CFR & audit trail reports on product testing.
 Cases of Personal hearing
Following cases were presented in 277th meeting of Registration Board, submitted on Form 5
along with enclosures on CTD format. The details of cases & decisions of Board are reproduced
as under:
846. Name and address of manufacturer / M/s BF Biosciences Ltd., 5-Km, Sundar Raiwind Road,
Applicant Raiwind.
Brand Name +Dosage Form + Strength Omera 40mg Infusion
(Lyophilized Powder For Solution For Intravenous
Injection)
Omeprazole (as sodium) …40mg
Pharmacological Group Proton pump inhibitors
Type of Form Form-5
Pack size & Demanded Price 1’s;As per SRO
Me-too status Risek Injection 40mg of M/s Getz Pharma
(Reg.#024170)
GMP status Last inspection report 08-09-2017 Panel concludes good
Remarks of the Evaluator.  Firm has section approval for Biological parenteral
only whereas applied formulation does not fall in this
category.
 Firm has submitted Enclosures along with form 5 as
per CTD format approved in 264th meeting of
registration Board.
 Firm has submitted reports of accelerated & real time
stability studies for three batches.
Decision: Registration Board deferred the case for personal hearing for clarification of firm’s
request to manufacture applied formulation in Biological parenteral section.
847. Name and address of manufacturer / M/s BF Biosciences Ltd., 5-Km, Sundar Raiwind Road,
Applicant Raiwind.
Brand Name +Dosage Form + Strength Esomega 40mg Infusion
(Lyophilized Powder For Solution For Intravenous
Injection)
Esomeprazole (as sodium) …40mg
Pharmacological Group Proton pump inhibitors
Type of Form Form-5
Me-too status X-Prazole 40mg Infusion of M/s Mediate
Pharmaceuticals, Karachi (Reg.#057925)
GMP status Last inspection report 08-09-2017 Panel concludes good
Remarks of the Evaluator.  Firm has section approval for Biological parenteral
only whereas applied formulation does not fall in this
category.
 Firm has submitted Enclosures along with form 5 as
per CTD format approved in 264th meeting of
registration Board.
 Firm has submitted reports of accelerated & real time
stability studies for three batches.
Decision: Registration Board deferred the case for personal hearing for clarification of firm’s
request to manufacture applied formulation in Biological parenteral section.
Following details have been submitted of Module 3 (Quality / CMC) for both above cited
applications:
Contents of Module: 3 (Quality / CMC)
Sub- Data submitted
Module Section Contents
section
3 3.2.S DRUG SUBSTANCE
General Information Detail submitted for
i. Nomenclature
3.2.S.1
ii. Structure
iii. General properties
Manufacture Detail submitted for
i. Manufacturer(s)
3.2.S.2
ii. Description of Manufacturing Process
and Process Controls
Characterization Detail submitted for
i. Elucidation of Structure and other
3.2.S.3
Characteristics
ii. Impurities
Control of Drug Detail submitted for
Substance i. Control of Drug Substance
ii. Specification
3.2.S.4 iii. Analytical Procedures
iv. Validation of Analytical Procedures
v. Batch Analyses
vi. Justification of Specification
Reference Standards Detail submitted for Reference Standards
3.2.S.5
or Materials
Container Closure Detail submitted for Container Closure System
3.2.S.6
System
Stability Detail submitted for Stability. (Protocol &
3.2.S.7
reports have been submitted)
3.2.P DRUG PRODUCT
Description and Detail submitted for Composition of Drug
3.2.P.1 Composition of Drug Product
Product
Pharmaceutical Detail submitted for Components of the Drug
3.2.P.2
Development Product.
Manufacture Detail submitted for
i. Manufacturer(s)
3.2.P.3
ii. Batch Formula
iii. Description of Manufacturing Process
and Process Controls
iv. Controls of Critical Steps and
Intermediates
Undertaking has been submitted for Process
validation
Control of Excipient Detail submitted for
i. Specifications
3.2.P.4 ii. Analytical Procedures
All excipients used are of Pharmacopoeal
grades
Control of Drug Detail submitted for
Product i. Specification(s)
ii. Analytical Procedures
3.2.P.5
iii. Validation of Analytical Procedures
(Protocol & report have been
submitted)
Reference Standards Detail submitted for Reference Standards or
3.2.P.6
or Materials Materials
Container Closure Detail submitted for Container Closure System
3.2.P.7
System
Stability Following have been submitted:
i. Stability Summary and Conclusions
ii. Post-approval Stability Protocol and
3.2.P.8
Stability Commitment
iii. Stability Data (Only reports have been
submitted.)
 Now, the firm has requested for personal hearing before the Honourable Drug
Registration Board to enable to them to present their case. The representatives of the firm
now have been called upon for personal hearing.
Proceedings: Dr. Ajmal Nasir (Director Technical) appeared before the Board and briefed
regarding justification for the manufacturing of non- biologicals along with bio-pharmaceuticals
at BF Biosciences Ltd as under:
“BF Biosciences is manufacturing six products i.e. Interferon Alpha 2a, Interferon Alpha 2b,
Pegylated interferon alpha 2a, Erythropoietin, Filgrastim and Terlipressin acetate injections.
Drug Substances manufactured using a Biological system using living organisms/cell lines
through culturing or Recombinant DNA are termed as BIOLOGICALS, whereas Drug Products
manufactured using already produced Biological Drug Substances (which no longer contain
living organisms) are termed as Bio-Pharmaceuticals. Dedicated facility is required for the
manufacturing of BIOLOGICAL SUBSTANCES and certain other highly sensitizing
compounds etc., but not for biopharmaceuticals
All above-mentioned products manufactured at BF Biosciences are Bio-Pharmaceuticals. These
bio-pharmaceutical formulations are peptides that are easily denatured by temperature as well as
pH changes, and thus can be eliminated from the facility through cleaning validation between
production batches. These do not therefore bear contamination risks carried by penicillin-based
antibiotics and other products requiring dedicated manufacturing facilities.
Bio-Pharmaceuticals formulation and filling / Lyophilization (if required) is allowed as per
WHO 1, Eudralex 2 and FDA 3 guidelines along with non-Biopharmaceuticals on Campaign
basis.
At BF Biosciences we intend to avail this allowance to manufacture non-Biologicals along with
Bio-Pharmaceuticals on Campaign basis.
All required controls and systems are in place and are compliant to requirements for campaign-
based manufacturing of biopharmaceuticals and non- biologicals.”
REFERENCES
1) Annex 3 WHO good manufacturing practices for biological products
Replacement of Annex 1 of WHO Technical Report Series, No. 822
Section 9 , 13 GMP OF BIOLOGICAL PRODUCTS WHO s22400en.pdf
2) EudraLex The Rules Governing Medicinal Products in the European Union Volume 4 EU
guidelines forGood Manufacturing Practice for Medicinal Products for Human and
Veterinary Us e Annex 2 Manufacture of Biological active substances and Medicinal
Products for Human Use Section 8 g and 9
3) FDA approves BioMarin’s manufacturing facility in Cork, Ireland he FDA has
approved BioMarin Pharmaceutical’s bulk biologics manufacturing plant, located in Cork,
Ireland for production of the formulated bulk substance. Niamh Marriott (European
Pharmaceutical Review)
 It is pertinent to mention that M/s BF Biosciences Ltd. Lahore was previously granted
registration for Omega injection (Omeprazole), Reg. No. 067967, in same manufacturing
facility vide letter no. F.15-7/2010-Reg-V (M-228) dated 10-12-2010.
Later Central Licensing Board in 235th meeting while discussing the case of renewal of DML
of M/s BF Bio Sciences, Lahore passed following orders in respect of Omega injection
(Omeprazole) , Reg. No. 067967:-
“The Board was apprised by licensing division that the firm in its renewal application has
mentioned that they have registration of omeprazole at biotech facility where as panel in the
inspection report has mentioned that the firm has dedicated biotech manufacturing facility
only. The Board in this regard advised to refer the case of registration of Omega injection
(Omeprazole), Reg. No. 067967 to Drug Registration Board for its consideration and further
necessary action accordingly”.
Registration Board in its 245th meeting held on 29th & 30th September, 2014 decided to issue
show cause for cancellation of registration of Omega injection (Omeprazole), Reg. No.
067967, registered in the name of M/s BF Biosciences Ltd. Lahore.
Subsequently Omega injection (Omeprazole), Reg. No. 067967 of M/s BF Biosciences Ltd.
Lahore, was de-registered vide letter no. F.15-2/2015-Reg-V (M-247)
Decison: Registration Board deliberated the matter in detail and decided to refer the
case to Centeral Licensing Board for their comments on firm’s request as
CLB has has granted for Biological parenteral section only.
RRR SECTION
Case No. 01 Cases received in accordance with SRO 1005(I) 2017
Federal Government vide SRO 1005(I)/2017 dated 5th October, 2017 approved the amendment in
Rule 27 (PR&A) of 1976 for the consideration of renewal of Registration after 60 days of expiry
of registration of drugs. This SRO has been placed in 275th meeting of Registration Board for
information and record. Furthermore, decision in the light of opinion of Legal Affairs Division
regarding submission of fee. In this regard more than 1300 applications received in this RRR-
Section of PE&R Division till 04th December, 2017.
RRR-Section of PE&R Division has evaluated 330 cases. Detail of which is as under;
Category Total
Locally Manufactured Finished Drug for Import
Human Veterinary Human Veterinary 330
287 30 11 02
A) Deferred Cases
Category Total
Locally Manufactured Finished Drug for Import
37
Human Veterinary Human Veterinary
32 03 02 --
1) Locally Manufactured (Human)
I II III IV V VI
S.
Firm Name Reg. No. Brand Name Date of Reg. Validity
No.
1. M/s. Med Asia 064112 Esasia 20 Capsules 13-07-2010 12-07-2020
Pharmaceuticals Each capsule contains:-
(Pvt) Ltd., Esomeprazole as Mg 3H2O (as E.C
Risalpur, K.P.K pellets) …. 20mg
Imported pellets from M/s Lee
Pharma Limited, Survey No.199,
plot No.3&4, D.No.5-9-265/1&2,
Rajive Gandhi Nagar, Prasanthi
Nagar India Extension, Kukatpally,
Hyderabad-72,a.P., India.
2. M/s. Med Asia 064113 Esasia 40 Capsules 13-07-2010 12-07-2020
(Pvt) Ltd., Esomeprazole as Mg 3H2O (as E.C
Risalpur, K.P.K pellets) …. 40mg
plot No.3&4, D.No.5-9-265/1&2,
3. M/s. Med Asia 064114 Antra 20 Capsules 13-07-2010 12-07-2020
(Pvt) Ltd., Omeprazole pellets eq. to
Risalpur, K.P.K Omeprazole … 20mg
plot No.3&4, D.No.5-9-265/1&2,
4. M/s. Med Asia 064115 Antra 40 Capsules 13-07-2010 12-07-2020
(Pvt) Ltd., Omeprazole pellets eq. to
Risalpur, K.P.K Omeprazole … 40mg
plot No.3&4, D.No.5-9-265/1&2,
5. M/s. Bayer 000024 Yomesan Tablet 19-04-1976 10-04-2021
Pakistan (Pvt) Each tablet contains:- Transfer of
Ltd., Karachi. Niclosamide …. 500mg Registration on
11-04-1996
6. M/s. Genix 016067 Enervin Syrup 21-11-1994 03-12-2019
Pharma Private Each 5ml contains:- Transfer of
Limited, L-Ornithine L Asparate … 300mg Registration on
Karachi. Nicotinamide ….25mg 04-12-2004
Riboflavin as 5 Phosphate Sodium
……… …. 1.0mg
Sodium Benzoate …. 6.0mg
Methyl Paraben …. 9.0mg
Propyl Paraben …. 1.0mg
Potassium Sorbate …. 6.0mg
Flavour Pineapple 9040 …. 0.02ml
Sodium metasbisulphate ....10mg
Sucralose.... 10mg
Propylene Glycol.... 250mg
D.I Water (q.s).... 5ml
7. Lowitt Pharma 050987 Lowcit 20mg Tablet 12-08-2008 11-08-2018
(Pvt) Ltd, Each film coated tablet contains:- Change of
Peshawar. Citalopram as HBr … 20mg Brand Name on
01-01-2011
8. Lowitt Pharma 050988 Lowpime Injection 1gm IV/IM 12-08-2008 11-08-2018
(Pvt) Ltd, Each vial contains:-
Peshawar. Cefepime as HCl … 1gm
9. Lowitt Pharma 050989 Lowpime Injection 500mg IV/IM 12-08-2008 11-08-2018
Peshawar. Cefepime as HCl … 500mg
10. Lowitt Pharma 050990 Sulcef Injection 1gm IV/IM 12-08-2008 11-08-2018
Peshawar. Cefoperazone as Sodium … 500mg
Sulbactam as Sodium … 500mg
11. Lowitt Pharma 050991 Motedone Tablet 12-08-2008 11-08-2018
(Pvt) Ltd, Each film coated tablet contains:-
Peshawar. Domperidone Maleate … 10mg
12. Lowitt Pharma 050992 EC-Pram Tablet 12-08-2008 11-08-2018
Peshawar. Escitalopram … 10mg
13. Lowitt Pharma 050993 Lowtral 100mg Tablet 12-08-2008 11-08-2018
Peshawar. Sertraline as HCl … 100mg
14. Lowitt Pharma 050994 Olan-Z Tablet 12-08-2008 11-08-2018
Peshawar. Olanzapine … 5mg
15. Lowitt Pharma 050995 Lomec Tablet 500mcg 12-08-2008 11-08-2018
(Pvt) Ltd, Each film coated tablet contains:- With the
Peshawar. Mecobalamine … 500mcg advice to
replace word
“film coated”
with “Sugar
Coated” in
reference
compostion
from the
concerned
section.
16. Lowitt Pharma 050996 Sulcef Injection 2gm IV/IM 12-08-2008 11-08-2018
Peshawar. Cefoperazone as Sodium … 1gm
Sulbactum as Sodium … 1gm
17. Lowitt Pharma 050997 Motedone Syrup 12-08-2008 11-08-2018
(Pvt) Ltd, Each ml contains:-
Peshawar. Domperidone … 1mg
18. Lowitt Pharma 050998 Olan-Z 10mg Tablet 12-08-2008 11-08-2018
Peshawar. Olanzapine … 10mg
19. Lowitt Pharma 050999 T-Kast 10mg Tablet 12-08-2008 11-08-2018
Peshawar. Montelukast … 10mg
20. Lowitt Pharma 051000 Lowtral 50mg Tablet 12-08-2008 11-08-2018
Peshawar. Sertraline as HCl … 50mg
21. Lowitt Pharma 051001 T-Kast 5mg Tablet 12-08-2008 11-08-2018
(Pvt) Ltd, Each film coated tablet contains:- With the
Peshawar. Montelukast … 5mg advice to
correct the
formulation by
the concerned
section.
22. Lowitt Pharma 052796 Napzol 20mg Capsule 11-11-2008 10-11-2018
(Pvt) Ltd, Each capsule contains:-
Peshawar. Esomeprazole as Magnessium
Trihydrate enteric coated pellets …
20mg
Imported pellets from M/s Smilax
Laboratories Ltd. Plot No.44, CIE
Ghandi Nagar, Balanagar,
Hyderabad India.
23. Lowitt Pharma 052797 Nurzol Capsule 20mg 11-11-2008 10-11-2018
(Pvt) Ltd, Each capsule contains:-
Peshawar. Omeprazole as enteric coated
pellets … 20mg
Hyderabad India.
24. Lowitt Pharma 052798 Letzol Capsules 30mg 11-11-2008 10-11-2018
(Pvt) Ltd, Lansoprazole as enteric coated
Peshawar. pellets … 30mg
Hyderabad India.
25. M/s. Soma 006593 Paracetamol Tablet 23-11-1982 Regularise the
Laboratories, Each tablet contains:- renewal from
Lahore Paracetamol … 500mg 23.11.2012 till
22.11.2017
26. Jaens 041783 Denatacin Eye Drop 03-07-2006 Regularise the
Pharmaceutical, Contains:- renewal from
Lahore Natamycin … 50mg 03-07-2011 till
02-07-2016
27. Jaens 044673 Lexicol Eye Drop 12-10-2006 Regularise the
Pharmaceutical, Contains:- renewal from
Lahore Chlorophenicol … 5mg 12-10-2011 till
Hydroxypropyl Methylcellulose … 11-10-2016
5mg
28. Advanced 070295 Calariadvan Tablet 25-06-2011 24-06-2021
Pharmaceutical Each tablet contains:
Clarithromycin …250mg
29. Advanced 070296 Clariadvan tablet 500mg 25-06-2011 24-06-2021
Pharmaceutical, Each tablet contains:-
Rawat, Clarithromycin … 500mg
Islamabad.
30. M/s. Zakfas 057069 Nutri-Gest Powder 03-04-2009 02-04-2019
Pharmaceuticals Each 1000gm contains:- With the
(Pvt) Ltd., Propionic Acid advice to omit
Multan. Calcium …. 250gm Propionic the exciepients
Acid Sodium …. 400gm from the
Acetanilide …. 150gm composition by
Magnesium Oxide …. 125mg the concerned
Iron II Sulphate … 400mg section.
Magnesium Sulphate …. 200mg
Copper Sulphate …. 450mg
Cobalt Sulphate …. 400mg
Sodium Molybdate …. 100mg
Sodium Chloride …. 20gm
31. M/s. Aims 052649 Cefaim Dry Suspension 13-10-2008 Deferred the
Pharmaceuticals Each 5ml contains:- case for
, Islamabad. Cefixime …. 100mg confirmation
of licensing
status from
Licensing
Division.
32. M/s. Aims 065426 Tamusin 0.4mg Capsule 20-08-2010 Deferred the
Pharmaceuticals Each capsule contains:- case for
, Islamabad. Tamsulosin HCl Pellets …. 0.4mg confirmation
(Pellets source required) of licensing
status from
Licensing
Division.
Decision: Registration Board decided as under;
i) Acceded to request of the firm of products at Sr. No. 01-30 and decide to
grant/regularize the renewal (s) mentined against each in column VI.
ii) Deferred the products at Sr. No. 31 & 32 for confirmation of licensing status
from Licensing Division.
2) Locally Manufactured (Veterinary)

I II III IV V VI
S Reg.
Firm Name Brand Name Date of Reg. Validity
No. No.
1. A&K 031567 Vital-P Powder 20-04-2004 19-04-2019
Pharmaceuticals Each 100gm contains:-
Vitamin A …. 2,000,000I.U
Vitamin D …. 400,000I.U
Vitamin E … 160I.U
Vitamin K3 … 900mg
Vitamin B1 …. 125mg
Vitamin B12 …. 3000mcg
Vitamin C …. 1000mg
Folic Acid … 200mg
Nicotinic acid …. 10,000mg
Calcium pantothenate....
3,000mg
2. A&K 031568 Coccikill Powder 20-04-2004 19-04-2019
Pharmaceuticals Each kg contains:-
Diaverdine …. 28gm
Sufaquinoxilone
Sodium..105gm
Vitamin A …. 5,000,000I.U
Vitamin K3 … 250,000mg
3. A&K 031569 Ozo-Plus Drench 20-04-2004 07-04-2020
Pharmaceuticals Each ml contains:- Change of Brand
Oxfendazole … 22.65mg name on
Selenium … 0.5mg 08-04-2005
Cobalt … 1.67mg
Decision: Registration Board acceded to request of the firm of products at Sr. No. 01-
03 and decide to grant/regularize the renewal (s) mentined against each in
column VI.
3) Finished Drugs for Import (Human)
I II III IV V VI
S Reg. Date of
Firm Name Brand Name Validity
No. No. Reg.
1. Morgan 045729 Avizole Injection 26-07-2007 Regularise the
Technologies Contains:- renewal from
Services, Omeprazole sodium … 42.6mg eq 26-07-2012 till
Karachi to 40mg Omperazole 25-07-2017
Imported from M/s. Yangzhou
AosalKang Pharmaceuticals Co.
Ltd.,China.
2. -do- 045728 Toprazole Injection (Pantoprazole 26-07-2007 Regularise the
Sodium Freeze Dried Lyophilized renewal from
Powder for Injection) 26-07-2012 till
Each vial contains:- 25-07-2017
Pantoprazole Sodium … 40mg
Imported from M/s. Yangzhou
AosalKang Pharmaceuticals Co.
Ltd.,China.
Decision: Registration Board acceded to request of the firm of products at Sr. No. 01 &
02 and decide to grant/regularize the renewal (s) mentined against each in
column VI subject to prevailing import policy.
B) New Cases
1) Locally Manufactured (Human)
I II III IV V VI
S Reg.
Firm Name Brand Name Date of Reg. Validity
No. No.
1. M/s. Medicon 056132 Medi-Xin Tablet 14-03-2009 13-03-2019
Pharmaceuticals Each tablet contains:-
Industries (Pvt) Ofloxacin …. 200mg
Ltd., Peshawar.
2. M/s. Medicon 056133 Medi-Lox Tablet 14-03-2009 13-03-2019
Industries (Pvt) Ciprofloxacin HCI ….
Ltd., Peshawar. 250mg
3. M/s. Medicon 056134 Medi-Lox Tablet 14-03-2009 13-03-2019
Industries (Pvt) Ciprofloxacin HCI ….
4. M/s. Medicon 056137 Medilar Tablet 14-03-2009 13-03-2019
Industries (Pvt) Clarithromycin …. 250mg
Ltd., Peshawar.
5. M/s. Medicon 056138 Medilar Tablet 14-03-2009 13-03-2019
Industries (Pvt) Clarithromycin …. 500mg
Ltd., Peshawar.
6. M/s. Medicon 056139 Medi Biotic Tablet 14-03-2009 13-03-2019
Industries (Pvt) Azithromycin …. 250mg
Ltd., Peshawar.
7. M/s. Medicon 056140 Medi Biotic Tablet 14-03-2009 13-03-2019
Industries (Pvt) Azithromycin …. 500mg
Ltd., Peshawar.
8. M/s. Medicon 056142 Medi-Nor Tablet 14-03-2009 13-03-2019
Industries (Pvt) Norfloxacin HCI ….
9. M/s. Medicon 056143 Medi-Al Tablet 14-03-2009 13-03-2019
Industries (Pvt) Artemether …. 20mg
Ltd., Peshawar. Lumefantrine …. 120mg
10. M/s. Medicon 056144 Medistop Tablet 14-03-2009 13-03-2019
Industries (Pvt) Metronidazole …. 400mg
Ltd., Peshawar.
11. M/s. Medicon 071611 Medigyne Vaginal Tablet 28-06-2011 27-06-2021
Industries (Pvt) Clotrimazole …. 500mg
Ltd., Peshawar.
12. M/s. Medicon 070302 Medifenic Tablet 22-06-2011 21-06-2021
Pharmaceuticals Each tablet contains:- With the advice to
Industries (Pvt) Diclofenac Sodium …50mg add word “Enteric
Ltd., Peshawar. Coated” in
reference
compostion by the
concerned section.
13. M/s. Medicon 070303 Medicit Tablet 22-06-2011 21-06-2021
Industries (Pvt) Cetirizine …. 10mg
Ltd., Peshawar.
14. M/s. Medicon 070304 Medicob 500mcg Tablet 22-06-2011 21-06-2021
Pharmaceuticals Each tablet contains:- With the advice to
Industries (Pvt) Mecobalamine …. 500mcg add word Sugar
Ltd., Peshawar. Coated in reference
compostion from
the concerned
section.
15. M/s. Medicon 070307 Medidome Tablet 22-06-2011 21-06-2021
Industries (Pvt) Domperidone …. 10mg
Ltd., Peshawar.
16. Amson Vaccines 029062 Amfax 37.5 mg Tablet 31-12-2002 08-01-2019
& Pharma (Pvt.) Each tablet contains: Transfer of
Ltd., Islamabad Venlafaxine HCl…37.5 mg registration dated
09-01-2004
17. Amson Vaccines 029063 Amfax 75 mg Tablet 31-12-2002 08-01-2019
Ltd., Islamabad Venlafaxine HCl 75 mg registration dated
09-01-2004
18. Amson Vaccines 037362 Amflox 200 mg Tablet 23-02-2005 22-02-2020
& Pharma (Pvt.) Each Film Coated tablet
Ltd., Islamabad Contains:
Ofloxacin…….200mg
19. Amson Vaccines 033045 Amsofen 50 Tablets 15-07-2004 14-07-2019
& Pharma (Pvt.) Each Tablet Contains With the advice to
Ltd., Islamabad Diclofenac Sodium add word “Enteric
BP…..50mg Coated” in
reference
compostion by the
concerned section.
20. Amson Vaccines 037365 Amsofen SR - 100 Tablets 23-02-2005 22-02-2020
& Pharma (Pvt.) Each Tablet Contains With the advice to
Ltd., Islamabad Diclofenac Sodium add word
BP…..100mg “Sustained
Release” in
reference
compostion by the
concerned section.
21. Amson Vaccines 029073 Amsoflour 20 Capsule 31-12-2002 06-07-2020
& Pharma (Pvt.) Each capsule contains: Transfer of
Ltd., Islamabad Fluoxetine HCl eq. to Registration
Fluoxetine USP 20 mg dated
07-07-2005
22. Amson Vaccines 029972 Amsozine 10 Tablet 06-03-2003 24-06-2018
Ltd., Islamabad Cetirizine …..10 mg registration dated
25-06-2008
23. Amson Vaccines 029971 Amsozine Syrup 06-03-2003 24-06-2018
& Pharma (Pvt.) Each 5ml contains Transfer of
Ltd., Islamabad Cetirizine HCl eq. to registration dated
Cetirizine…. 5 mg 25-06-2008
24. Amson Vaccines 037363 Cotecxin Dry Powder 23-02-2005 22-02-2020
& Pharma (Pvt.) Each 80 ml contains:
Ltd., Islamabad Dihydroartemisinin….
160mg
25. Amson Vaccines 030994 Ethrifin Tablets 06-09-2003 05-09-2018
& Pharma (Pvt.) Each Tablet Contains
Ltd., Islamabad Ethambutol HCl …300mg
Rifampicin ...150mg
Isoniazid (INH)…75mg
26. Amson Vaccines 048000 Ezetin 10/10 Tablets 03-01-2008 02-01-2018
& Pharma (Pvt.) Each Tablet contains
Ltd., Islamabad Ezetimibe…10mg
Simvastatin...10mg
Simvastatin…20mg
Simvastatin…40mg
Simvastatin…80mg.
30. Amson Vaccines 050189 Famcivir Tablet 250mg 22-07-2008 21-07-2018
Ltd., Islamabad Famciclovir…250mg
31. Amson Vaccines 021612 Fanim -5 Tablet 20-05-1998 19-05-2018
& Pharma (Pvt.) Each tablet contains:
Ltd., Islamabad Folic Acid USP…5mg
32. Amson Vaccines 033044 Hepazid 600mg Tablet 15-07-2004 14-07-2019
Ltd., Islamabad Ribavarin…..600mg
33. Amson Vaccines 029066 Hepazid Capsule 31-12-2002 08-01-2019
Ltd., Islamabad Ribavirin USP…..400 mg registration
dated:09-1-2004
34. Amson Vaccines 056429 Lidocaine 1% Injection 31-03-2009
& Pharma (Pvt.) Each ml contains: 30-03-2019
Ltd., Islamabad Lignocaine HCl … 10 mg
35. Amson Vaccines 029071 Loramine Syrup 31-12-2002 24-06-2018
& Pharma (Pvt.) Each 5ml contains: Transfer of
Ltd., Islamabad Loratadine …. 5 mg registration dated
25-06-2008
36. Amson Vaccines 029072 Loramine Tablet 31-12-2002 24-06-2018
Ltd., Islamabad Loratadine ….10 mg registration dated
25-06-2008
37. Amson Vaccines 052657 Meflonate Tablets 15-10-2008 14-10-2018
Ltd., Islamabad Artesunate…. 200mg
Mefloquine HCl….. 250mg
38. Amson Vaccines 052839 Migrex Tablets 100mg. 20-11-2008 19-11-2018
Ltd., Islamabad Sumatriptan as Succinate…
100mg
39. Amson Vaccines 050192 Migrex Tablets 50mg 22-07-2008 21-07-2018
Ltd., Islamabad Sumatriptan as
Succinate……50mg
40. Amson Vaccines 066441 Neo-Cotecxin 02-12-2010 01-12-2020
& Pharma (Pvt.) Injection 40 mg
Ltd., Islamabad Each ml contains:
Artemether …40 mg
41. Amson Vaccines 033046 Newmac Tablet 15-07-2004 14-07-2019
Ltd., Islamabad Clarithromycin
USP……500mg
42. Amson Vaccines 50193 Oxiflox Tablets 400mg 22-07-2008 21-07-2018
Ltd., Islamabad Moxifloxacin (as
HCl)…….400mg
43. Amson Vaccines 030993 Pisoriz Tablets 06-09-2003 05-09-2018
Ltd., Islamabad Rifampicin BP….60mg
Isoniazid BP…..30mg
Pyrazinamide BP…..150mg
44. Amson Vaccines 017349 Pyricam Capsules 10 mg 27-06-1995 21-10-2018
Ltd., Islamabad Piroxicam USP….. 10 mg registration dated
22-10-2003
45. Amson Vaccines 017350 Pyricam Capsules 20 mg 27-06-1995 21-10-2018
Ltd., Islamabad Piroxicam USP…..20 mg registration dated
22-10-2003
46. Amson Vaccines 056925 Randrin Tablet 28-07-2009 27-07-2019
& Pharma (Pvt.) Each Tablet contains:
Ltd., Islamabad Glucosamine
Sulphate…500 mg
Chondroitin Sulphate….
400mg
47. Amson Vaccines 050191 Sindam-P DS Tablets 22-07-2008 21-07-2018
& Pharma (Pvt.) 1st Tablet contains
Ltd., Islamabad Artesunate…..100mg
2nd Tablet Contains
Sulfadoxine.......500mg
Pyrimethamine ... 25mg
48. Amson Vaccines 050190 Sindam-P Tablets 22-07-2008 21-07-2018
& Pharma (Pvt.) 1st Tablet contains
Ltd., Islamabad Artesunate…....50mg
2nd Tablet Contains
Sulfadoxine.....500mg
Pyrimethamine ... 25mg
49. M/s. Pfizer 028760 Ponstan Flash Tablets 19-09-2002 31-05-2021
Pakistan Limited, Each tablet contains: Transfer of
Karachi Mefenamic Registration
Acid……250mg dated 01-6-2011
50. M/s. Pfizer 016143 Parketin 100mg Capsule 07-02-1995 31-05-2021
Pakistan Limited, Each capsule contains: Transfer of
Karachi Gabapentin…100mg Registration
dated 01-6-2011
51. M/s. Pfizer 016141 Parketin 400mg Capsule 07-02-1995 31-05-2021
Karachi Gabapentin…400mg Registration
dated 01-6-2011
52. M/s. Pfizer 012817 Feldene Gel 0.5% 19-08-1991 31-05-2021
Pakistan Limited, Each gram contains: Transfer of
Karachi Piroxicam…..5mg registration dated
01-06-2011
53. M/s. Pfizer 012301 Lincocin Syrup 13-02-1991 31-05-2021
Pakistan Limited, Each 5ml contains: Transfer of
Karachi Lincomycin HCl…. registration dated
monohydrate eq.to 01-06-2011
Lincomycin base 50mg
54. M/s. Pfizer 000208 Sytron Liquid 24-04-1976 31-05-2021
Karachi Sodium Iron Edetate registration dated
equivalent to…..55mg Iron 01-06-2011
55. M/s. Pfizer 000124 Dilantin Capsules 100mg 24-04-1976 31-05-2021
Karachi Phenytoin Sodium Registration
USP…100mg Dated 01-6-2011
56. M/s. Pfizer 000136 Dilantin Suspension 24-04-1976 31-05-2021
Karachi Phenytoin USP…30mg Registration
Dated01-6-2011
57. M/s. Pfizer 005284 Ferradol Syrup 02-04-1980 31-05-2021
Karachi Vitamin A….6000IU Registration
Vitamin D…266IU Dated
Vitamin B1…..1.3mg 01-06-2011
Vitamin B2….0.6mg
Ferric Ammonium
Citrate,Green NF…90mg
Niacinamide… 13.5mg
58. M/s. Pfizer 002798 Minipress Tablet 2mg 26-09-1977 31-05-2021
Pakistan Limited, Each Tablet contains: Transfer of
Karachi Prazosin HCl…equivalent registration dated
to Prazosin ….2mg 01-06-2011
59. M/s. Pfizer 002799 Minipress Tablet 1mg 26-09-1977 31-05-2021
Pakistan Limited, Each Tablet contains: Transfer of
Karachi Prazosin HCl…equivalent registration dated
to Prazosin ….1mg 01-06-2011
60. M/s. Pfizer 014428 Dilzem Retard Tablet 90mg 14-10-1993 31-05-2021
Karachi Diltiazem HCl…..90mg Registration
dated 01-6-2011
61. M/s. Pfizer 014429 Dilzem SR Tablet 180mg 14-10-1993 31-05-2021
Karachi Diltiazem HCl…..180mg Registration
dated 01-6-2011
62. M/s. Efroze 048599 Floxer 750mg Tablet 14-05-2008 13-05-2018
Chemical Each tablet contains:
Industries Levofloxacin Hemihydrate
(Pvt.),Karachi eq. to
Levofloxacin….750mg
63. M/s. Efroze 030092 Acudot Tablet 10-02-2003 09-02-2018
Industries (Pvt.), Isoniazid…75mg
Karachi Rifampicin…150mg
Ethambutol….275mg
64. M/s. Efroze 053111 Arbitel 20mg Tablet 10-11-2008 09-11-2018
Industries (Pvt.), Telmisartan….20mg
Karachi
Karachi
Karachi
67. M/s. Efroze 053103 Savuros 5mg Tablet 10-11-2008 09-11-2018
Chemical Each Tablet contains:
Industries (Pvt.), Rosuvastatin (as
Karachi calcium)….5mg
Industries (Pvt.), Rosuvastatin (as
Karachi calcium)….10mg
Industries (Pvt.) Rosuvastatin (as
,Karachi calcium)….20mg
70. M/s. Efroze 002205- Mefnac DS Suspension 18-09-2009 17-09-2019
Chemical Ex Each 5ml contains:
Industries (Pvt.), Mefanamic Acid….100mg
Karachi
71. M/s. Efroze 048602 Dryllin Syrup 24-05-2008 23-05-2018
Chemical Each 5ml contains:
Industries Aminophylline…32.0mg
(Pvt.),Karachi Ammonium Chloride.30mg
Diphenhydramine HCl
…8.0mg
Menthol….0.98mg
72. M/s. Efroze 058361 Worbenzol 200mg Tablet 15-08-2009 14-08-2019
Industries (Pvt.), Albendazole….200mg
Karachi
73. M/s. Xenon 071481 Osmolarz –ORS 28-10-2011 27-10-2021
Pharmaceuticals Each gram contains:
(Pvt.) Ltd., Sodium Chloride…1.3gm
Lahore Potassium Chloride..0.75gm
Trisodium citrate dehydrate
…1.45gm
Glucose anhydrous..6.75gm
74. Macter 055847 Co-Amoxi Tablets 1000mg 28-04-2009 08-05-2021
International Each tablet contains: Change of brand
(Pvt.) Limited, Amoxicillin (as Triydrate) name dated
Karachi ….875mg 09-05-2011
Clavulanic Acid (as
Potassium salt)….125mg
75. M/s. Hilton 030053 Celart 100mg Capsules 19-03-2003 18-03-2018
Pharma (Pvt.) Each capsule contains:
Ltd.,Karachi Celecoxib….100mg
76. M/s. Hilton 030054 Celart 200mg Capsules 19-03-2003 18-03-2018
Pharma (Pvt.) Each capsule contains:
Ltd.,Karachi Celecoxib….200mg
77. M/s. MKB 002715- Cetamol CF Tablets 24-11-2010 23-11-2020
Pharmaceuticals EX Each tablets contains:
(Pvt.) Ltd., Paracetamol….500mg
Peshawar Chlorpheniramine Maleate
….4mg
Pseudoephedrine HCl
..60mg
78. M/s. MKB 002725- Cetamol Drops 24-11-2010 23-11-2020
Pharmaceuticals EX Each ml contains:
(Pvt.) Ltd., Paracetamol….100mg
Peshawar
79. M/s. MKB 002720- Cetamol Extra Tablet 24-11-2010 23-11-2020
Pharmaceuticals EX Each tablet contains:
(Pvt.) Ltd., Paracetamol…500mg
Peshawar Caffeine….65mg
80. M/s. MKB 002716- Diaract Tablets 24-11-2010 23-11-2020
Pharmaceuticals EX Each tablet contains:
(Pvt.) Ltd., Metronidazole…400mg
Peshawar
81. M/s. MKB 002726- Diaract Suspension 24-11-2010 23-11-2020
Pharmaceuticals EX Each 5ml contains:
(Pvt.) Ltd., Metronidazole (as
Peshawar Benzoate)…200mg
82. M/s. Xenon 071480 Mesicol Tablet 28-10-2011 Deferred for
Pharmaceuticals Each tablet contains: confirmation of
(Pvt.) Ltd., Mesalazine…..400mg formulation and
Lahore coating nature of
tablet from the
concerned section.
83. Amson Vaccines 047998 Funginor Capsules 03-01-2008 Deferred for
& Pharma (Pvt.) Each Capsule Contains confirmation of
Ltd., Islamabad Itraconazole BP….. 100mg source of pellets
(B.P) from the concerned
section.
84. Amson Vaccines 038348 Amoxcine 250 mg Injection 26-05-2005 Deferred for
& Pharma (Pvt.) Each Vial Contains confirmation of
Ltd., Islamabad Amoxycillin Sodium Ph penicillin section
Eur. Eq to Amoxycillin by the licensing
…..250mg Division.
85. Amson Vaccines 037364 Amoxcine 500 mg Capsule 23-02-2005 Deferred for
& Pharma (Pvt.) Each Capsule Contains: penicillin section
Ltd., Islamabad Amoxycillin Trihydrate BP by the licensing
eq. to Amoxycillin B.P Division.
…..500mg
86. Amson Vaccines 029058 Curoxime 1.5g Injection 31-12-2002 Deferred for
& Pharma (Pvt.) Each vial contains Transfer of confirmation of
Ltd., Islamabad Cefuroxime Sodium USP registration dated cephalosporin
eq. to 25-06-2008 section from
Cefuroxime….1.5 g Licensing Division
87. Amson Vaccines 029056 Curoxime 250 mg Injection 31-12-2002 Deferred for
eq. to 25-06-2008 section from
Cefuroxime…250 mg Licensing Division
88. Amson Vaccines 029057 Curoxime 750 mg Injection 31-12-2002 Deferred for
eq. to Cefuroxime …750mg 25-06-2008 section from
Licensing Division
89. Amson Vaccines 029054 Cepham 250 mg Capsule 31-12-2002 Deferred for
& Pharma (Pvt.) Each capsule contains: Transfer of confirmation of
Ltd., Islamabad Cephalexin Mohohydrate registration dated cephalosporin
USP eq. to 25-06-2008 section from
Cephalexin 250 mg Licensing Division
90. Amson Vaccines 029053 Cepham 250 mg 31-12-2002 Deferred for
& Pharma (Pvt.) Suspension Transfer of confirmation of
Ltd., Islamabad Each 5ml contains: registration dated cephalosporin
Cephalexin Mohohydrate 25-06-2008 section from
USP eq. to Cephalexin Licensing Division
…….250mg
91. Amson Vaccines 029055 Cepham 500 mg Capsule 31-12-2002 Deferred for
& Pharma (Pvt.) Each capsule contains: Transfer of confirmation of
Ltd., Islamabad Cephalexin Mohohydrate registration dated cephalosporin
USP eq. to 25-06-2008 section from
Cephalexin 500 mg Licensing Division
92. Amson Vaccines 029052 Cepham 125 mg 31-12-2002 Deferred for
& Pharma (Pvt.) Suspension Transfer of confirmation of
Ltd., Islamabad Each 5ml contains registration dated cephalosporin
Cephalexin Mohohydrate 25-06-2008 section from
USP eq. to Licensing Division
Cephalexin….125 mg
93. Amson Vaccines 025848 Aceta INH Tablet 22-05-2000 Last Renewal
& Pharma (Pvt.) Thiacetazone…50 mg Transfer of Required (year
Ltd., Islamabad INH…100 mg registration dated 2010-2015)
07-07-2005 In this regard
shortcoming letter
has been
communicated to
the firm.
94. Amson Vaccines 021782 Agrippals - 1 Injection 20-05-1998 Transfer letter
& Pharma (Pvt.) Each 0.5ml dose contains required
Ltd., Islamabad 45 mcg of Viral Last Renewal
Hemagglutinins, Required
Consisituted by 15 mcg of Biological Product
Hemagglutinins may be referred to
derived from each of the concerned division
following strians for onward
An processing at their
A/WUHAN/359/96(H3N2) own end.
Like Strain In this regard
An shortcoming letter
A/BAYERN/7/95(H1N2)- has been
Like Strain communicated to
A B/BEIJING/ 184/93- the firm.
Like Strain
95. Amson Vaccines 019652 Albendal Suspension 07-08-1996 Last Renewal
& Pharma (Pvt.) Each 5ml contains Transfer of Required (2011-
Ltd., Islamabad Albendazole USP… registration dated 2016)
100mg 22-09-2006 In this regard
shortcoming letter
has been
communicated to
the firm.
96. Amson Vaccines 019651 Albendal Tablets 07-08-1996 Last Renewal
& Pharma (Pvt.) Albendazole USP…200mg Transfer of Required (2011-
Ltd., Islamabad registration dated 2016)
shortcoming letter
has been
communicated to
the firm.
97. Amson Vaccines 038532 Aller-Eze Syrup 08-06-2005 Last Renewal
& Pharma (Pvt.) Each 5ml contains Required
Ltd., Islamabad Clemastine Hydrogen (2010-2015)
Fumarate USP eq to In this regard
Clemastine USP….0.25mg shortcoming letter
has been
communicated to
the firm.
98. Amson Vaccines 025581 Amchoram - 4 Tablet 08-03-2000 Last Renewal
& Pharma (Pvt.) Each tablet contains: Transfer of Required
Ltd., Islamabad Chlorpheniramine Maleate registration dated (2010-2015)
BP…. 4 mg 09-06-2005 In this regard
shortcoming letter
has been
communicated to
the firm.
99. Amson Vaccines 017353 Amfen Tablets 200 mg 27-06-1995 Last Renewal
Ltd., Islamabad Ibuprofen BP…. 200 mg registration dated (2010-2015)
shortcoming letter
has been
communicated to
the firm.
100. Amson Vaccines 017354 Amfen Tablets 400 mg 27-06-1995 Last Renewal
Ltd., Islamabad Ibuprofen BP…. 400 mg registration dated (2010-2015)
shortcoming letter
has been
communicated to
the firm.
101. Amson Vaccines 021780 Amfer Tablet 20-05-1998 Transfer of
& Pharma (Pvt.) Each tablet contains: registration letter
Ltd., Islamabad Ferrous required
Fumarate USP 200 mg Last Renewal
required
In this regard
shortcoming letter
has been
communicated to
the firm.
102. Amson Vaccines 030388 Amflu 200 mg Capsule 30-05-2003 Last Renewal
& Pharma (Pvt.) Each capsule contains: Transfer of Required (2010-
Ltd., Islamabad Fluconazole……..200 mg registration dated 2015)
shortcoming letter
has been
communicated to
the firm.
103. Amson Vaccines 030386 Amflu 50 mg Capsule 30-05-2003 Last Renewal
& Pharma (Pvt.) Each capsule contains: Transfer of Required (2010-
Ltd., Islamabad Fluconazole …..50 mg registration dated 2015)
shortcoming letter
has been
communicated to
the firm.
104. Amson Vaccines 030389 Amflu Infusion 30-05-2003 Last Renewal
& Pharma (Pvt.) Each ml contains Transfer of Required (2010-
Ltd., Islamabad Fluconazole…. registration dated 2015)
2 mg 07-07-2005 In this regard
shortcoming letter
has been
communicated to
the firm.
105. Amson Vaccines 030385 Amflu Suspension 30-05-2003 Last Renewal
& Pharma (Pvt.) Each 5ml contains Transfer of Required (2010-
Ltd., Islamabad Fluconazole…..50 mg registration dated 2015)
shortcoming letter
has been
communicated to
the firm.
106. Amson Vaccines 048005 Amlat Tablet 10/10 03-01-2008 Confirmation of
& Pharma (Pvt.) Each Tablet contains submission of
Ltd., Islamabad Atorvastatin (as renewal of year
Calcium)…10mg 2018
Amlodepine (as In this regard
Besylate)…10mg. shortcoming letter
(Amson's Specs) has been
communicated to
the firm.
Calcium)………..20mg 2018
Besylate)………..10mg. shortcoming letter
(Amson's Specs) has been
communicated to
the firm.
has been
communicated to
the firm.
has been
communicated to
the firm.
110. Amson Vaccines 025162 Amrocin Tablets 05-08-1999 Last Renewal
& Pharma (Pvt.) Erythromycin stearate eq. Transfer of Required
Ltd., Islamabad to registration dated (2010-2015)
Erythromycin base BP… 31-01-2005 In this regard
250 mg shortcoming letter
has been
communicated to
the firm.
111. Amson Vaccines 029064 Amsim Tablet 10 mg 31-12-2002 Last Renewal
Ltd., Islamabad Simvastatin USP 10 mg registration dated (2009-2014)
shortcoming letter
has been
communicated to
the firm.
112. Amson Vaccines 029065 Amsim Tablet 20 mg 31-12-2002 Last Renewal
Ltd., Islamabad Simvastatin USP… 20 mg registration dated (2009-2014)
shortcoming letter
has been
communicated to
the firm.
113. Amson Vaccines 030390 Amsol -C Tablet 30-05-2003 Transfer
& Pharma (Pvt.) Each tablet contains: registration letter
Ltd., Islamabad Paracetamol USP 500 mg required
Codeine Phosphate USP 15 Last renewal
mg required
In this regard
shortcoming letter
has been
communicated to
the firm.
114. Amson Vaccines 025161 Amsolin Capsule 05-08-1999 Last Renewal
& Pharma (Pvt.) Each capsule contains: Transfer of Required
Ltd., Islamabad Amoxycillin Trihydrate eq. registration dated (2010-2015)
to 31-01-2005 In this regard
Amoxycillin Base Bp shortcoming letter
…500 mg has been
communicated to
the firm.
115. Amson Vaccines 025439 Amsoprin Tablet 23-11-1999 Last Renewal
Ltd., Islamabad Acetyl Salicylic Acid registration dated (2010-2015)
…300 mg 09-06-2005 In this regard
shortcoming letter
has been
communicated to
the firm.
116. Amson Vaccines 024290 Amsoton Capsule 12-03-2002 Last Renewal
Ltd., Islamabad Mefenamic Acid BP…..250 registration dated (2012-2017)
mg 10-07-2007 In this regard
shortcoming letter
has been
communicated to
the firm.
117. Amson Vaccines 025849 Amsozid Tablet 22-05-2000 Last Renewal
Ltd., Islamabad INH….300 mg registration dated (2010-2015)
shortcoming letter
has been
communicated to
the firm.
118. Amson Vaccines 025435 Amsozide - 100 Tablet 23-11-1999 Last Renewal
& Pharma (Pvt.) Isoniazid BP…… 100 mg Transfer of Required
Ltd., Islamabad registration dated (2010-2015)
shortcoming letter
has been
communicated to
the firm.
119. Amson Vaccines 018089 Amspar Syrup 24-09-1995 Last Renewal
& Pharma (Pvt.) Each 5ml contains Transfer of Required
Ltd., Islamabad Piperazine Citrate BP …. registration dated (2010-2015)
937.5 mg eq to 31-10-2005 In this regard
Piperazine Hydrate….. shortcoming letter
500 mg has been
communicated to
the firm.
120. Amson Vaccines 018088 Amspar Tablet 24-09-1995 Last Renewal
& Pharma (Pvt.) Piperazine Citrate BP eq Transfer of Required
Ltd., Islamabad to registration dated (2010-2015)
Piperazine Hydrate ….100 31-10-2005 In this regard
mg shortcoming letter
has been
communicated to
the firm.
121. Amson Vaccines 030992 Amzid Tablets 06-09-2003 Last Renewal
& Pharma (Pvt.) Each Tablet Contains Required
Ltd., Islamabad Rifampicin BP….150mg (2010-2015)
Isoniazid BP…..75mg In this regard
shortcoming letter
has been
communicated to
the firm.
122. Amson Vaccines 040693 Calciglu Effervescent 08-07-2005 Last Renewal
& Pharma (Pvt.) Tablets Required
Ltd., Islamabad Each Tablet Contains (2010-2015)
Calcium Lactate In this regard
Pentahydrate BP eq. to shortcoming letter
Calcium Lactate …..422mg has been
Calcium D Gluconate communicated to
Monohydrate BP eq. to the firm.
Calcium-D
Gluconate…....578mg
Calcium Carbonate
BP..........327mg
Vitamin C BP.........500mg
123. Amson Vaccines 037529 Ciprox Tablet 01-03-2005 Last Renewal
& Pharma (Pvt.) Each Tablet Contains: Required
Ltd., Islamabad Ciprofloxacin (as (2010-2015)
HCl)…….100mg In this regard
shortcoming letter
has been
communicated to
the firm.
124. Amson Vaccines 037530 Ciprox Tablet 01-03-2005 Last Renewal
& Pharma (Pvt.) Each Tablet Contains: Required
Ltd., Islamabad Ciprofloxacin (as (2010-2015)
HCl)…….750mg In this regard
shortcoming letter
has been
communicated to
the firm.
125. Amson Vaccines 025434 Cloxam-250 Capsule 23-11-1999 Last Renewal
Ltd., Islamabad Cloxacillin Sodium eq. to Registration (2010-2015)
Cloxacillin base 250 mg dated In this regard
09-06-2005 shortcoming letter
has been
communicated to
the firm.
126. Amson Vaccines 017375 Coenza Capsules 27-06-1995 Last Renewal
Ltd., Islamabad Ubidecarenone…. 50 mg registration dated (2010-2015)
shortcoming letter
has been
communicated to
the firm.
127. Amson Vaccines 017347 Damex Cough Syrup 27-06-1995 Last Renewal
& Pharma (Pvt.) Each 5 ml contains:- Transfer of Required
Ltd., Islamabad Aminophylline BP… 32 registration dated (2010-2015)
Diphenhydramine BP… 8 shortcoming letter
mg has been
Ammonium Chloride BP… communicated to
30 mg the firm.
Menthol…. 0.98 mg
128. Amson Vaccines 018726 Dipet Injection 08-02-1996 Transfer letter
& Pharma (Pvt.) Each 0.5ml contains: required
Ltd., Islamabad Diphtheria Toxoid….30 IU Last Renewal
Tetanus Toxoid…. 60 Required.
IU Biological product
Bordetella Pertussis…. 4 IU may be referred to
concerned division
for onward
processing at their
end.
In this regard
shortcoming letter
has been
communicated to
the firm.
129. Amson Vaccines 017356 Epiphen Capsules 27-06-1995 Last Renewal
& Pharma (Pvt.) Phenytoin Sodium BP…. Transfer of Required
Ltd., Islamabad ..100 mg registration dated (2010-2015)
shortcoming letter
has been
communicated to
the firm.
130. Amson Vaccines 025846 Ethrifid - P Tablet 22-05-2000 Last Renewal
& Pharma (Pvt.) Rifampicin…120 mg Transfer of Required
Ltd., Islamabad Ethambutol HCl…. 225 registration dated (2010-2015)
INH….60 mg shortcoming letter
Pyrazinamide…. 300 mg has been
communicated to
the firm.
131. Amson Vaccines 042604 Flugon Capsules 75mg 25-02-2006 Last Renewal
& Pharma (Pvt.) Each Capsule contains: Required
Ltd., Islamabad Oseltamivir Phosphate eq. (2011-2016)
to Oseltamivir……75mg In this regard
shortcoming letter
has been
communicated to
the firm.
132. Amson Vaccines 042605 Flugon Suspension 25-02-2006 Last Renewal

& Pharma (Pvt.) Each 5ml contains: Required
Ltd., Islamabad Oseltamivir Phosphate eq. (2011-2016)
to Oseltamivir……60mg In this regard
shortcoming letter
has been
communicated to
the firm.
133. Amson Vaccines 017366 Gentam Injection 40 27-06-1995 Last Renewal
& Pharma (Pvt.) Each 2ml ampoule Transfer of Required
Ltd., Islamabad contains: registration dated (2010-2015)
Gentamycin Base 40 mg 07-07-2005 In this regard
shortcoming letter
has been
communicated to
the firm.
134. Amson Vaccines 017367 Gentam Injection 80 27-06-1995 Last Renewal
Gentamycin Base 80 mg 07-07-2005 In this regard
shortcoming letter
has been
communicated to
the firm.
135. Amson Vaccines 017357 Gliclasol Tablet 27-06-1995 Last Renewal
& Pharma (Pvt.) Gliclazide BP…. 80 mg Transfer of Required
Ltd., Islamabad registration dated (2010-2015)
shortcoming letter
has been
communicated to
the firm.
136. Amson Vaccines 042900 Glimer Tablets 1mg 18-03-2006 Last Renewal
& Pharma (Pvt.) Each Tablet contains Required
Ltd., Islamabad Glimepiride…1mg (2011-2016)
In this regard
shortcoming letter
has been
communicated to
the firm.
Ltd., Islamabad Glimepiride..2mg (2011-2016)
In this regard
shortcoming letter
has been
communicated to
the firm.
In this regard
shortcoming letter
has been
communicated to
the firm.
In this regard
shortcoming letter
has been
communicated to
the firm.
140. Amson Vaccines 019671 Hemofer Tablet 07-08-1996 Last Renewal
Ltd., Islamabad Ferrous Sulphate BP …150 registration dated (2011-2016)
Folic Acid BP…. 0.5 mg shortcoming letter
has been
communicated to
the firm.
141. Amson Vaccines 019663 Hypril 4 Tablets 07-08-1996 Last Renewal
Ltd., Islamabad Perindopril INN 4 mg registration dated (2011-2016)
shortcoming letter
has been
communicated to
the firm.
142. Amson Vaccines 040699 Ibro Spray 08-07-2005 Last Renewal
& Pharma (Pvt.) Contains Required
Ltd., Islamabad Ipratropium (2010-2015)
Bromide….40mcg In this regard
shortcoming letter
has been
communicated to
the firm.
143. Amson Vaccines 021613 Irosul Tablet 200 mg 20-05-1998 Transfer letter
& Pharma (Pvt.) Each tablet contains: required
Ltd., Islamabad Ferrous Sulphate Last Renewal
USP…..200 mg Required.
In this regard
shortcoming letter
has been
communicated to
the firm.
144. Amson Vaccines 027540 Isotham Tablet 04-05-2002 Last Renewal
Ltd., Islamabad Isoniazid BP…..150 mg registration dated (2009-2014)
Ethambutol HCl BP…..400 18-08-2004 In this regard
mg shortcoming letter
has been
communicated to
the firm.
145. Amson Vaccines 019650 Levam 40 mg tablets 07-08-1996 Last Renewal
Ltd., Islamabad Levamisole USP (As HCl) registration dated (2011-2016)
….40 mg 22-09-2006 In this regard
shortcoming letter
has been
communicated to
the firm.
146. Amson Vaccines 017368 Majeepam Injection 10 mg 27-06-1995 Last Renewal
Diazepam BP 10 mg 07-07-2005 In this regard
shortcoming letter
has been
communicated to
the firm.
147. Amson Vaccines 025657 M-Butamol Tablet 30-03-2000 Last Renewal
Ltd., Islamabad Salbutamol BP 4 mg registration dated (2010-2015)
shortcoming letter
has been
communicated to
the firm.
148. Amson Vaccines 017377 Metro 200 mg Tablet 27-06-1995 Last Renewal
Ltd., Islamabad Metronidazole BP 200mg registration dated (2010-2015)
shortcoming letter
has been
communicated to
the firm.
149. Amson Vaccines 017378 Metro 400 mg Tablet 27-06-1995 Last Renewal
Ltd., Islamabad Metronidazole BP 400mg registration dated (2010-2015)
shortcoming letter
has been
communicated to
the firm.
150. Amson Vaccines 017379 Metro Suspension 27-06-1995 Last Renewal
& Pharma (Pvt.) Each 5ml contains: Transfer of Required
Ltd., Islamabad Metronidazole Benzoate registration dated (2010-2015)
shortcoming letter
has been
communicated to
the firm.
151. Amson Vaccines 025844 M-Pcin Capsule 22-05-2000 Last Renewal
Ltd., Islamabad Rifampicin BP 150 mg registration (2010-2015)
dated: In this regard
has been
communicated to
the firm.
152. Amson Vaccines 025845 M-Pcin Capsule 22-05-2000 Last Renewal
& Pharma (Pvt.) Rifampicin BP 300 mg Transfer of Required
Ltd., Islamabad registration (2010-2015)
dated: In this regard
has been
communicated to
the firm.
153. Amson Vaccines 025159 Nacilin Injection 05-08-1999 Last Renewal
& Pharma (Pvt.) Each vial contains Transfer of Required
Ltd., Islamabad Ampicillin Sodium eq. to registration dated (2010-2015)
Ampicillin base… 250 mg 31-01-2005 In this regard
shortcoming letter
has been
communicated to
the firm.
154. Amson Vaccines 025160 Nacilin Injection 05-08-1999 Last Renewal
Ltd., Islamabad Ampicillin Sodium eq. to registration dated (2010-2015)
Ampicillin base … 500 mg 31-01-2005 In this regard
shortcoming letter
has been
communicated to
the firm.
155. Amson Vaccines 017370 Phemate Injection 50 mg 27-06-1995 Last Renewal
Ltd., Islamabad contains: registration (2010-2015)
Pheniramine Maleate BP… dated: In this regard
50 mg 07-07-2005 shortcoming letter
has been
communicated to
the firm.
156. Amson Vaccines 025843 Pulmobutol Tablet 22-05-2000 Last Renewal
Ltd., Islamabad Ethambutol…. 400 mg registration dated (2009-2014)
shortcoming letter
has been
communicated to
the firm.
157. Amson Vaccines 018087 Pyraquin Syrup 24-09-1995 Last Renewal
Ltd., Islamabad Chloroquine Phosphate…. registration dated (2010-2015)
eq. to Chloroquine….50 mg shortcoming letter
has been
communicated to
the firm.
158. Amson Vaccines 018086 Pyraquin Tablets 24-09-1995 Last Renewal
& Pharma (Pvt.) Each contains (Film/Sugar) Transfer of Required
Ltd., Islamabad contains registration dated (2010-2015)
Chloroquine Phosphate 31-10-2005 In this regard
242.5 mg shortcoming letter
eq. to has been
Chloroquine……..150 mg communicated to
the firm.
159. Amson Vaccines 025847 Pyzam Tablet 22-05-2000 Last Renewal
Ltd., Islamabad Pyrazinamide….. 500 mg registration dated (2009-2014)
shortcoming letter
has been
communicated to
the firm.
160. Amson Vaccines 040698 Resonate Tablets 35mg 08-07-2005 Change of brand
& Pharma (Pvt.) Each Tablet contains name evidence
Ltd., Islamabad Risedronate Sodium…. required
35mg Last Renewal
Required
(2010-2015)
In this regard
shortcoming letter
has been
communicated to
the firm.
161. Amson Vaccines 040697 Resonate Tablets 5mg 08-07-2005 Change of brand
& Pharma (Pvt.) Each Tablet contains name evidence
Ltd., Islamabad Risedronate Sodium…. required
5mg Last Renewal
Required
(2010-2015)
In this regard
shortcoming letter
has been
communicated to
the firm.
162. Amson Vaccines 027542 Rhoza Tablet 04-05-2002 Last Renewal
& Pharma (Pvt.) Rifampicin BP …150 mg Transfer of Required
Ltd., Islamabad Isoniazid BP….75 mg Registration (2012-2017)
Pyrazinamide BP… 400 dated: In this regard
mg 10-07-2007 shortcoming letter
has been
communicated to
the firm.
163. Amson Vaccines 030991 Rifason Tablets 06-09-2003 Last Renewal
& Pharma (Pvt.) Each Tablet Contains Required
Ltd., Islamabad Rifampicin BP….60mg (2008-2013)
Isoniazid BP…..30mg In this regard
shortcoming letter
has been
communicated to
the firm.
164. Amson Vaccines 027539 Ripazin Tablet 04-05-2002 Last Renewal
Ltd., Islamabad Rifampicin BP….150 mg Registration (2012-2017)
Isoniazid BP….150 mg dated In this regard
Pyrazinamide BP…500 mg 10-07-2007 shortcoming letter
has been
communicated to
firm.
165. Amson Vaccines 027541 Ripe Tablet 04-05-2002 Last Renewal
Ltd., Islamabad Rifampicin BP….150 mg registration dated (2009-2014)
Isoniazid BP 75 mg 18-08-2004 In this regard
Ethambutol HCl BP….275 shortcoming letter
mg has been
Pyrazinamide BP…..400 communicated to
mg the firm.
166. Amson Vaccines 019656 Synoxil 1.2 Injection 07-08-1996 Last Renewal
Ltd., Islamabad Clavulanic Acid (As registration dated (2011-2016)
Potassium Salt) 22-09-2006 In this regard
USP…200mg shortcoming letter
Amoxycillin Trihydrate eq. has been
to Amoxycillin Base communicated to
USP…..1000 mg the firm.
167. Amson Vaccines 019653 Synoxil 375 mg Tablet 07-08-1996 Last Renewal
USP…..125mg shortcoming letter
USP….250 mg the firm.
168. Amson Vaccines 019657 Synoxil 600 Injection 07-08-1996 Last Renewal
Potassium Salt) USP 22-09-2006 In this regard
100mg shortcoming letter
to Amoxycillin Base USP communicated to
500 mg the firm.
169. Amson Vaccines 019655 Synoxil 625 mg Tablet 07-08-1996 Last Renewal
& Pharma (Pvt.) Clavulanic Acid (As Transfer of Required
Ltd., Islamabad Potassium Salt) USP registration dated (2011-2016)
125mg 22-09-2006 In this regard
Amoxycillin Trihydrate eq. shortcoming letter
to Amoxycillin Base USP has been
500 mg communicated to
the firm.
170. Amson Vaccines 019654 Synoxil Suspension 07-08-1996 Last Renewal
USP….31mg shortcoming letter
USP…..125 mg the firm.
171. Amson Vaccines 021781 Tetradox 100 Capsule 20-05-1998 Transfer letter
& Pharma (Pvt.) Each capsule contains: required
Ltd., Islamabad Doxycycline BP….. 100 Last Renewal
mg Required
(2008-2013)
In this regard
shortcoming letter
has been
communicated to
the firm.
172. Amson Vaccines 019669 Thiaben Tablet 07-08-1996 Last Renewal
Ltd., Islamabad Thiabendazole BP….. 500 registration dated (2011-2016)
shortcoming letter
has been
communicated to
the firm.
173. Amson Vaccines 025436 Vitam Tablet 23-11-1999 Last Renewal
& Pharma (Pvt.) Vitamin B1 B.P 15 mg Transfer of Required
Ltd., Islamabad Vitamin B2 B.P 10 mg Registration (2010-2015)
Vitamin B6 B.P 5 mg dated In this regard
Vitamin B12 B.P 4 mcg 09-06-2005 shortcoming letter
Niacinamide B.P 100 mg has been
Calcium Pantothenate BP communicated to
20 mg the firm.
Vitamin C B.P 500 mg
174. Amson Vaccines 019648 Worex Tablet 07-08-1996 Last Renewal
Ltd., Islamabad Mebendazole USP ….. 100 registration dated (2011-2016)
shortcoming letter
has been
communicated to
the firm.
175. Amson Vaccines 019649 Worex Tablet 07-08-1996 Last Renewal
Ltd., Islamabad Mebendazole USP….. 500 registration dated (2011-2016)
shortcoming letter
has been
communicated to
the firm.
176. Amson Vaccines 042904 Zolimat 2.5mg Tablets 18-03-2006 Last Renewal
Ltd., Islamabad Zolmitriptan…2.5mg (2011-2016)
In this regard
shortcoming letter
has been
communicated to
the firm.
177. M/s. Pfizer 008546 Trosyd Dermal Cream 13-11-1985 Change of brand
Pakistan Limited, Each gm contains: Transfer of name evidence
Karachi Tioconazole….10mg Registration required.
Dated In this regard
has been
communicated to
the firm.
178. M/s. Efroze 037342 Faxy Tablet 18-02-2005 Last Renewal
Chemical Each tablet contain: Required
Industries Fexofenadine (as (2010-2015)
(Pvt.),Karachi HCl)….120mg In this regard
shortcoming letter
has been
communicated to
the firm.
179. M/s. Efroze 042344 Faxy Tablet 20-04-2006 Last Renewal
Chemical Each tablet contain: Required
Industries Fexofenadine (as (2011-2016)
(Pvt.),Karachi HCl)….60mg In this regard
shortcoming letter
has been
communicated to
the firm.
180. M/s. Medicure 042495 Vizamed 1mg Tablet 28-07-2006 Last Renewal
Laboratories, Each tablet contains: Required
Karachi Risperidone….1mg (2011-2016)
DML Required,
Confirmation of
Manufacturer
Address Required.
In this regard
shortcoming letter
has been
communicated to
the firm.
181. M/s. Medicure 042496 Vizamed 2mg Tablets -do- -do-
Laboratories, Each tablet contains:
Karachi Risperidone….2mg
182. M/s. Medicure 007414 Vitamin B Compound 18-12-1984 Last Renewal
Laboratories, Tablets Required
Karachi Each tablet contains: (2009-2014)
Thiamine HCl….1mg In this regard
Riboflavine….1mg shortcoming letter
Nicotinamide…15mg has been
communicated to
the firm.
183. M/s. Medicure 039788 Irocure 50mg Syrup Change of brand Initial Reg. Letter
Laboratories, Iron Protein Polymaltose name dated required
Karachi Complex-50mg 20-05-2008
184. M/s. Medicure 042485 Osto 250mg Tablets 27-07-2006 Last Renewal
Karachi Naproxen (2011-2016). In this
Sodium(base)…250mg regard shortcoming
letter has been
communicated to
the firm.
185. M/s. Medicure 042497 Medbles 20mg Tablet 28-07-2006 Last Renewal
Karachi Paroxetine….20mg (2011-2016)
Confirmation of
Manufacturer
Address Required
In this regard
shortcoming letter
has been
communicated to
the firm.
186. M/s. Medicure 042493 Norflu 180mg Tablets 27-07-2006 -do-
Karachi Fexofenadine….180mg
187. M/s. Medicure 007415 Medi Vit Tablets Change of brand Initial Registration
Laboratories, name dated letter required
Karachi 04-04-1996 Last Renewal
Required
(2011-2016)
In this regard
shortcoming letter
has been
communicated to
the firm.
188. M/s. Medicure 042486 Osto 500mg Tablet 27-07-2006 Last Renewal
Karachi Naproxen (2011-2016)
Sodium(base)….500mg Confirmation of
Manufacturer
Address Required
In this regard
shortcoming letter
has been
communicated to
the firm.
189. M/s. Medicure 042487 Paralin Tablets 27-07-2006 -do-
Karachi Paracetamol….450mg
Orphenadrine Citrate.35mg
190. M/s. Medicure 007400 Paracetamol Tablets 500mg 18-12-1984 Last Renewal
Karachi Paracetamol….500mg (2009-2014)
In this regard
shortcoming letter
has been
communicated to
the firm.
191. M/s. Medicure 070537 Ezma 40mg Capsules 30-04-2011 Prescribed fee of
Laboratories, Each capsule contains: imported pellets
Karachi Esomeperazole enteric required
coated pellets eq. to Pellets are imported
Esomeperazole…. 40mg from
M/s. Murli Krishna
Pharma (Pvt.) Ltd.
D-98 Ranjangaon
M.I.D.C.
Ranjangaon,
Taluka-
Shirur,District-
Pune,412209-
Maharashtra, India
In this regard
shortcoming letter
has been
communicated to
the firm.
192. M/s. Medicure 042482 Lacmed Syrup Form 5-B, Initial
Laboratories, Registration letter
Karachi required, Last
Renewal Required
(if any)
In this regard
shortcoming letter
has been
communicated to
the firm.
193. M/s. Medicure 048524 STL 100mg Tablet -do-
Laboratories,
Karachi
194. M/s. Medicure 012757 Medirol Powder 04-08-1991 Form 5-B
Laboratories, Each Packet contains: Required,
Karachi Sodium Chloride B.P Initial Registration
…3.5gm letter required, last
Potassium Chloride B.P Renewal Required
…1.5gm (2011-2016)
Trisodium Citrate B.P In this regard
….2.9gm shortcoming letter
Glucose B.P…20gm has been
Lemon Powder B.P.C communicated to
….0.1gm the firm.
195. M/s. Medicure 007885 Medidex 03-02-1985 last Renewal
Laboratories, Contains: Required
Karachi Iodine…4%w/w (2010-2015)
Methyl Salicylate…5%w/w In this regard
shortcoming letter
has been
communicated to
the firm.
196. M/s. Medicure 070534 OME MED 20mg Capsules 30-04-2011 Prescribed fee of
Karachi Omeperazole enteric coated required
pellets eq. to Pellets are imported
Omeperazole….20mg from
M/s. Murli Krishna
Pharma (Pvt.) Ltd.
D-98 Ranjangaon
M.I.D.C.
Ranjangaon,
Taluka-
Shirur,District-
Pune,412209-
Maharashtra, India
In this regard
shortcoming letter
has been
communicated to
the firm.
197. M/s. Medicure 044270 Sangofer Syrup Change of brand Initial Registration
Laboratories, Iron Protein name dated letter required, Last
Karachi Succinylate…800mg eq. to 13-08-2007 Renewal Required
IronFe….40mg (2012-2017)
In this regard
shortcoming letter
has been
communicated to
the firm.
198. M/s. Medicure 042490 Tormed 20mg Tablet 27-07-2006 Last Renewal
Karachi Atorvastatin (as calcium (2011-2016)
trihydrate salt)…..20mg In this regard
shortcoming letter
has been
communicated to
the firm.
199. M/s. Medicure 042492 Norflu 120mg Tablet 27-07-2006 Last Renewal
Karachi Fexofenadine….120mg (2011-2016). In this
regard shortcoming
letter has been
communicated to
the firm.
200. M/s. Medicure 042488 Merota 10mg Tablet 27-07-2006 Last Renewal
Karachi Loratadine…10mg (2011-2016)
Change of brand
name evidence
required.
In this regard
shortcoming letter
has been
communicated to
the firm.
201. M/s. Medicure 007412 Aspirin Compound Tablet Initial Registration
Laboratories, Each tablet contains: letter required, Last
Karachi Aspirin….300mg Renewal Required
Paracetamol…200mg (if any)
Caffeine…30mg In this regard
shortcoming letter
has been
communicated to
the firm.
202. M/s. Medicure 042489 Tormed 10mg Tablets 27-07-2006 Last Renewal
Karachi Atorvastatin (as Calcium (2011-2016)
Trihydrate)…. 10mg In this regard
shortcoming letter
has been
communicated to
the firm.
203. M/s. Medicure 070535 Ezma 20mg Capsules 30-04-2011 Prescribed fee of
Karachi Esomeperazole enteric required
coated pellets eq. to Pellets are imported
esomeperazole…20mg from
M/s. Murli Krishna
Pharma (Pvt.) Ltd.
D-98 Ranjangaon
M.I.D.C.
Ranjangaon,
Taluka-
Shirur,District-
Pune,412209-
Maharashtra, India
In this regard
shortcoming letter
has been issued to
the firm.
204. M/s. Medicure 042483 Medic-P 75mg Tablet 27-07-2006 Last Renewal
Karachi Diclofenac (2011-2016)
Potassium….75mg In this regard
shortcoming letter
has been
communicated to
the firm.
205. M/s. Medicure 048523 STL 50mg Tablet Form 5-B,Initial
Laboratories, Registration letter
Karachi required, Last
Renewal Required
(if any)
In this regard
shortcoming letter
has been
communicated to
the firm.
206. M/s. Medicure 012758 Promethex Elixir 04-08-1991 Initial Registration
Laboratories, Each 5ml contains: letter required for
Karachi Promethazine HCl…5mg confirmation of
Vitamin C….10mg address
Citric Acid…..50mg Last Renewal
Required
(2011-2016)
In this regard
shortcoming letter
has been
communicated to
the firm.
207. M/s. Medicure 042484 Wabrofen Tablet 27-07-2006 Last Renewal
Karachi Flurbiprofen…..100mg (2011-2016)
In this regard
shortcoming letter
has been
communicated to
the firm.
208. M/s. Xenon 026061 Xedol Tablets 12-09-2000 Last Renewal
Pharmaceuticals Each tablet contains: Required
(Pvt.) Ltd., Albendazole….200mg (2010-2015)
Lahore DML Required
In this regard
shortcoming letter
has been
communicated to
the firm.
209. M/s. Xenon 026062 Xedol Suspension -do- -do-
Pharmaceuticals Each 5ml contains:
(Pvt.) Ltd., Albendazole…100mg
Lahore
210. M/s. Spadix 062923 Zodex Injection Initial Registration
Pharmaceuticals Letter required,
,Islamabad Form 5-B, DML
Required,
Post Registration
letter required (if
any)
In this regard
shortcoming letter
has been issued to
the firm.
211. M/s. Spadix 062939 Dexime Capsules -do-
Pharmaceuticals
,Islamabad
212. M/s. Spadix 62920 Nodex Injection -do-
Pharmaceuticals
,Islamabad
213. M/s. Spadix 62915 Dexpime Injection -do-
Pharmaceuticals
,Islamabad
214. M/s. Spadix 62916 Dexpime Injection 1gm -do-
Pharmaceuticals
,Islamabad
215. M/s. Spadix 62935 Dexef Capsules -do-
Pharmaceuticals
,Islamabad
216. M/s. Spadix 62933 Dexef Dry Suspension -do-
Pharmaceuticals
,Islamabad
217. M/s. Spadix 62924 Zodex Injection -do-
Pharmaceuticals
,Islamabad
218. M/s. Spadix 62938 Dexime Suspension -do-
Pharmaceuticals
,Islamabad
Pharmaceuticals
,Islamabad
220. M/s. Spadix 62934 Dexef Dry Suspension -do-
Pharmaceuticals
,Islamabad
Pharmaceuticals
,Islamabad
222. M/s. Spadix 62937 Dexime Suspension -do-
Pharmaceuticals
,Islamabad
223. M/s. Medisure Puroxan 400mg Form 5-B, Initial
Laboratories Registration Letter
Pakistan Required, Post
(PVT.)Limited,K Registration
arachi Variation (if any),
Last Renewal (if
any), DML
Required. In this
regard shortcoming
letter has been
communicated to
the firm.
224. M/s. Medisure Tolymax 50mg -do-
Laboratories
Pakistan (PVT.)
Limited,Karachi
225. M/s. Medisure Tamlev 250mg -do-

Laboratories
Pakistan (PVT.)
Limited,Karachi
226. M/s. Medisure Mal-Anx Dry suspension -do-
Laboratories
Pakistan (PVT.)
Limited,Karachi
227. M/s. Medisure Xopra Plus -do-

Laboratories
Pakistan (PVT.)
Limited,Karachi
228. M/s. Medisure Abgenix 20mg Tablet -do-

Laboratories
Pakistan (PVT.)
Limited,Karachi
229. M/s. Medisure Miosil 5mg -do-

Laboratories
Pakistan (PVT.)
Limited,Karachi
230. M/s. Medisure Miosil 10mg -do-

Laboratories
Pakistan (PVT.)
Limited,Karachi
231. M/s. Medisure Pinsure 10mg -do-

Laboratories
Pakistan (PVT.)
Limited,Karachi
232. M/s. Medisure Arthosure Gel -do-

Laboratories
Pakistan (PVT.)
Limited,Karachi
233. M/s. Medisure Pinsure 7.5mg -do-

Laboratories
Pakistan (PVT.)
Limited,Karachi
234. M/s. Medisure Nidol 100mg Tablet -do-

Laboratories
Pakistan (PVT.)
Limited,Karachi
235. M/s. Medisure Diabetal 2mg -do-

Laboratories
Pakistan (PVT.)
Limited,Karachi
236. M/s. Medisure Onyfine 125mg Tab -do-

Laboratories
Pakistan (PVT.)
Limited,Karachi
237. M/s. Medisure Ascorium Sachet -do-
Laboratories
Pakistan (PVT.)
Limited,Karachi
238. M/s. Medisure Diabetal 1mg -do-
Laboratories
Pakistan (PVT.)
Limited,Karachi
239. M/s. Medisure Kovence -do-
Laboratories
Pakistan (PVT.)
Limited,Karachi
240. M/s. Medisure Albuterol Syrup -do-
Laboratories
Pakistan (PVT.)
Limited,Karachi
241. M/s. Medisure Chewron Syrup -do-
Laboratories
Pakistan (PVT.)
Limited,Karachi
242. M/s. Medisure Lactusure Syrup -do-
Laboratories
Pakistan (PVT.)
Limited,Karachi
243. M/s. MKB 047902 Bonjour 0.5mcg Tablet 05-12-2007 Transfer letter from
Pharmaceuticals Each Tablet contains: Change of brand M/s. Nova
(Pvt.) Ltd., Alfacalcidol….0.5mcg name dated Pharmaceuticals to
Peshawar 27-03-2010 M/s. MKB
Pharmaceuticals
required
In this regard
shortcoming letter
has been
communicated to
the firm.
244. M/s. MKB 047901 Bonjour 1mcg Tablet -do- -do-
Pharmaceuticals Each Tablet contains:
(Pvt.) Ltd., Alfacalcidol….1mcg
Peshawar
245. Macter 011656 Sigel Suspension 02-09-1990 Last Renewal
International Ech 5ml contains: Required
(Pvt.) Limited, Aluminium Hydroxide (2010-2015)
Karachi Gel….300mg In this regard
Magnesium Hydroxide shortcoming letter
…150mg has been
Simethicone….125mg communicated to
the firm.
246. Macter 055752 Mac Mether Plus Tablet 15-04-2009 Change of brand
International Each tablet contains: name evidence
(Pvt.) Limited, Artemether…20mg required.
Karachi Lumefantrine…120mg In this regard
shortcoming letter
has been
communicated to
the firm.
247. M/s. Ahad 045824 Safemed Injection 20-01-2007 Fee as per S.R.O
International Each 100ml contains: Required
Pharmaceuticals, Metronidazole….500mg Initial Registration
Ltd.,Dera Ismail Water for injection q.s to letter required
Khan make 100ml DML Required.
In this regard
shortcoming letter
has been
communicated to
the firm.
248. M/s. Regent 007692 Multivitamin Tablets 12-11-1984 DML Required
Laboratories,Kara Each tablet contains: In this regard
chi Vitamin D…300 Units shortcoming letter
Vitamin A ..2500 Units has been
Riboflavine…0.5mg communicated to
Thiamine HCl….1.0mg the firm.
Nicotinamide…7.5mg
Ascorbic Acid…15.0mg
249. M/s. Nexus 039538 Flycold CF Tablet 31-08-2005 Initial Registration
Pharma (Pvt.) Each tablet contains: (as per Form 5- letter required, Last
Ltd.,Karachi Paracetamol…500mg B) Renewal Required
Pseudoephidrine (2010-2015), DML
HCl…60mg Required. In this
Chlorpheniramine regard shortcoming
Maleate…4mg letter has been
communicated to
the firm.
250. M/s. Nexus 039335 P-Dart (ORS) Sachet 04-06-2005 -do-
Pharma (Pvt.) Sodium Chloride..3.50gm (as per Form 5-
Ltd.,Karachi Potassium Chloride B)
…1.50gm
Sodium Citrate…2.90gm
Glucose (Anhydrous)
…20gm
251. M/s. Sanofi- 011034 Brulidine Cream 16-05-1990 Last Renewal
Aventis Pakistan Each 15gm contains: Transfer of Required (2011-
Limited Dibromopropamidine Registration of 2016). Transfer to
Isethionate B.P…0.16% product dated Sanofi-Aventis
w/w 28-07-2006 Pakistan Limited
Karachi Plant is
still pending as per
Form 5-B. In this
regard shortcoming
letter has been
communicated to
the firm.
252. M/s. Medicon 8418 Saldrine 120ml Syrup Initial reg. letter
Pharmaceuticals Each 5ml contains:- In this regard
Industries (Pvt) Ammonium Chloride …. shortcoming letter
Ltd., Peshawar. 30mg has been
Menthol …. 0.98mg communicated to
Aminophlline …. 32mg the firm.
Diphenhydramine …. 8mg
253. M/s. Medicon 8420 Ferrobex Capsule Initial reg. letter
Pharmaceuticals Each capsule contains:- In this regard
Industries (Pvt) shortcoming letter
Ltd., Peshawar. has been
communicated to
the firm.
254. M/s. Medicon 8380 Lybex Syrup 01-10-1985 Transfer letter
Pharmaceuticals Each 30ml contains:- Formulation
Industries (Pvt) Thiamine HCl …. 25mg In this regard
Ltd., Peshawar. Riboflavin …. 10mg shortcoming letter
Sodium Pyridorine HCI …. has been
6mg communicated to
Cyanocobalamine …. 50mg the firm.
Calcium D-Pantothenate
…. 15mg
Inositol …. 30mg
Nicotinamide …. 108mg
Ascorhive Acid …. 450mg
Lysine Mono HCI ….
200mg
255. M/s. Medicon 15173 Silugel Syrup Initial reg. letter
Industries (Pvt) Aluminium Hydroxide …. shortcoming letter
Magnesium Hydroxide …. communicated to
80mg the firm.
Simethicone …. 25mg
256. M/s. Medicon 5752 Alkasid Syrup 05-07-1984 Transfer
Industries (Pvt) Sodium Acid Citrate …. shortcoming letter
Ltd., Peshawar. 1.25gm has been
communicated to
the firm.
257. M/s. Medicon 5749 Paracetamol Elixir Syrup Initial reg. letter
Industries (Pvt) Paracetamol …. 125mg shortcoming letter
communicated to
the firm.
258. M/s. Medicon 8113 Salcos Sachet 30-04-1985 Transfer
Pharmaceuticals Each Sachet contains:- Formulation
Industries (Pvt) Sodium Chloride …. 3.5gm In this regard
Ltd., Peshawar. Potassium chloride …. shortcoming letter
1.5gm has been
Glucose Anhydrous..20gm communicated to
Trisodium Citrate the firm.
Dihydrate …. 2.9gm
259. M/s. Medicon 7621 Phenobarabitone Tablet 18-11-1984 Initial reg. letter
Pharmaceuticals Each tablet contains:- In this regard
Industries (Pvt) Phenobarbitone …. 30mg shortcoming letter
communicated to
the firm.
260. M/s. Medicon 11313 Medixil Syrup 125mg 17-06-1990 Transfer
Pharmaceuticals Each 5ml contain:- Change of Brand In this regard
Industries (Pvt) Amoxicillin …. 125mg name on shortcoming letter
Ltd., Peshawar. 15-06-2001 has been
communicated to
the firm.
261. M/s. Medicon 11310 Medixil Syrup 250mg 19-06-1990 Transfer
Pharmaceuticals Each 5ml contain:- Change of Brand Dosage form
Industries (Pvt) Ampicillin Trihydrate eq. to name on In this regard
Ltd., Peshawar. Ampicillin base …. 125mg 26-09-2003 shortcoming letter
Cloxacillin Sodium eq. has been
Cloxacillin … 125mg communicated to
the firm.
262. M/s. Medicon 11311 Medixil Capsule 500mg 17-06-1990 Transfer
Pharmaceuticals Each capsule contains:- Change of brand
Industries (Pvt) Amoxicillin …. 500mg name
Ltd., Peshawar. In this regard
shortcoming letter
has been
communicated to
the firm.
263. M/s. Medicon 8379 Medistan Forte Tablet Initial reg. letter
Pharmaceuticals Each tablet contains:- In this regard
Industries (Pvt) Mefenamic Acid …. 500mg shortcoming letter
communicated to
the firm.
264. M/s. Medicon 8200 Pyomed 450ml Solution Initial reg. letter
Pharmaceuticals Each bottle contains:- In this regard
Industries (Pvt) Povidone Iodine Topical shortcoming letter
Ltd., Peshawar. …. 450MI has been issued to
the firm.
265. M/s. Medicon 8378 Ferrobex Syrup Transfer letter
Industries (Pvt) Ferrous Gluconate …. shortcoming letter
Thiamine HCI …. 2mg communicated to
Riboflavine …. 2mg the firm.
266. M/s. Medicon 000070- Medifen Suspension 19-09-2001 Last renewal
Pharmaceuticals EX Each 5ml contains:- In this regard
Industries (Pvt) Ibuprofen … 100mg shortcoming letter
communicated to
the firm.
267. M/s. Medicon 000074- Mediceph 250mg Capsule 19-09-2001 Last renewal
Pharmaceuticals EX Each capsule contains:- In this regard
Industries (Pvt) Cephradine …. 250mg shortcoming letter
communicated to
the firm.
268. M/s. Medicon 000076- Mediceph 125mg/5ml D/S 19-09-2001 Last renewal
communicated to
the firm.
269. M/s. Medicon 000075- Mediceph 500mg Capsule 19-09-2001 Last renewal
Pharmaceuticals EX Each capsule contains:- In this regard
communicated to
the firm.
270. M/s. Medicon 000077- Mediceph 250mg/5ml D/S 19-09-2001 Last renewal
communicated to
the firm.
271. M/s. Medicon 000080- Medivit - L Syrup 19-09-2001 Last renewal
Industries (Pvt) Thiamine HCL …. 3mg shortcoming letter
Ltd., Peshawar. Riboflavin …. 3mg has been
Nicotinamide …. 23mg communicated to
Lysine Mono HCI …. the firm.
33.33mg
272. M/s. Medicon 000334- Medoxicam 20mg Tablet 25-03-2005 Last renewal
Pharmaceuticals EX Each tablet contains:- In this regard
Industries (Pvt) Piroxicam …. 20mg shortcoming letter
communicated to
the firm.
273. M/s. Medicon 000335- Axodipin 30mg Tablet 25-03-2005 Last renewal
Pharmaceuticals EX Each tablet contains:- In this regard
Industries (Pvt) Nimodipine …. 30mg shortcoming letter
communicated to
the firm.
274. M/s. Libra (Pvt) 073288 Kidcare Sachet 19-10-2011 Last renewal. In
Ltd., Peshawar. Each Sachet contains:- this regard
Sodium Chloride …. 2.6g shortcoming letter
Potassium Chloride…. 1.5g has been
Tri-Sodium Citrate communicated to
Dihydrate …. 2.9g the firm.
Glucose Anhydrous.. 13.5g
Orage flavour powder..2.5g
275. M/s. Libra (Pvt) 023803 Retrot Capsule 26-10-2001 Correction in reg.
Ltd., Peshawar. Each capsule contains:- Change in Brand no. in covering
Omeprazole …. 20mg name on letter. Last renewal
11-09-2004 Source of pellets
In this regard
shortcoming letter
has been
communicated to
the firm.
276. M/s. Libra (Pvt) 023761 RI-Q Tablet 250mg 13-11-2001 Correction in reg.
Ltd., Peshawar. Each tablet contains:- Change of Brand no. in covering
Ciprofloxacin …. 250mg name on letter.
10-12-2004 Last renewal
In this regard
shortcoming letter
has been
communicated to
the firm.
277. M/s. Libra (Pvt) 023762 RI-Q 500mg 13-11-2001 Correction in reg.
Ltd., Peshawar. Each tablet contains:- Change of Brand no. in covering
Ciprofloxacin …. 500mg name on letter.
10-12-2004 Last renewal
In this regard
shortcoming letter
has been
communicated to
the firm.
278. M/s. Libra (Pvt) 023806 Selectin Syrup 26-10-2001 Last renewal
Ltd., Peshawar. Each 5ml contains:- In this regard
Loratadine …. 5mg shortcoming letter
has been
communicated to
the firm.
279. M/s. Libra (Pvt) 023805 Selectin Tablet 26-10-2001 Last renewal
Ltd., Peshawar. Each tablet contains:- In this regard
Loratadine …. 10mg shortcoming letter
has been issued to
the firm.
280. M/s. Libra (Pvt) 025478 Chixicol Syrup 31-12-1999 Last renewal
Ltd., Peshawar. Each 5ml contains:- In this regard
Promethazone HCI …. shortcoming letter
1.5mg has been
Pholcedine …. 1.5mg communicated to
the firm.
281. M/s. Medicraft 028981 Cefpomed Tablet 15-01-2003 Last renewal. In
Pharmaceuticals Each tablet contains:- this regard
(Pvt) Ltd., Cefpodoxime Proxetil … shortcoming letter
Peshawar. 100mg has been issed to
the firm.
282. M/s. Medicraft 028983 Tremomed Capsule 50mg 15-01-2003 Last renewal
Pharmaceuticals Each capsule contains:- In this regard
(Pvt) Ltd., Tramadol HCI …. 50mg shortcoming letter
Peshawar. has been
communicated to
the firm.
283. M/s. Medicraft 028984 Noxacin Tablet 15-01-2003 Last renewal. In
Pharmaceuticals Each tablet contains:- this regard
(Pvt) Ltd., Nrofloxacin …. 400mg shortcoming letter
Peshawar. has been
communicated to
the firm.
284. M/s. Medicraft 028990 Fcozole Dry Suspension 15-01-2003 Last renewal
(Pvt) Ltd., Fluconazole …. 50mg shortcoming letter
Peshawar. has been
communicated to
the firm.
285. M/s. Medicraft 028992 Mega Iron Syrup (Suprion 15-01-2003 Change of Brand
Pharmaceuticals Syp) name letter
(Pvt) Ltd., Each 5ml contains:- Last renewal
Peshawar. Iron III Hydroxide In this regard
Polymaltose Complex …. shortcoming letter
50mg has been
communicated to
the firm.
i) Acceded to request of the firm of product at Sr. No. 01-81 and decided
to grant/regularize the renewal mentined gainst each in column VI.
ii) Deferred the cases of products at Sr. No. 82 & 83 regarding
confirmation mentioned against each from concerned section
iii) Deferred the cases of products at Sr. No. 84-92 regarding
confirmation mentioned against each from Licensing Division.
iv) Deferred the cases of products at Sr. No. 93-285 for rectification of
shortcomings communicated to the firm.
2) Locally Manufactured (Veterinary)
I II III IV V VI
S Reg.
Firm Name Brand Name Date of Reg. Remarks
No. No.
1. M/s. Pfizer 000455 Terramycin Capsule 250mg 17-04-1976 Change of brand
Pakistan Limited, Each capsule contains: Transfer of name evidence
Karachi Oxytetracycline Registration required.
Hydrochloride USP dated In this regard
equivalent to 01-06-2011 shortcoming letter
Oxytetracycline….250mg has been issued to
the firm.
2. M/s. Westmont 048186 Sulf Amprol 16-07-2008 Initial Registration
Pharmaceuticals Letter Required,
Industry, Form 5-B
Rawalpindi Required, DML
Required
In this regard
shortcoming letter
has been issued to
the firm.
3. -do- 048187 Benzomont Oral powder 16-07-2008 -do-
4. -do- 048188 Coccimont 16-07-2008 -do-
5. -do- 048190 Flushmont 16-07-2008 -do-
6. -do- 048191 Salicorb 16-07-2008 -do-
7. -do- 048192 Tylo Cd 16-07-2008 -do-
8. -do- 048193 Zerocox 16-07-2008 -do-
9. -do- 048194 Albamont Ora Suspension 16-07-2008 -do-
10. -do- 048195 Levol Oral Suspension 16-07-2008 -do-
11. -do- 048196 Darvimont 16-07-2008 -do-
12. -do- 048199 oxamont 16-07-2008 -do-
13. -do- 048200 Oxanide Oral Suspension 16-07-2008 -do-
14. -do- 049557 Coliclor N 05-08-2008 -do-
15. -do- 053931 Colimont Powder 19-02-2009 -do-
16. -do- 058933 Coccivet Oral Powder 30-07-2009 -do-
17. -do- 058934 Coltin 550 Powder 30-07-2009 -do-
18. -do- 058936 Anrox Plus 10% 30-07-2009 -do-
19. -do- 063742 Bromomont Oral Liquid 24-09-2010 -do-
20. -do- 063743 Liver fit Oral Suspension 24-09-2010 -do-
21. -do- 063744 Albawest 2.5% Oral 24-09-2010 -do-
Suspension
22. -do- 063745 Ab Triclamont CS Oral 24-09-2010 -do-
Suspension
23. -do- 063746 Enbro 20 24-09-2010 -do-
24. -do- 063747 Ampronil 50 24-09-2010 -do-
25. -do- 063748 Normethaprim 24-09-2010 -do-
26. -do- 063749 Ascirex Plus Oral Powder 24-09-2010 -do-
27. -do- 063750 Toltrazic Oral Liquid 24-09-2010 -do-
28. -do- 063751 Oxcosel Suspension 24-09-2010 -do-
29. -do- 063752 Gumbosol Powder 24-09-2010 -do-
30. -do- 063753 Myco Td 20/40 24-09-2010 -do-
Decision: Registration Board deferred the cases of products at Sr. No. 01-30 for
rectification of shortcomings communicated to the firm.
3) Finished Drugs for Import (Human)
I II III IV V VI
S
Firm Name Reg. No. Brand Name Date of Reg. Remarks
No.
1. M/s. Pfizer 000604 Solucortef Injection Transfer of Initial Registration letter not
Pakistan 100mg Registration attached
Limited, Each 2ml contains: dated Manufacturer Abroad approval
Karachi Hydrocortisone Sodium 01-06-2011 letter required
Succinate…100mg Imported from Pfizer Belgium
NV, Rijksweg 12, B-2870
Puurs, Belgium.
In this regard shortcoming letter
has been communicated to firm.
2. M/s. Pfizer 000603 Solucortef Injection Initial Registration letter not
Pakistan 250mg Transfer of attached.
Limited, Each 2ml contains: Registration Manufacturer Abroad approval
Karachi Hydrocortisone Sodium dated letter required
Succinate…250mg 01-06-2011 Imported from Pfizer Belgium
NV, Rijksweg 12,B-2870
Puurs, Belgium
3. M/s. Pfizer 008253 Solucortef Injection Initial Registration letter not
Pakistan 500mg Transfer of attached.
Limited, Each 4ml contains: Registration Manufacturer Abroad approval
Karachi Hydrocortisone Sodium dated letter required
Succinate…500mg 01-06-2011 Imported from Pfizer Belgium
NV, Rijksweg 12, B-2870
Puurs, Belgium
4. M/s. Pfizer 001081 Trobicin Injection 2gm Initial Registration letter not
Pakistan Each ml contains: Transfer of attached. Manufacturer Abroad
Limited, Sterile Registration approval letter required
Karachi Spectinomycin…..2g dated Imported from Sanico NV,
01-06-2011 Veedijk 50,B-2300,Turnhout,
Belgium
5. M/s. Pfizer 017282 Etoposide Injection 23-05-1995 Manufacturer Abroad approval
Pakistan Each ml contains: Transfer of letter required
Limited, Etoposide….20mg Registration Imported from Pfizer Perth Pty
Karachi dated Limited,15 Brodie Hall Drive,
01-06-2011 Technology Park,Bently,
Westren Australia,6102,
Australia
6. M/s. Pfizer 020650 Feldene Flash Fast 25-11-1997 Manufacturer Abroad approval
Pakistan Dissolving Tablet Transfer of letter required
Limited, Each tablet contains: registration Imported from Catalant Pharma
Karachi Piroxicam….20mg dated Solutions, Inc, Frankland Road,
29-06-2011 Blackgrove,Swindon, Wiltshire
SN5 8RU,UK
7. M/s. Pfizer 010094 Feldene I.M. Injection 17-04-1989 Manufacturer Abroad approval
Pakistan Each ml contains: Transfer of letter required. Imported from
Limited, Piroxicam….20mg registration Pfizer,BP 109,37401 Amboise,
Karachi dated France. In this regard
29-06-2011 shortcoming letter has been
communicated to firm.
8. M/s. Pfizer 004111 Prostin F-2 Alpha 03-05-1978 Manufacturer Abroad approval
Pakistan 5mg/ml Injection Transfer of letter required.
Limited, Each ml contains: registration Imported from M/s.Pfizer
Karachi Dinoprost…..5mg dated Belgium NV,Rijksweg 12,B-
01-06-2011 2870 Puurs, Belgium
9. M/s. 010616 Nephrosteril 21-03-1980 Product is imported from
Medipak 1 Litre contains: Fresenius Kabi Austria GmbH
Limited,La L-Isaleucine…5.1g Hafnertrasse 36,A-8055
hore L-Leucine…10.3g Garz,Austria
L-Lysine Monoacetate (as per Form 5-B)
…10.1g Change of Manufacturer
L-Methionine…2.80gm Abroad approval letter required.
L-Lysine….7.1g Firm submitted evidence of
Acetyl Cysteine…0.50g Renewal of year 2015 which is
L-Cysteine…0.37g within time.
L-Phenylalanine...3.80g In this regard shortcoming letter
L-Threonine…4.80g has been communicated to the
L-Trytophane…1.90g firm.
L-Valine…6.20g
Arginine….4.90g
L-Histidine…4.30g
Aminoacetic Acid..3.20g
L-Alanine….6.30g
L-Proline…4.30g
L-Serine…4.50g
L-Malic Acid….1.50g
Glacial Acetic Acid
….1.38g
Water for Inj. q.s. 1201
KJ/L=280Kcal/L
Content of Amino
Acid=70g/litre
10. M/s. Drug’s 028464 Brunac Eye Drops 19-07-2003 Product is imported from M/s.
Inn, Each 100ml contains: Bruschittini s.r.l., Italy
Islamabad N-Acetylcysteine…5gm In this regard shortcoming letter
11. M/s. Anwar 028439 Daclon Surgical Sutures 11-03-2003 Clarification regarding address
& Sons, required as address on DSL and
Rawalpindi initial Registration letter is not
similar Product is imported
from M/s. SMI AG, Belgium
rectification of shortcomings communicated to thhe firm.
4) Finished Drugs for Import (Veterinary)

I II III IV V VI
S
Firm Name Reg. No. Brand Name Date of Reg. Remarks
No.
1. M/s. 057157 Enrofloxacin 10% Injection 03-06-2009 Imported from
Muhammad Each ml contains: M/s.Hebei Yuanzheng
Hanif & Enrofloxacin…100mg Pharmaceutical Co.
Company, Ltd., China
Karachi DSL Required
In this regard
shortcoming letter has
been communicated to
the firm.
2. -do- 057158 Oxytetracycline 10% -do- -do-
Injection
Each ml contains:
Oxytetracycline
HCl…100mg
3. -do- 039964 Ivermectin Injection 03-09-2005 Veterinary Product
Each ml contains: Imported from
Ivermectin….10mg M/s.Hebei Yuanzheng
Pharmaceutical Co.
Ltd.,China
DSL Required
Last Renewal Required
(2010-2015).
In this regard
shortcoming letter has
been communicated to
the firm.
rectification of shortcomings communicated to thhe firm.
Case No. 02 Cases Received in Year 2017.

Registration Board in 276th meeting approved the SOP’s for the submission of renewal
applications for locally manufactured drugs (Human & Veterinary) and finished drugs for import
(Human & Veterinary) and approved the criteria for consideration of renewal applications.
The RRR-Section of PE&R Division has evaluated the cases received in December, 2017. The
cases which has not been submitted in accordance with approved SOP’s, shortcoming letter has
been communicated to the firms for completion of their documents.
Following cases has been submitted as per approved SOP’s.
a) M/s. Shaheen Pharmaceutical, Sawat.
I II III IV V
Sr. Initial date of
Reg. No. Product Name Validity
No. Registration
1. 074573 Easyast 4mg Chewable Tablet 14-12-2012 13-12-2022
Each tablet contains:-
Montelukast Sodium 4.16 eq. to
Montelukast …. 4mg
2. 074574 Easyast 5mg Chewable Tablet Do Do
Montelukast Sodium 5.20 eq. to
Montelukast …. 5mg
3. 074575 Migcare 2.5mg Capsule Do Do
Each capsule contains:-
Zolmitriptan …. 2.5mg
4. 074576 Zate Syrup Do Do
Each 5ml contains:-
Zinc Sulphate Monohydrate eq. to
Elemental Zinc…20mg
5. 074577 Ipro-Plus Syrup Do Do
Each 5ml contains:-
Iron protein Succinylate 800mg eq. to
Elemental Iron …. 40mg
Folic Acid …. 5mg
6. 074578 Diarlope 2mg Capsule Do Do
Loperamide …. 2mg
7. 074579 Nodal 500mg Tablet Do Do
Paracetamol …. 500mg
07 and decided to grant renewal (s) mentined against each in column V.
M/s. Medizan Laboratories (Pvt) Ltd., Islamabad

I II III IV V
Sr. Initial date of
No. Registration
8. 073191 Azizan 250mg Tablet 07-12-2012 06-12-2022
Azithromycin (as dehydrate) …. 250mg
9. 073192 Azizan 500mg Tablet Do Do
Azithromycin (as dehydrate) …. 500mg
10. 073193 Levomay 750mg Tablet Do Do
Levofloxacin (as Hemihydrate) …. 750mg
11. 073194 Rerox 50mg Dispersible Tablet Do Do
Each dispersible tablet contains:-
Roxithromycin …. 50mg
12. 059328 Navidic SR-100 Tablet 09-10-2009 12-12-2022
Each tablet contains:- Change of Brand
Diclofenac Sodium …. 100mg Name on 13-12-2012
13. 059321 Navidic Tablet 75mg Do Do
Each tablet contains:- With the advice to
Diclofenac Sodium …. 75mg change the
nomenclature of
formulation by the
concerned section.
14. 038794 Navidic Tablet 50mg 14-06-2005 Do
Each tablet contains:- Change of Brand With the advice to
Diclofenac Sodium …. 50mg Name on change the
13-12-2012 nomenclature of
formulation by the
concerned section.
b) M/s. Ferozsons Laboratories Limited, Nowshera, Khyber Pakhtunkhwa.

I II III IV V
Sr. Initial date of
No. Registration
15. 003917-EX Clarithromycin 500mg Tablet 19-12-2012 18-12-2022
Each film coated tablet contains:-
Clarithromycin ….500mg
16. 003918-EX Clarithromycin Suspension Do Do
Each 5ml contains:-
Clarithromycin ….125mg
17. 003919-EX Levofloxacin 500mg Tablet Do Do
Levofloxacin hemihydrate eq. to
Levofloxacin …. 500mg
18. 029019 Montekast 5mg Tablet 14-12-2002 13-12-2022
Each tablet contains:- With the advice to
Montelukast Sodium 5.20 eq. to Montelukast change the
…. 5mg nomenclature of
formulation by the
concerned section.
19. 047975 Memra Tablet 18-12-2007 17-12-2022
Memantine HCl …. 10mg
20. 072544 Truvada Tablet 20-12-2012 19-12-2022
Each tablet contains:- Change of
Emtrictibine …. 200mg Tenofovir manufacturer
Disoproxil Fumarate 300mg eq. to 245mg of name on
Tenofovir disproxil 30-09-2013
(Manufactured by M/s. Takeda GmbH,
Oranienburg, Germany)
21. 047974 Esomega 20mg Capsule 18-12-2007 17-12-2022
Each capsule contains:- Regularised the
Esomeprazole as Magnesium Trihydrate renewal of year
Pellets …. 20mg 2012 from
Imported Pellets from M/s. Lee Pharma Ltd; 18-12-2012 till
Survay No.199, Plot No.3&4, Rajive Gandhi 17-12-2017
Nagar, Prasanthi Nagar Hyderabad, India.
c) M/s. CCL Pharmaceuticals (Pvt) Ltd., Lahore.

I II III IV V
Sr. Initial date of
No. Registration
22. 048022 Tropiset Injection 05-01-2008 04-01-2023
Each 2ml contains:-
Tropisetron HCI …. 2mg
23. 048023 Tropiset Injection Do Do
Each 5ml contains:-
Tropisetron HCI …. 5mg
24. 048024 Rivamine Capsule Do Do
Tivastigmine as Tartrate …. 1.5mg
25. 048025 Rivamaine Capsule Do Do
Tivastigmine as Tartrate …. 6mg
26. 048026 Graniset Tablet Do Do
Granisetron (as HCl) …1mg
27. 048027 Graniset Injection 3mg/3ml Do Do
Each 3ml ampoule contains:-
Granisetron (as HCl) …3mg
28. 048028 Tropiset Capsule Do Do
Tropisetron HCl …. 5mg
29. 048029 Rivamine Capsule Do Do
Tivastigmine as Tartrate …. 3mg
30. 048030 Osteopam Capsule Do Do
Parnidronate …. 100mg
31. 048031 Defcap Tablet Do Do
Deferiprone …. 500mg
32. 074267 Abnate Tablet 07-01-2013 06-01-2023
Ibandronate (as Sodium) …. 2.5mg
33. 001778-EX Telsartan Plus Tablet 21-01-2013 20-01-2023
Telmisartan …. 40mg
Hydrochlorothiazide …. 12.5mg
34. 001779-EX Kadlok Tablet 75mg Do Do
Clopidogrel (as Bisulphate) …. 75mg
35. 001780-EX Fenotab Tablet 200mg Do Do
Fenofibrate …. 200mg
36. 001781-EX Fenotab Tablet 67mg Do Do
Fenofibrate …. 67mg
37. 001782-EX Fosfomyn Capsule 500mg Do Do
Fosfomycin (as calcium) …. 500mg
38. 001783-EX Fosfomyn Suspension Do Do
Each 5ml contains:-
Fosfomycin as calcium …. 250mg
39. 001784-EX Potetek Tablet 30mg Do Do
Pioglitazone (as HCl) …. 30mg
40. 001785-EX Potetek Tablet 15mg Do Do
Pioglitazone (as HCl) …. 15mg
41. 001786-EX Zuvastat Tablet 10mg Do Do
Rosuvastatin calcium eq. to Rosuvastatin
…. 10mg
42. 001787-EX Zuvastat Tablet 5mg Do Do
Rosuvastatin calcium eq. to Rosuvastatin
…. 5mg
43. 001788-EX Moxy-F Tablet 400mg Do Do
Moxifloxacin (as HCl) …. 400mg
44. 001789-EX Ntavir Tablet 1mg Do Do
Entecavir (as monohydrate) …. 1mg
45. 001790-EX Ntavir Tablet 0.5mg Do Do
Entecavir (as monohydrate) …. 0.5mg
46. 074281 Xylizine Syrup 22-01-2013 21-01-2023
Each 5ml contains:-
Levocetirzine dihydrochloride …. 2.5mg
47. 074282 Bactcid Suspension 5% 22-01-2013 Do
Each 5ml contains:- Change of Brand
Ciprofloxacin as Hcl …. 250mg Name on 13-5-2014
48. 074283 Yukon Injection 30mg 22-01-2013 Do
Each 1ml contains:-
Ketorolac as Tromethamine …. 30mg
49. 074284 Yukon Injection 10mg Do Do
Each 1ml contains:-
50. 074285 Yukon Tablet 10mg Do Do
51. 074286 Alaska Tablet 200mg Do Do
Hydroxychloroquine Sulphate … 200mg
52. 048382 Crestat Tablet 02-02-2008 01-02-2023
Rosuvastatin as Calcium …. 5mg
53. 048383 Deflam Tablet 75mg Do Do
Each tablet contains:- With the advice
Diclofenac Potassium …. 75mg to add word
Sugar Coated in
reference
compostion
from concerned
section.
54. 048384 Simzet 10/10 Tablet Do Do
Ezetimibe …. 10mg
Simvastatin …. 10mg
Ezetimibe …. 10mg
Ezetimibe …. 10mg
57. 000851-EX Clopitab Tablet 21-02-2008 20-02-2023
Clopidogrel …. 75mg
58. 000853-EX Clopitab-EA Tablet Do Do
Clopidogrel …. 75mg Aspirin …. 75mg
d) M/s. Genix Pharma (Pvt) Ltd., Karachi.
I II III IV V
Sr. Initial date of
No. Registration
59. 073669 Comin 500mcg /ml Injection 10-01-2013 09-01-2023
Each ml contains:-
Mecobalamin …. 500mcg
60. 073670 Ketor 30mg/ml Injection 10-01-2013 Do
Each ml contains:- Change of Brand
Ketorolac trometamol …. 30mg Name on 18-01-2016
61. 073671 Water for Injection 10-01-2013 Do
Each ampoule contains:-
Water for injection
62. 073672 Dimis-L Injection Do Do
Each 2ml contains:-
Diclofenac Sodium …. 75mg
Lidocaine HCl ….. 20mg
63. 073673 Divertigo 50mg/ml Injection Do Do
Each ml contains:-
Dimenhydrinate …. 50mg
64. 073674 S-Flox Infusion 250mg/50ml Do Do
Each 50ml contains:-
65. 073675 S-Flox Infusion 750mg/150ml Do Do
Each ml contains:-
66. 073676 Karmol 1000 Infusion Do Do
Each ml contains:-
67. 073677 Prozyl 500mg/100ml Infusion Do Do
Each ml contains:-
Metronidazole …. 5mg
68. 073678 Efecip Infusion 400mg/200ml Do Do
Each ml contains:-
Ciprofloxacin lactate eq. to Ciprofloxacin
….. 2mg
69. 073679 S-Flox Eye Drops Do Do
Each ml contains:-
Levofloxacin Hemihydrate eq. to
70. 073680 Plop Forte Ophthalmic Solution Do Do
Each ml contains:-
Olopatadine hydrochloride eq. to
Olopatadine …. 2mg
71. 073681 Fifen 0.03% Eye Drops Do Do
Each ml contains:-
Flurbiprofen sodium …. 0.3mg
72. 073682 Moptol Eye Drops Do Do
Each ml contains:-
Timolol Maleate eq. to Timolol …. 5mg
73. 073683 Nyle Eye Drops Do Do
Each ml contains:-
Polyvinyl alcohol …. 14mg
Povidone ….. 6mg
74. 073684 Pitalo 1mg Tablet Do Do
Each Film coated tablet contains:-
Pitavastatin calcium eq. to Pitavastatin …
1mg
75. 073685 Diphos Sachet 15/120mg Do Do
Each sachet contains:-
Dihydroartemisinin ….. 15mg
Piperaquine Phosphate …. 120mg
76. 073686 Gvia-M Tab 50mg/1000mg 10-01-2013 Do
Each film coated tablet contains:- Change of Brand
Sitagliptin as phosphate monohydrate ….. Name on 02-07-2014
50mg Metformin HCl ….. 1000mg
77. 073687 Pitalo 4mg Tablet 10-01-2013 Do
Pitavastatin calcium eq. to Pitavastatin ….
4mg
78. 073688 Zoleric 40mg Powder for Injection /Infusion Do Do
Each vial contains:-
Esomeprazole sodium eq. to Esomeprazole
…. 40mg
79. 073689 Mep 40mg Powder for Injection/Infusion Do Do
Omeprazole sodium eq. to Omeprazole …..
40mg
80. 073690 Aclovir 250mg Powder for Infusion Do Do
Acyclovir sodium eq. to Acyclovir …..
250mg
81. 073691 Aclovir 500mg Powder for Infusion Do Do
Acyclovir sodium eq. to Acyclovir …..
500mg
82. 073692 Larith 500mg Powder for Infusion Do Do
Clarithromycin …. 500mg
e) M/s. Medicaids (Pak) Ltd., Karachi.

I II III IV V
Sr. Initial date of
No. Registration
83. 003853-EX Cef X Dry Suspension 18-12-2012 17-12-2022
Each 5ml contains:-
Cefixime …. 100mg
84. 003854-EX Cefiter Injection 1gm IV Do Do
Ceftriaxone Base …. 1mg
85. 073554 Brimotim Opthalmic Solution 17-12-2012 16-12-2022
Each ml contains:-
Brimonidine Tartrate …. 2mg
Timolol as Maleate …. 5mg
f) M/s. MKB Pharmaceuticals (Pvt) Ltd., Peshawar.

I II III IV V
Sr. Initial date of
No. Registration
86. 003844-EX Cyprdin Syrup 13-12-2012 12-12-2022
Each 5ml contains:-
Cyproheptadine (as HCl) …. 2mg
87. 003845-EX Alvon-DM Syrup Do Do
Each 5ml contains:-
Diphenhydramine HCl …. 5mg
Dextromethorphan HBr …. 6.25mg
88. 003846-EX Ferbex Syrup Do Do
Each 5ml contains:-
Ferrous Sulphate …. 131mg
Cyanocobalamine (Vit B12) …. 6.25mcg
Ascorbic Acid (Vit C) …. 125mg
Thiamine HCl (Vit B1) …. 1.5mg
Riboflavin-5 Phosphate Sodium (Vit B2) ….
1.5mg
Pyridoxine HCl (Vit B6) …. 1.25mg
Nicotinamide …. 7.5mg
Calcium -D Pantothenate …. 2.5mg
89. 003847-EX Vitonic Syrup Do Do
Each 5ml contains:-
Vitamin A …. 3000 I.U
Vitamin D …. 400 I.U
Thiamine HCl ((Vit B1)) …. 1.5mg
Riboflavin 5-Phosphate Sodium (Vit B2) ….
1.2mg
Pyridoxine HCl (Vit B6) …. 1mg
Cyancobalamine (Vit B12) …. 3mcg
Ascorbic Acid (Vit C) …. 50mg
g) M/s. Sami Pharmaceuticals (Pvt) Ltd., Karachi.

I II III IV V
Sr. Initial date of
No. Registration
90. 047403 Fexofen 60mg Tablet 08-01-2008 07-01-2023
Fexofenadine HCl …. 60mg
91. 047404 Winurina 400mg Capsule Do Do
Each Capsule contains:-
Gabapentin …. 400mg
92. 047405 Somerol-N Forte Tablet Do Do
Orphenadrine Citrate …. 50mg
93. 073697 Tercica 200mg Tablet 11-01-2013 10-01-2023
Dexibuprofen …. 200mg
94. 073698 Breeky 200mcg Tablet Do Do
Misoprostol …. 200mcg
95. 073700 Nixaf 550mg Tablet Do Do
Rifaximin …. 550mg
96. 073701 Cynfo 250mg/5ml Suspension Do Do
Each 5ml of reconstituted suspension contains:-
Fosfomycin calcium eq. to Fosfomycin ….
250mg
97. 073702 Cynfo 500mg Capsule Do Do
Fosfomycin calcium eq. to Fosfomycin ….
500mg
98. 029394 Bisleri Capsule 08-02-2003 07-02-2023
Iron (III) Hydroxide Polymaltose complex eq.
to Elemental Iron …. 100mg
Folic Acid … 350mcg
99. 029396 Bisleri Chewable Tablet Do Do
Each chewable tablet contains:-
Iron (III) Hydroxide Polymaltose complex eq.
to Elemental Iron …. 100mg
Folic Acid … 350mcg
h) M/s. Genome Pharmaceuticals (Pvt) Ltd., Hattar.

I II III IV V
Sr. Reg. Initial date of
Product Name Validity
No. No. Registration
100. 075520 Cefrid 125mg Dry Powder Suspension 04-01-2013 03-01-2023
Each 5ml contains:-
Cephradine (as Monohydrate) …. 125mg
101. 075521 Cefrid 250mg Dry Powder Suspension Do Do
Each ml contains:-
102. 075522 Ipod 40mg Dry Powder Suspension Do Do
Each ml contains:-
Cefpodoxime as proxetil …. 40mg
103. 075523 Cefrid 250mg Capsule Do Do
104. 075524 Cefrid 500mg Capsule Do Do
105. 075525 Zefnir 125mg Dry Powder Suspension Do Do
Each 5ml contains:-
Cefdinir …. 125mg
106. 075526 Zefnir 250mg Dry Powder Suspension Do Do
Each 5ml contains:-
Cefdinir …. 250mg
107. 075527 Zefnir 100mg Capsule Do Do
Cefdinir …. 100mg
108. 075528 Zefnir 300mg Capsule Do Do
Each capsssule contains:-
Cefdinir …. 300mg
109. 075529 Ipod 100mg Capsule Do Do
Cefpodoxime (as proxetil) …. 100mg
110. 075530 Brutek 100mg Dry Powder Suspension Do Do
Each ml contains:-
Dexibuprofen …. 100mg
111. 075531 Zim 200mg Dry Powder Suspension Do Do
Each ml contains:-
Azithromycin (as dihydrate) …. 200mg
112. 075532 Fascar 125mg Dry Suspension 04-01-2013 Do
Each 5ml contains:- Change of Brand
Clarithromycin …. 125mg Name on 06-05-2016
113. 075533 Zincor 20mg Dry Powder Suspension Do Do
Each 5ml contains:-
Zinc sulphate monohydrate eq. to Zinc
(Elemental) … 20mg
114. 075534 Funzil 50mg Dry Powder Suspension Do Do
Each 5ml contains:-
Fluconazole … 50mg
115. 003990- Noremox 20mg Capsule 21-01-2013 20-01-2023
EX Each capsule contains:-
Rabeprazole Sodium enteric coated pellets eq.
to Rabeprazole …. 20mg
Imported pellets from M/s. Glukem
Pharmaceuticals (Pvt) ltd; Plot No. 205/2A,
First Floor, IDA, Phase-II, Cherlapally,
Hyderabad, Andhra Pradesh, India.
i) M/s. Highnoon Laboratories Ltd., Lahore.

I II III IV V
Sr. Initial date of
No. Registration
116. 048369 Lipirex-Z Tablet 30-01-2008 29-01-2023
Ezetimibe …. 10mg
Atorvastatin as calcium Trihydrate …. 20mg
117. 048370 Pyctomet Tablet Do Do
Pioglitazone as HCl … 15mg
Metformin HCl … 850mg
118. 048371 Rosulin Tablet Do Do
121. 020929 Emesson Injection 4mg 24-01-1998 23-01-2023
Each 2ml contains:-
Ondansetron HCl dihydrate 5mg eq. to
Ondansetron base …. 4mg
122. 020930 Emesson Injection 8mg Do Do
Each 2ml contains:-
Ondansetron HCl dihydrate 10mg eq. to
Ondansetron base …. 8mg
j) M/s. Barret Hodgson Pakistan (Pvt) Ltd., Karachi.
I II III IV V
123. 029393 Mobikare SR 100mg Capsule 17-02-2003 16-02-2023
Imported pellets from M/s Pelltech Healthcare
Pvt. Ltd., 20B, Tansa Farms Industrial Estate,
Village Met Gohsai, Bhiwandi-Wada Rd,
Wada, Thane-421312 (Maharashatra), India.
124. 029938 MylAxon Tablet 06-03-2003 05-03-2023
125. 029939 MylAxon Injection Do Do
Each ml contains:-
126. 029940 Romicef Injection 500mg Do Do
Cefpirome Sulphate (Sterile) eq. to Cefpiron
…. 500mcg
127. 029941 Romicef Injection 1000mg Do Do
Cefpirome Sulphate (Sterile) eq. to Cefpiron
…. 1000mcg
k) M/s. Werrick Pharmaceuticals, Islamabad.

I II III IV V
128. 075107 Acne-Derm Cream 02-01-2013 01-01-2023
Each gm contains:-
Azelaic Acid …. 0.2gm
129. 029546 Anti-C Capsule 09-01-2003 08-01-2023
Ribavirin …. 100mg
130. 029547 Anti-C Capsule Do Do
131. 029548 Anti-C Capsule Do Do
132. 029549 Anti-C Tablet Do Do
133. 029550 Anti-C Syrup Do Do
Each 5ml contains:- Confirmation of
Ribavirin …. 50mg formulation regarding the
international availability
from the firm.
134. 029551 Anti-C Syrup Do Do
Each 5ml contains:- Confirmation of
Ribavirin …. 100mg formulation regarding the
international availability
from the firm.
135. 029552 Methyl-Dopa Tablet Do Do
Mythyldopa …. 250mg
136. 029553 Inhalerin Syrup Do Do
Each 5ml contains:-
Salbutamol Sulphate eq. to Salbutamol
…. 2mg
137. 029554 Inhalerin Tablet Do Do
…. 2mg
138. 029555 Inhalerin SR Tablet Do Do
…. 4mg
139. 029556 Inhalerin SR Tablet Do Do
…. 8mg
140. 029557 Promethazine Elixir Do Do
Each 5ml contains:-
Promethzine HCl …. 5mg
141. 029558 Chlorpheniramine Syrup Do Do
Each 5ml contains:-
Chlorpheniramine Maleate …. 2mg
142. 029559 Paracetamol Syrup Do Do
Each 5ml contains:-
143. 029560 Welon Tablet 4mg Do Do
Ondansetron HCl …. 4mg
144. 029561 Welon Tablet 8mg Do Do
Ondansetron HCl …. 8mg
145. 029562 Werrick Erythromycin Tablet Do Do
Erythromycin (as stearate) …. 250mg
146. 029563 Werrick Erythromycin Tablet Do Do
Erythromycin (as stearate) …. 500mg
147. 029564 Werrick Erythromycin Suspension Do Do
Each 5ml contains:-
Erythromycin as Stearate …. 200mg
148. 029565 Werridal Suspension Do Do
Each 5ml contains:-
Ibuprofen …. 100mg
149. 029566 Werridal Tablet Do Do
150. 029567 Werridal Forte Tablet Do Do
151. 029568 Werridal Tablet 600mg Do Do
152. 029569 Menidazole Suspension Do Do
Each 5ml contains:-
Benzyl Metronidazole eq. to
153. 029570 Menidazole Tablet Do Do
Benzyl Metronidazole eq. to
154. 029571 Cardiovasc Tablet Do Do
Amlodipine besylate eq. to Amlodipine
…. 5mg
155. 029572 Cardiovasc Tablet Do Do
Amlodipine besylate eq. to Amlodipine
…. 10mg
156. 029573 Monitor Tablet Do Do
Bisoprolol Fumarate …. 2.5mg
157. 048041 Impact Tablet 400mg 08-01-2008 07-01-2023
Eprosartan as Meyslate …. 400mg
158. 048042 Impact Tablet 600mg Do Do
Eprosartan as Meyslate …. 600mg
159. 048058 Retro Syrup 14-01-2008 13-01-2023
Each 5ml contains:-
Silymarin ….105mg
160. 048059 Retro Tablet Do Do
Silymarin ….200mg
l) M/s. Trigon Pharma (Pvt) Ltd., Lahore.

Application for renewal of registration are received late but within 60 days with prescribed fee.
I II III IV V
Sr. Initial date of
No. Registration
161. 074189 Neodon Suspension 06-12-2012 05-12-2022
Each ml contains:-
Domperdone …. 1mg
162. 074190 Ketomal Injection Do Do
Each ml contains:-
Ketorolac as Tromethamin …. 10mg
163. 074191 Trimed Tablet Do Do
Artemether …. 20mg Lumefantrine …. 120mg
164. 074192 Trimed Injection Do Do
Each ml contains:-
Artemether …. 80mg
165. 074193 Ketomal Injection Do Do
Each ml contains:-
Ketorolac as Tromethamin …. 30mg
166. 074194 Kote Suspension Do Do
Each 5ml contains:-
Sucralfate …. 1gm
167. 074195 Kote Tablet Do Do
Sucralfate …. 1gm
168. 074196 Neodon Tablet Do Do
Domperidone as Maleate … 10mg
m) M/s. Getz Pharma (Pvt) Ltd., Karachi.

I II III IV V
Sr. Initial date of
No. Registration
169. 029437 Getryl Tablet 1mg 14-12-2002 20-03-2023
Each tablet contains:- Change of Brand Name on
Glimepiride …. 1mg 21-03-2003
170. 029438 Getryl Tablet 2mg Do Do
Glimepiride …. 2mg
173. 030199 Lidocaine Injection 1% 21-03-2003 20-03-2023
Each ml contains:-
Lidocaine HCl …. 12.20mg
174. 042273 Cartigen Plus Tablet 21-03-2006 25-03-2023
Each tablet contains:- Change of Brand Name on
Glucosamine Sulphate …. 750mg 26-03-2008
Ghondrotin Sulphate …. 600mg
175. 029959 Getiflox 400mg Tablet 19-03-2003 18-03-2023
Ofloxacin …. 400mg
n) M/s. Remington Pharmaceutical Industries (Pvt) Ltd., Lahore.
I II III IV V
176. 074259 Moxear Otic Drops 02-01-2013 01-01-2023
Each ml contains:-
Moxifloxacin HCl eq. to
Moxifloxacin …. 5mg
Decision: Registration Board acceded to request of the firm of products at Sr. No. 176
and decided to grant renewal mentined against in column V.
o) M/s. Atco Laboratories Ltd., Karachi.

I II III IV V
177. 013893 Atcosef DS Dry Suspension 18-01-1993 17-01-2023
Each 5ml contains:- Change of Brand Name
Cephradine …. 250mg on 03-02-2005
178. 013894 Bronkal Syrup Do Do
Each 5ml contains:-
Salbutmol …. 2mg
179. 013895 Gentacil Eye/Ear Drops Do Do
Contains:-
Gentamicin base 0.3% w/v as
Gentamicin Sulphate
180. 013896 Gentacil Ointment Do Do
Each gm contains:-
Gentamicin base 3000 units as
Gentamicin Sulphate
181. 047425 Atconate 5mg Tablet 12-01-2008 11-01-2023
Risedronate Sodium …. 5mg
182. 047426 Atconate 35mg Tablet Do Do
Risedronate Sodium …. 35mg
183. 047454 Rheumaquin 200mg Tablet 21-01-2008 20-01-2023
Each Film coated tablet contains:-
Hydroxychloroquine as Sulphate..155mg
184. 048420 Syngab 50mg Capsule 31-01-2008 30-01-2023
Pregabalin …. 50mg
185. 013958 Penfen Injection 16-01-1993 15-01-2023
Each 3ml contains:-
186. 013959 Gentacil Injection Do Do
Each ml contains:-
Gentamicin as Gentamicin Sulphate
40mg base
187. 073724 Atcam 4mg Tablet `23-01-2013 22-01-2023
Lornoxicam …. 4mg
188. 073723 Atcam 8mg Tablet Do Do
Lornoxicam …. 8mg
189. 048421 Syngab 100mg Capsule 31-01-2008 30-01-2023
190. 048422 Syngab 200mg Capsule Do Do
191. 013891 Bunorfin Tablet 18-01-1993 17-01-2023
Each tablet contains:- Change of Brand Name
Buprenorphine …. 0.2mg on 25-10-1993
192. 013892 Anxit Tablet 18-01-1993 Do
Bromazepam …. 3mg
p) M/s. Indus Pharma (Pvt) Ltd., Karachi.

I II III IV V
193. 029086 Celetab Capsule 100mg 15-01-2003 14-01-2023
Celecoxib …. 100mg
194. 029087 Celetab Capsule 200mg Do Do
Celecoxib …. 200mg
195. 047398 Dearie Tablet 40mg 07-01-2008 06-01-2023
Drotaverine HCI …. 40mg
196. 047416 Dearie 40mg/2ml Injection 12-01-2008 11-01-2023
Each 2ml contains:-
Drotaverine HCI …. 40mg
197. 047400 E-Dynapram 10mg Tablet 07-01-2008 06-01-2023
Escitalopram …. 10mg
198. 047450 Fumium 5mg Tablet 11-01-2008 10-01-2023
Olanzapine …. 5mg
199. 047451 Fumium 10mg Tablet Do Do
Olanzapine …. 10mg
200. 047449 Gaily 5mg Tablet Do Do
Buspirone HCl …. 5mg
201. 047339 Intensofer Injection 100mg/5ml 07-01-2008 06-01-2023
Each 5ml contains:-
Iron Sucrose Complex eq. to Iron Sucrose
…. 100mg
202. 047427 Mob 400mg Tablet 14-01-2008 13-01-2023
Moxifloxacin as HCl …. 400mg
203. 047428 Mob 400mg /250ml Infusion Do Do
Moxifloxacin as HCI …. 400mg
q) M/s. Amson Vaccines & Pharma (Pvt) Ltd., Islamabad.

204. 075059 Osso-D Tablet 20-12-2012 19-12-2022
Ossein Mineral complex … 830mg
Eq. to Calcium …. 177.6mg
Phosphorus …. 82mg
Residual Mineral Salts …. 24.9mg
Collagen …. 224mg
Other Proteins …. 66.4mg
Trace Elements F, Mg, Fe, Zn, Cu, Ni
Corresponding to approx. 440mg Hydroxyapatite
Vitamin D ... 400.I.U.
Equivalent to … 0.01mg
r) M/s. Semos Pharmaceuticals (Pvt) Ltd., Karachi.

205. 073694 Moslve 750mg Tablet 11-01-2013 10-01-2023
Levofloxacin ….. 750mg
s) M/s. Hisun Pharmaceuticals Industries, Swabi.

Applications for renewal of registration are received late but within 60 days. Firm has
submitted differential fee.
206. 047955 Hilcat Capsule 250mg 18-12-2007 17-12-2022
Cephradine …. 250mg
207. 047956 Hilcat Capsule 500mg Do Do
208. 047957 Hilcat Suspension 125mg Do Do
Each 5ml contains:-
209. 047958 Hilcat Suspension 250mg Do Do
Each 5ml contains:-
210. 047959 Dexphen Syrup Do Do
Each 5ml contains:-
Dextrometharphan HBr …. 6.25mg
Diphenhydramine HCI …. 5mg
211. 047960 Gyrolev Tablet 250mg Do Do
Levofloxacin as Hemihydrate …. 250mg
212. 047961 Gyrolev Tablet 500mg Do Do
Levofloxacin as Hemihydrate …. 500mg
213. 047962 Kelvin Tablet 250mg Do Do
Ciprfloxacin as HCI …. 250mg
214. 047963 Kelvin Tablet 500mg Do Do
Ciprfloxacin as HCI …. 500mg
Case No. 03 Applications Received after Expiry of Registration.
I) M/s Z-Jans Pharmaceuticals (Pvt) Ltd., Peshawar

M/s Z-Jans Pharmaceuticals (Pvt) Ltd., Peshawar has submitted a letter in which they have stated
that some of their products which are already applied for renewal in 2014, although they admit
that these are applied late but submitted at least and the SRO says “The firms who could not
submit the application”. They have further stated that they have submitted the application 3 years
ago and in these 3 years no correspondence was made with them from DRAP that either their
applications were accepted or rejected. We have applied more than 100 products in time but no
renewal certificate or any other letter is issued in response, so they also considered this case as
per routine. The said SRO is published in Oct, 2017 and they have applied in Nov, 2014 and the
Fee is deposited in Oct, 2014. They want to settle this problem with mutual coordination.
Registration Board in its 258th meeting held on 25-26th April, 2016, while discussing the
case of M/s Gene Tec Pharma (Pvt) Ltd. Karachi (Avemar), deliberated that the negligence for
not applying of renewal of registered drug either within prescribed time or within sixty days lies
on part of the firm (registration holder) in accordance with Rule 27 of Drugs (Licensing,
Registering & Advertising) Rules, 1976.
It is further submitted that vide SRO 1005(I)/2017 cut-off date for submission of renewal
application with three times of fee was 4th December, 2017 due to public holiday on 3rd
December, 2017 (Sunday). The amendment vide SRO 1005(I)/2017 has been informed to the
stockholders and also been placed on DRAP website. In this regard more than 1300 renewal
applications have been submitted by various firms.
Furthermore, as per available record, M/s Z-Jans Pharmaceuticals has submitted 49
applications for renewal of registration of drugs after 60 days of expiry of registration. The initial
scrutiny of the documents submitted along with these applications reveals that all these
applications are received after 60 days of expiry of registration. These applications appear to be
fall in the category of SRO but firm did not avail the opportunity provided vide SRO
1005(I)/2017 rather than they have submitted a letter narrated as above. Detail of these 49
products is as under;
Sr. Reg. Application
Brand Name Reg. Date
No. No. Receiving Date
1 064329 Slewel Tablet 7.5 mg 02-09-2010 17-04-2017
2 032288 Cesef Suspension 100mg/5ml 14-07-2004 26-12-2014
3 059486 Xocrel Capsule 40mg 04-08-2009 26-12-2014
4 059487 Xocrel Capsule 20mg 04-08-2009 26-12-2014
5 032062 Azour 200mg/5ml Suspension 14-07-2004 26-12-2014
6 059460 Zeporin Injection 1gm 04-08-2009 11-11-2014
7 059468 Ceforan Injection 500mg 04-08-2009 11-11-2014
8 059461 Emexin Injection 250mg 04-08-2009 11-11-2014
9 059452 Ofloxa-Z Infusion 2mg 04-08-2009 11-11-2014
10 059459 Zeporin Injection 500mg 04-08-2009 11-11-2014
11 059458 Zeporin Injection 250mg 04-08-2009 11-11-2014
12 059481 Rinai Injection 04-08-2009 11-11-2014
13 059462 Emexin Injection 500mg 04-08-2009 11-11-2014
14 059482 Linzee Injection 04-08-2009 11-11-2014
15 045946 Revicel Syrup 06-01-2007 11-11-2014
16 059485 Examic Injection 500mg 04-08-2009 11-11-2014
17 059484 Examic Injection 250mg 04-08-2009 11-11-2014
18 059483 Irozee Injection 04-08-2009 11-11-2014
19 045944 Parasol Plus Suspension 06-01-2007 11-11-2014
20 045945 Irozee Syrup 06-01-2007 11-11-2014
21 045948 Zelium Suspension 06-01-2007 11-11-2014
22 045947 Kufzee Syrup 06-01-2007 11-11-2014
23 059477 Triam Injection 04-08-2009 11-11-2014
24 059448 Rinai Tablet 04-08-2009 11-11-2014
25 059478 Lamin Injection 04-08-2009 11-11-2014
26 059474 Zortum 1gm Injection 04-08-2009 11-11-2014
27 059463 Emexin 1gm Injection 04-08-2009 11-11-2014
28 059479 Lofsim Injection 04-08-2009 11-11-2014
29 059467 Cefep 1gm Injection 04-08-2009 11-11-2014
30 059473 Zortum 500mg Injection 04-08-2009 11-11-2014
31 059464 Lores 500mg Injection 04-08-2009 11-11-2014
32 059471 Cefro-Z 1.5gm Injection 04-08-2009 11-11-2014
33 059470 Cefro-Z 250mg Injection 04-08-2009 11-11-2014
34 059480 Nilvom Injection 04-08-2009 11-11-2014
35 059465 Lores 1gm Injection 04-08-2009 11-11-2014
36 059466 Cefep 500mg Injection 04-08-2009 11-11-2014
37 059469 Rox-Z 750mg Injection 04-08-2009 11-11-2014
38 059472 Zortum Injection 250mg 04-08-2009 11-11-2014
39 059453 Azogyl Infusion 04-08-2009 11-11-2014
40 059454 Zoclan Injection 04-08-2009 11-11-2014
41 059447 Depset Tablet 20mg 04-08-2009 11-11-2014
42 059449 Oxirase Infusion 04-08-2009 11-11-2014
43 059475 Z-JANS Water 04-08-2009 11-11-2014
44 059450 Oxirase DS Infusion 04-08-2009 11-11-2014
45 059476 Z-Dex Injection 4mg 04-08-2009 11-11-2014
46 059451 Oxa-Z Infusion 04-08-2009 11-11-2014
47 059455 Zoclan Injection 500mg 04-08-2009 11-11-2014
48 059456 Azosul 1gm Injection 04-08-2009 11-11-2014
49 059457 Azosul 500mg Injection 04-08-2009 11-11-2014
It is further submitted that M/s Z-Jans Pharmaceuticals (Pvt) Ltd., Peshawar has
submitted following applications to avail the opportunity provided vide SRO 1005(I)/2017 after
cut-off date i.e. 04th December, 2017.
Sr. Reg. Application
Brand Name Reg. Date
No. No. Receiving Date
1 064328 Eppam 2mg Tablet 02-09-2010 06-12-2017
2 052740 U1-Nil Suspension 15-09-2008 06-12-2017
3 044598 Zebex Syrup 06-09-2006 06-12-2017
II) M/s. Zaynoon Pharmaceutical (Pvt.) Limited, Peshawar.

M/s. Zaynoon Pharmaceutical (Pvt.) Limited, Peshawar has submitted Renewal Application of
their 19 products on 27-10-2017. During evaluation of application, it was observed that firm has
submitted last renewal after 7 months approx. of expiry of registration. Firm did not avail the
opportunity vide SRO 1005(I)/2017 for the regularization of renewal of year 2012. The detail of
the status is enunciated below:
Sr. Initial Reg.
Reg. No. Product Name Application Receiving Date
No. Date
1. 017634 Zeebent Suspension Transfer of (Due Date: 07-05-2017)
Each 5ml contain: Registration 27-10-2017
Mebendazole …100mg dated Last renewal submitted on
08-05-2007 10-12-2012
(after 7 month of expiry)
2. 017633 Zaypep Suspension -do- -do-
Each 5ml contain:
Famotidine …10mg
3. 032231 Novalac Syrup -do- -do-
Each 5ml contain:
Lactulose ….67gm
4. 016891 Raid M Syrup -do- -do-
Each 5ml contain:
Thaimine HCL….3mg
Riboflavin….3mg
Pyridoxin Hcl….2mg
Nicotinamide..23mg
5. 040603 Nafaflux P Syrup -do- -do-
Each 5ml contain:
Iron III Hydroxide Polymaltose
Complex eq to to Elemental
Iron…50mg
6. 016008 Fe Fa Syrup -do- -do-
Each 5ml contain:
Iron as Hydroxide Polymaltose
Complex …50mg
Folic Acid…..0.35mg
7. 016007 Nafpol Suspension -do- -do-
Each 5ml contain:
Paracetamol …..120mg
8. 016427 Zaygor Syrup -do- -do-
Each 5ml contain:
Pizotifen as Hydrogen
Malate….0.5mg
9. 016892 Multinaf Syrup 28.41ml -do- -do-

Each 5ml contain:
Vit A …..1400IU
Vit D 1400IU
Thiamine HCl….2.8mg
Riboflavin …3.4mg
Ascorbic Acid….85.2mg
Nicotinamide….28.4mg
10. 017636 Neurobec Syrup -do- -do-
Each 5ml contain:
Thiamine HCl….100mg
Pyridoxine HCl….100mg
Cyanocobalanmine …100mg
Riboflavine….20mg
Nicotinamide…200mg
11. 016428 Nafralin DM Syrup -do- -do-
Each 5ml contain:
Dextromethorphan HBr…10mg
Di Phenhydramine HCl….8mg
12. 016894 Zolonaf Suspension -do- -do-
Each 5ml contain:
Metronidazole ….200mg
13. 016006 Naftran Suspension -do- -do-
Each 5ml contain:
Trimethorpin …..40mg
Sulphamethoxasole….200mg
14. 016895 Uronaf Syrup -do- -do-
Each 5ml contain:
Sodium Acid Citrate….1.25gm
15. 031142 Peristal Suspension 07-10-2003 -do-
Each 5ml contain: Transfer of
Domperidone….5gm registration
dated
08-05-2007
16. 017635 Farmide Syrup Transfer of -do-
Each 5ml contain: registration
Metoclopramide Hcl…. 5mg dated
08-05-2007
17. 016429 Zayrollin Syrup -do- -do-
Each 5ml contain:
Aminophylline …32mg Di
Phenhydramine Hcl…. 8.mg
Ammonium Chloride…..30mg
Menthol ….0.98mg
18. 016893 Nafardol Suspension -do- -do-
Each 5ml contain:
Furazolidone ….25mg
Metronidazole….75mg
19. 016426 Amonaf Syrup -do- -do-
Each 5ml contain:
Ammonium Chloride …100mg
Ephedrin Hcl…..7mg
Diphenhydramine HCl…. 8mg
The case regarding applications received after expiry of registration was forwarded for the
opinion of Legal Affair Division and their opinion is as under;
After amendments vide S.R.O. 1005(I)/2017, Rules 27 of the Drug (Licensing, Registration and
Advertising) Rules, 1976 shall be read as follows: -
“Rule 27. Duration of certificate of registration: - A certificate of registration under this
chapter, shall unless earlier suspended or cancelled, be in force for a period of five years
from the date of registration of the drugs and may thereafter be renewed for periods not
exceeding 5 years and a certificate to this effects shall be issued within one month at a
time.
Provided that an application shall be made within sixty dates after the expiry of the
registration and when an application has been aforesaid the registration shall subject to
the orders passed on the application for the renewal continue in force for the next period
of five years and a certificate to this effect shall be issued within one month.
Provided further that one-time opportunity shall be given to those firms who have not
complied with the first proviso since 1st January, 2010 till the issuance of this notification
and those within sixty days after issuance of this notification shall deposit three times of
their applicable renewal fee for their registration to continue to be valid until explicit
orders are passed on the request by the Registration Board. After expiry of sixty days of
issuance of this notification, the registration of the products shall be considered as
cancelled and any manufacturing shall be penalized under the provision of the Act.
Provided also that those firms who do not fulfil the first proviso, and additional fee shall
be charged equivalent to applicable renewal fee for each month till one year of the expiry
of registration and one year the registration shall be cancelled.
Provided further that in case of an imported drugs, the renewal may be granted and a
renewal certificate shall be issued, if in the opinion of the Registration Board it is
necessary to do so in the public interest.”
Foregoing in view, any application for renewal of drugs registration submitted prior
issuance of above SRO cannot be considered as it was late under previous Rule 27. Moreover,
one-time opportunity of sixty days given by the SRO expired on 04-12-2017 and the registration
of the products who could not avail this opportunity shall be considered as cancelled and
procedure for cancellation of registration of registered products is given in Drugs Act 1976
which is as under;
Section 42. Cancellation or suspension of registration of registered drugs: - Where any
person has been found to have contravened any of the provision of this Act, or the rules
in respect of any registered drugs, the Registration Board may, after giving such person
an opportunity of being heard, cancel the registration of such drugs or suspend such
registration for specified period.
Legal Affair Division has given further opinion that the firm may be advised to submit
fresh applications under L.R.A. Rules and the Registration Board may consider these application
out-of-queue considering the nature of the products and public interest, if it deems appropriate.
Submitted for consideration of the Registration Board for the procedure of cancellation of
registration of drugs for which renewal applications received after expiry of registration.
Decision: Registration Board delebrated on the opinipon of Legal Affair Division and
decided to adopt the cancellation procedure as per Section 42 of drug act
1976.Registration Board further advised the section that the show cause
notice darft should be wetted by Legal Affair Division prior to its issuance.
Case No.04 Renewal Status of products of M/s. Global Veterinary and Technical Services
Pvt. Limited, Multan.
Registration Board in its 269th meeting deferred the case for detail history of application
for change of manufacturer name from R-I section.
Accordingly comments from R-I section are as under;
The firm initially applied for change of name of manufacturer with renewal of drugs
which was on 19-01-2007 which was within due renewal period (Due date 03-09-2008). The
GMP status of manufacturer abroad i.e., M/s Eagle Vet Tech. Co. Ltd., Korea was declared
satisfactory and recommended by the Board in its 212th Meeting held on June, 2008.
Regarding change of business address, the case is yet to be decided as the firm claim that they
have submitted application in renewal section.
After scrutiny of documents in the light of comments furnished by R-I section, it is
revealed that the renewal application of year 2013 of their products are submitted on 12-12-2011
with fee of Rs.7500/- i.e., 2 year in advance. Fee schedule has been revised in 2012 and fee for
imported drug at present is Rs.20,000/- subject to prevailing import policy.
Differential fee of Rs.12500/- for each product is required for further processing the case.
Registration Board in 275th meeting advised the firm to submit fee as per revised fee schedule for
consideration of the Board.
Now firm has submitted fee of Rs.12500/- for each product. Detail of which is as under;
S. Reg. Initial Reg. 1st Renewal 2nd Renewal 3rd Renewal due
Product Name
No. No. Date Due on due on on
1 021437 Enprotil Solution 04-09-1998 03-09-2003 03-09-2008 03-09-2013
Each litre contains:- Validity Firm has The firm has
Enrofloxacin...100gm period was submitted submitted renewal
given up till application application on
03-09-2008 for renewal 12-12-2011
in 2007 (Two year advance)
along with Rs.12500/-
change of submitted on
title in R-I 12-12-2017
section
2 021438 Enprotil 50 Injection 04-09-1998 Do Do Do
Each ml contains:-
Enrofloxacin... 50mg
3 021440 Collie-SP Powder 04-09-1998 Do Do Do
(composition as per
annxure-II)
4 021441 Cocci-AF Powder 04-09-1998 Do Do Do
Each kg contains:
Amprolium ... 200gm
Furaltadone Hcl..200gm
Decision: Registration Board acceded to the request of the firm and decided to grant
the renewal till 03-09-2018.
Case No.05 Renewal Status of products of M/s. Miracle Pharmaceuticals (Pvt.) Ltd.,
Rawat-Islamabad.
M/s. Miracle Pharmaceuticals (Pvt.) Ltd., Rawat- Islamabad has submitted a letter
wherein they have stated that they have submitted their renewal fee on 19-11-2015 with double
fee within sixty days after expiry of registration. On same day they visited the DRAP to get
endorsement of Statistical Department on renewal request letter. But there was strike on that day.
Then they dropped a complete set of their renewal registration cases to dispatcher of R & I and
take the receiving. The Statistical Officer of that time was absent due to investigation. So we
visited DRAP several times to get endorsement from statistical Department but no one was found
there. At last they get endorsement on their documents on 1st December, 2015. Now the renewal
section marked their products as unregistered products. Furthermore, they requested to study
their case with proofs and give them the clearance letter for given 27 products.
It is submitted that case was processed after discussion with Director (PE&R) with
reference to the information given by the firm. R & I Section of Administration Division is
consulted for verification of evidence provided by the firm. According to record of R & I dairy
register, renewal dossiers along with fee challan was received in the said section on 19-11-2015
for endorsement of fee from statistical office. While the R&I endorsing date on original renewal
dossiers submitted in RRR section is 01-12-2015, according to which renewal application was
received after 60days of expiry of registration. In the light of evidence of R & I dairy Register,
firm submitted its renewal application on 19-11-2015 which is within 60 days after expiry of
registration with prescribed fee. The detail of the products is given as under;
Application Receiving Date
S. Initial Reg.
Reg. No. Product Name Due Date along with detail of submitted
No. Date
fee
1. 066286 Esoday 20 Capsules 20-09-2010 19-09-2015 01-12-2015 (as per renewal
Each capsules contains: dossiers).
Esomeprazole Enteric 19-11-2015 (as per record of
Coated (Pellets) … 20mg R&I for statistical endorsement)
Rs.40,000/- paid by the firm,
source of pellets: M/s. Vision
Pharmaceuticals, Islamabad.
2. 066287 Esoday 40 Capsules -do- -do- -do-
Each capsules contains:
Esomeprazole Enteric
Coated (Pellets) … 40mg
3. 066282 Omi-B 20 Capsule -do- -do- 01-12-2015 (as per renewal
Each capsule contains: dossiers).
Omeprazole … 20mg 19-11-2015 (as per record of
Sodium Bicarbonate … R&I for statistical endorsement)
1100mg Rs.40,000/- paid by the firm,
source of pellets:
SMS Pharmaceuticals Limited
Plot No.19-III,Road No. 71,
Hyderabad, India
4. 066283 Omi-B 40 Capsule -do- -do- -do-
Each capsule contains:
Omeprazole … 40mg
Sodium Bicarbonate …
1100mg
5. 066284 Omeday 20 Capsules -do- -do- -do-
Omeprazole Enteric Coated
(Pellets) … 20mg
6. 066285 Omeday 40 Capsules -do- -do- -do-
Omeprazole Enteric Coated
(Pellets) … 40mg
7. 066272 Mevoflox-250 Capsules -do- -do- 01-12-2015 (as per renewal
Each capsule contains: dossiers)
Levofloxacin (as 19-11-2015(as per record of
Hemihydrate) … 250mg R&I for statistical endorsement)
Rs.20,000/- paid by the firm as
the renewal application is
received late but within 60 days.
8. 066273 Mevoflox-500 Capsules -do- -do- -do-
Levofloxacin (as
Hemihydrate) … 500mg
9. 066274 Cipocin-250 Capsules -do- -do- -do-
Ciprofloxacin as HCl …
250mg
10. 066275 Cipocin-500 Capsules -do- -do- -do-
Ciprofloxacin as HCl …
500mg
11. 066276 Fadol Capsules -do- -do- 01-12-2015 (as per renewal
Each capsule contains: dossiers)
Alfacalcidol … 0.5mcg 19-11-2015(as per record of
R&I for statistical endorsement)
Rs.20,000/- paid by the firm as
the renewal application is
received late but within 60 days.
12. 066277 Meridox 100mg Capsule -do- -do- -do-
Doxycycline as Hyclate …
100mg
13. 066278 F-Tin 20mg Capsules -do- -do- -do-
Fluoxetine as HCl … 20mg
14. 066279 Maricam-20 Capsules -do- -do- -do-
Piroxicam … 20mg
15. 066280 Azomer-250 Capsules -do- -do- -do-
Azithromycin as Dihydrate
… 250mg
16. 066281 Azomer-500 Capsules -do- -do- -do-
Azithromycin as Dihydrate
… 500mg
17. 066295 Merigor 0.5mg Oral Syrup 21-09-2010 20-09-2015 -do-
Each 10ml contains:
Pizotifen as Hydrogen
Maleate … 0.5mg
18. 066296 Kuflin Syrup -do- -do- -do-
Each 5ml contains:
Aminophylline … 32mg
Diphenhydramine … 8mg
Ammonium Chloride.30mg
Menthol … 0.98mg
19. 066297 Sucraz 1gm Suspension -do- -do- -do-
Each 5ml contains:
Sucralfate … 1gm
20. 066298 Maripep 10mg Suspension -do- -do- -do-
Each 5ml contains:
Famotidine … 10mg
21. 066299 Paracetamol 120mg Oral -do- -do- -do-
Suspension
Each 5ml contains:
Paracetamol … 120mg
22. 066300 Paracetamol 250mg DS -do- -do- -do-
Suspension
Each 5ml contains:
Paracetamol … 250mg
23. 066301 Domid 5mg Suspension -do- -do- -do-
Each 5ml contains:
Domperidone as Maleate
… 5mg
24. 066302 Ibunol 100mg Oral -do- -do- -do-
Suspension
Each 5ml contains:
Ibuprofen … 100mg
25. 066303 Polytose F Syrup -do- -do- -do-
Each 5ml contains:
Iron III Hydroxide
Polymaltose Complex eq.
to Elemental Iron … 50mg
Folic Acid … 0.35mg
26. 066304 Mirazin 5mg Oral -do- -do- -do-
Suspension
Each 5ml contains:
Cetrizine as
Dihydrochloride … 5mg
27. 066305 I-Rol 50mg Syrup -do- -do- -do-
Each 5ml contains:
Iron III Hydroxide
Polymaltose Complex eq.
to Elemental Iron … 50mg

i) Acceeded to the request of firm for products at Sr.No.1 – 6 & 11 – 16 and
decide to gant the renewal till 19-09-2020.
ii) Deferred the case of products at Sr. No. 07- 10 for confirmation of
availability f dosage form in Refernce Regulatory Agencies by the firm.
iii) Acceded to the request of firm for products at Sr. No. 17 – 27 and decided to
grant the renewal till 20-09-2020.
Case No.06 Renewal Status of products of M/s. Danas Pharmaceuticals (Pvt.) Ltd.,
Islamabad.
Control Drugs Division requested to verify the renewal status of products registered in the name
of M/s. Danas Pharmaceuticals (Pvt) Ltd., Islamabad.
Subsequently a letter from M/s Danas Pharmaceuticals (Pvt) Ltd. regarding the
application of quota, reference # AD/CD-AM/2017, AD/CD-BM/2017/AD/CD-LM/2017 and
AD/CD-DM/2017 dated 06-03-2017 and their request letter No. 001/2015 dated 08-05-2015 for
renewal of registration of sixteen (16) products in which they have stated that they have
deposited fee for 16 products on 08-05-2015 well before expiry that is 11-05-2015 and it was
endorsed by Statistical Division on same day. It is also stated in letter of M/s Danas
Pharmaceuticals (Pvt) Ltd. that they have submitted their intimation thereof on 11-05-2015, as
9th & 10th May was holidays.
The case was referred to Licensing Division for the confirmation of approval of
psychotropic section and current status of license of the firm. The reply of the said division is
furnished below.
“As per record of this division, the psychotropic section was approved in 220th meeting of
Central Licensing Board held on 05th November, 2009. Moreover, the application for
renewal of license of M/s. Danas Pharmaceuticals (Pvt) Ltd., Islamabad (DML #
000569) for the period of 13-05-2015 till 12-05-2020 is under process. Hence, it is
submitted that the said DML is valid at present. In addition to it firm has applied for the
change of management but decision is yet not communicated.”
Detail of products is as under;
Sr. Reg.
Product Name Initial Reg. Date Application Receiving Date
No. No.
1 063237 Trancodan Tablet 1mg 11-05-2010 Due date:
Each tablet contains:- (10-05-2015)
Lorazepam USP … 1mg Application Receiving Date
(11-05-2015)
2 063238 Trancodan Tablet 2mg Do Do
Lorazepam USP … 2mg
3 063239 Prazodan Tablet 0.25mg Do Do
Alprazolam … 0.25mg
4 063240 Prazodan Tablet 0.5mg Do Do
5 063241 Prazodan Tablet 1mg Do Do
Alprazolam … 1mg
6 063242 Brodan Tablet 1.5mg Do Do
Bromazepam … 1.5mg
7 063243 Brodan Tablet 3mg Do Do
Bromazepam … 3mg
8 063244 Brodan Tablet 6mg Do Do
Bromazepam … 6mg
9 063245 Benzopine Tablet 2mg Do Do
Diazepam … 2mg
Diazepam … 5mg
Diazepam … 10mg
Decision: Registration Board deferred the case for opinion of Legal Affair Division
Case No.07 Applications Received with Shortcomings
This section apprised the Board that Directorate of (PE&R) is dealing with number of
applications submitted for renewal of drugs which are incomplete or have shortcoming especially
with reference to the submitted prescribed renewal fees.
The following applications for renewal of drugs are submitted on Form 5-B after the
expiry of validity of the certificate of registration but within sixty days after validity of
certificate of registration. The applications for renewal are incomplete with reference to renewal
application fee or having some other deficiency.
RULE 27 Drug (Licensing, Registering & Advertising) Rules, 1976 (Duration of certificate
of registration). A certificate of registration under this chapter, [shall unless earlier suspended
or cancelled, be in force for a period of five years from the date of [Registration of the drug] and
may thereafter be renewed for period not exceeding five years and a certificate to this effect
shall be issued within one month] at a time.
Provided that an application for the renewal of registration shall not be entertained unless it has
been made within sixty days after the expiry of the registration and when an application has
been made aforesaid the registration shall subject to the orders passed on the application for the
renewal continue in force for the next period of five years and a certificate to this effect shall be
issued within one month].
Provided further that in case of an imported drug, the renewal may be granted and a renewal
certificate shall be issued, if in the opinion of the Registration Board it is necessary to do so in
the public interest.
Following cases are placed below for consideration of the Registration Board.
i) Cases for Imported Pellets.
a) M/s. Star Laboratories (Pvt.) Ltd., Lahore.
Costing & Pricing Division requested to verify the renewal status of following product.
Product Name Application Receiving date
1 003289 Segazole Capsule 26-08-1997 Due date (25-08-2017)
Each capsule contains:- Fee of Rs.10,000/- deposited on
Omeprazole … 20mg 28-07-2017. As these are imported pellets
from M/S Smilax Laboratories LTD Plot
No.88/A Sarala Nivas APTS, Flat No.404,
Street No. 1 Sagar Society Road N0.2.
Banjara Hills Hyderabad-500 034 India. So,
remaining fee of Rs.10,000/- is deposited on
18-12-2017.
Decision: Registration Board acceded to request of firm and decided to grant renewal
of product till 25-08-2022.
b) M/s. Heal Pharmaceuticals (Pvt.) Ltd., Peshawar.
Case is referred by R-IV Section.
1 046135 Opra Capsule 20mg 30-04-2007 Due date (29-07-2017)
Omeprazole … 20mg 10-04-2017. As these are imported
(as enteric coated pellets) pellets from M/S Smilax Laboratories
LTD Plot No.88/A, Flat No.401,
Sarala Niwas, Street No. 1, Sagar
Society Road N0.2. Banjara Hills
Hyderabad-500 034 India. So,
remaining fee of Rs.10,000/- is
deposited on 28-07-2017.
c) M/s. Innvotek Pharmaceuticals, Islamabad.

Case is referred by R-III Section.
1 072285 Esocap 20 Capsule 18-08-2011 Due date (17-08-2016)
Esomeprazole as (Mag-coated 19-09-2016. As these are imported
22.5% Pellets) … 100mg pellets from M/S Zen Bio Tech Pvt.
Ltd. 195/4, Phase-II Sector-3 Line-7
I.D.A. Cheriapally, Hyderabad-500
51, India. So, remaining fee of
Rs.10,000/- is deposited on
29-11-2017.
d) M/s. Linear Pharma, Rawat, Islamabad.

1 063327 Dulox 30mg Capsule 04-06-2010 Due date (03-06-2015)
Enteric coated pellets of 28-05-2015. As these are imported
Duloxetin HCl eq. to pellets from M/S Smilax
Duloxetin … 30mg Laboratories LTD Plot No.88/A, Flat
No.401, Sarala Niwas, Street No. 1,
Sagar Society Road N0.2. Banjara
Hills Hyderabad-500 034 India. So,
of product till 03-06-2020
e) M/s Davis Pharmaceutical Laboratories, Islamabad.
1. 032088 Opza 20mg Capsule 09-02-2004 Due date (08-02-2014)
Omeprazole (Coated Pellets) 30-01-2014. As these are imported
225mg eq. to Omeprazole … pellets from M/s Lee Pharma Ltd;
20mg Survey No.199, Plot No.3&4, D.
No.5-9-265/1&2, Rajive Gandhi
Nagar Indl. Extension, Kukatpally,
Hyderabad-72, A. P. India.
Remaining fee of Rs10,000/- is
f) M/s. Unison Chemical Works, Lahore.

Sr. Initial date of
Reg. No. Product Name Application Receiving date
No. Registration
1. 062555 Omson Capsule 23-02-2010 Due date (22-02-2015)
Omeprazole (Pellets) … 20mg 13-02-2015. As these are imported
pellets from M/S Spansules formulations
Plot No. 154/A4, I.D.A Bollaram, Medak
Dist. Hyderabad-502325, India. So,
remaining fee of Rs.10,000/- is deposited
on 07-12-2017.
2. 052556 Esoson-20 Capsule Do Do
Esomeprazole Coated pellets
of Magnesium trihydrate eq. to
Esomeprazole … 20mg
3. 052557 Lansuni Capsule Do Do
Lansoprazole (Pellets) …
30mg
4. 052558 Unipanto Capsule Do Do
Pantoprazole as Sodium
sesquihydrate (Pellets) …
40mg
5. 052559 Esoson-40 Capsule Do Do
Esomeprazole Coated pellets
of Magnesium trihydrate eq. to
Esomeprazole … 40mg
of products at Sr. No. 01-05 till 22-02-2020.
g) M/s. Well & Well Pharma (Pvt) Ltd., Islamabad.
Product Name Registration
Application Receiving date
No. No.
1. 066651 Empel 20mg Capsule 07-12-2010 Due date (06-12-2015)
Esomeprazole as (Mg-coated 16-11-2015. As these are imported
8.5% Pellets) … 20mg pellets from M/S Spansules pharmatech
Pvt. Ltd., Plot No-163, Subash Nagar,
Phase-I, I.D.A, Jeedimtla, Hyderabad-
Rs.10,000/- is deposited on 25-01-2018.
2. 066652 Empel 40mg Capsule Do Do
Esomeprazole as (Mg-coated
22.5% Pellets) … 40mg
3. 066444 Omrel 20 Capsule 11-10-2010 Due date (10-10-2015)
Omeprazole (Pellets) … 20mg 09-10-2015. As these are imported
pellets from M/S Spansules pharmatech
Pvt. Ltd., Plot No-163, Subash Nagar,
Phase-I, I.D.A, Jeedimtla, Hyderabad-
Rs.10,000/- is deposited on 23-01-2018.
4. 066445 Omrel 40 Capsule Do Do
Omeprazole (Pellets) … 40mg
Decision: Registration Board acceded to request of firm and decided as under;
i) To grant renewal of products at Sr. No. 01 & 02 till 06-12-2020.
ii) To grant renewal of products at Sr. No. 03 & 04 till 10-10-2020.
ii) With Differential Fee

a) M/s. Well & Well Pharma (Pvt) Ltd., Islamabad.
1. 072001 Ebavel 10mg Tablet 25-06-2011 Due date (24-06-2016)
Each tablet contains:- Fee of Rs.10,000/- deposited on
Ebastine … 10mg 28-06-2016. As application received
within 60 days after expiry of Reg.
Remaining Fee of Rs.10,000/-
2. 072002 Ebavel 20mg Tablet Do Do
Ebastine … 20mg
3. 072005 Zithrovel 250mg Tablet Do Do
Azithromycin (as Dihydrate)
… 250mg
4. 072006 Zithrovel 500mg Tablet Do Do
Azithromycin (as Dihydrate)
… 500mg
5. 072017 Entehep 0.5mg Tablet 27-06-2011 Due date (26-06-2016)
Entecavir … 0.5mg 28-06-2016. As application received
Remaining Fee of Rs.10,000/-
6. 072018 Entehep 1mg Tablet Do Do
Entecavir … 1mg
i) To grant renewal of products at Sr. No. 01-04 till 24-06-2021.
b) M/s. Unison Chemical Works, Lahore.

1. 065727 Unilexin 1mg Tablet 16-09-2010 Due date (15-09-2015)
Each tablet contains:- Fee of Rs.10,000/- deposited on 16-
Alprazolam … 1mg 09-2015. As application received
within 60 days after expiry of Reg. So
remaining Fee of Rs.10,000/-
2. 065728 Unilexin 0.5mg Tablet Do Do
3. 065729 Unilexin 0.25mg Tablet Do Do
4. 065730 Unibro 6mg Tablet
Bromazepam … 6mg
5. 065731 Unibro 3mg Tablet
Bromazepam … 3mg
6. 065732 Uninor 0.2mg Tablet Do Do
Buprenorphine (as HCl) …
0.2mg
7. 065734 Pyson 25mg Tablet Do Do
Pentazocine HCl … 25mg
8. 065735 Tymil 50mg Tablet Do Do
Tramadol HCl … 50mg
9. 065736 Larison 2mg Tablet
Lorazepam … 2mg
10. 065737 Larison 1mg Tablet
Lorazepam … 1mg
11. 065738 Unichlore 5mg Tablet Do Do
Chlordiazepoxide … 5mg
12. 065739 Ovinol 10mg Tablet Do Do
Olanzapine … 10mg
13. 065740 Ovinol 5mg Tablet Do Do
Olanzapine … 5mg
14. 065741 Meldin 2mg Tablet Do Do
Risperidone … 2mg
15. 065742 Meldin 1mg Tablet Do Do
Risperidone … 1mg
c) M/s. Elegance Pharmaceuticals, Rawalpindi. (Veterinary)

1. 073916 Bioenrocolis Liquid 06-09-2012 Due date (05-09-2017)
Each 100ml contains:- Fee of Rs.10,000/- deposited on 21-
Enrofloxacin … 10g 09-2017. As application received
Colistin Sulphate … 52MIU within 60 days after expiry of Reg. So
remaining Fee of Rs.10,000/-
deposited on
27-09-2017.
2. 073917 Bromo-Plus Liquid Do Do
Each ml contains:-
Bromhexine HCl … 20mg
Menthol … 40mg
3. 073918 Restidox Liquid Do Do
Doxycycline HCl … 200g
Tylosin tartrate … 100gm
Colistin sulphate … 500MIU
Bromhexine HCl … 10gm
4. 073919 Florex 23 Liquid Do Do
Each ml contains:-
Florfenicol … 23%
5. 073920 Florex Liquid Do Do
Each ml contains:-
Florfenicol … 10%
6. 073921 Amrocol Powder Do Do
Each 100gm contains:-
Enrofloxacin HCl … 10gm
Colistin Sulphate … 4gm
Amantadine HCl … 4gm
7. 073922 S3 Plus Powder Do Do
Sulphachlorpyrazine Sodium
… 30gm
Vitamin K3 … 0.4gm
Vitamin A … 1.5MIU
8. 073923 Biotylomant Powder Do Do
Doxycycline HCl … 200gm
Amantadine HCl … 40gm
Tylosin Tartrate … 100gm
9. 073924 Colabex Powder Do Do
Enrofloxacin Hydrochloride …
10%
Colistin Sulphate … 500MIU
Amantadine Hydrochloride …
4%
10. 073925 Coli CN Powder Do Do
Neomycin Sulphate … 70gm
Chloretetracyclin HCl …
80gm
Colistin Sulphate … 40gm
i. Acceded to request of the firm and decided to grant renewal of products
at Sr. No. 01-05, 07 & 10 till 05-09-2022.
ii. Deferred the case of product at Sr. No. 06, 08 & 09 regaridng
confirmation of formulation from concerned section.
d) M/s. Webros Pharmaceuticals, Rawat, Islamabad.

1. 034707 Wefen 400mg Tablet 02-12-2004 Due date (01-12-2014)
Each tablet contains:- Fee of Rs.10,000/- deposited on 02-12-
Ibuprofen … 400mg 2014.(Photocopy) As application
received within 60 days after expiry of
Reg. Remaining Fee of Rs.10,000/-
2. 034694 Webnizole Tablet Do Do
Metronidazole … 200mg
3. 066389 Mycelex Cream 01-10-2010 Due date (30-09-2015)
Each gm contains:- Fee of Rs.10,000/- deposited on 26-10-
Clotrimazole … 1%w/w 2015.(Photocopy) As application
received within 60 days after expiry of
Reg. Remaining Fee of Rs.10,000/-
4. 066391 Acticin Cream Do Do
Each tube contains:-
Premethrin … 5%w/w
5. 066393 Alicam Gel Do Do
Each gel contains:-
Piroxicam … 0.5%
6. 066394 Adan Gel Do Do
Each gel contains:-
Diclofenac as Diethyl
Ammonium Salt … 1gm
i) To grant renewal of products at Sr. No. 01 & 02 till 01-12-2019.
e) M/s. Crest Pharmaceuticals Islamabad.

1. 065411 Elcical Tablet 19-08-2010 Due date (18-08-2015)
Alfacalcidol … 0.5mcg 08-2015. (photocopy). As application
received within 60 days after expiry
of Reg. So remaining Fee of
Rs.10,000/- deposited on 11-10-2017.
2. 065412 Rebyb Tablet Do Do
Mecobalamine … 500mcg
3. 065413 Azi Once 250 Tablet Do Do
Azithromicin as Di-hydrate …
250mg
4. 065414 Doclocid DS Tablet Do Do
Naproxen Sodium … 550mg
5. 065415 Doclocid Tablet Do Do
Naproxen Sodium … 275mg
6. 065416 Cyclocam Plus Tablet Do Do
Piroxicam β Cyclodextrin eq.
to Piroxicam … 20mg
7. 065417 Fendol 50 Tablet Do Do
Diclofenac Sodium … 50mg
8. 065418 Flexy 75 Tablet Do Do
Diclofenac Sodium … 75mg
9. 065419 Crescip Tablet Do Do
Ciprofloxacin HCl … 250mg
10. 065420 Crescip DS Tablet Do Do
Ciprofloxacin HCl … 500mg
11. 065421 Creslevo Tablet Do Do
Levofloxacin as Hemihydrate
… 250mg
12. 065422 Creslevo DS Tablet Do Do
Levofloxacin as Hemihydrate
… 500mg
13. 065423 Gemcid Tablet Do Do
Gemifloxacin Mesylate eq. to
Gemifloxacin … 320mg
14. 065424 Malacid DS Tablet Do Do
Atemether … 40mg
Lumifantrine … 240mg
15. 065425 Malacid Forte Tablet Do Do
Atemether … 80mg
Lumifantrine … 480mg
of products at Sr. No. 01-15 till 18-08-2020 with the advice to add word
“Sugar Coated” in reference composition of product at Sr. No. 02 and
“Enteric Coated” in refrence compostion of product at Sr. No. 07 & 08 from
the concerned section.
f) M/s. Danas Pharmaceuticals (Pvt) Ltd., Islamabad.

1. 041071 Nordan Tablet Extra 21-11-2005 Due date (20-11-2015)
Paracetamol … 650mg 11-2015. (photocopy). As application
Orphanadrine Citrate … 50mg received within 60 days after expiry
of Reg. So remaining Fee of
Rs.10,000/- deposited on 15-12-2017.
2. 041689 Sidik Cream Do Do
Contains:-
Fusidic Acid … 2%
of products at Sr. No. 01 & 02 till 20-11-2020.
g) M/s. Shaigan Pharmaceuticals (Pvt) Ltd., Rawalpindi.

R-III section requested to verify the renewal status of following products for processing
their application for source fixation.
1. 024060 Laclose Syrup 30-05-2002 Due date (29-05-2017)
Each 5ml contains:- Fee of Rs.10,000/- deposited on
Lactulose … 3.35gm 19-04-2017. As this product is Bulk
Import and Locally Repacked, So,
h) M/s. Libra (Pvt.) Ltd., Peshawar.
Case is referred by CD Division.
1. 016495 Freedom 3mg Tablet 24-11-1994 Due date (23-11-2014)
Bromazepam … 3mg 24-11-2014). As application received
So remaining fee of Rs.10,000/-
i) M/s. Derma Techno Pakistan, Lahore.

1. 071254 Alofex 60mg Tablet 18-08-2011 Due date (17-08-2016)
Each film coated tablet Fee of Rs.10,000/- deposited on
contains:- 29-09-2016. As application received
Fexofenadine HCl … 60mg within 60 days after expiry of Reg.
So remaining fee of Rs.10,000/-
2. 071255 Etrazine-L mg Tablet Do Do
Levocetirizine dihydrochloride
… 5mg
3. 071256 Technozole 150mg Capsule Do Do
Fluconazole … 150mg
4. 071257 Herpirid Cream Do Do
Each gram contains:-
Acyclovir … 50mg
5. 071258 Tretiderm Gel Do Do
Isotretinoin … 0.05%
6. 071259 Doxit Capsule Do Do
Doxycycline (as hyclate) …
100mg
7. 071260 Tretocin Gel Do Do
Erythromycin … 20mg
Isotretinoin … 0.50mg
8. 071261 Bezclin Gel Do Do
Clindamycin (as phosphate) …
10mg
Benzoyl peroxide … 50mg
9. 071262 Tinabin 125mg Tablet Do Do
Each film coated tablet
contains:-
Terbinafine (as HCl) … 125mg
10. 071263 Tinabin 250mg Tablet Do Do
contains:
Terbinafine (as HCl) … 250mg
11. 071264 Aforal 500mg Tablet Do Do
contains:-
Metformin HCl … 500mg
12. 071265 Cabsole Cream Do Do
Clobetasol propionate …
0.5mg
13. 071266 Tycelex 1% Lotion Do Do
Each ml contains:-
Clotrimazole … 10mg
14. 071268 Kitcon 2% Solution Do Do
Each ml contains:-
Ketoconazole … 20mg
15. 071269 Technobet Lotion Do Do
Each ml contains:-
Betamethasone (as valearate)
… 1mg
16. 071270 Regrow 2% Solution Do Do
Each ml contains:-
Minoxidil … 2%
17. 071271 Tycelex Cream Do Do
Clotrimazole … 1%
Hydrocortisone … 1%
18. 071272 Technobet-G Cream Do Do
Betamethasone dipropionate …
0.5mg
Gentamicin sulphate … 1mg
19. 071273 Technobet S Cream Do Do
Betamethasone dipropionate …
0.05%
Salicylic acid … 3%
20. 071274 Technobet Cream Do Do
Betamethasone (as valearate)
… 1mg
21. 071275 Fsid H Cream Do Do
Fusidic acid … 20mg
Hydrocortisone acetate …
10mg
Case No.08 Confirmation of Renewal Status for Export M/s. Well & Well Pharma (Pvt)
Ltd., Islamabad.
Federal Inspector of Drugs-III from QA & LT Division has requested for the verification
of renewal of registration of drugs to issue CoPP for the export to Myanmar. List of drugs along
with their renewal status is as under;
Sr. Initial date
Reg. No. Product Name Application Receiving date
No. of Reg.
1. 065118 Allerno 5mg Tablet 22-07-2010 Due date (21-07-2015). Received within 60
Each tablet contains:- days after expiry of Reg. with fee of Rs.20,000/-
Levocetrizine 2HCl … 5mg deposited on 24-08-2015
2. 065123 Lefnil 250mg Tablet Do Do
Levofloxacin Hemihydrate…
250mg
3. 065124 Lefnil 500mg Tablet Do Do
Levofloxacin Hemihydrate…
500mg
4. 069819 Malavel Tablet 04-04-2011 Due date (03-04-2016)
Each tablet contains:- Received within 60 days after expiry of Reg.
Artemether … 80mg with Fee of Rs.20,000/- deposited on 07-09-
Lumifantrine … 480mg 2015.
5. 069818 Malavel Tablet Do Due date (03-04-2016)
Artemether … 40mg 28-06-2016. As application received within 60
Lumifantrine … 240mg days after expiry of Reg. Remaining Fee of
Rs.10,000/- deposited on 18-01-2018.
6. 072003 Hepaid 100mg Tablet 25-06-2011 Due date (24-06-2016).Fee of Rs.10,000/-
Each tablet contains:- deposited on 28-06-2016. As application
Lamivudine … 100mg received within 60 days after expiry of Reg.
Remaining Fee of Rs.10,000/- deposited on 18-
01-2018
7. 072004 Mecowell 500mcg Tablet Do Due date (24-06-2016). Fee of Rs.10,000/-
Each tablet contains:- deposited on 28-06-2016. As application
Mecobalamine … 500mcg received within 60 days after expiry of Reg.
Remaining Fee of Rs.10,000/- deposited on 25-
01-2018.
8. 066443 Velfenac Capsule 11-10-2010 Due date (10-10-2015). Fee of Rs.10,000/-
Each capsule contains:- deposited on 09-10-2015. As these are imported
Diclofenac Sodium … 50mg pellets from M/S Spansules pharmatech Pvt.
Ltd., Plot No-163, Subash Nagar, Phase-I,
I.D.A, Jeedimtla, Hyderabad-500055, India. So,
remaining fee of Rs.10,000/- is deposited on 18-
01-2018.
i) To grant renewal of products at Sr. No. 01-03 till 21-07-2020.
iii) To grant renewal of products at Sr. No. 06 & 07 till 24-06-2021 with the
advice to add word “Sugar Coated” in reference composition of product
at Sr. No. 07 from the concerned section.
iv) To grant renewal of products at Sr. No. 08 till 10-10-2020.
REGISTRATION-I
Case.No.01:- Correction in Composition of Approved Products.

The following products approved in various meetings of Registration Board required
corrections in composition in accordance with the CoPP before issuance of Registration letters as
per details mentioned below:
A. “Irinotecan medac 100mg/5ml Injection” of M/s. Amgomed, Islamabad.

Registration Board in its 260th meeting approved the following product of M/s.
Amgomed, Islamabad as per following details:
S. Name of importer / manufacturer Name of Drug(s) Demanded Decision of Board,
No Pack size approved prices and
& Price remarks
1. M/s. Amgomed, Office # 5, 1st Floor Irinotecan medac Approved as per
Rose 1, Plaza I-8 Markaz, Islamabad. 100mg/5ml Injection As per import Policy for
Market authorization holder Each vial contains:- SRO/5ml Finished Drugs.
M/s. MEDAC, Gesellschaft fur Irinotecan……..100
klinische Spezialpraparate mbH, mg
Fehlandtstrasse 3 20354 Hamburg, (Advanced
Germany. Colorectal cancer)
Labelling, Secondary Packaging, Manufacturer’s
Quality Control/ testing & Batch Specifications
release by: M/s. MEDAC, Gesellschaft 03 years
fur klinische Spezialpraparate mbH,
Theaterstr, 6, 22880 Wedel, Germany.
Manufactured by: M/s Oncotec
pharma produktin GmbH, Am
Pharmapark, 06861 Dessau-Rosslau,
Germany.
The composition of the said product was inadvertently incorporated in the minutes as
follow and the same was forwarded for MRP fixation:
“Each vial contains:-
Irinotecan…100mg
Subsequently, the Costing and Pricing Division fixed the MRP of the said
product/formulation @ Rs.7125/ for 5ml vial vide SRO.No.1219(I)/2017 dated 27-11-2017.
Whereas, the correct composition of the said product as per CoPP (German Authority) is as
follow:
“Each 5ml vial contains:
Irinotecan hydrochloride trihydrate…100mg”
Decision: Registration Board approved the correction in composition of above mentioned
product in accordance with CoPP (issued by German authority) as per
following details and the same shall be referred to Costing & Pricing Division
for MRP confirmation/fixation:
“Each 5ml vial contains: Irinotecan hydrochloride trihydrate…100mg”
Board further decided that in order to standardized the composition in accordance with
reference regulatory authorities/agencies, this decision shall also be applicable to all such
products previously approved by Registration Board wherein the composition was
inadvertently mentioned as “Each vial contains irinotecan 100mg”.
B. “Fludara IV 50mg injection” of M/s. Sanofi-aventis Pakistan Limited, Karachi.
Registration Board in its 264th meeting approved the cancellation of registration of
Fludara IV Injection from the name of M/s. SciTech Health (Private) Limited, Karachi and
registration of the same in the name of M/s. Sanofi-Aventis Pakistan Limited, Karachi on same
terms and condition and as per Import Policy for Finished Drugs.
S. No. Name of Drug Approved Sites.
1. Fludara IV injection Manufacturing & Primary Packaging Site:
Reg.No.025267 M/s. Baxter Oncology GMBH, Kantstrasse 2, Halle/Westfalen, 33790,
Germany.
Labeling/Secondary Packaging & Releasing Site:
M/s. Genzyme Limited, 37 Hollands Road, Haverhill, Suffolk CB9
8PU, United Kingdom.
As per decision of Registration Board a reference was sent to Costing & Pricing Division
for MRP to be given to the said product. In response, the concerned Division communicated,
vide letter, the MRP to be given i.e Rs.66313/5 vials with the following composition which was
mentioned on initial registration letter:
“Each vial contains:
Fludarabine Phosphate
Equivalent to 39.05mg of the
principal blood metabolite Fludarabine (2F-ara-A)
as a lyphophilized solid cake”.
However, the following composition of the aforesaid product as per CoPP issued by
MHRA has now been referred to Costing & Pricing Division for confirmation/clarification of
MRP with the corrected composition (in accordance with the CoPP).
Fludarabine Phosphate…50mg”
Decision: Registration Board approved/endorsed the correction in composition of
Fludara 50mg IV injection (in accordance with CoPP issued by MHRA) as
per following details;
Fludarabine Phosphate…50mg”
C. “Fentanyl Sandoz 25µg/h (10.5cm2)” of M/s. Novartis Pharma, Karachi.

Registration Board in its 257th meeting approved the following product of M/s. Novartis
Pharma (Pakistan) Limited, Karachi as per below mentioned details.
S. Name of importer / Name of Drug(s) / composition Demanded Remarks
No. manufacturer. Price / Pack
size
1. M/s Novartis Pharma Fentanyl Sandoz 25µg/h (10.5cm2) MRP Approved.
(Pakistan), Limited, Transdermal Patch Rs:4227.00 /
Karachi Each transdermal Patch contains: 5’s
Manufacturer Fentanyl…25µg/hour
M/s. Hexal AG, (Cancer Pain/Pain Management)
Industries 25 83607, Manufacturer Spec
Holzkirchen, Germany (Dermal Route)
The case was referred to Costing & Pricing Division for MRP fixation/clarification with
composition of the said product mentioned as “Fentanyl…5.78mg” in accordance with the CoPP
issued by German authority. The concerned Division in response fixed the MRP of Rs. 1596/5’s
vide S.R.O.No.1219(I)/2017 dated 27-11-2017 with the following composition:
“Each transdermal Patch contains:
Fentanyl…25µg/h”
It is clarified that the composition of the said product in meeting minutes of Registration
Board (mentioned in above table) shows the release rate of the product and is not the actual
composition. The correct composition of the product as per CoPP issued by (German authority)
is as follow and the same has now been referred to Costing & Pricing Division for
confirmation/clarification of MRP with the corrected composition:
“One transdermal patch a 10.5cm2 contains:
Fentanyl….5.78mg”
The Board was further informed that another strength of the same product was also
approved in the same meeting (M-257) with release rate not mentioning the actual composition
i.e quantity of Fentanyl…11.56mg.
Decision: Registration Board approved/endorsed the correction in composition of
Fentanyl Sandoz Transdermal patches approved in 257th Registration Board
meeting in accordance with CoPP issued by German authority as per following
details;
a. Fentanyl Sandoz 25µg/h (10.5cm2)
“One transdermal patch a 10.5cm2 contains:
(Release rate: 25µg/h)
b. Fentanyl Sandoz 50µg/h (21cm2)
“One transdermal patch a 21cm2 contains:
(Release rate: 50µg/h)
Case.No.02:- Request of M/s. Amgomed, Islamabad for change of manufacturing site of
approved product.
M/s Amgomed, Office No.5, 1st Floor Rose 1 Plaza, I-8 Markaz, Islamabad has applied
for change of manufacturing site of their following already approved product in 267th meeting of
Registration Board held on 20th-21st, February, 2017 as per details given below. The registration
letter has not yet been issued.
S. Name of Drugs / New Proposed Site / Batch Releaser / Product License Holder
Existing approved site
No Composition (as per COPP)
1. Farmatide M/s West Pharma, Manufacturer, Primary and Secondary Packaging, Control:-
50mg Tab Prducoes de M/s. Atlas Pharma, S.A. Berrechid, Quartier Industrial
Each tablet Especialiaes Route Principal numero 7, Rue C 26100 Casablanca,
contains: - Farmaceuticas, SA Rua Morrocos.
Bicalutamide Joao de Deus, N. 11, Batch Releaser:
50mg Amadora, 2700-486, M/s,Tecnimede-Sociedade Tecnico Medicinal, S.A Quinta
Portugal. da Cerca, Caixaria, Dois Portos-2565-187, Portugal.
Product License Holder:
M/s. Farmoz Sociedade Tecnico Medicinal, S.A Rua da
Tapada Grande, n2, Abrunheira, 2710-089 Sintra, Portugal.
The firm have deposited fee of Rs. 100,000/- and submitted following supporting documents:
a) Application on Form 5A
b) Original & legalized CoPP from Spanish and Portuguese authorities for new
manufacturing site.
c) Certificate to whom it may concern.
d) Attested GMP certificate licensed by Portugal authority for new
manufacturing site.
e) Copy of drug sale license.
f) Site master plan of the new manufacturer.
Decision: Registration Board approved the following variations with respect to product
Farmatide 50mg Tablet subject to import policy for finished drugs;
i. Change of manufacturing site from M/s West Pharma, Prducoes de
Especialiaes Farmaceuticas, SA Rua Joao de Deus, N. 11, Amadora, 2700-
486, Portugal to M/s. Atlas Pharma, S.A. Berrechid, Quartier Industrial
Route Principal numero 7, Rue C 26100 Casablanca, Morrocos (as
Manufacturer, Primary and Secondary Packaging, Control).
ii. Batch releaser as M/s,Tecnimede-Sociedade Tecnico Medicinal, S.A Quinta
da Cerca, Caixaria, Dois Portos-2565-187, Portugal.
iii. Product License Holder as M/s. Farmoz Sociedade Tecnico Medicinal, S.A
Rua da Tapada Grande, n2, Abrunheira, 2710-089 Sintra, Portugal.
Case.No.03:- Request of M/s. Highnoon Laboratories, Lahore for exemption from

inspection of manufacturer located in India for their approved
product.
M/s. Highnoon Laboratories Ltd, Lahore has requested for exemption from inspection for
their approved product, in 262nd meeting of Registration Board, as per following details:-
Name of Product Name & Composition Demanded Decision/
importer/manufacturer Pack size & remarks
MRP
M/s. Highnoon Laboratories Pirfenex 200mg Tablet Not given Approved as per
Limited, 17.5 KM, Multan Each film coated tablet contains: Import Policy for
Road, Lahore. / Pirfenidone…200mg Finished Drugs
M/s. Cipla Ltd., (Idiopathic Pulmonary Fibrosis)
Village Malpur, Baddi New Molecule
District Solan, Himachal 24 months
Pradesh, India.
The firm has provided legalized copy of certificate issued by WHO having title as follow:
“WHO Prequalification Team-Inspection Services
inspection report closing of inspection”
The aforesaid certificate reports that the site is considered to be operating to the standards
of GMP published by WHO for the scope of listed activities which includes the manufacturing
process of tablet dosage form.
The case was presented before Post Registration Variation Committee wherein the
Committee evaluated the case in light of Import Policy for finished drugs approved by Policy
Board, DRAP which specifies that the products prequalified by WHO will be considered for
exemption from inspection of manufacturer abroad. However, since the firm has provided a
legalized copy of GMP compliance report issued by WHO for the site, so it has been decided in
2nd PRVC meeting to defer the case and also to seek the guidance of Registration Board in the
matter.
Decision: Keeping in view the above explained position, Registration Board did not
accede to M/s. Highnoon Laboratories Limited, Lahore request for
exemption from inspection of manufacturer i.e M/s. Cipla Ltd., Village
Malpur, Baddi District Solan, Himachal Pradesh, India for their approved
product “Pirfenex 200mg Tablet” as the approved Import Policy for Finished
Drugs only allows WHO prequalified products for consideration of
exemption from inspection of manufacturer aboard.
Board, further, decided that a working paper shall be prepared for
consideration of Registration Board for policy decision regarding the
exemption from inspection of WHO prequalified manufacturers.
Case No.04:- Request of M/s. GSK Pakistan, Karachi for registration of locally
manufacturer drug for import.
M/s. GlaxoSmithKline Pakistan Limited, Karachi has requested for registration of
following locally manufactured drug for import in finished form as per following details:
S.No Product Name and Reg.No Approved Approved Manufacturer & Product License
Composition Packaging MRP Holder (as per CoPP)
1. Ventolin Evohaler 041195 200- Rs.200/- Manufacturer/Packager:
Per unit dose contains: Actuations M/s. Glaxo Wellcome SA, Avenida
Salbutamol De Extremadura 3, Aranda De
Sulphate…120.50mcg Duero, Burgos, E-09400, Spain.
M/s. Smithkline Beecham Limited,
Stockley Park West, Uxbridge,
Middlesex, UB11 1BT, United
Kingdom.
The brief history of the case is as follow:
i. The product was initially registered dated 27-03-2006 in favor of M/s. GlaxoSmithKline
Pakistan Limited, Karachi for finished import from Spain.
ii. Later, the firm was granted permission dated 07-09-2016 for local manufacturing of the
said product at licensed premises at DML 000017.
iii. Subsequently, the firm has informed that they are unable to start local manufacturing of
the Ventolin Evohaler due to some technical issues at their manufacturing premises (West
Wharf factory), including delay in availability of imported packaging components of the
product, to carry out some revalidation of processes and equipment of CFC free
manufacturing area etc, which can lead to potential risk of supplies and availability of
Ventolin Evohaler in local market. The firm was granted permission dated 10-05-2017 to
import Ventolin Evohaler for six months.
iv. Subsequently, the firm has informed that GSK has reconsidered its original intent to
manufacture the product in Pakistan and decided to continue import of the said product
from the same global supply site initially approved. In support of the request, firm has
submitted application on Form 5A (with all details) along with fee of Rs.100,000/- and
Original, valid and legalized CoPP issued by MHRA.
v. Meanwhile, National Program Manager from Ministry of Climate Change (National
Ozone Unit), Government of Pakistan informed DRAP that:
i. GSK may not be given any further permission for import of drug;
ii. DRAP may take steps to get the commitment under MOA, on part of GSK to be
fulfilled;
iii. GSK may be conveyed about the meeting with DRAP and its recommendations
with advice to sort technical impediments and ensure implementation of
remaining activities under the MOA.
vi. The case was discussed in 272nd meeting of Registration Board wherein following
decision was taken.
“Registration Board deliberated the matter in detail and advised M/s GSK
Pakistan Ltd., Karachi to settle their case with Ministry of Climate Change
(National Ozone Unit). Further processing of instant case shall be considered
after settlement of matter.”
vii. Keeping in view the high demand in winter season, the case was discussed in 275th
Registration Board meeting and decided as follow:
“Registration Board noted that the drug is expected to be in high demand in the
coming months as the winter season starts. In order to avoid shortages of the drug
the Board decided to extend the permission for temporary import of Ventolin
Evohaler, manufactured by M/s. Glaxo Wellcome SA, Avenida De Extremadura 3,
Aranda De Duero, Burgos, E-09400, Spain and packed by M/s GlaxoSmithKlin,
Australia Pvt Ltd., Australia, for another 45 days from the date of expiry of previous
permission. The Board further advised M/s GSK to immediately settle the matter
with Ministry of Climate Change under intimation to the Board for further action.”
Now M/o Climate Change has informed this office vide letter dated 03-01-2018 that:
i. UNDP Bangkok, the implementing agency for project has advised to return the unspent
funds.
ii. Regarding the permission for import of medicine is concerned, DRAP may take decision
as per the prescribed rules and procedures.
Decision: Keeping in view the above explained position, Registration Board approved
M/s. GSK Pakistan, Karachi’s request for import of Ventolin Evohaler
(Reg.No. 041195) in finished form as per following details (as per CoPP)
subject to import policy for finished drugs.
Manufacturer/Packager:
M/s. Glaxo Wellcome SA, Avenida De Extremadura 3, Aranda De Duero,
Burgos, E-09400, Spain.
M/s. Smithkline Beecham Limited, Stockley Park West, Uxbridge,
Middlesex, UB11 1BT, United Kingdom
Case No.05: Change of Name/Status of M/s. AGP (Pvt) Limited, Karachi for Approved
Product Ledvir 90mg/400mg Tablet.
Registration Board in its 257th meeting approved the following product of M/s. AGP
(Pvt) Ltd, Karachi as per details mentioned along side;
Name of importer / Name and Composition of Demanded Decision of Board,
manufacturer Drug(s) Pack size & approved prices
Price and remarks
M/s. AGP (Private) Limited Ledvir 90mg/400mg tablet 30% less than Approved as per
Importer B-2, S.I.T.E, Karachi Each film coated tablet contains: originator import policy
Manufacturer: M/s. Mylan Sofosbuvir... 400mg price/28’s
Laboratories limited, F-4 & F- Ledipasvir...90mg
12, MIDC, Malegaon, Sinnar, (Anti-Hep-C)
Nashik, 422 113, Maharashtra, (Manufacturer specs)
India.
The firm has informed that the name/status of importer has been changed from M/s. AGP
(Private) Limited, Karachi to M/s. AGP Limited, Karachi and requested to grant the Registration
letter with the later name. The Address of the importer remains the same.
It is pertinent to mention that Registration Board in its 275th meeting has already granted
change in company status/ name from M/s. AGP (Pvt) Ltd., B-23, SITE, Karachi to M/s. AGP
Ltd., B-23, SITE, Karachi for four registered products.
Decision: Registration Board approved firm’s request for change in name/status of

importer from M/s. AGP (Pvt) Ltd., B-23, SITE, Karachi to M/s. AGP Ltd., B-
23, SITE, Karachi in respect of approved product “Ledvir 90mg/400mg
Tablet”.
Case.No.06: Request of M/s. Roche Pakistan Ltd, Karachi for De-registration/

cancellation of registration registered Products.
M/s. Roche Pakistan Limited, Karachi has applied for de registration/cancellation of
registration of following registered imported products as per details mentioned alongside.
DE-REGISTRATION OF DRUGS ON FIRM’S REQUEST
S. Firm Reg. Reason for De-Reg Alternative
Product(s) Name
No Name No (stated by firm) registered product
1. M/s Bondronat 2mg/2ml 043006 Bondronat (Ibandronic There is no alternative
Roche concentrate for solution for acid) is not a drug of brand available in
Pakistan infusion. choice in the management Pakistan for
Ltd, 37-C, Each 2ml vial contains:- of bone metastasis. That is Bondronate 2mg/2ml
Block-6, 2.25mg ibandronic acid why it is recommended to vial. However its
PECHS, monosodium salt, deregister this product generic (Ibandronic
Karachi monohydrate corresponding acid) is available in
to 2mg ibandronic acid other formulations.
2. -do- Bondronat 6mg/6ml 043007 -do- There is no alternative
concentrate for solution for brand available in
infusion. Pakistan for
Each 6ml vial contains:- Bondronate 6mg/6ml
2.25mg ibandronic acid vial. However, its
monosodium salt, generic (Ibandronic
monohydrate corresponding acid) is available in
to 2mg ibandronic acid other formulations.
3. -do- Roaccutane 20mg Capsule 023613 Due to its adverse event List of alternative
Each soft gelatin capsule feature during pregnancy registered products is
contains:- an undertaking is required provided by the firm.
Isotretinoin…20mg at the level of patient and
chemist. With availability
of many generics and
cumbersome undertaking
process for patients the
product was discontinued.
4. -do- Roaccutane 10mg Capsule 023613 -do- -do-
Each soft gelatin capsule
contains:-
Isotretinoin…10mg
5. -do- Tarceva 25mg Tablets 043001 Low dose of Tarceva is There is no alternative
Each film coated tablet only recommended in rare brand available in
contains:- and limited conditions Pakistan for Tarceva
Erlotininb hydrochloride where dose modifications 25mg Tablet.
corresponding to 25mg of / reductions are required However, Tarceva is
Erlotininb to manage side effects; available in strength
therefore, it is never of 100mg and 150mg.
prescribed by physician in
Pakistan. The
recommended dose of
Tarceva in lung cancer &
pancreatic cancer is
150mg & 100mg (once
daily) respectively, which
is already marked.
The firm has also provided the following supporting documents:-
a. Copy of registration status and renewal.
b. Justification (for de-registration/cancellation of registration).
c. List of alternative brands available in Pakistan (Where applicable).
d. An undertaking that no case is pending at any forum/court of law.
It is pertinent to mention that for product at Sr.No.5 the firm has not applied for the renewal of
registration since initial registration.
Decision: The Board observed that the requirement of the above products needs to be
evaluated before taking final decision. The Board further decided to call
representative of M/s. Roche Pakistan Limited, Karachi for personnel
hearing with regards to their instant request.
Case.No.07: Request of M/s. AJ Mirza (Pvt) Ltd, Karachi for change of manufacturing
unit VI to X of M/s. Cipla Ltd, Verna Goa India for approved products.
Following are the details of products of M/s. AJ Mirza (Pvt) Ltd, Karachi approved by
Registration Board in various meetings.
S.No Name of importer / manufacturer Name of Drug(s) Approval
1. M/s AJ Mirza Pvt Ltd, 7-Ground Floor, Soranib 200mg Tablet M-259
Shafi Court, Merewether Road, Civil Each film coated tablet contains:-
Lines, Karachi. Sorafenib Tosylate eq to Sorafenib
Manufactured by: M/s Cipla Ltd, Plot M- ……200mg
61, M-62 & M-63, Verna Industrial
Estate, Verna Goa.
2. -do- Erlocip 150mg Tablet M-259
Erlotinib HCl eq to Erlotinib
…..150mg
3. -do- Erlocip 100mg Tablet M-259
Erlotinib HCl eq to Erlotinib
………..100mg
4. -do- Imatib 400mg Tablet M-259
Imatanib Mesylate eq to
Imatanib……400mg
5. -do- Imusporin-25 capsule. M-259
Cyclosporin ………..25mg
6. -do- Imusporin-100 capsule. M-259
Cyclosporin ………..100m
7. -do- Cellmune Tablet 500mg M-259
Mycophenolate Mofetil……….500mg
8. -do- Gefticip Film coated Tablet M-263
Gefitinib……….250mg
9. -do- Cytomid 250mg Tablet M-260
Each uncoated tablet contains:-
Flutamide USP……….250mg
Excipients…….q.s.
While scrutiny of documents for the above mentioned products submitted by firm for
exemption from inspection of manufacturer i.e M/s. Cipla Ltd, Verna Goa India it was revealed
that the manufacturing site has number of independent units within the same premises which
were not mentioned in Form-5A and resultantly not appeared in agenda/minutes. The firm was
also advised to clarify its position regarding the manufacturing status of products mentioned at
Sr.No.5, 6 and 7 as the products are not mentioned in the list of products to be manufactured at
unit-X of M/s. Cipla Ltd, Verna Goa India.
Upon discussion with the firm representative during a meeting, he informed that the
aforementioned products initially were to be manufactured at unit-VI of M/s. Cipal Ltd, Verna
Goa India. However, by the time approval was granted, due to capacity constraints M/s. Cipla
Ltd, Verna Goa India established a modernized unit within the same premises named it as Unit-X
and the said unit is inspected and approved by MHRA. While with reference to products at
Sr.No.5, 6 and 7 the firm has informed that these products have been discontinued from the
principal.
For change of manufacturing unit from unit-VI to unit-X of M/s. Cipla Ltd, Verna Goa
India the firm has submitted the following:
a. Revised Form-5A for products at Sr.No.1-4, 8 & 9, mentioning the unit number of
manufacturing site i.e M/s. Cipla Ltd., Unit-X, plot No., L-139, S-103 & M-62,
Verna Industrial Estate, Verna IN-403 722, India along with Fee of Rs.5000/- for
each product (Total of Rs.30,000/- for six products).
b. Site master file of M/s. Cipla Ltd, Verna Goa India.
Furthermore, as per DSL the name of importer has been mentioned as M/s. AJ Mirza
Pharma (Pvt) Ltd., with premises situated at 1st Floor Shafi Court Merewether Road Civil Line,
Karachi while as per minutes of Registration Board the name of importer is mentioned as M/s.
AJ Mirza Pvt Ltd.
Decision: Keeping in view the above explained position, Registration Board decided as
follow;
a. Approved the change in manufacturing unit from unit-VI to unit-X of M/s.
Cipla Limited, Verna Goa, India for products at Sr.No.1-4, 8 &9.
b. Approved the change in name of importer from M/s. AJ Mirza Pvt Ltd to
M/s. AJ Mirza Pharma (Pvt) Ltd having address 1st Floor Shafi Court
Merewether Road Civil Line, Karachi in accordance with Drug Sale
License.
c. For products at Sr.No.5, 6 and 7 clarification from the firm shall be sought
regarding the exact manufacturing site.
Case.No.08:- Registration of drugs of M/s. A & Z Health Services, Islamabad.

M/s. A & Z Health Services, Islamabad has requested for registration of product Xenetix
350mg/ml Solution for injection (Reg.No.027353) in their name. The brief history of the case is
as follow:
a. M/s. A & Z Health services, Islamabad applied for transfer of registration of the
above mentioned product registered in the name of M/s. Digital imaging systems,
Lahore for import in finished form manufactured by M/s. Guerbet France on 11-
05-2009.
b. M/s. A & Z Health services, Islamabad initially deposited fee of Rs.15,000/- and
later submitted the differential fee of Rs.35,000/-. Along with application for
transfer of registration, the firm had also submitted a copy of cancellation of
distribution agreement with M/s. Digital Imaging services, Lahore issued by M/s.
Guerbet France and a copy of distribution agreement in favor of M/s. A & Z
Health services, Islamabad. However, no NOC was provided by the firm from
M/s. Digital Imaging services, Lahore.
c. M/s. Digital Imaging services has been asked twice for provision of NOC
required for transfer of registration of said product. Subsequently, the firm was
issued show cause notice served through the field officer for cancellation of
registration of the said product as per practice in vogue but the firm did not
responded.
d. Renewal status of the product was soughed from renewal section on 9-9-2014.
The renewal section in response informed that the renewal of the said product was
due on 17-04-2012, however, the firm has not applied for renewal on due date.
e. The above mentioned renewal status of the said product was presented before
Registration Board in 246th meeting. The Board decided as follow:
“Registration Board did not accede to request of firm as
registration of the drug is not valid.”
In response of the above decision made by the Board, the firm has informed that they
could not deposit renewal fee on due date as registration was not transferred in their name. The
firm now requested to consider their application on the analogy that a case of the same nature has
been considered by the Board in its 261st meeting of M/s. Indus Pharma, Karachi wherein the
firm has applied for registration of product before expiry of validity.
The case was considered by Registration Board in its 274th meeting and decided as follow:
“Keeping in view above explained position, Registration Board re-considered M/s. A & Z
Healthcare Services, Islamabad request for change in registration status of registered
product Xenetix 350mg/ml Solution for injection (Reg.No.027353) and advised the firm to
submit the following documents.”
i. Fresh registration application along with required fee and valid &
legalized CoPP.
ii. Original and Notarized sole agency agreement with the manufacturer
abroad/principle.
iii. Original and Notarized termination letter from manufacturer
abroad/principle for previous importer.
In compliance to Registration Board decision, the firm has provided the following
documents:
a. Application on Form-5A along with fee of Rs.50,000/-
b. Original valid and legalized CoPP issued by French Chamber of Commerce.
c. Original and Notarized “Termination of Contractual Relationship” issued by M/s.
Guerbet Asia Pacific Ltd, Hong Kong for previous importer i.e M/s. Digital Imaging
System 123, Habtat, Shadman II, Ghaus-ul-Azam Road, Lahore.
d. Original and Notarized exclusive distribution agreement with M/s. Guerbet Asia Pacific
Ltd, Hong Kong.
The details of the product as per CoPP issued by French authority is as follow:
S.No Name of Product and Manufacturing site/market Proposed Pack
Composition authorization holder Shelf Life Size
1 Xenetix 350mg/ml injectable Market authorization Holder: 3 years 100ml
solution M/s. Guerbet, BP 57400, F-95943
Per 100ml of solution contains: Roissy CdG Cedex, France
Iobitridol… 767.80mg/ml Manufacturing site:
Corresponding quantity of M/s. Guerbet, 16-24 rue Jean Chaptal,
iodine…350mg/ml 93600 Aulnay-sous-Bois, France
Decision: Registration Board decided as follow:
a. Cancellation of registration of Xenetix 350mg/ml injectable solution
(Reg.No. 027353) from the name of M/s. Digital Imaging System 123,
Habtat, Shadman II, Ghaus-ul-Azam Road, Lahore.
b. Registration of Xenetix 350mg/ml in the name of M/s. A & Z Health
services, Islamabad as per details mentioned below.
Name of Product and Manufacturing site/market Proposed Pack
Composition authorization holder Shelf Life Size
Xenetix 350mg/ml injectable Market authorization Holder: 3 years 100ml
solution M/s. Guerbet, BP 57400, F-95943
Per 100ml of solution contains: Roissy CdG Cedex, France
Iobitridol… 767.80mg/ml Manufacturing site:
Corresponding quantity of M/s. Guerbet, 16-24 rue Jean Chaptal,
iodine…350mg/ml 93600 Aulnay-sous-Bois, France
c. A reference shall be sent to Costing & Pricing Division for their
comments regarding MRP of the product.
Case.No.09: Registration of Drugs under the Drugs Act, 1976.

Registration Board in its 243rd meeting approved the following product of M/s. A & Z
Health Services, Islamabad as per decision mentioned alongside.
S. Name of Importer/ Name of Drugs/ Composition Pack Shelf Decision/
No. Manufacturer Sizes Life Remarks
1. M/s. A & Z Health Services, Dotarem Solution for Injection 10ml 03 Approved
Rawalpindi Each 100ml contains:- 15ml years
M/s. Guerbet Gadoteric Acid…..27.932mg 20ml
RoisssyCdGCedex, France. corresponding to Dota........20.246gm
Gadolinium Oxide..9.062gm
With reference to instant case following details are submitted:
i. The CoPP submitted with application had expired, however, the firm has now submitted
fresh CoPP in which the complete address of manufacturer and marketing authorization
holder is as under, which is proposed to be incorporated in registration certificate:-
(a) Manufacturer:
M/s. Guerbet 16 - 24 rue Jean Chaptal 93600 AULNAY SOUS BIOS-France.
(b) Marketing Authorization Holder:
M/s. Guerbet BP 57400 F-95943 RoissyCdGCedex-France.
ii. The original dossier of the product is being traced from the old record, which may require
some time as the record is being organized. However, the firm has provided a duplicate
copy of the same.
iii. The composition of Gadoteric Acid mentioned in the minutes is “27.932mg

corresponding to DOTA 20.246gm” while as per CoPP the composition is “27.932gm
corresponding to DOTA 20.246gm”. The price was also fixed for the composition
mentioned in the minutes. There appears to be typographic errors in the minutes as mg is
mentioned instead of gm in composition of Gadoteric Acid, though the quantity of active
constituent (DOTA) is correctly mentioned in minutes and price SRO. It is pertinent to
mention that the correct composition i.e 27.932gm corresponding to DOTA 20.246gm”
(in accordance with the CoPP issued by French authority) was referred to Costing &
Pricing Division for MRP clarification.
iv. Three packs sizes viz 10ml, 15ml, & 20ml were approved by the Registration Board.
However as per pricing SRO, the price is also fixed for 5ml pack in addition to the
aforementioned packs. As per prevailing practice the firm was advised to provide its
choice for one pack. In response the firm has requested for 15ml pack.
v. M/s. A & Z Health Services, Islamabad has been shifted to a new premise in Islamabad,
for which local storage facility has been verified by the concerned area FID.
Decision: Registration Board approved following variations in respect of Dotarem

Solution for Injection already approved in 247th meeting:
i. Complete address of manufacturer and marketing authorization holder as
per CoPP as under:
(a) Manufacturer:
M/s. Guerbet 16 - 24 rue Jean Chaptal 93600 AULNAY SOUS BIOS-
France.
(b) Marketing Authorization Holder:
M/s. Guerbet BP 57400 F-95943 RoissyCdGCedex-France.
ii. Correction in composition of DOTA in accordance with the CoPP issued by
French authority as per following details:
“Gadoteric Acid…..27.932gm
corresponding to Dota.......................20.246gm”
iii. As per firms request the pack size of 15ml is granted.
iv. The address of the importer shall be in accordance with the drug sale license
i.e Suit No.2 Block 27, I&T Center, G-9/4, Islamabad,
Case.No.10: Registration of drugs of M/s. Lundbeck, Karachi

Registration Board in its 260th meeting approved the following products of M/s.
Lundbeck Pakistan (Pvt) Ltd, Karachi as per details decision mentioned alongside each.
S. Name of importer / manufacturer Name of Drug(s) Demanded Decision of Board,
No. Pack size approved prices
& Price and remarks
1. M/s. Lundbeck Pakistan (Pvt) Ltd., 40 T/4, Brintellix 10mg Rs.265/ Approved as per
Blessing Street, Block 6, P.E.C.H.S, Tablets tablet Import Policy for
Karacki. Market Authorization Holder. Each film coated Finished Drugs
M/s. H. Lundbeck A/S, Ottiliavej 9, 2500 tablet contains:-
Valby, Denmark. Vortioxetine
Manufacturer also responsible for batch hydrobromide
release QC, Primary & Secondary …10mg
Packaging. equivalent to 10mg
M/s. H. Lundbeck A/S, Ottiliavej 9, 2500 Vortioxetine
Valby, Denmark. (Receptor
Site Responsible for Quality Control Antagonist).
M/s Eurofins Pharma A/S, Ornebjergvej 1, New Molecule
2600 Glostrup, Denmark. Manufacturer’s
Site for Primary & Secondary Packaging. Specifications
M/s Elaiapharm, 2881, route des Cretes, Z.I. 30 months
Les Bouillides, Sophia Antipolis, 06560,
France.
2. M/s. Lundbeck Pakistan (Pvt) Ltd., 40 T/4, Brintellix 20mg Rs.398/ Approved as per
Blessing Street, Block 6, P.E.C.H.S, Tablets tablet. Import Policy for
Karacki. Each film coated Finished Drugs
tablet contains:-
Authorization Holder. Vortioxetine
M/s. H. Lundbeck A/S, Ottiliavej 9, 2500 hydrobromide
Valby, Denmark. …20mg
Manufacturer also responsible for batch equivalent to 20mg
release QC, Primary & Secondary Vortioxetine
Packaging. (Receptor
M/s. H. Lundbeck A/S, Ottiliavej 9, 2500 Antagonist).
Valby, Denmark. New Molecule
Site Responsible for Quality Control Manufacturer’s
M/s Eurofins Pharma A/S, Ornebjergvej 1, Specifications
2600 Glostrup, Denmark. 30 months
Site for Primary & Secondary Packaging.
M/s Elaiapharm, 2881, route des Cretes, Z.I.
Les Bouillides, Sophia Antipolis, 06560,
France.
While considering the case for issuance of registration letter it has been observed that
multiple sites are mentioned in minutes of Registration Board meeting. Later, the firm informed
vide letter that M/s. H. Lundbeck A/S, Ottiliavej 9, 2500 Valby, Denmark is the site responsible
for manufacturer and market authorization holder for import of the said products into Pakistan.
Accordingly, registration letter has been granted to the firm with manufacturing site and
market authorization holder as M/s. H. Lundbeck A/S, Ottiliavej 9, 2500 Valby, Denmark.
Decision: Registration Board noted and endorsed the action taken.
Case.No.11:- Request of M/s. OBS Pakistan, Karachi for Change of Manufacturing

Site/Market Authorization Holder.
M/s. OBS Pakistan, Karachi’s request for change of manufacturing site/market

authorization holder for the following registered products has been considered and approved by
Registration Board in its 276th meeting as per details mentioned alongside:
S.No Reg.No Product Name & Composition Previous New Approved Manufacturing
Manufacturing Site/ Marketing Authorization
Site Holder (as per CoPP)
1. 021100 Trusopt Ophthalmic Solution Manufacturer: Manufacturer:
Each ml of Trusopt 2% contains: M/s. Merck M/s. Laboratoires Merck Sharp &
20mg Dorzolamide Sharp & Dohme Dohme- Chibret, Route de
Hydrochloride (22.3mg of B.V. Holland. Marsat, Riom, 63963 Clermont
Dorzolamide Hydrochloride). Ferrand Cedex 9, France.
Marketing Authorization Holder:
M/s. MSD France, 34, avenue
Leonard de Vinci, 92400
Courbevoie, France.
2. 025294 Cosopt Ophthalmic Solution -do- -do-
Each ml contains:
22.26mg Dorzolamide Hcl
equivalent to Dorzolamide 20mg
base.
6.83mg Timolol Maleate USP
equivalent to 5mg Timolol base.
The composition of the product at Sr.No. 1, as per CoPP, differs from the composition in
initial registration letter as per following details:
Composition as per initial Registration letter Composition as per CoPP
Each ml of Trusopt 2% contains: Each ml of Trusopt contains:
20mg Dorzolamide Hydrochloride (22.3mg of Dorzolamide…20mg (as Dorzolamide
Dorzolamide Hydrochloride) hydrochloride…22.26mg)
The correction in composition was proposed for consideration of Registration Board.
However, while recording agenda and discussion during the meeting it was inadvertently not
considered and subsequently not mentioned in the minutes.
Keeping in view the above position, post registration variation approval has been granted
to the firm with correct composition (as mentioned in above table), with approval of Chairman
Registration Board, for which the Board authorized its Chairman.
Decision: Registration Board noted and endorsed the action taken.
Case.No.12:- Request of M/s. Roche Pakistan Limited, Karachi for Exemption at the time
of import from the Drugs (Labeling & Packing) Rules, 1986, for Tamiflu
(Oseltamvir) 75mg Capsules.
M/s Roche Pakistan Limited, Karachi has requested for exemption from Drug
(Labeling and Packaging) Rules, 1986 for import of their registered drug Tamiflu 75mg Capsule
for the prevention / treatment of H1N1 influenza. The firm stated that six-month period is
required for Pakistan specific labeling and packaging by their principal at Switzerland, while
considering the recent upsurge of the disease, which could take form of epidemic / pendemic, the
product is required immediately. M/s Roche Pakistan Ltd, therefore, requested for grant of
exemption from Drug (Labeling and Packaging) Rule, 1986 including Urdu text, MRP,
registration number etc for import of 10,000 packs of Tamiflu 75mg Capsule in public interest.
2. During the meeting, the Board was informed that M/s Roche Pakistan Ltd has
subsequently requested permission for local re-dressing of these packs at the licensed premises
of M/s Martin Dow Limited, Plot No. 37, Sector 19, Korangi Industrial Area, Karachi in order to
comply Drug (Labeling and Packing) Rules, 1986.
Decision: The Board decided as under: -
“Keeping in view the necessity of the drug for the treatment / prevention of
H1N1 influenza, the Registration Board approved import of 10,000 packs (10’s)
of Tamiflu 75mg Capsules (Reg. No.039619) without Urdu text, Registration
number and MRP, and printing the same at the licensed premises of M/s Martin
Dow Limited, Plot No. 37, Sector 19, Korangi Industrial Area, Karachi for
ensuring compliance with Drugs (Labeling and Packing) Rules, 1986 before sale
/ distributions. The other terms & conditions shall remain the same.
Case No. 13: Registration of Drugs under the Drugs Act, 1976-Inspection reports of
Manufacturer Abroad.
The Registration Board approved drugs in various meetings subject to inspection of
manufacturer abroad as per import policy. The inspections were accordingly carried out by the
approved inspection panel. The following panel inspection reports of manufacturer abroad have
reported certain observations or non-recommendations as per details mentioned below:-
(A) M/s. Pharmadix Corp. S.A.C. Urbanizacion La Aurora-Ate Lima 3-Peru.
S. Name of Importer/ Name of Drug/ Composition/ Panel of Inspector(s)/
No. Manufacturer & meeting Date of inspection
number
1. M/s. Ghazi Brothers, (i) Metri-CEF 3 Intrauterine (i) Dr. Amanullah Khan,
Karachi-75350./ Suspension Director, DTL,
Product License Holder:- Each 30ml contains:- Quetta/Member
M/s. Agrovet Market S.A., Cephalexin monohydrate Registration Board.
San Luis, Lima, Peru. (Base)……………600mg (ii) Ch. Zeeshan Nazir,
Manufacturer Under Neomycin sulfate Deputy Director (QA),
Product License Holder:- (Base)……………1.02gm DRAP, Islamabad.
M/s. Pharmadix Corp. Cloxacillin Benzathine………1.50gm 03-04-2017
S.A.C. Urbanizacion La Vitamin A……30.000 IU &
Aurora-Ate Lima 3-Peru. 04-04-2017
(M-252) (ii) Catofos B9 + B12 Injectable
Solution
Each ml contains:-
Butaphosphan……100mg
Vitamin B9 (Folic
Acid)………………15mg
Vitamin B12
(Cyanocobalamin)…0.05mg
(Vitamin and Mineral).
(iii) ADEFORTEX Injectable Solution

Each mL contains:-
Vitamin A (Palmitic ester of Vitamin
A)..500,000 I.U
Vitamin D3 (Pure
Cholecalciferol)..75,000 I.U
Vitamin E (Alpha-Tocopherol
Acetate)...50mg
Comments/ Remarks of the Panel.
Keeping in view the detailed inspection, the panel is of the view that:-
(i) Oral Liquid Syrup/Suspension Section recommended.
(ii) Sterile area for injectable not recommended on the following grounds.
a) Bioburder not maintained j) Bag filters and prefillter chocked with dust.
b) Distillation assembly not installed. k) Change rooms of sterile area with HVAC.
c)Poor area monitoring/ l) Epoxy flood found broken.
d) Manufacturing of sterile products double m) Bracket fans installed in the injectable
pan R.O. Water. packing hall.
e) TOC not installed. n) QA inspector of sterile is having only six
f) LPC not available. months experience.
g) Require tem data for distilled water not o) Air sampling not performed.
provided/available.
h) HEPA filter in the filling area not installed.
i) Ducts found raised.
Decision: In view of the shortcomings highlighted and the recommendations given by

the inspection panel, the Board decide to reject the registration application(s)
of Catofos B9 + B12 Injectable Solution and ADEFORTEX Injectable
Solution. While Metri-CEF 3 Intrauterine Suspension was approved as per
recommendations of the panel.
(B) M/s. Vetanco S.A. Buenos Aires, Argentina.

S. No. Name of Importer/ Name of Drug/ Panel of Inspector(s)/ Date
Manufacturer & Composition/ of inspection
meeting number
1. M/s. Ghazi Brothers, Ketoxilen Injection (i) Shaikh Faqeer
Karachi. / Each 100ml contains:- Muhammad, Director
Manufactured by M/s. Oxytetracycline……20gm (Licensing), DRAP,
Vetanco S.A. Buenos Ketoprofen…………3gm Islamabad.
Aires, Argentina. (Antibiotic/Anti- (ii) Syed Zia Husnain, F.I.D,
inflammatory). DRAP, Lahore.
(M-252) 13-11-2017 & 14-11-2017
Comments/ Remarks of the Panel. Not recommended

Panel evaluated various documents in connection with quality assurance and inspected
various areas of the plant including manufacturing area, quality control. Panel has the following
observations:
1) Plant located in residential area. 10) Open sewage and drains were seen in the
2) Material management was very poor. manufacturing areas.
Penicillin and General products were placed 11) In production area firm has only partial
together in raw material store. HVAC system. HVAC is not located in the
3) No concept of quarantine approved and corridors; hence pressure differentials can not
rejected area in the raw material store. be maintained.
4) Materials were placed in hap hazardous 12) Washing area for vials / primary containers
manner in raw material stores and finished was also very poor.
goods store. 13) Water treatment system was also not
5) No de-dusting area was in place. Upon proper. Storage tank and pipes were not proper.
receipt of materials; door of the raw material 14) HVAC air handling units were placed is
store opens directly into the street and has great very poor condition and cannot be maintained
potential of contamination of dust in the raw properly.
materials to be used for manufacturing of 15) Quality Control Laboratory process
pharmaceutical products. validations and validation of method was not
6) No sampling and dispensing booths were available.
available. 16) Microbiology in-charge was part time
7) Cleanliness is stores were very poor. employee.
8) In process quarantine store was also within 17) Microbiology laboratory was not properly
the same location of raw materials stores. maintained and things were placed in hap
9) Wooden pallets were being used in the hazardous manner.
production and raw material stores.
Keeping view of various critical observations, the panel decided to not recommended the
firm M/s. Vetanco S.A. Chile 33 (B1603 CMA) Vicente Lopez Buenos Aires, Argentina for
registration of their products.
of Ketoxilen Injection.
(C) M/s. Instituto Rosenbusch S.A. de Biologia Experimental Agropecuaria, San Jose
1469 (1136) Buenos Aires, Argentina.
S. Name of Importer/ Name of Drug/ Composition/ Panel of Inspector(s)/
No. Manufacturer & Date of inspection
meeting number
1. M/s. Seignior Pharma (i) Ceftiofur LPU Injectable (i) Shaikh Faqeer
Karachi. / Each 100ml vial contains: - Muhammad, Director
M/s. Instituto Ceftiofur HCL……50mg (Licensing), DRAP,
Rosenbusch S.A. de Excipients………..100ml Islamabad.
Biologia Experimental (Antibiotic) (ii) Syed Zia Husnain,
Agropecuaria, San Jose (ii) Florfenicol 30% Rosenbusch Injectable F.I.D, DRAP, Lahore.
1469 (1136) Buenos Each 100ml vial contains: 17-11-2017 &
Aires, Argentina. Florfenicol……….....30gm 18-11-2017
(M-252) Excipients q.s……...100ml (Antibiotic)
Panel evaluated various documents in connection with quality assurance and inspected
various areas of the plant including manufacturing area, quality control.
During inspection it was found that manufacturing/ formulation site is at the address M/s.
Instituto Rosenbusch S.A Soreda 4151, Sarandi Buenos Aires, Argentina which was other than
mentioned in the DRAP letter no F.8-12/2016-Reg-I dated 01-11-2016, where in site address was
M/S Instituto Rosenbusch S.A de Biologia Experimental Agropecuaria, San Jose 1469 (1136),
Buenos Aires, Argentina. During evaluation firm informed that their production and quality
control is divided at four different places including washing and sterilization of vials,
formulation, and sterilization of final product by radiation and quality control. Firm informed
that samples for testing are sent to quality control through post and IPQC was also not properly
maintained, Upon the question of SOPs, Manufacturing License and other related documents
firm informed that such documents are not available on manufacturing site and all such
documents may be available at site located at M/s. Instituto Rosenbusch S.A San Jose 1469,
Buenos Aires, Argentina where Quality Control was also being conducted. Following were
observations of the panel after inspection of one formulation site and quality control site of the
firm.
1. Manufacturing was being conducted at four sites however in the letter of DRAP only one
site was mentioned.
2. Documentation and SOPs were not available at the formulation site.
3. Samples as informed were being sent through post for quality control and have the potential
of mix ups and loss of potency etc.
4. Material stores were not properly maintained and chances of cross contamination exist.
5. Formulation site building was main hall which was portioned inside. Area of raw material
store was not proper.
6. No de-dusting area outside of stores was in place.
7. Quality Control site was in a biological plant which was located in residential area.
8. QC instruments were in place in mix-up manner. No separate instrument room established.
9. SOPs of QC and method validations were not available in Q.C.
10. Firm itself informed that sole agent in Pakistan M/s Seignior Pharma, Karachi did not inform
them timely and requested for appropriate time for the inspection (Original submission
enclosed).
After thorough inspection panel decided to not recommend the M/s. Instituto Rosenbusch
S.A. San Jose 1469, Buenos Aires, Argentina for registration of their products in Pakistan.
of Ceftiofur LPU Injectable and Florfenicol 30%.
(D) M/s. Laboratorio Eczane Pharma S.A. Laprida 43, Buenos Aires Argentina.
S. Name of Importer/ Manufacturer & Name of Drug/ Panel of Inspector(s)/ Date of
No. meeting number Composition/ inspection
1. M/s. Seignior International, Liberprost 50mg Oral (i) Shaikh Faqeer Muhammad,
Karachi. / Tablet Director (Licensing), DRAP,
M/s. Laboratorio Eczane Pharma Each tablet contains:- Islamabad.
S.A. Laprida 43, Buenos Aires Bicalutamide……50mg (ii) Syed Zia Husnain, F.I.D,
Argentina. DRAP, Lahore.
License Holder: M/s. Laboratorio 13-11-2017 & 14-11-2017
LKM S.A. Artilleros 2436 Buenos
Aires Argentina. (M-226)
According as policy of Federal Govt. respective units also required to be verified for
facilities of manufacturing, quality control and quality assurance. M/s. Seignior International,
Karachi was sole agent in Pakistan. Sole agent under reference agreed upon the inspection
schedule by signing the inspection scheduled and its submission to registration division of DRAP
for approval and which was accordingly approved by DRAP. However, proceeding of panel of
Argentina for inspection as per approved schedule, sole agent of. M/s. Seignior International,
Karachi did not keep further coordination for arrangement of inspection of above mentioned
companies in Argentina. Other applicant namely M/s. Ghazi Brothers, Karachi who also signed
joint schedule alongwith with M/s. Seignior International, Karachi number of times expressed
their reservations about non-coordination of M/s. Seignior International, Karachi after the
proceeding of the panel to Argentina as per approved schedule by the DRAP.
After conducting two inspections of manufacturers with to Ghazi Brothers, Karachi,
panel itself coordinated with the management of M/s. Seignior Pharma, Karachi & M/s. Seignior
International, Karachi and enquired about the arrangement of inspection related to their products
applied for purpose of registration at DRAP as per approved schedule. Panel also informed about
their hotel address in Beunos Aires, Argentina to M/s. Seignior Pharma, Karachi & M/s. Seignior
International, Karachi to facilitate the further coordination for inspection by local manufacturers
in Argentina and also the sole agents.
Resultantly M/s. Seignior Pharma, Karachi sent person at the eleventh hour for inspection
of M/s. Institute Rosenbusch S.A Soreda 4151, Sarandi Buenos Aires, Argentina. However, it is
pertinent to mention that M/s. Seignior Pharma, Karachi was remained reluctant for inspections.
Inspection of M/s. Institute Rosenbusch S.A Soreda 4151, Sarandi Buenos Aires, Argentina was
conducted as per schedule approved however it was conducted during the time period of hotel
management by M/s. Ghazi Brothers, Karachi instead of M/s. Seignior Pharma Karachi. M/s.
Ghazi Brothers, Karachi expressed their reservations many times telephonically about non
coordination of M/s. Seignior Pharma, Karachi and M/s. Seignior International Karachi. M/s.
Seignior Pharma, Karachi and M/s. Seignior International Karachi also did not arrange the
tickets and bank draft as per SOP or any hotel arrangements as required in the SOP for
inspections approved by the Government.
As M/s. Seignior International Karachi or the respective manufacturer/ license holder did
not coordinate with panel and did not arrange the inspections as per SOP till last date of hotel
reservation and ticket arrangements by M/s. Ghazi Brothers, Karachi as informed by
representative of Ghazi Brothers, Karachi. Hence panel decided that firm and importer are no
more interested in the inspection of M/s. Laboratorio Eczane Pharma S.A Lapride 43, Buenos
Aires Argentina and M/s. Laboratorio LKM, S.A. Artilleros 2436 Buenos Aires Argentina. Panel
also brought the situation into the notice of Deputy Director (Registration-I) DRAP, Islamabad
telephonically. Hence under the explained circumstances panel decided to not-recommend the
facility M/s. Laboratorio Eezane Pharma S.A Lapride 43, Buenos Aires Argentina and M/s
Laboratorio LKM, S.A. Artilleros 2436 Buenos Aires Argentina on the basis of non-arrangement
of this inspection under reference as per SOP.
Decision: In view of the position highlighted and the recommendations given by the
inspection panel, the Board decide to reject the registration application(s) of
Liberprost 50mg Oral Tablet as the applicant M/s. Seignior International,
Karachi does not appear to be interested in carrying out the inspection of
manufacturing sites.
(E) M/s. Yangzhou No.3 Pharmaceutical Co. Ltd. Guotai Road, Yiling Town, Jiangdu
Distrcit, Yangzhou City, Jiangsu, P.R. China.
S. No. Name of Importer/ Name of Drug/ Composition/ Panel of Inspector(s)/
Manufacturer & meeting Date of inspection
number
1. M/s. Allmed Laboratories, Salbusol Inhalation Aerosol i) Mr. Hyder Bux
Karachi. / 100mcg/dose, Bozdar, Director (MIS),
M/s. Yangzhou No.3 200 doses DRAP, Islamabad.
Pharmaceutical Co. Ltd. Each dose contains:- ii) Mr. Muhammad
Guotai Road, Yiling Town, Salbutamol BP…100mcg Abdul Ghaffar, Deputy
Jiangdu Distrcit, Yangzhou Excipients…………q.s. Director (Costing &
City, Jiangsu, P.R. China. Pricing), DRAP,
Islamabad. 04-11-2017
(M-242) & 06-11-2017
Overall evaluation of the inspection report……..Un-satisfactory/not recommended.

Comments/ Remarks of the Panel.
The inspection was conducted strictly to confirm GMP compliance in a professional manner.
Evaluation:
(i) Change control: poor un-satisfactory.
(ii) Quarantine product placed hazardly.
(iii) No follow up on national control authority recommendations.
(iv) Rusted pipes in water treatment plant.
(v) Cleaning and maintenance not appropriate.
(vi) Entry of employees is not controlled, so no cleanness is maintained. Everybody
can enter the manufacturing area from rear side of the building.
(vii) Rusted pipes were found in RO water plant system.
(viii) Documentation is very poor.
(ix) Floor was found to be dirty with foot prints with dust because any workers can
come from any side/RMS entry which has no proper change control system.
(x) The company could not satisfy the capacity of containers with respect of batch
size and production. The vacuums filtration was carried out without proper
filtration pressure.
(xi) Material system. The instrument did not have pressure gauges. They have no
records. A warehouse was seen where the company stored packaging materials,
raw materials, finished drug together.
(xii) No quarantine area, no separations etc. There was no inventory system. All
materials were present haphazard.
(xiii) Warehouse is a combined store for raw materials, finished drugs, API, liquid
drums, packaging materials. No rodent’s controls. No lights, no temp controls.
(xiv) Equipments used for mixing does not satisfy the capacity of production.
(xv) Packing store is full of many batches of the drug with no identification.
(xvi) QC lab did not exist in the factory premises. The company showed us another QC
lab located in other building across the road which was claimed to be the same
factory where API is produced. In this QC lab the company could not shown
records of samples produced in the factory.
Over all evaluation of the inspection team un-satisfactory/ not recommended.
of Salbusol Inhalation Aerosol 100mcg/dose.
(F) M/s. Biovet JSC, 39, Petar Rakov Street, Peshtera, Pazardzhik, Bulgaria.
Registration Board in its 259th meeting approved the following imported veterinary
products of M/s. Bin Sadiq International, Lahore, Pakistan subject to inspection of manufacturer
abroad as per import policy as per detail mentioned below.
Name of Importer/ Manufacturer & Name of Drugs/ Decontrolled/ Shelf Decision/
meeting number Composition Packs Size Life Remarks
M/s. Bin Sadiq International, 89-A, Injection Buparvex 50ml Not Approved
Canal View Housing Society, Lahore 50mg/ml mentioned USP
Pakistan. Each 1ml contains:- Specifications
Manufactured by M/s. Biovet JSC, Buparvaquone….....50mg
39, Petar Rakov Street, Peshtera,
Pazardzhik, Bulgaria. (M-259)
Inspection of the manufacturer abroad M/s. Biovet JSC, 39, Petar Rakov Street, Peshtera,
Pazardzhik, Bulgaria was carried out by the nominated panel comprising Mr. Ghulam Rasool
Dutani, Director (PE&R) & Mr. Zaheeruddin M. Babar, Deputy Director (Reg-I), DRAP,
Islamabad on 10th -11th July, 2017 and the panel rated the manufacturing facility as "good".
The panel in the above mentioned report while recommending the facility/ site informed
that Injection Buparvex is not a registered product of M/s. Biovet Bulgaria nor it is free sale in
Bulgaria. In fact, this product is manufactured for M/s. Cross Vetpharm Ireland on contract basis
by M/s. Biovet.
In view of the above position reported by the panel the dossier of Buparvex Injection,
received from the PEC, was further scrutinized and following facts were noted.
(i) The manufacturer of the product mentioned in Form-5A was M/s. Bimeda Chemicals
Export, (a division of cross Vetpharm Group Ltd), Broomhill Road, Tallaght, Dublin 24,
Ireland.
(ii) The Distribution Agreement submitted was made between Gross Vet Pharma Ltd., (T/A
Bimeda) Ireland and Bin Sadiq International, Lahore Pakistan.
After the inspection M/s. Bin Sadiq submitted following documents,
(i) Original, legalized and attested CoPP issued by HPRA Ireland mentioning M/s. Cross
Vet Pharma Ltd., Dublin, Ireland as applicant and M/s. Biovet joint stock company
Bulgaria as manufacturer. The product, however, is not licensed to be placed in the
market of exporting country i.e. Ireland with the remarks that the product is developed
exclusively for the treatment of the topical disease, Theileriosis, not endemic in the
country of export.
(ii) Copy of the contract manufacturing agreement signed between M/s. Cross Vetpharm
Group Limited, Broomhill Road Tallaght Bublin 24 and M/s. Biovet Joint Stock
Company (Biovet JSC), 39 Petar Rekov Street, 4550 Peshtera, Bulgaria for contract
manufacturing of products including Buparvex.
(iii) Site master file of M/s. Biovet Joint Stock Company (Biovet JSC), 39 Petar Rekov Street,
4550 Peshtera, Bulgaria including copies of drug manufacturing license, GMP certificate
issued by Bulgarian Food Safety Agency, Bulgaria.
Decision: In view of the position/status provided by the panel and the available record the
Board decided to provide a final opportunity to the applicant/importer to clarify
the free sale status in the country of origin/reference countries and status of
manufacturer and product license holder.
VETERINARY
Case No.14. Inspection of Manufacturer Abroad/Issuance of Registration Letter.
Drug Registration Board in its 236th and 237th meetings approved the registration of
following imported veterinary products in the name of M/s. International Chempharma
(Pakistan) Lahore as per decision mentioned alongside.
S. Name of Importer/ Name of Drugs/ Composition Decontrolled/ Shelf Decision/
No. Manufacturer Packs Size Life Remarks
1. M/s. International ANTI-C.R.D Water Soluble 500gm 02 Approved
Chempharma (Pakistan) Powder years
33-Anarkali, Lahore. / Contains:-
Manufactured by M/s. Spectinomycin HCI....2,000mg
Bio-Pharmachemie Joint Lincomycin …...1,100mg
Venture Company 2/3 Colistin Sulfate ..6,000, 000IU
Tang Nhon Phu Street, Bromhexine HCI …150mg
Phuoc Long B Ward,
District 9, Ho Chi Minh (M-236)
City- Vietnam.
2. -do- Bio-Super COC Water Soluble 500gm 02 Approved
Powder years
Contains:
Sulfachloropyrazine Sodium
...........6,500mg
Sulfaquinoxaline Sodium
….3500mg
Diaveridine HCI…4,500mg
(M-236)
3. -do- Bivermectin 1% Sterile 20ml 02 Approved
Solution for Injection 50ml years Firm requested
Each ml contains:- 100ml for grant of 50ml
Ivermectin……............10mg 250ml pack among the
(M-237) approved pack
sizes
4. -do- Bio Dewormer Oral Suspension 30ml 02 Approved
Each ml contains:- 100ml years
Albendazole……….....100mg 150ml
(M-237) 250ml
500ml
1000ml
With reference to instant case following details are submitted:

(i) In compliance, inspection of the manufacturer abroad M/s. Biopharmachemie Co. Ltd,
Tang Naon PHU Street, Phudc, Vietnam has been carried out by the nominated panel
comprising Mr. Abdul Razzaq Jawinda, Director, Drug Testing Laboratory Sindh,
Karachi and Ms. Qurratul Ain Jamil, Assistant Drugs Controller, Drug Regulatory
Authority of Pakistan, Lahore.
(ii) As the firm’s report is silent about list of equipment’s for production and quality control
department further the name of products not mentioned on page (20) of the report.
Therefore, the panel was advised to explain why they have submitted incomplete report.
(iii) In response, member of the inspection team Mr. Abdul Razzaq Jawinda, Director, Drug
Testing Laboratory Sindh, Karachi has submitted the list of the equipments, instruments /
production department and quality control department of M/s. Biopharmachemie Co. Ltd,
Tang Naon PHU Street, Phudc, Vietnam and the name of products / drugs (vet) on page
(20) of the inspection report.
(iv) The original free sale certificate submitted by the firm has expired. However, now the
firm has submitted valid and legalized original Free Sale Certificate and GMP Certificate
for the above products.
(v) For products at St. No. 1 & 2 the composition in the minutes needs to be
clarified/corrected as under in accordance with CoPP :-
“Each 100gm contains”
(vi) The finish product specifications for the above products are not mentioned in minutes.
However the firm vide letter informed that the firm has claimed innovator specification,
which may be granted accordingly in the light decision made in 264th & 266th meetings of
Registration Board.
(vii) Furthermore, Registration Board in its 270th meeting authorized Chairman Registration
Board to grant approval of inspection report of manufacturer abroad, submitted by the
nominated panel before issuance of registration letter.
(viii) The firm has deposited the differential fee Rs. 85000 x 4 = Rs.340,000/- (Rs. 15,000/
per product already deposited).
(ix) The Federal Inspector of Drugs in its reported dated 28th April, 2015 pointed out certain
shortcomings in local storage facilities. The case was again discussed in 250th meeting
regarding local storage facility and it was decided to convey the shortcoming pointed in
previous report to the firm for rectification & subsequent confirmation by Federal
Inspector of drugs. Now Federal Inspector of Drugs, Lahore vide fresh report has
recommended the storage facility for drugs at room temperature.
Decision: In view of the report of inspection panel recommending the manufacturing
site abroad and of FID, Lahore, recommending the storage facilities for
drugs at room temperature, the Board endorsed the decision for grant of
registration of above referred drugs.
Case No. 15: Request of M/S. Decent Pharma, Rawat, Islamabad/Registration of Drugs
under the Drugs Act, 1976.
Registration Board in its 237th meeting held on 26-02-2013 constituted a sub-committee
for evaluation of application of veterinary products for ensuring completion of codal formalities.
The Board further authorized its Chairman, Registration Board for taking decision on
recommendations of the committee following the 10 products per section policy.
The sub-committee in its meeting held on 25-04-2013 deferred following product of M/s.
Decent Pharma, Rawat, Islamabad as per detailed mentioned alongside for therapeutic
justification for formulation:
S. Name of Manufacturer/ Name of drug(s) & Composition Decontrolled/ Shelf Life
No Importer with Demanded MRP. Packs Size
1. M/s. Decent Pharma, Tribiotic Oral Powder 100gm 02 years
National Industrial Zone Each 100g powder contains:- 250gm
Rawat. Islamabad. Amoxicillin Trihydrate..20g 500gm
Lincomycin HCI……...8.8g 1Kg
Spectinomycin 2HCI…8.8g 5Kg
(Antibacterial). 10Kg
25Kg
Subsequently M/s. Decent Pharma, Rawat, Islamabad submitted various documents
relating to specification & usage of individual components of the above drugs combination. The
above compositions are me-too drugs.
The case was again discussed in its 267th meeting of Registration Board and decided to
refer the case for further evaluation and recommendations of Dr. Qurban Ali. The expert opinion
of Dr. Qurban Ali is as under:-
S. Name of Name of drug(s) & Comments of Dr. Qurban Ali
No Applicant Composition
1. M/s. Decent Tribiotic Oral Powder The product is combination of antibiotics
Pharma, National Each 100g powder contains:- used for a number of bacterial infections in
Industrial Zone Amoxicillin Trihydrate..20g food producing and pet animals.
Rawat. Islamabad. Lincomycin HCI……...8.8g
Spectinomycin 2HCI…8.8g Amoxicillin given orally is stable in
(Antibacterial). gastrointestinal tract with higher absorption
than naturally occurring Penicillins.
Furthermore, residues in liver, kidney,
muscle and fats are depleted.
Lincomycin hydrochloride is bacteriostatic

and is rarely used in humans due to high
likelihood of severe gastrointestinal
disturbance; instead Clindamycin (7-Chloro
derivative of Lincomycin) is used in human
medicicne as an alternative to Penicillins. Its
antibacterial spectrum is similar to
erythromycin.
Primarily bacteriostatic, Spectinomycin in

used in human medicine as an alternative to
Ceftriaxone and other beta-lactams almost
exclusively for rectal and genital
gomorrhoea with 95% cure rate. In livestock
production, Spectinomycin is usually
administered with Lincomycin for a variety
of infections and as preventative therapy.
The referred product in combination form is

me-too product also; thus is a fair candidate
for registration and is Recommend for
approval for veterinary use.
Decision: The Board deferred the case form confirmation of latest GMP status of the
firm from QA&LT Division.
REGISTRATION-II
Case No.1 Change of Brand Name of M/S. Noa Hemis Pharmaceutical, Karachi. 1st
meeting PRVC
M/s Noa Hemis Pharmacueitcal, Plot No. 154, Sector 23, Korangi Indistrial Area, Karachi
applied for change of brand name of Gynotec 1% cream (Clotrimazole 1% w/w). The details are
as follows:
S.# Regn. Existing Name Proposed Initial registration with renewal Remarks
No. Name
I II III IV V VII
1. 032203 Gynotec Cream Calcrem i) Initial regn dated 27.02.2004 Dy # 24657
Contains: Cream ii) letter for renewal dated Dated 12-12-2017
Clotrimazol Contains: 04.06.2009 Complete case.
w/w…1% Clotrimazo iii) last renewal dated 28.01.2014
l w/w…1%
Justification:
The firm has stated that they have also been granted same brand name i.e. ‘Gynotec’ for
clotrimazole 2% cream that has a different indication than the approved indication for 1 %
cream. Clotrimazole 2% cream is prescribed for internal vaginal use by applicator, whereas
Clotrimazole 1% is not recommended prescription for internal vaginal diseases therapeutically.
Due to similarity in brand name it may also cause a serious error on the chemist end as the both
brand have different indications.
The firm has deposited fee of Rs. 20,000/- for this purpose and provided documents as
per SOPs.
The Post Registration Variation Committee (PRVC) in its 1st meeting deferred the case of
change of brand name of “Gynotec Cream” (product at Sr. No 1) for presentation before the
Registration Board.
Decision: The Board deliberated on the matter and observed that the Clotrimazole 1%
cream has topical use whereas 2% cream is used for intra-vaginal
application. Similarity in brand names of both products is likely to have a
medication error. The Board therefore decided to grant brand name
‘Calcrem’ for clotrimazole 1% cream.
Case No.2 Withdrawal of Show Cause Notice of M/s. Spencer & Company (Pvt.) Ltd; of
DML # 000272.
Secretary Central Licensing Board forwarded a letter regarding show cause notice dated
23rd June, 2017 which was placed before 256th meeting of Central Licensing Board held on 9th
& 10th November, 2017. The Central Licensing Board has decided as under:-
“The Board after perusal of facts and completion of codal formalities for the purpose of renewal
of Drug Manufacturing License decided to cease the operation of suspension order for further
period with immediate effect”.
It is further informed that the operation of suspension order dated 25th September, 2017 is
ceased with immediate effects.
Decision: Based upon the decision of Central Licensing Board in its 256th meeting as
mentioned above, Registration Board decided to withdraw its earlier decision
regarding suspension of registration of drugs granted to M/s Spencer &
Company (Pvt), Ltd, Karachi.
Case No.3 Permission for Procesution and Cancellation of DML No.000247 of M/s.
Ankaz Pharmex, (Pvt.) Ltd; Karachi under section 41 of the Drugs Act, 1976
read with Rule of the Drugs (Licensing, Registering & Advertising) Rule
1976 read with Rule 12 of Drugs ((Licensing, Registering & Advertising)
Rules, 1976.
The Licensing Division has forwarded a letter wherein it is informed that Federal
Inspector of Drugs, Karachi along with team inspected the business premises (M/s. Ankaz
Pharmaex, Ltd; Pvt. Karachi) on 19-04-2014, indentified the non-compliance of GMP and toll
the samples for test analysis. He reported the following recommendations: -
i. That an extension in the period of seizure and not to dispose off articles may be granted
under DRAP, Act, 2012.
ii. Safe custody of all seized articles may also be granted till the fate of the case.
iii. The contents of the case may be kept on the agenda of forthcoming meeting of CLB for
cancellation of their DML a larger public interest or permission for prosecution against the firm
may be granted for violating the Section 23(1)(a)(viii) of Drugs Act, 1976”.
I. The samples of the drugs were also referred to Federal Government Analyst for
test/analysis.
II. It was identified that the firm was involved in manufacturing the Rumin Suspension in
back dated whose registration had already been cancelled by Registration Board in its 237th
meeting held on 26-02-2013 which was communicated to the firm vide letter dated 22-03-2013.
III. That the samples of Rumin 200mg tablet Batch no. 640, Rumin 400mg Table Batch No.
Nil, Rumin 200mg Tablet Batch No. Nil, Rumin 400mg Tablet Batch No. 1105, Biprim DS
Tablet, Batch No. 305, Biprim Tablet DS, Batch No. 524 were declared as substandard by the
Federal Government Analysis. The firm again applied for re-testing by the appellate laboratories,
NIH, Islamabad. The NIH also declared it of substandard quality.
IV. That after due process, Registration Board cancelled the registration of said products and
referred the case to Central Licensing Board for cancellation of license in its 246th meeting held
on 10–11th December, 2014.
V. That the Central Licensing Board in its 239th meeting held on 22-01-2015 considered the
case and decided to issue the show cause notice for the cancellation of Drug Manufacturing
License under 41 of Drug Act, 1976 and also for prosecution of the above named firm and the
accused persons in the Drug Court of Sindh.
VI. That the personal hearing was given to the firm and its nominated persons in Central
Licensing Board in its 246th meeting held on 22-02-2016.
VII. That the Drug Court Lahore directed to suspend the Drug Manufacturing License of M/s.
Ankaz Pharmex, Pvt. Ltd, Karachi till the arrest of accused persons in separate case.
VIII. That the firm filed an appeal before the Appellate Board against the decision of
Registration Board but Appellate Board decided to maintains the decision of Registration Board
in its 146th meeting hled on 24-05-2017.
IX. After the decision of Appellate Board, the case was again presented before the Licensing
Board in its 255th meeting held on 17th –18th August, 2017. The Central Licensing Board
considered the complete case under the facts and relevant law and decided to
i. Cancel DML of M/s. Ankaz Pharmex, (Pvt.) Ltd; Karachi under section 41 of the Drugs
Act, 1976 read with rule 12 of the Drugs (Licensing, Registering and Advertising) Rules, 1976
due to poor GMP compliance that resulted in manufacturing of substandard durg and also for
manufacturing the unregistered drug i.e Rumin Suspension.
ii. The CLB also granted the permission of prosecution t the Federal Inspector of Drugs,
Karachi against the firm under Section 23 and 27 of the Drugs Act, 1976 and rules framed there
under in the Court of Law.
He has requested to prosecute against the firm and its nominated persons i.e Mr. Ali
Abbass (Managing Director), Mr. Akbar Ali (Production Incharge) and Mr. Safdar Alam
(Quality Control Incharge) under section schedule II & III of DRAP Act, 2012 and under section
23 and 27 of the Drug Act, 1976 and rules framed thereunder in the court of law under the
intimation of this office.
Decision: Based upon the decision of Central Licensing Board in its 255th meeting
regarding cancellation of Drug Manufacturing License of M/s Ankaz Pharmex,
(Pvt.) Ltd; Karachi, Registration Board decided to cancel registration of all the
drugs granted to M/s. Ankaz Pharmex, (Pvt.) Ltd; Karachi with immediate
effect.
Case No.4 Correction in Specification of Ezomol IV 40mg Injection of M/s. Abbott Labs,
Karachi.
The Registration Board in 274th meeting approved the following product of M/s. Abbott
Labs, Karachi and subsequently registration letter was issued with USP Specification vide
(Reg.No.086081):-
Name and address of manufacturer / M/s. Abbott labs, opposite radio Pakistan transmission
Applicant center, industrial estate, Hyderabad road, Landhi
Karachi
Brand Name +Dosage Form + Strength Ezomol IV 40mg (Lyophilized)
Esomeprazole sodium e. to Esomeprazole………40 mg
Type of Form Form-5
Pack size & Demanded Price 10 ml /As Per SRO
Approval status of product in Reference Esomeprazole of Consilient pharma (MHRA)
Me-too status ESSO-40 of shaigan
concludes that firm is following the GMP guidelines.
Remarks of the Evaluator. Lyophilized section present
Decision :Approved
Now the firm has informed that above product is not yet included in any pharmacopeia, therefore
they may be granted Manufacturer / In-house Specification for above mentioned product.
Decision: Registration Board deferred the case to confirm status of the product in
pharmacopeia of any reference regulatory authority approved by
registration board.
Case No.5 New Indication for Duphaston 10mg Tablet “Luteal support in In-Vitro
Fertilization (IVF)” of M/S. Abbott Labs, Karachi.
Background of the case:
M/s Abbott Laboratories (Pakistan) Limited, Karachi had intimated that new approved indication
of Duphaston 10mg Tablet in the country of origin (Netherland) Duphaston tablet is now also
indicated in “Luteal support in In-Vitro Fertilization (IVF)”.
The firm has informed that they are updating their local PIL with new indication of Duphaston
approved in the country of origin by their regulatory authority, as per Drugs (LR & Advertising)
Rules, 1976, chapter 3, Rule 30, Section 10(b) which says that “if a clinical information for a
drug is approved by the Drug Regulatory Authority in any of the said country (USA, European
Union Countries, Canada, Japan, Australia), the same clinical information shall be considered as
approved for drug registration in Pakistan unless modified by the Registration Board on the basis
of scientific data available to it, and such clinical information may include indications contra-
indications, side effects precaution, dosage, etc”.
The firm have provided following documents:
i) CPP of Duphaston from country of origin with SmPC.
ii) Comparison table of new and proposed changes in CCDS
iii) The MEB (NL Health authority) approval letter for this new indication.
iv) Rationale for studying Dupaston for an RT treatment indication.
v) Clinical Overview-Luteal Support as part of an ART treatment.
vi) Synopsis of Clinical study.
vii) Deposit slip of Rs. 5000/- as a fee of new indication.
viii) Updated PIL of Duphastan.
ix) Copy of CRF clearance
x) Copy of Registration and renewal letter.
Decision 275th meeting: Registration Board deferred the case for confirmation of approval of
Assisted Reproductive Technology (ART) as a new indication for Duphaston 10 mg Tablet in the
reference regulatory authorities (other than Netherlands) as specified by the Board.
Updated Status:
M/s. Abbott Laboratories (Pakistan) Limited, Karachi has informed that the new indication was
approved in Netherland on June 8, 2017. Thereafter, a variation was submitted to different
countries where Duphaston FCT was registered and marketed.
They have provided a list of 20 countries where Duphaston 10mg film coated Tablet is
approved with new indications: -
i. The Netherlands ii. Moldova iii. Russai iv. Nigeria
v. Bangladesh vi. Sudan vii. Mauritius viii. Botswana
ix. Ukraine x. Ecuador xi. Egypt xii. Kenya
xiii. Namibia xiv. Uganda xv. Kazakhstan xvi. Tanzania
xvii. Paraguay xviii. Thailand xix. Chile xx. Turkey
Decision: Registration Board acceded to the request of the firm and approved the new
indication ‘Assisted Reproductive Technology (ART)’ for Duphaston 10mg
Tablet that was based upon the approval granted to the product by
Netherlands.
Case No.6 Request for Change of Registration Status of Products of M/S. Getz Pharma,
Karachi.
M/s. Getz Pharma (Pvt.) Ltd; Karachi has requested for transfer the registration of
following contract manufacturing from M/s Opal Lab, Karachi to M/s Herbion Pakistan (Pvt)
Ltd, Islamabad. The details are given below:-
S.No. Reg.No. Name of Drug(s) Remarks
1. 000435-EX Lactulose 67g/100ml Solution Registered through contract
Each 5ml contains:- manufacturing by M/s. Opal
Lactulose …………. 3.35gm Laboratories, Karachi.
2. 020590 Lilac Syrup 67g/100ml Registered through contract
Each 5ml contains:- manufacturing by M/s. Opal
Lactulose ………… 3.35gm Laboratories, Karachi.
Now the firm has requested to change the contract manufacturing of above products from M/s.
Opal Laboratories, Karachi to M/s. Herbion Pakistan (Pvt.) Ltd; Industrial Triangle Kahuta
Road, Islamabad. They have provided following documents for this purpose.
i. Fee of Rs. 1,00,000/- for each product.
ii. Form -5 and contract agreement of above products.
iii. Copies of initial letter of registration and renewal applications.
iv. Legalized GMP of source/ COA not provided.
v. NOC for CRF not provided. (The firm has provided a court order dated 30-06-2016
and the Court has ordered to issue notice to the respondents and DAG for 14.07.2016. Till next
date of hearing, the respondents are restrained from taking any adverse / coercive action against
the petitioner subject to deposit of disputed amount i.e 49.96 milion with the Nazir of this Court.
Nazir is directed to invest the said amount in nay Government profitable scheme till further
orders).
Sind High Court in its order dated 31.3.2017 had passed an order to come up on 26.4.2017 and
interim order made earlier to continue till next date that needs further clarification from Legal
Affairs Division.
Decision: Registration Board deferred the case for complete documents as per
approved SOP and for comments of Budget and Accounts Division on the
status of court orders in the Writ Petition filed by the firm regarding CRF
payment to DRAP.
Case No. 7 Drug product of M/s Nabiqasim Industries (Pvt.) Ltd., Karachi - Deferred in
269th meeting
M/s Nabiqasim Industries (Pvt.) Ltd., Karachi had requested that they want to revise their
following finished products specification as per directive of Section 3 of the Drugs Act, 1976:
S. Reg. Name of drug(s) & Current Available Initial Registration Date
No. No. Composition Finished monograph in and Renewal Status
product Pharmacopoeia
specification
1. 010006 Gynosporin Vaginal Tablets - USP-39, 2016 30th October, 1988.
Each tablet contains: Last Renewal submitted
Clotrimazole … 500 mg on 30-09-2013
The renewal status of the above mentioned product was not clarified by the firm along with
request. The above case was presented in 269th meeting of Registration Board. The Board
considered the case and decided as under:-
The Registration Board deferred the request of the firm for confirmation of registration renewal
status of the above mentioned product in its 269th meeting.
Reply of RRR Section:
Now RRR section has informed vide their letter No.F.9-38/2006-RRR(Vol-I) dated
08-11-2017 that renewal application of year 2013 is received within time, under the Rules 27 of
Drug Licensing, Registering & Advertising Rules, 1976.
Decision: Registration Board approved USP specifications for Gynosporin Vaginal
Tablets (Clotrimazole … 500 mg) (Reg # 010006) at the same terms and
conditions.
Case No. 8. Change of Primary Packaging Material of Drug(S) Of M/S. GlaxoSmithkline

Pakistan Limited, Karachi. (Incorporated in No.F.1-42/2016-Reg-II).
M/s. GlaxoSmithKline Pakistan Limited, F-268, SITE, Karachi have requested for
change of packaging material from Amber Glass Bottle to Alu Alu Blister packaging with
dessiflex of their following already registered products:-
S.No. Reg.No. Name of Drug(s) Initial letter of registration with renewal
status.
1. 017297 Augmentin Tablet 625mg i. Initial registration date 11-6-1995
Each tablet contains:- (Pages 252-253/cor.)
Amoxycillin trihydrate eq. to 500mg ii. Transfer dated 30-08-2003
Amoxycillin base (Pages 256-260/cor.)
Potassium Clavulanate eq. to 125mg iii. 1st renewal dated 21.07.2008 after
Clavulanate Potassium transfer of registration (page 263/cor.)
iv. 02nd renewal dated 19.07.2008.
2. 022244 Augmentin BD Tablet i. Initial registration date 29-08-1998
Each tablet contains:- (Pages 254-255/cor.)
Amoxycillin trihydrate eq. to 875mg ii. Transfer dated 30-08-2003
Amoxycillin base (Pages 261/cor.)
Potassium Clavulanate eq. to 125mg iii. 1st renewal dated 11.08.2008 after
Clavulanate Potassium transfer of registration (page 265/cor.)
iv. 02nd renewal dated 19.08.2013
(page 264/cor).
The firm has provided following documents as per SOPs:-
S.# Required documents Submitted documents
a) Application with required fee as per relevant SRO. The firm has deposited fee of Rs. 5000/-
for this purpose.
b) Copy of registration letter and renewal status As described above.
c) NOC for CRF clearance. Page 266/cor.
d) Justification of proposed change Dessiflex Alu Alu blister overall
improves the working environment and
free form possible risks and secure the
tablets from light and moisture as
compared to amber glass bottle and
stability data found satisfactory.
e) Accelerated stability studies of 6 months with Page 268-274 and 275-285/cor.
undertaking to conduct real time stability studies up
to assigned shelf life & report if any result falls
outside shelf life specifications (with proposed
action).
f) Shelf life of the drug product supported with Page 282/cor.)
justification.
Moreover, the firm has submitted public assessment report of MHRA as reference for
international availability in proposed packing.
The firm was asked to provide following information for above products: -
i. Protocols of stability studies.
ii. Copy of stability data supported by relevant copies of chromatograms.
The firm has provided stability data as per following details: -
S.# Stability requirements Submitted documents
i Stability protocols The firm has provided copies of protocol of on-going stability
with the testing frequency of 0, 1, 3, 6, 9, 12, 18, 24, months at
30°C / 65% RH. However, firm did not provide specifications
for packaging material.
ii. Copy of stability data Stability data for three batches for each product has been
supported by relevant copies provided with single point testing on ambient conditions 30°C
of chromatograms. / 65% upto 24 months without mentioning batch sizes.
Furthermore, only one chromatogram without refereeing to
testing point date and time has been provided in general.
The PRVC deferred the case in its 2nd meeting for presentation before Registration Board after
evaluation of stability studies.
Decision: Registration Board deliberated on the matter and approved change of
packaging material from Amber Glass Bottle to Alu Alu Blister packaging with
dessiflex for Augmentin Tablet 625mg (Reg# 017297) and Augmentin BD Tablet
(Reg # 022244) as the product is available in the same packaging in one of the
reference authority MHRA.
Board further decided that if a primary packaging is available in any of reference
regulatory authorities, approval will be granted to the applicant subject to the condition
that the firm will submit an undertaking that they will perform 6 months’ accelerated
stability studies (3 batches commercial scale) and real time stability studies (3 batches
commercial scale) till the assigned shelf life.
However, if the primary packaging is not available in any of reference authorities, the
applicant will support their application with 6 months’ Stability Data (3 batches
commercial scale) and an undertaking to perform real time stability studies (3 batches
commercial scale) till the assigned shelf life.
Case No. 9. Change of Specification of Gen-M Suspension 15mg/90mg (Reg.No.053285)

of M/S. Genix Pharma (Pvt.) Ltd; Karachi.
M/s. Genix Pharma (Pvt.) Ltd; Karachi has requested that they were granted the
registration of “Gen-M 15/90 Dry Suspension” (Artemether……15mg+Lumefantrine…. 90mg)/
5ml (Reg.No.053285) with Manufacturer’s Specification.
The firm has requested to change the specification from Manufacturer’s Specification to
International Pharmacopeia (Ph. Int). They have deposited following documents.
i. Copy of initial letter of registration dated 03-12-2008 and renewal application
dated 31-10-2013.
ii. Original challan of fee of Rs. 5000/-.
iii. Pharmacopeial reference.
iv. DY.No 5653-R&I dated 12.06.2017.
The PRVC in its 2nd meeting directed to place the request of the firm for consideration of
Registration Board.
Decision: Registration Board deliberated on the matter and decided to grant approval
of International Pharmacopeia specifications to the above mentioned
product.
Case No. 10. Change of specification of Drug(s) of M/S. Mediate Pharmaceuticals (Pvt.)
Ltd; Karachi.
M/s. Mediate Pharmaceuticals (Pvt.) Ltd; Karachi has requested for change of
specification of following already drug(s).
I II III IV V VI
Sr. Reg.No. Name of drug(s) with existing Demanded Remarks Diary No and
No. formulation Specification Date
1. 034412 Clariset Tablet 250mg USP Formulation is 20152-R&I
Each tablet contains:- Specification available in film Dated
Clarithromycin ………. 250mg coating, however, the 06.11.2017
firm has not applied.
2. 034413 Clariset Tablet 500mg USP -do- -do-
Each tablet contains:- Specification
Clarithromycin ………. 500mg
3. 034414 Clariset Suspension 125mg/5ml USP Formulation is -do-
Each 5ml contains:- Specification available in the form
Clarithromycin ………. 125mg of granules.
4. 057945 Essomac Capsule 20mg USP Formulation is 20153-R&I
Each capsule contains:- Specification available as Dated
Esomeprazole enteric coated Esomeprazole as 06.11.2017
pellets eq. to Esomeprazole.. 20mg Magnesium.
(Manufacturer Specification)
5. 057946 Essomac Capsule 40mg USP -do- -do-
Each capsule contains:- Specification
Esomeprazole enteric coated
pellets eq. to Esomeprazole.. 40mg
(Manufacturer Specification)
6. 037029 Metroate Tablet 400mg USP Formulation is 20154-R&I
Each tablet contains:- Specification available as film Dated
Metronidazole ………… 400mg coated. 06.11.2017
7. 034716 Metroate Suspension USP -do-
Each 5ml contains:- Specification
Metronidazole (as Benzoate)
…….200mg
8. 032442 Mediprazole 20mg Capsule USP 20955-R&I
Each capsule contains:- Specification Dated
Omeprazole USP (as enteric 14.11.2017
coated granules) …… 20mg
They have provided following documents:-
i. Copy of initial letter of registration and renewal status.
ii. Copy of NOC of CRF.
iii. Original challans of Rs. 5000/- for each product.
vi. Pharmacopeial references.
The PRVC in its 2nd meeting deferred the case for provision of documents as per SOPs,
confirmation of renewal status, application for correction of pharmaceutical forms and also
directed to place the case in agenda for consideration of the Registration Board after fulfillment
of the shortcomings.
Decision: Registration board deliberated on the matter and approved USP Specifications
for the above mentioned products at Sr. 1-8. Moreover, the board also approved
correction in pharmaceutical form/ description of the products at Sr. 1-6 as per
column V of the table.
Case No. 11. Correction in Formulation of Drug(S) of M/S. Maxitech Pharma (Private)
Ltd; Karachi. (Incorporated in No.F.1-7/2007-Reg-II).
M/s. Maxitech Pharma (Pvt) Ltd., Plot No. E-178, SITE, Karachi have requested for
issuance of corrigendum of their following already registered products. The details are as under:
I II III IV
Sl.# Regn Existing name with composition / Correction required in composition /
No. Specifications Specification
1. 083706 Nifty 60mg Tablet Nifty 60mg Tablet
Each film coated tablet contains:- Each film coated tablet contains:-
Fexofenadine HCl eq. to Fesofenadine… 60mg Fexofenadine HCl ……… 60mg
(USP Specification)
Fexofenadine HCl eq. to Fesofenadine Fexofenadine HCl ……… 120mg
………… 120mg (USP Specification)
Fexofenadine HCl eq. to Fesofenadine…180mg Fexofenadine HCl ……… 180mg
(USP Specification)
4. 083704 Maxithro 250mg Tablets Maxithro 250mg Tablets
Each film coated tablet contains: Each film coated tablet contains:
Azithromycin (as hydrate)…..250mg Azithromycin (as dihydrate)…..250mg
(As per *Innovator’s Spec.) (USP Specification)
5. 083705 Maxithro 500mg Tablets Maxithro 500mg Tablets
Azithromycin (as hydrate)…..500mg Azithromycin (as dihydrate)…..500mg
6. 083716 Terbimax 250mg Tablets Terbimax 250mg Tablets
Each tablet contains: Each tablet contains:
Terbinafine hydrochloride eq. to Terbinafine hydrochloride eq. to
Terbinafine………….250mg Terbinafine………….250mg
7. 083717 Levcin 500mg Tablet Levcin 500mg Tablet
Levofloxacin hemihydrate eq to Levofloxacin Levofloxacin hemihydrate eq to
…………500mg Levofloxacin…………500mg
8. 083718 Levcin 250mg Tablet Levcin 250mg Tablet
Levofloxacin hemihydrate eq to Levofloxacin Levofloxacin hemihydrate eq to
…………250mg Levofloxacin…………250mg
It is submitted the firm was granted the registration of products at Sr.No.1 to 3
Fexofenadine HCl eq. to Fesofenadine while the firm has claimed that they have applied the
formulation as Fexofenadine HCl, the firm was issued corrigendum of products at Sr.No.4-8 with
as per *Innovator’s specification* while the initial letter of registration was issued with correct
specification i.e USP specifications. If agreed, we may correct the formulation of above products
as well as specification as mentioned above.
The PRVC in its 2nd meeting directed to place the case in agenda for consideration of
Registration Board.
Decision: Registration board deliberated on the matter and approved USP
Specifications for the above mentioned products at Sr. 1-8. Moreover, the
Board also approved correction in pharmaceutical form/ description of the
products at Sr. 1-3 as per column IV of the table.
Case No.12. Correction in Registration letter of M/s. Barrett Hodgson Pakistan (Pvt.) Ltd,
Karachi (Dy # 24816 dated 18-12-2017) and M/s. S.J.&G Fazul Ellahie (Pvt.)
Ltd; Karachi (Incorporated in No.F.6-13/2017-Reg-II).
a. M/s. Barrett Hodgson Pakistan (Pvt.) Ltd; Karachi has informed that they were granted
the registration of following product while there is some omission in the registration letter: -
S.# Regn No. Product(s) with existing composition. Product(s) with correct composition.
1. 083222 Bar-D Injection I.M Bar-D Injection
Each ml contains:- Each ml contains:-
Vitamin D3 (Cholecalciferol) USP…5mg Vitamin D3 (Cholecalciferol)…… 5mg
(B.P Specification) (As per Innovator’s Specification)
The firm has requested to omit the B.P Specification and mention Innovator’s Specification
instead of B.P specification. They attached copies of minutes of various meetings of Registration
Board in which many firms have been granted Innovator’s Specification without mentioned I.M.
Furthermore, the Registration Board in its 262nd meeting the product with Manufacturer’s
Specification.
The PRVC in its 3rd meeting deferred the case for verification of calculation and presentation
the case before Registration Board.
b. M/s. S.J.&G Fazul Ellahie (Pvt.) Ltd; Karachi has informed that they were granted the
registration of following product while there is some omission in the registration letter:-
S.# Regn No. Product(s) with existing composition. Product(s) with correct composition.
1. 083164 Care-D Injection I.M Care-D Injection
Each ml contains:- Each ml contains:-
Cholecalciferol …………… 5mg Cholecalciferol …………… 5mg
(200,000IU) (200,000IU)
(B.P Specification) (As per Innovator’s Specification)
The firm has requested to omit the B.P Specification and mention Innovator’s Specification
instead of B.P specification. They attached copies of minutes of various meetings of Registration
Board in which many firms have been granted Innovator’s Specification without mentioned I.M.
The product was approved in 262nd meeting of Registration Board, however, specification was
not mentioned in the minutes of the Registration Board.
The PRVC in its 3rd deferred the case for verification of calculation and presentation the case
before Registration Board.
Now the firm has provided following calculations: -
PARAMETERS CARE-D3 INJECTION (SJG) CHOLECALCIFEROL INJECTION

(INNOVATOR’S SPECS) (B.P.)
Composition (per ml) Each ml contains:- Each ml contains:-
Cholecalciferol ………. 5mg Cholecalciferol ……. 7.5ng
(200,000 IU)* (300,000 IU)
Composition (%) 0.5% w/w 0.75% w/w
Life of 0.45 tp 0.55% w/w or 180,000 to 220,000 0.87 to 0.83% w/v or 268,000 to
Cholecalciferol IU/ml i.e. 90.0% to 110.0 of the labeled 332,000 IU/ml i.e. 89.33 to 110.66%
amount. of the labeled amount.
Minimum %age 0.45%w/v 0.67%w/v
Maximum %age 0.55% w/v 0.83%w/v
Route of I.M. and orally I.M. only
administration
Decision: Registration board deferred the both cases for further deliberation and to
evaluate the case in the light of approval granted to the product by ANSM
France.
Case No.13. Reduction of Shelf Life of Registered Drug of M/S. Reckitt Benckiser
Pakistan Limited, Karachi.
M/s. Reckitt Benckiser Pakistan Limited, Karachi has informed that their following product is
available in market since 25 years with approved shelf life of three years:-
S.No. Name of Drug(s) Reg.No. Registration history
1. Disporol Suspension 000484 Change of brand name 29-06-1982
2nd change of brand name 28-10-1991
Change of title of company dated 21-12-2000
Renewal applied on 04-11-2013
They have further stated that Disprol is their global brand name and originally launched in UK
with approved shelf life of two years. Therefore, the firm has requested to reduce the shelf life of
their above product from three years to two years. They have also submitted reference for this
purpose from UK. Furthermore, it is also in the interest of patients. For harmonization of global
process, they want to remain in the line with country of origin. They have deposited fee of Rs.
5000/- for this purpose.
The PRVC in its 3rd meeting decided to place the case before Registration Board.
Decision: Registration board deliberated on the matter and approved reduction in shelf life
of the product from 3 years to 2 years for Disporol Suspension (Reg # 000484).
Case No.14. Transfer of Registration of products to M/S. Nexus Pharma, Karachi.

M/s. Nexus Pharma (Pvt.) Ltd; Karachi has requested for transfer of registration
following registered drug(s) from their old name i.e M/s. Pride Pharmaceuticals to their new
name M/s. Nexus Pharma (Pvt.) Ltd; Karachi. Site remains the same.
S.No. Name of Drug(s) Reg.No. Registration history
1. Blush FA Tablet 039329 Init. Date of reg. 04-06-2005
Each tablet contains:- Name changed dated 22-01-2009
Iron (III) Hydroxide polymaltose complex Renewal applied on 04-02-2014 with
eq. to elemental Iron …….. 100mg fee of Rs. 20,000/-
Folic acid ………….. 350mg
2. Blush Syrup 039636 Init. Date of reg. 04-06-2005
Each 5ml contains:- Name changed dated 22-01-2009
Iron (III) Hydroxide polymaltose complex Renewal applied on 04-02-2014 with
eq. to elemental Iron …….. 50mg fee of Rs. 20,000/-
3. Gyala Capsule 039635 Int.date of Reg. 24-10-2005
Each capsule contains:- Name changed dated 22-01-2009
Cefixime…………… 400mg Renewal applied on 04-02-2014 with
fee of Rs. 20,000/-
4. Gyala Suspension 039635 Int.date of Reg. 24-10-2005
Cefixime…………… 100mg Renewal applied on 04-02-2014 with
fee of Rs. 20,000/-
5. Coozip Capsule 20mg 039633 Int.date of Reg. 24-10-2005
Oemprazole …………… 20mg Renewal applied on 03-07-2013 with
fee of Rs. 10,000/-
6. Nitaxim Injecion 250mg 039561 Int. date of Reg. 31-08-2010
Each dry powder vial contains:- Name changed dated 08-11-2008
Cefotaxim as Sodium ….. 250mg Renewal applied on 03-07-2013 with
fee of Rs. 10,000/-
7. Nitaxim Injecion 500mg 039562 Int. date of Reg. 31-08-2010
Cefotaxim as Sodium ….. 500mg
8. Nitaxim Injecion 1gm 039563 Int. date of Reg. 31-08-2010
Cefotaxim as Sodium ….. 1gm Renewal applied on 03-07-2013 with
fee of Rs. 10,000/-
9. Flur Tablet 100mg 039529 Int. date of Reg. 31-08-2010
Each tablet contains:- Name changed dated 08-11-2008
Flurbiprofen ……………. 100mg Renewal applied on 03-07-2013 with
fee of Rs. 10,000/-
10 Nettle Capsule 250mg 039557 Int. date of Reg. 31-08-2010
Cefaclor as Monohydrate … 250mg Renewal applied on 03-07-2013 with
fee of Rs. 10,000/-
11. Nettle Capsule 500mg 039558 Int. date of Reg. 31-08-2010
fee of Rs. 10,000/-
12. Nettle Dry Suspension 125mg 039555 Int. date of Reg. 31-08-2010
fee of Rs. 10,000/-
13. Nettle Dry Suspension 250mg 039555 Int. date of Reg. 31-08-2010
fee of Rs. 10,000/-
14. Nettle Drops 50mg /1ml 039555 Int. date of Reg. 31-08-2010
fee of Rs. 10,000/-
The brand names of above products were changed vide letter No.F.1-67/2007-Reg-II(s) dated
08.11.2008 and No.F.1-50/2005-Reg-II(s) dated 22-01-2009.
They have deposited fee of Rs. 20,000/- for each product and submitted following documents:-
S.# Required documents Submitted documents
a. Application with Form-5 and required fee Fee of Rs. 20,000/- for each product is provided.
as per relevant SRO
b. Copy of registration letters & and renewal Copy of initial letter of registration and renewal
status status attached and the firm applied renewal
applications in accordance of change of brand name
of above products.
c. NOC for CRF clearance Attached.
d. Copy of approved section by Central The Licensing Division vide their letter No.F.2-
Licensing Board. 4/91-Lic(Vol-III) dated 22-10-2008 had changed the
title of the firm from M/s. Pride Pharmaceuticals,
Plot No. 4/19 – 4/36, Sector 21, Korangi (DML #
000421) M/s. Nexus Pharma (Pvt.) Ltd; Plot No.
4/19 – 4/36, Sector 21, Korangi (DML # 000421).
e. Copy of last inspection report. Provided.
f. NOC from existing manufacturer / Change of title of the firm only.
registration holder permitting for
cancellation of product from its name and
grant to new registration holder /
manufacturer.
g Statement / undertaking that applicant do Provided.
not have registration of same products. If
so, it has to apply for cancellation of
product.
The PRVC in its 3rd meeting deferred the case for provision of complete information and
clarification from the firm and presentation before Registration Board. Now the firm has
provided copies of Form-5 and other documents.
Decision: Registration Board deferred the case to obtain renewal status from RRR section.
Case No. 15. Withdrawal of Products Registration Status of Products from Plant-I to
Plant-II of Drug (s) of M/S. Bosch Pharmaceuticals (Pvt.) Ltd; Karachi.
M/s. Bosch Pharmacueticals (Pvt.) Ltd; Karachi has informed that they had
applied for transfer of registration of following products from M/s. Bosch Pharmaceuticals Plant-
I (DML# 000350) to M/s. Bosch Pharmaceuticals Plant-II (DML# 000707). They have informed
that they have not yet received yet any response from DRAP, Islamabad and they are no more
interested to transfer these products from Plant-I to Plant-II and they have requested for
withdrawal of their previous request: -
S.No. Name of Drug(s) with existing formulation Reg.No.
1. Tariflox 200mg Infusion 021506
Each 100ml vial contains:-
Ofloxacin ……….200mg
(Manufacturer’s Specification)
2. Quinoflox 100mg Infusion 023020
Ceprofloxacin Lactate M.S eq. to 100mg Ciprofloxacin
Sodium Chloride ….. 450mg
Ceprofloxacin Lactate M.S eq. to 200mg Ciprofloxacin Sodium
Chloride ….. 900mg
Ciprofloxacin Lactate M.S eq. to 400mg Ciprofloxacin
5. Quinoflox DS 400mg Infusion 048489
Ciprofloxacin Lactate M.S eq. to 400mg Ciprofloxacin
Sodium chloride …… 900mg
6. Troz 500mg IV Infusion 034856
Metronidazole ……… 500mg
7. Qumic 500mg Injection 024244
Levofloxacin hemihydrates 512.46mg eq. to Levofloxacin … 500mg
8. Qumic 750mg/150ml Injection 061073
Levofloxacin (as hemihydrates) …… 750mg
9. Qumic 250mg/50ml Injection 061075
Levofloxacin (as hemihydrates) …… 250mg
10. Cizo 500mg Injection 015902
Cefazolin Sodium eq. to
Cefazolin ………. 500mg
11. Furoxy 750mg Injection 025111
Cefazolin Sodium eq. to
Cefazolin ………... 750mg
12. Cryaxon 1gm Injection 017739
Ceftriaxone Sodium eq. to Seftriazone ………….. 1000mg
13. Baxidayme 1gm Injection 000221-
Each vial contains:- EX
Ceftazidime pentahydrate eq. to
Ceftazidine ………… 1gm
14. Clinbaxef 1000mg Injection 000282-
Cefotaxime Sodium eq. to
Cefotaxime ……….. 1000mg
15. Cizo 1000mg Injection 000283-
Cefazolin Sodium eq. to 1000mg Cefazolin
16. Boxolyn 200mg/100ml Infusion 000293-
Each 100ml vial contains:- EX
Ciprofloxacin Lactate eq. to Ciprofloxacin ……… 200mg
17. Trend 1000mg Injection 000301-
Ciprofloxacin Sodium eq. to Ciprofloxacin ……… 1000mg
18. Alax 1000mg Injection 000302-
Ceftrixone Sodium eq. to Ceftriaxone ………… 1000mg
Ceftrixone Sodium eq. to Ceftriaxone ………… 250mg
20. Trend 500mg Injection 000312-
Cefotaxime Sodium eq. to Cefotaxime ………….. 500mg
21. Xinlanic 600mg Injection 000376-
Amoxycillin (as sodium) …. 500mg
Clavulanic Acid (as Potassium Clavulanate) ………. 100mg
22. Xinlanic 1200mg Injection 000377-
Amoxycillin (as sodium) …. 1000mg
Clavulanic Acid (as Potassium Clavulanate) ………. 200mg
Ceftriaxone Sodium eq. to Ceftriaxone ……….. 500mg
24. Bofalgan 1gm / 100ml Infusion 000381-
Paracetamol ………….. 1gm
25. Cefxone-S 375mg Injection 002157-
Ceftrixone Sodium eq. to Ceftriaxone ………. 250mg
Sulbactum Sodium eq. to Sulbactum ……….. 125mg
26. Cefxone-S 750mg Injection 002159-
Ceftriaxone Sodium to Ceftriaxone ………. 1000mg
Sulbactum Sodium eq. to Sulbactum ……….. 500mg
27. Desri 2gm Injection 002757-
Cefoperazone Sodium eq. to
Cefoperazone ……..… 1000mg
Sulbactum sodium eq. to
Sulbactum …………. 1000mg
28. Protoriff 500mg / 100ml Infusion 002838-
Levofloxacin as hemihydrates eq. to Levofloxacin …….. 500mg
29. Cefxone 0.25gm Injection 017656
Ceftriaxone Sodium eq. to Ceftriaxone …………… 250mg
30. Cefxone 0.5gm Injection 017657
31. Cefxone 1gm Injection 017739
32. Cefxone 2gm Injection 055913
33. Cefotax 250mg Injection 015130
Cefotaxime Sodium eq. to Cefotaxime …………. 250mg
36. Cefazone 0.25gm Injection 015901
Cefazolin (as sodium) eq. to Cefazolin ………… 250mg
37. Cefazone 0.5gm Injection 015902
38. Cefazone 1gm Injection 015903
39. Cefrinex 250mg Injection 015127
Cephradine ………… 250mg
42. Ceprazone 0.25mg Injection 022970
Cefoperazone (as Sodium) eq. to Cefoperazone …………. 250mg
43. Ceprazone 0.5mg Injection 019245
44. Ceprazone 1gm Injection 019246
45. Fortazim 0.25gm Injection 025112
Ceftazidime (as Pentahydrate) eq. to Ceftazidime ………. 250mg
46. Fortazim 0.5gm Injection 025113
47. Fortazim 1gm Injection 025114
48. Zecef 0.25gm Injection 026199
Cefuroxime (as Sodium) eq. to Cefuroxime ………….. 250mg
51. Ivcef 250mg Injection 027733
Cefpirome Sulphate eq. to Cefpirome …………… 250mg
52. Ivcef 500mg Injection 027735
Cefpirome Sulphate eq. to Cefpirome …………… 500mg
53. Tezox 250mg Injection 034859
Ceftizoxime Sodium eq. to Ceftizoxime ……….. 250mg
56. Cebac 1gm Injection 037630
Cefoperazone Sodium eq. to Cefoperazone …………. 500mg
Sulbactum Sodium eq. to Sulbactum …………… 500mg
57. Cebac 2gm Injection 037631
Cefoperazone Sodium eq. to Cefoperazone …………. 1000mg
Sulbactum Sodium eq. to Sulbactum …………… 1000mg
58. Nuxipim 500mg Injection 044356
Cefepime (as Cefepime HCl) ……….. 500mg
59. Nuxipim 1gm Injection 044357
Cefepime (as Cefepime HCl) ……….. 1gm
It is submitted that the case was considered in 254th meeting of Registration Board as under:-
Decision: Registration Board decided as follows:
Cancellation of registrations of products except at S. No. 11, 12, 13, 23, 24 and 25 from M/s
Bosch-I (Pvt) Ltd., Karachi.
Registration of products except at S. No. 11, 12, 13, 23, 24 and 25 in the name of M/s Bosch-II
(Pvt) Ltd., Karachi. For products at S.No.1-4, firm will select either IM or IV. The Registration
Board authorized its Chairman for issuance of registration letters after comments / fixation of
MRP by Cost & Pricing Division.
Products at S. No. 11, 12, 13, 23, 24 and 25 were deferred for confirmation of approval status by
the reference drug regulatory authorities.
The Chairman Registration Board directed to place the before Registration Board in its 3rd
meeting of PRVC.
Decision: Registration board deferred the case for the following:

1. To obtain opinion from legal affair division whether applicant needs to submit
fee of Rs: 20000 and Form 5 for transfer to their previous site.
2. To obtain renewal status from RRR section.
Case No.16 Change of coating of Epival of M/s Abbott Laboratories, Karachi- Deferred
in 275th Meeting.
M/s Abbott Laboratories (Pakistan) Limited, Karachi has requested for change of coating
material of Epival 250mg Tablet Reg. No. 007160 and Epival 500mg Tablet Registration No.
007161 from Acetone to other solvent, Acryl-Eze. The firm has further stated that change in
coating of Epival 250mg tablet and Epival 500mg tablet will have no effect in existing label
claims, efficacy, quality and safety of these products.
2. In support the firm have provided following documents:
i) Current and revised formulations of Epival 250mg & Epival 500mg tablet.
ii) Protocols, Stability Data and Chromatograms of Epival 250mg & 500mg for all batches
(three trial batches & one Routine batch) with new aqueous coating material named Acryl-Eze,
Stability studies comply with the testing method and results are within specification limits.
iii) Copy of registration letter with renewal status.
iv) NOC for CRF.
Undertaking to conduct stability studies for complete shelf life.
Original Rs. 5000/- fee for each product.
Registration Board in its 275th meeting deferred the case for further deliberation in light of
processing of Controlled Drugs Division.
Update Status:
“It is submitted that the above change in coating material was suggested by Controlled Drugs
Division of DRAP on 06-06-2016 with the advice to the firm that to strictly comply with times
lines submitted by the firm for switching over to other solvents with in 24 months and submit
quarterly progress report to their office and authenticate / get approval of formulation changer
from PE&R Division”.
Decision: Registration Board deferred the case to obtain comments/ scientific justification
from the firm for changing the dosage form of the product i.e change from
Immediate Release to Delayed release tablet.
Deferred products of M/s. SJ&G, Fazul Ellahi, Karachi.

The Registration Board in its 213th & 214th meetings deferred the following products of
M/s. S.J&G Fazul Ellahi, Karachi for reasons as mentioned below: -
S.No. Name of Drug(s) Pack size Demanded Decision of
MRP Registration
Board
1 Trispa Injection 6 Rs. 210.00 Deferred for
Each 4ml ampoule contains:- ampoules review committee
Hydrated Phloroglucinol......40mg M-213
Trimethylphloroglucinol…0.04mg
(Antispasmodic)
2. Trispa Tablet 30’s Rs. 150.00 Deferred for fate in
Each film coated tablet contains:- the light of review
Hydrated hloroglucinol F.P. … 80mg Committee’s
Trimethylphloroglucinol M.S … 80mg decision. M-214
(Musculotropic Antispasmodic)
The management of the firm has provided following documents: -

i. Form 5 and original challans of remaining fee of Rs. 12000/- for each product.
ii. Copies of challans of Rs. 8000/- for each product.
Decision: Registration board deferred the case to obtain comments from QA Division
on GMP status of the firm in the light of latest GMP inspection report.
Case No.17. Deferred product of M/s. Pliva Pakistan (Pvt.) Ltd; Karachi.
The Registration Board in its 252nd & 254th meetings decided the applications of
M/s. Pliva Pakistan (Pvt.) Ltd; Karachi as per following details: -
S. Reg. No. Name of Products Decision of Registration Board
No.
1. 008619 Amoxicillin Injection 500mg Registration Board in its 254th meeting
Each vial contains: deferred request of the firm for
Amoxicillin as sodium salt…… confirmation of renewal status.
500mg
The Renewal Section granted the renewal of above product till 05-11-2015. (252nd meeting of
the Registration Board was held on 07– 08th September, 2015 and 254th meeting was held on 11-
12th November, 2015). The application of M/s. Pliva Pakistan (Pvt.) Ltd; Karachi of above
product was received when the registration was valid.

 Cancellation of above products from M/s Mehran International, Karachi
 Registration of above products to M/s M/s Pliva Pakistan (Pvt.) Ltd;
Karachi, Karachi.
 Reference will be sent to Cost and Pricing Division for confirmation of
price and authorized Chairman registration board for issuance of
Case No. 18. Adoption of pharmacopoeial specification of registered product(s) of M/s.

Atco Laboratoreis, Limited, Karachi.
M/s. Atco Laboratories Limited B-18, S.I.T.E., Karachi-75700 has requested for
adoption of pharmacopoeial specifications of following products as per details given below:-
S.No. Reg.No. Name of Drug(s) Existing Demanded
Specification Specification
1. 048486 Solo 4mg Tablet Manufacturer’s B.P
Each Sachet contains:- Specification
Montelukast Sodium ……….. 4mg
3. 002194- Montemax 5mg Tablet (Manufactuter’s B.P
EX Each chewable tablet contains:- Specification)
Montelukast as Sodium ………….. 5mg
4. 002195- Montemax 10mg Tablet (Manufactuter’s B.P
EX Each chewable tablet contains:- Specification)
Montelukast as Sodium ………….. 10mg
5. 003850- Montemax 4mg Sachet (Manufactuter’s B.P
EX Each sachet contains:- Specification)
Montelukast Sodium eq. to Montelukast…4mg
The management of the firm has provided following documents:-
i. Challans of fee of Rs. 5000/- for each product.
ii. Copies of initial letters of registration and renewal status.
iii. Pharmacopieal references.
The firm has stated that they are exporting above products to Vietnam and for the purpose CoPP
will be required from local ADC office, DRAP, Karachi. In prescribed format of CoPP as per
WHO guidelines, there is a point of availability of product in exporting country and they have
registered range of same formulations for local manufacturing purpose with the brand name Solo
where the specification is mentioned. The firm has requested in compliance of 267th meeting of
Registration to allow the pharmacopoeial specification accordingly.
Decision: Registration Board deliberated on the matter and decided to grant BP
Specifications for the products at Sr. 1-5 of above table.
Case No.19. Deferred product of M/s. Karachi Chemical Industries Karachi.

The Registration Board in its 237th meeting of deferred the following product of
M/s. Karachi Chemical Industries, Karachi:-
M/s Fovir Tablets 300mg As per SRO As per 30-06-2010
Karachi Each film coated tablet SRO 1260
Chemical contains:- Form-5
Industries, Tenofovir Disoproxil Rs.8000/-
Karachi Fumarate………..300mg
(Anti viral)
Decision of Registration Board: The board referred the applications after submission of
differential fee for registration submitted in April, May and June, 2010 to committee comprising
of Professor Dr. Rafi-uz-Zaman Saeed-ul-Haq, University of Lahore, Islamabad (Member
Registration Board) and A.Q. Javed Iqbal, Chief Pharmacist, PIMS, Islamabad (Member
Registration Board), DDG (Reg-I) and concerned DDC for securitization, verification of codal
requirements and recommendations for me-too registration applications. The recommendations
of committee will be submitted to Chairman, Registration Board for decision.
Now, the firm has deposited fee remaining fee of Rs. 12,000/- (copy of challan) and renewal
inspection dated 15.8.2017 for this purpose and requested to issue the registration of above
products.
Decision: Registration Board deferred the case for submission of new Form 5 and to
present the same in meeting of registration board.
Case No.20. Transfer of Registration of Products of M/S. Scilife Pharma (Pvt) Ltd,
Karachi.
M/s Scilife Pharma (Pvt) Ltd., Plot No. FD-57/58-A2, Korangi Creek Industrial
Park (KCIP), Karachi has requested for change of registration from M/s McOlson Resarch
Laboratories, Plot No. 2 M-2Pharma Zone, 26th KM Lahore Sharikpur Road Sheikhupura to
their name. The products detail is as under:
S.# Regn Name of product Date of registration
No.
1. 069242 Lipofen Capsule 67mg 26.03.2011
Fenofibrate……….67mg
2. 069235 Lipofen Capsule 200mg 26.03.2011
Fenofibrate……….200mg
In support to above the firm has provided following documents:

i) Request with prescribed fee amounting to Rs. 20,000/- for each product.
ii) Form 5.
iii) Initial Registration letter
iv) Updated Section approval, inspection report dated 31.12.2016.
v) NOC from M/s McOlson Resarch Laboratories, Plot No. 2 M-2 Pharma Zone, 26-KM
Lahore Sharikpur Road Sueikhupura for transfer permission for products.
vii) Undertaking of not have same product registration already.
The firm was asked to provide valid NOC which have issued not more than 6 months.
The firm has provided valid NOC from M/s McOlson Resarch Laboratories, Sheikhupura dated
13.12.2017.
 Cancellation of above products from M/s McOlson Resarch Laboratories,
Sheikhupura.
 Registration of above products to M/s Scilife, Karachi.
 Reference will be sent to Cost and Pricing Division for confirmation of
price and authorized Chairman registration board for issuance of
Case No. 21. Request for contract manufacturing of drug by M/s. Tabros Pharma (Pvt.)
Ltd; Karachi.
M/s. Tabros Phamra (Pvt.) Ltd; Karachi was granted the registration of following product: -
Reg.No. Name of Drug(s) Registration History Remarks
026886 Biflor Sachet 250mg Init. Date of Reg. 12-05-2001 Renewal
Each sachet contains:- Copy of 1st renewal application dated confirmation
Lyophilised Saccharomyces 04-02-2006 required
boulardil ………. 285mg Cop of 2nd renewal application dated from RRR
(Corresponding to 250mg of 14-04-2011 section.
Yeast) Copy of 03rd renewal dated 18-02-2016
The management of the firm has provided following documents:-

i. Fee of Rs. 50,000/- for this purpose.
ii. Copy of renewal of registration and copies of renewal applications.
iii. Contract agreement on stamp paper.
iv. Last inspection of M/s. Hilton Pharma, Karachi dated 19-07-2017.
v. Approval of Section by CLB of M/s. Hilton Pharma, Karachi.
vi. NOC from M/s. Hilton Pharma, Karachi.
M/s. Tabros Pharma, Karachi has requested to change the registration status of above product to
contract manufacturing by M/s. Hilton Pharma (Pvt.) Ltd; Plot 13-14, Sector 15, Korangi
Industrial Area, Karachi. The firm has further stated that they are planning to establish Probiotic
facility.
M/s Hilton Pharma, Karachi was granted Sachet (Enflor) Section on 4.12.2014 with following
remarks:
“The Central Licesing Board has granted provisional approval of amendments/expansion in
already existing sachet (Enflor) section. The active ingredient of sachet Enflor is Sacharomyces
Boulardii is probiotic which is not a drug after the promulgation of DRAP Act, 2012. Since the
firm has registration of Enflor sachet product, therefore the Board directed to refer the cae to
Divison of Pharmaceutical Evaluation & Research, DRAP, Islamabad to take review of
registration of probiotic (Sachet Enflor) product of the firm and to inform CLB for necessary
action accordingly”.
Decision: Registration Board referred the matter to Licensing Division for evaluation
in light of decision of DRAP’s authority in the subject matter.
Case No 22: Request of M/s GlaxoSmithKline OTC (Pvt) Limited, Jamshoro for
additional flavours of Cac 1000 Plus Effervescent Tablet.
M/s GlaxoSmithKline OTC (Pvt) Limited, Jamshoro have applied for change of flavor of
their already registered following drugs. Furthermore, firm has applied for grant of additional
flavours for the same product as well:
S.No Reg.No. Name of Drug(s) & Composition with Existing Additional Flavours
Flavour
1 084750 CaC 1000 Plus Effervescent Tablet Cola
Each tablet contains:- Orange
Calcium Carbonate…. 327 mg Lemon
Ascorbic Acid… 500 mg
Calcium Lactate Gluconate… 1000 mg
Pyridoxine HCl… 10 mg
Vitamin D3… 4 mg
Pineapple Flavour…. 20 mg
(As per Innovator’s Specification)
Firm has submitted following documents for each flavor:

i. Form-5 with prescribed fee of Rs. 20,000/-
ii. Copy of Registration Letter and renewal status (Renewal not due as product was
registered on 20th July, 2017)
iii. NOC for CRF Clearance
iv. Specifications of existing and proposed flavour
v. Data for 06 months accelerated stability (However, Stability is of 08 July, 2012
performed by M/s Novartis at Jamshoro Plant.)
vi. Undertaking.
The firm has submitted that they have acquired all over the couner portfolio of Novartis
including but not limited to all pack sizes, flavours and strengths. Hence in April, 2016, they
have applied all registered flavours of CaC 1000 Plus Effervescent Tablet but also for change of
flavor application of Pineapple to Mango, which was later acceded to Novartis Pharma.
Furthermore, they have submitted stability protocols and stability data alongwith relevant
chromatograms.
Decision: Registration Board approved the change in flavour of CaC 1000 Plus
Effervescent Tablet (Reg# 084750) from Pine Apple to Mango flavour. Moreover,
3 more additional flavours Cola, Orange and Lemon are also approved for CaC
1000 Plus Effervescent Tablet with new registration numbers, as firm has
completed requisite documents as per SOP for this purpose.
Case No. 23: Request for approval of additional packaging site for interim period.
M/s GlaxoSmithKline Pakistan, Limited, Karachi have applied for approval of additional
packaging site for interim period for following product:
S.No Reg. No Name of Drug(s) Packing Date of Initial
registration
1 000401 Fefol Spansules 20 24-03-1976
Each spansule capsule contains:- Spansules
Exsiccated ferrous sulphate… 150mg
Folic acid… 0.5 mg
The firm has requested that Punjab Government have awarded them a tender of about 4.2
million packs of Fefol (Each pack of 56 capsules) that should be supplied during first half of
2018.
Currently, abovementioned product is manufactured and packed at West Wharf site
(DML No. 000017). Due to large number of tender quantities and challenging timelines, they
have planned to carry out packaging of Fefol stocks additionally at our F 268 site (DML
No.0000233) as well to deliver the stock to Punjab Government on time.
M/s GSK Pakistan Limited have requested to grant one-time special permission to carry
out packaging of Government supplies of Fefol at F-268 site as well till May 31, 2018, while
manufacturing will remain at west wharf site.
The firm has submitted following documents:
i. Fee of Rs. 5000/- Rs. 15000/-
ii. Initial Registration Letter dated 24-03-1076
iii. Renewal applications for 2008 and 2013
iv. Registration in name of GSK Pakistan
v. Updated CRF
vi. GMP certificate of F-268 site
Registration Board deliberated on the case in its 275th meeting. GSK, Karachi has now
submitted a breakdown of packaging at their F-268 site as follows:
Product No. of Batches No. of Packs to be packed at F-268 Site
Fefol Capsules 96 2,112,000 (Each pack of 56’s Capsule)
Furthermore, firm has provided a letter from Primary and Secondary Healthcare Department,
Government of Punjab signed by Tender Coordination Officer-I and addressed to Director,
Regulatory Affairs, GSK, Karachi. The officer concerned has mentioned in letter that “this
department has no objection on supply of said product from either manufacturing site (GSK F-
268 SITE, Karachi, GSK Dockyard Road West Wharf) subject to approval of Drug Regulatory
Authority of Pakistan.”
The Board in its 276th meeting advised that:

“Registration Board deliberated that reference of Government of Punjab has mentioned supply of
said product from either manufacturing site and M/s GSK, Karachi is asking for two
manufacturing sites. The Board decided to defer the case for further clarification for
manufacturing sites and relevant rule status.”
Now, the firm has submitted a letter from the same officer of the Punjab Government
with “either/both sites” expression. Firm has further stated that we should like to draw your
attention towards Section 4 of Drugs (L,R&A) Rules, 1976, which allows manufacture on more
than one set of premises.
(LR&A) 4. Manufacture on more than one set of premises: If drugs are manufactured on more
than one set of premises, a separate application shall be made and a separate licence shall be
issued in respect of each such set of premises.
The case was presented in 277th meeting of the board wherein it was decided to seek oipinioon of
legal affairs division. In 278th meeting of Registration Board, Legal Affiars division furnished
their opinion and case was decided as follows:
Decision: Registration Board deliberated the matter in detail. Mr. Amer Lateef,
Deputy Director (Legal Affair) also participated in the discussion. He opined
that instant request can be considered as per provision of Rule 20A (1)(c) of
Drugs (L, R & A) Rules, 1976. The Board deliberated on the matter and it
was decided to constitute committee comprising Director, DTL, Karachi,
Director, CDL, Karachi and Mr. Afnan Ali, Assistant Director, CDL
Karachi to determine packaging capacity on 24 hours’ basis of M/s GSK F-
268 SITE, Karachi, GSK Dockyard Road West Wharf (DML # 000017). The
Board further advised to issue letter in this regard immediately and as this is
a time limit case that requires prompt action to ensure availability of Fefol
Spansules as required by Government of Punjab.
Case No. 24: Export Registration Cases.
Case i: M/s. High-Q Pharmaceuticals, Karachi have requested for grant of registration of
following drugs for export purpose only. The case
S. Name of drug(s) & Composition Details of
1) form 5,
2) fee &
3) Me-too status
Empaglin Tablet 1) form 5-D
Each film coated tablet contains: 2) Rs. 50,000/-
Empagliflozin…………10mg 3) Me-too status
Linagliptin……………..5mg The product was not registered in Pakistan. However, the
firm has provided an evidence of international
availability.
Empaglin Tablet 1) form 5-D
Each film coated tablet contains: 2) Rs. 50,000/-
Empagliflozin…………25mg 3) Me-too status
Linagliptin……………..5mg The product was not registered in Pakistan. However the
availability
Letrum-M Tablet 1) form 5
Each film coated tablet contains: Pages 578-584/Corr
Linagliptin……………..…2.5mg 2) Rs. 20,000/- & Rs.30,000/-
Metformin HCl…………..500mg *3) Me-too status
The product was not registered in Pakistan However the
availability
Each film coated tablet contains: 2) Rs. 20,000/- & Rs. 30,000/-
Linagliptin…………………2.5mg *3) Me-too status
Metformin HCl………..850mg The product was not registered in Pakistan However the
availability
Each film coated tablet contains: 2) Rs. 20,000/- & Rs. 30,000/-
Linagliptin…………………2.5mg *3) Me-too status
Metformin HCl ………..1000mg The product was not registered in Pakistan. However the
availability
Letrum Tablet 1) form 5
Each film coated tablet contains: 2) Rs. 20,000/- & Rs.30,000/-
Linagliptin…………………5mg *3) Me-too status
The product was not registered in Pakistan However the
availability
2. The details of requirements as per SOP (approved by Registration Board in its M-240th
meeting F/A) and the documents submitted by the firm are as under:
S.# Requirement as per SOPs Documents submitted by the firm.
1. Application on form 5 with required fee as per As described in above table.
relevant SRO
2. NOC for CRF clearance. NOC for CRF dated 19.04.2017 valid up
to 31.12.2017 Page 647/Corr.
3. Copy of approval section from CLB CLB approval Pages 646/Corr.
4. Copy of last inspection report Panel inspection dated 31.08.2016 Pages
648-660/Corr.
5. An undertaking that applied registration is exclusively Undertaking (Page 363, 372, 381, 390,
for export purpose and will not be sold in Pakistan. 441, 450, 460, 469, 478, 521, 531, 586,
597, 609, 644, 688, 698 and 707/Corr)
6. Me-too status As described in above table.
3. The Case was presented in 2nd PRVC and The Committee decided to defer the above
export registration applications for presentation before registration board in the light of IPO
remarks dated 11 Nov, 2015 issued by Assistant Director (Patent).
A patent is defined as a set of “Exclusive Rights” granted by a sovereign State to an
inventor or assignee for a limited period of time (i.e. twenty years) in exchange for detailed
public disclosure of an invention which exclude everyone else except the patentee / right holder
for its use like for making, using or selling the invention in that country without patentee’s
consent for a fixed period of time.
Hence, registration of patent guarantees absolute ownership for a period of twenty (20)
years from the date of filing and excludes any other person or entity from its use for the defined
term, unless licensed by the right holder. The same principle is envisaged in Section 30 of the
Patent Ordinance, 2000, reproduced below for the ease of reference:
Section 30 of the Ordinance, stipulates: -
“Right conferred by patent: -
(1) Subject to other provisions of this Ordinance, the holder of a valid patent in Pakistan shall
have the following rights, namely: -
(a) Where the subject matter of Patent is a product, the holder of valid patent may prevent
third parties not having the owner’s consent from the acts of making, using, offering for sale,
selling, or importing for these purposes that product; and
(b) where the subject matter of a patent is a process, the holder of a valid patent may
prevent third parties not having the owner’s consent from the act of using the process, and from
the acts of using, offering for sale, selling, or importing for these purposes at least the product
obtained directly by that process……..”
Section 31 of the Ordinance, stipulate the term of the patent:
The term of a patent under this Ordinance shall be twenty years from the filing date.
Keeping in view above legal references and the decision of Honorable Sindh High Court,
Karachi, it is concluded that the rights of “Linagliptin”, only confers to the patentee till the
validity of the Patents No. 141311, 141044 and 141068. Its unauthorized use in any manner by
third parties will be violation of the Patent Ordinance, 2000. Therefore, third parties shall be
restrained to use it in any manner without patentee’s consent.
Decision: Legal Affair Division, DRAP furnished their opinion vide letter No.F.11-1/
2013 /DD(LA) dated 31.01.2018, thus Registration Board decided to forward
forementioned opinion to IPO Pakistan for their comments. Moreover,
Deputy Director, Legal Affair Division, DRAP was advised to follow up the
matter with IPO Pakistan for their response.
Case ii: M/s. Sami Pharmaceuticals (Pvt) Ltd, F-95, S.I.T.E., Karachi have requested for
grant of registration of following drugs for export purpose only. The details are as under: -
S. Name of drug(s) & 1)Fee 1)International Avilability / Remarks
No. Composition 2) R&I date Mee-Too status
3) Form Type 2) GMP/Inspection Report
SOP Documents/DML, 3)Source of Pellets
CRF 4) Undertakings exclusively for
export purpose
5) Undertaking Brand Name.
1. DALAFIL 10mg Tablets 1)Fee Rs. 50,000/- 1) International availability
Each film coated tablet (Page 142-143/Corr) provided (pages 153-185/Corr)
contains: 2) Dy.No 11327/R&I 2) Inspection report dated
Tadalafil USP……10mg dated 08.08.2017 02.11.2016
(USP Spec’s) 3) Form 5-D 3) Not Applicable
(Page 145-148/Corr) 4)Provided (Page 149/Corr)
4) CRF upto 31.12.2017 5) Provided (Page 151/Corr)
(Pages 227/Corr)
5) Section approval
(pages 228/Corr)
The Case was presented in 1st PRVC and the Committee decided to defer the case for presenting
before registration board.
Decision: Registration Board deferred the case for further deliberation.
REGISTRATION-III
Case No.1: M/s Trison Pharmaceuticals (Pvt) Ltd, Sargodha

(a) Products initially deferred in 223rd meeting of Registration Board:
The Registration Board in its 223rd meeting deferred the following products of M/s Trison
Pharmaceuticals (Pvt) Ltd, Sargodha. The firm has submitted that in 2010 the Registration Board
in its 223rd meeting granted five products per section to the new licensees and deferred the
remaining product as per policy. The case was then considered in 239th meeting of Registration
Board and registration Board decided as mentioned in the 2nd last column below:
S. Brand Name / Label Claim Demanded Fee paid Previous International
No. Price & Decision taken in availability and me-
Pack Size 239th meeting of too status
Registration
Board
1 Triphenamol Tablets Rs.350/ Fee The Norgesic of M/s
Each tablet contains:- 100’s Rs.20,000 Registration iNova
Orphenadrine Board deferred Pharmaceuticals
Citrate………35mg the above Australia Pvt. Ltd.
Paracetamol……..450mg registration approved by TGA
(Manufacturer Specifications) applications for of Australia
the evaluation
of the FLEXODIN TAB
registration of M/s Remington
2 Tricidol Tablets 0.5mcg Rs.145/ Fee dossiers. For PMDA (Japan)
Each film coated tablet 10’s Rs.20,000 Alfacalcidol Approved
contains:- tablet, product
Alfacalcidol ……0.5mcg specific Alfacal Tablet of
(USP Specifications) inspection will M/s Platinum
3 Trivelox 400mg Tablets Rs.460/ Fee be carried out Avelox 400 mg
Each film coated tablet 5’s Rs.20,000 by Director film-coated tablets
contains:- DTL, Lahore of M/s Bayer plc,
Moxifloxacin (as and area FID for (MHRA approved)
hydrochloride)……400mg confirmation of
manufacturing Metoxim 400mg
and quality Tablet of M/s Foray
control Pharmaceutical
4 Trigesic 550mg Tablets Rs.180/ Fee facilities. Naproxen 500mg
Each film coated tablet 20’s Rs.20,000 Tablets- Accord
contains:- Healthcare
Naproxen sodium….550mg (MHRA)
(Manufacturer Specifications)
Anex of M/s
Pharmevo
5 Trinolol Tablets 50mg Rs.110/ Fee Atenolol 50 mg
Each film coated tablet 20’s Rs.20,000 tablets (UK-
contains:- MHRA)
Atenolol ……….50mg Cardi 50mg tablets
(USP Specifications) of M/s Benson
pharma.
6 Tribastin Tablets 10mg Rs.100/ Fee EBASTINE
Each film coated tablet 10’s Rs.20,000 ALMIRALL 10 mg
contains:- film-coated tablet
Ebastine ………….10mg (ANSM)
Atmos of Scotmann
Pharmaceuticals
7 Trizadine Tablets 2mg Rs.102/ Fee Tizadine of Sandoz
Each film coated tablet 10’s Rs.20,000 (USFDA)
contains:-
Tizanidine (as hydrochloride) Analar by AGP
……2mg
(USP Specifications)
Now the firm has submitted duplicate dossiers which have been evaluated and the firm has
submitted panel inspection report for renewal of DML dated 22-08-2017 & 12-10-2017 which
concludes that “Keeping in view the above improvements made by the firm, the members of the
panel are of the opinion to recommend the grant of renewal of DML for following sections:
Tablet general section, Capsule general section, and Dry Powder Suspension (general) section”.
Decision: Registration Board approved the above products in the name of M/s Trison
Pharmaceuticals, Sargodha.
(b) Products initially deferred in 226th meeting of Registration Board:

The Registration Board in its 226th meeting deferred the following products of M/s Trison
Pharmaceuticals (Pvt) Ltd, Sargodha for the reasons mentioned in the 2nd last column as below.
The firm had informed that they have developed their own facility of Capsule (General) and Dry
Powder Suspension (General) sections. The firm had therefore requested that the above
mentioned products which were initially applied on contract manufacturing may please be
registered in their own name. For product at S.No.8 (Iron Polymaltose and folic acid Syrup) the
firm has clarified that the dosage form is Dry Powder Suspension. In support of this, the firm has
stated that they have already been granted Registration of Iron Polymaltose formulation plain in
Dry Powder Suspension Reg.No.063300 (Brand name Trifer) while on form 5 dosage form is
mentioned as “syrup” and provided manufacturing method is also for liquid syrup. The case was
again considered in 239th meeting of Registration Board and registration Board decided as
mentioned in last column below:
S. Brand Name / Label Claim Demanded Fee paid International Previous Previous
No. Price & availability and me- Decision taken Decision taken
Demanded too status in 226th meeting in 239th meeting
Pack Size of Registration of Registration
Board Board
1 Gerdnil 40mg Capsule Rs.300/ Fee Nexium Capsule Deferred for The
Each capsule contains:- 14’s Rs.20,000 40mg of Astra toll Policy Registration
Esomeprazole as Zeneca Board
Magnesium enteric coated Pharmaceuticals deferred the
(Pellets) Eq. to (USFDA) above
Esomeprazole……..40mg registration
(Product Complies to Esorid Capsule applications
Manufacturer 40mg of M/s for the
Specifications) Hilton evaluation of
Source of pellets: M/s Pharmaceuticals the
Vision Pharmaceuticals registration
2 Prelin 75mg Capsules Rs.800/ Fee Lyrica 75mg Deferred for dossiers.
Each capsule contains:- 14’s Rs.20,000 Capsule of M/s toll Policy
Pregabalin……..75mg PF Prism CV,
(USFDA)
Lyrica 75mg
Capsule of M/s
Pfizer
3 Prelin 150mg Capsules Rs.1200 Fee Lyrica 150 mg Deferred for
Each capsule contains:- /14’s Rs.20,000 Capsules of PF toll Policy
Pregabalin…….150mg Prism CV, USA
(Manufacturer (USFDA)
Specifications) Gabica 150 mg
Capsules of M/s
Getz
4 Azotri Capsule Rs.500/ Fee Approved by Deferred for
Each capsule contains: 6’s Rs.20,000 MHRA toll Policy
Azithromycin (as
diyhydrate) …..250mg Azofas of
(Manufacturer Fassgen
Specifications) Pharmaceuticals
5 Omegab 20mg Capsule Rs.475/ Fee Losec Capsule Deferred for
Each capsule contains:- 14’s Rs.20,000 20mg by Astra toll Policy
Omeprazole as enteric Zaneca UK-
coated Pellets.……20mg MHRA
(Manufacturer Aksozole
Specifications) Capsule 20mg
Source of pellets: M/s of Akson
Vision Pharmaceuticals Pharmaceuticals
6 Trigab 100mg Capsules Rs.85/1 Fee USFDA Deferred for
Each capsule contains:- 0’s Rs.20,000 approved toll Policy
Gabapentin …….100mg
(Manufacturer Neogan by
Specifications) Hilton Pharma
7 Trigab 300mg Capsules Rs.220/ Fee USFDA Deferred for
Each capsule contains:- 10’s Rs.20,000 approved toll Policy
Gabapentin …….300mg
(Manufacturer Gab of TG
Specifications) pharma
8 Hematose –F Syrup Rs.80/6 Fee Internationally Deferred for
Each 5ml contains:- 0ml Rs.20,000 not available. toll Policy
Iron (III) Hydroxide
Polymaltose Complex Eq. Hemoplex-F
to Elemental Syrup of M/s
Iron…………….50mg Synchro
Folic Acid ….….0.43mg Pharmaceuticals
Now the firm has submitted duplicate dossiers which have been evaluated and the firm
has submitted panel inspection report for renewal of DML dated 22-08-2017 & 12-10-2017
which concludes that “Keeping in view the above improvements made by the firm, the members
of the panel are of the opinion to recommend the grant of renewal of DML for following
sections:
Tablet general section, Capsule general section, and Dry Powder Suspension (general) section”.
a) Approved the products at S. No. 1-7 in the name of M/s Trison
Pharmaceuticals, Sargodha.
b) Rejected the product at S. No. 8 since the firm does not possess the
manufacturing facility/section for this product.
Case No. 2: Transfer of registration from import to local manufacture under contract
manufacturing agreement.
M/S. Drug’s Inn 1-I, Parkview Plaza, Markaz F-10, Islamabad have requested for transfer
of registration from import to local manufacture under contract manufacturing by M/s EG
Pharmaceuticals, Islamabad for following products:
S. Initial Product name & formulation Renewal status Local/international
No. registration (Remarks of RRR section availability
date & via letter F. No. 11-
number 24/2007-RRR dated 24-
11-2017)
1. 017436 Ceftim 250mg Injection Renewal application of
Claforan injection of
10-07-1995 Each vial contains: year 2015 received
Aventis
Cefotaxime as sodium…250mg within time accompanied
(MHRA Approved)
with prescribed fee.
Cefotax of Bosch
2. 016192 Ceftim 500mg Injection -do- Claforan injection of
07-02-1995 Each vial contains: Aventis
Cefotaxime as sodium…500mg (MHRA Approved)
Cefotax of Bosch
3. 016193 Ceftim 1gm Injection Renewal application of Claforan injection of
24-11-1994 Each vial contains: year 2014 received Aventis
Cefotaxime as within time accompanied
sodium…1000mg with prescribed fee. Getex Dry powder
Injection 1gm of M/s
Amarant
4. 014957 Famodin 20mg -do- Pepcid by Valeant
06-06-1994 Each film coated tablet Pharms
contains: (USFDA Approved)
Famotidine….20mg Ulfam tablet of
Highnoon
5. 022691 Amkeen 100mg Injection -do- MHRA approved
16-02-1999 Each 2ml contains:
Amikacin as sulphate…. 100mg Mifate Injection
100mg/2ml of M/s
Swiss Pharma
6. 022692 Amkeen 500mg Injection -do- MHRA approved
16-02-1999 Each 2ml contains:
Amikacin as sulphate…. 500mg Grasil of Sami
The firm has submitted following documents:-

a) Fee of Rs.50,000/- per product for this purpose.
b) Form-5 from M/s EG Pharmaceuticals, Islamabad.
c) Contract manufacturing agreement between M/S. Drug’s Inn, Islamabad and M/s EG
Pharmaceuticals, Islamabad.
d) Copy of registration and renewal
e) Technical data and manufacturing process.
f) Last GMP inspection report of M/s EG Pharmaceuticals, Islamabad (dated 22-06-2017)
concluding that the firm was considered to be operating at reasonable level of compliance
with GMP guidelines.
g) Section approval letter of M/s EG Pharmaceuticals, Islamabad.
h) Copy of Drug Sale License of M/S. Drug’s Inn, Islamabad (renewed upto 01-01-2015)
Decision: Registration Board deferred the request of M/s. Drug’s Inn, Islamabad for
opinion of QA Division regarding GMP status of M/s EG Pharmaceuticals,
Islamabad.
Case No.3: Change in Contract Manufacturer:

Registration Board initially in its 276th and then in 277th meeting considered the case
wherein M/s. Honig Pharmaceutical Laboratories, Rawalpindi have requested for change in
contract manufacturer from M/s Global Pharmaceuticals, Islamabad to M/s Linear
Pharmaceuticals, Islamabad for their following already registered products. Their previous
approval was granted by the Registration Board in its 258th meeting till 30.06.2020 as per
detailed below:
S. No. Name of Existing New Reg. No. Name of drug(s) & Composition Date of
Applicant Manufacturer Manufacturer application,
Diary No. &
Form
1. M/s. Honig M/s Global M/s Linear 050751 Fixing 100mg Suspension 27-10-2017
Pharmace- Pharmaceu- Pharmaceutica Each 5ml contains: Dy.No.19280
utical ticals, ls, Islamabad Cefixime (as Trihydrate) Rs.50,000/-
Laboratories, Islamabad …100mg
Rawalpindi (USP Specification)
2. -do- -do- -do- 050755 Pinig 500mg Injection 27-10-2017
Each vial contains:- Dy.No.19279
Cefepime (as HCL)..500mg Rs.50,000/-
Sterile Arginine…….250mg
(USP Specification)
3. -do- -do- -do- 050756 Pinig 1gm Injection 27-10-2017
Cefepime (as HCL)…1gm Rs.50,000/-
Sterile Arginine…500mg
(USP Specification)
4. -do- -do- -do- 050757 Sulnig 1gm Injection 27-10-2017
Cefoperazone (as sodium) Rs.50,000/-
…….0.5gm
Sulbactum (as sodium)
……0.5gm
(USP Specification)
5. -do- -do- -do- 050758 Sulnig 2gm Injection 27-10-2017
Cefoperazone (as sodium) Rs.50,000/-
…….1gm
Sulbactum (as sodium)
……1gm
(USP Specification)
6. -do- -do- -do- 050759 Cefining 250mg Injection 27-10-2017
Ceftriaxone (as Sodium) Rs.50,000/-
………250mg
(USP Specification)
7. -do- -do- -do- 050760 Cefining 500mg Injection 27-10-2017
……500mg
(USP Specification)
8. -do- -do- -do- 050761 Cefining 1gm Injection 27-10-2017
………1gm
(USP Specification)
9. -do- -do- -do- 050752 Fixing 400mg Capsule 27-10-2017
Each capsule contains: Dy.No.19272
Cefixime (as Trihydrate) Rs.50,000/-
……400mg
(USP Specifications)
Firm has submitted following documents in this regard:
a) Application/Form 5 along with fee of Rs.50,000/- for each product.
b) Copy of contract manufacturing agreement between M/s. Honig Pharmaceutical
Laboratories, Rawalpindi and M/s Linear Pharmaceuticals, Islamabad dated 05.09.2017.
c) Latest GMP inspection report of M/s Linear Pharmaceuticals, Islamabad (dated
19.01.2016) concluding that firm has done up-gradations with regard to advises given in
previous inspections.
d) DML of both contract giver (applied for renewal on 22-08-2014) and acceptor
(29.07.2014).
e) Evidence of approval of Cephalosporin (Capsule, Dry Powder for Suspension and Dry
Powder for Injectable) section by CLB (M/s Linear Pharmaceuticals, Islamabad).
Decision of registration Board taken in its 276th meeting:
Registration Board deferred the request of M/s. Honig Pharmaceutical Laboratories,
Rawalpindi for submission of latest GMP inspection report of M/s Linear Pharmaceuticals,
Islamabad which should be conducted within a period of last one year.
The firm then submitted the latest GMP inspection report of M/s Linear Pharmaceuticals dated
30-11-2017 which concludes that firm is operating at fair level of GMP compliance.
Decision of registration Board taken in its 277th meeting:
Registration Board deferred the request of M/s. Honig Pharmaceutical Laboratories,
Rawalpindi for opinion of QA Division regarding GMP status of M/s Linear Pharmaceuticals,
Islamabad.
The firm has now submitted GMP certificate dated 23-01-2018 issued on the basis of
inspection and evaluation conducted on 30-11-2017.
Decision: Registration Board acceded to the request of M/s. Honig Pharmaceutical

Laboratories, Rawalpindi for change in contract manufacturer from M/s Global
Pharmaceuticals, Islamabad to M/s Linear Pharmaceuticals, Islamabad.
Permission is at same terms and conditions and remains valid till 30.06.2020.
Case No.4: Registration of products (Pregaba capsules 75 and 150mg) of M/s Nimrall
Laboratories deferred in 271st meeting of Registration Board
The products Pregaba 75mg capsules and Pregaba 150mg capsules were initially deferred
by the Registration Board in its 225th meeting. The decision of Board is reproduced below:
S.No. Company name Brand name and Composition Pack Decision of 225th meeting of
size Regn. Board
1. Nimrall laboratories Pregaba 75mg capsules 2x7’s Deferred
2. Nimrall laboratories Pregaba 150mg Capsules 2x7’s Deferred
The status in reference regulatory agencies was checked and confirmed as follows:
Sr. Molecule Strength/Dosage Form Status in Reference Regulatory
No Agencies
75mg Capsules Lyrica 75mg capsules by PF PRISM
Pregabalin CV, USFDA approved.
1. 150mg Capsules Lyrica 150mg capsules by PF PRISM
CV, USFDA approved.
The firm has also submitted the balance fee Rs.12000/- for each product and requested to
grant the registration of above mentioned products. The case was considered in 271st meeting
and Registration Board decided as follows:
Decision of registration Board taken in its 271st meeting:
Registration Board deferred the case for submission of latest GMP inspection report conducted
during last one year.
Now, the firm has submitted latest GMP inspection report dated 21-12-2017 concluding
that “firm is operating at fair level of compliance with GMP.”
Decision: Registration Board approved the above products in the name of M/s Nimrall
Laboratories, Islamabad.
Case No. 5: Transfer of registered products from previous site (I-10/3) to new site (Kahuta
Triangle Islamabad) of M/s Vision Pharmaceuticals:
M/s Vision Pharmaceuticals, Islamabad have requested for transfer of registration of

below mentioned products form their previous site i.e. Plot No.224, Street No.1, I-10/3,
Islamabad to new site Plot No.22-23, Industrial Triangle, Kahuta Road, Islamabad as per detailed
below:-
S. Product for registration Reg. Initial Renewal Status Remarks
No. with generic No. registration
name date
1. Cibrotam Injection 1gm 037784 22-03-2005 Rs.30,000/- + Not verifiable
Each 5ml contains: Rs.30,000/- dated
Piracetam…….1gm 27-11-2017 vide Nootropil injection
SRO 1005(I)/2017 by Glaxosmithkline,
(Case is discussed Pakistan 1G/ 5ml
by RRR in M-277)
2. Acetofeb Extra Tablet 038900 30-06-2005 -do- Paracaff
Each tablet contains: (TGA Approved)
Paracetamol….500mg
Caffeine Calpol Plus by GSK
anhydrous……..65mg
3. Adfin 400mg Tablet 041729 15-12-2005 -do- Ibuprofen 400mg of
Each tablet contains: Boots,
Ibuprofen…….400mg (MHRA)
Brufen of Abbott
4. Inflanil Tablet 250mg 041736 15-12-2005 -do- Not verifiable
Each tablet contains: Ponsic Tablet of
Mefenamic acid….250mg M/s Safe
Pharmaceuticals
(Pvt.) Limited,
Karachi
5. Protozoid Tablet 037563 21-03-2005 -do- Not verifiable
Each tablet contains:
Metronidazole….250mg Didomet by
Di-Iodohydroxyquinolone Munawar Pharma
……………….…325mg
6. Epilax Tablet 200mg 037572 21-03-2005 -do- USFDA approved
contains: Carbawel by
Carbamazepine…200mg Welmark
7. Fevonor Suspension 056309 20-02-2009 Rs.30,000/- dated MHRA aaproved
Each 5ml contains: 27-11-2017 vide
Paracetamol…….120mg SRO 1005(I)/2017 Calpol Suspension
by M/s GSK
8. Fevonor Plus Suspension 056310 20-02-2009 -do- MHRA aaproved
Each 5ml contains:
Paracetamol…….250mg Calpol-6 Plus of
M/s GSK
9. Coxyzin Syrup 050289 28-07-2008 -do- Cetrizine (USFDA)
Each 5ml contains:
Cetirizine hydrochloride Zanlan by Novartis
………………….5mg Pharma
10. Epilax Syrup 100mg/5ml 037573 21-03-2005 Rs.30,000/- + Approved in
Each 5ml contains: Rs.30,000/- dated suspension dosage
Carbamazepine ….100mg 27-11-2017 vide form by MHRA and
SRO 1005(I)/2017 USFDA
Lexopine Syrup of
M/s Highnoon
11. Mycomide Tablet 500mg 037554 21-03-2005 -do- Zinamide Tablets
Each tablet contains: 500mg (MHRA
Pyrazinamide…….500mg approved)
Pyrazinamide
500mg Tab Of M/S
Fazul Ellahie
The firm have provided following documents in support of their request as per approved SOP:
a) Application with form 5 and requirement fee amounting to Rs.20,000/-.
b) Copy of registration letter and renewal.
c) Evidence of Section as revealed by the GMP certificate (Tablet General, Capsule
General, General Sachet powder, Dry Powder Suspension General, Dry Powder Sterile
General, LVP, SVP)
d) DML of new site issued on 01-04-2014.
e) Copy of NOC for CRF Clearance valid upto 31-12-2017
f) Copy of last inspection report dated 26-04-2017 concluding that company is following
the GMP guidelines and the compliance status was good.

a) Acceded to the request of firm for transfer of registration of products at S.
No. 2, 3, 6, 11 form their previous site i.e. Plot No.224, Street No.1, I-10/3,
Islamabad to new site i.e. Plot No.22-23, Industrial Triangle, Kahuta Road,
Islamabad.
b) Deferred the request of firm for products at S. No. 1, 4, & 5 for evidence of
approval in reference regulatory authorities.
c) Deferred the request of the firm for products at S. No. 7-10 for evidence of
approval of section/manufacturing facility.
REGISTRATION-IV
Case No.1: Correction in Formulation of Astenac Syrup of M/s. Astellas Pharmaceuticals

(Pvt) Ltd., Peshawar
M/s Astellas Pharmaceuticals (Pvt) Ltd., Peshawar was granted approval for registration of
Astenac Syrup, vide 272ND meeting of Drug Registration Board as per following details:
Name of Drugs & Composition Demanded Pack Decision of 272ND

size & Price Meeting
Astenac 100mg/15mg/ 5ml Syrup 120ml /As Per Approved with
Each 5ml contains: SRO Innovator’s
Ibuprofen………100mg specifications.
Pseudoephedrine hydrochloride…..15mg
( Manufacturer’s specifications)
However, the registration letter was with held for correction in formulation as the standard
formulation approved by Reference Regulatory Authorities is “suspension”. The firm has now
submitted correct formulation & requested for issuance of registration letter.
Decision: The Registration Board approved the correction in formulation/ dosage form
of Astenac Syrup to "suspension” in accordance with the standard formulation
approved by Reference Regulatory Authorities.
Case No.2: Similar Brand Names of M/s. Lowitt Pharma (Pvt) Ltd, Peshawar.
M/s. Lowitt Pharma (Pvt) Ltd, Peshawar was directed to provide alternate brand names for their
already registered products due to resemblance with registered brand name of M/s. Highnoon
Laboratories Lahore:-
S. Regn. Existing Name & Proposed Initial Justificatio Remarks

# No. Composition Name registration with n
renewal Status
I II III IV V VI VII
1. 040428 Lopran-P Tablets Each Loflam-P  15-06-2005 Similarity Standard formulation
Tablet contains:-  1st Renewal with Loprinapproved by
Diclofenac Potassium applied on 01- Tablet Reference Regulatory
….50mg 03-2010 with fee containing Authority is film
of Rs.4000/- Aspirin of coated & USP
 2nd Renewal M/s. monograph is
applied on 18- Highnoon available for
02-2015 with fee Laboratories
diclofenac postassium
of Rs.10,000/ Ltd, Lahore.
tablets.
Needs correction in
Formulation/
specifications
accordingly.
2 040429 Lopran-S Tablets Each Loflam-S  15-06-2005 Similarity Standard
Tablet contains:-  1 st
Renewal with Loprin formulation
Diclofenac Sodium applied on 01- Tablet approved by Austria
….50mg 03-2010 with fee containing is Film coated.
of Rs.4000/- Aspirin of However,
 2nd Renewal M/s. formulation is not
applied on 18- Highnoon available in USP/BP.
02-2015 with fee Laboratories Needs correction in
of Rs.10,000/ Ltd, Lahore. Formulation/
specifications
accordingly.
3 040430 Lopran-SR Tablets Loflam-  15-06-2005 Similarity Diclofenac sodium
Each Tablet contains:- SR  1st Renewal with Loprin extended release
Diclofenac Sodium applied on 01- Tablet tablet is available in
….100mg 03-2010 with fee containing USP. Needs
of Rs.4000/- Aspirin of correction of
 2nd Renewal M/s. specifications and
applied on 18- Highnoon standardization of
02-2015 with fee Laboratories nomenclature as
of Rs.10,000/ Ltd, Lahore. under:
"Sustained Release
film coated tablet "
The firm has already been granted registration of Loflam 75mg Tablets containing Diclofenac
Sodium…75mg (Reg. No.085098) vide 269th meeting of Registration Board. The Post
Registration Variation Committee evaluated the case for change of brand names of above
mentioned products (S.No.1-3) in the light of SOPs approved by the Registration Board & on
recommendation of the Committee, the Chairman Registration Board referred the request of the
firm for change of brand name to Drug Registration Board.
Decision: Registration Board decided as under:

i. For product at S.No.1, approved the correction in formulation to “film
coated tablet” & specifications to “USP Specifications”. Moreover, in view of
patient safety and in order to avoid prescribing errors, the firm shall be
directed to submit alternate brand names for Diclofenac potassium.
ii. For product at S.No.2, approved the change in brand name to Loflam-S
along with correction in formulation to “enteric coated tablet” in accordance
with the standard formulation approved by Reference Regulatory
Authorities & specifications to “As per Innovator’s Specifications”.
iii. For product at S.No.3, approved the change in brand name to Loflam-SR
along with correction in specifications to “USP Specifications” and
standardization of nomenclature to “Each Sustained Release film coated
tablet”
Case No.3. Deferred Products of M/s Rakaposhi Pharmaceuticals, Peshawar

A number of registration applications of M/s Rakaposhi, Peshawar were deferred in M-
271 for confirmation of availability in Reference Regulatory Authorities. For the following
products the firm submitted revised dossiers in accordance with the formulations approved by
the Reference Regulatory Authorities. However, the case was deferred in 276th meeting of
Registration Board for submission of fresh fee for each case/correction.
S.No. Name of product & previous Name of product & revised Remarks
composition composition
1. Lomexin 200 mg tab Lomexin 400 mg tab Approved by
Each tablet contains:- Each film coated tablet contains:- ANSM France
Lomefloxacin HCl eq. to Lomefloxacin HCl eq. to
Lomefloxacin…..200mg Lomefloxacin…400mg
Reg.No.035628
2. Ralfate 500mg Tablets Ralfate 1g Tablets Approved by
Each tablet contains:- Each tablet contains:- USFDA
Sucralfate…………500mg Sucralfate…………1g
Reg.No.038165
The firm has now submitted fresh fee of Rs.20,000/-each & requested for issuance of
Decision: The Registration Board approved the grant of registration to Lomexin 400mg
Tablet & Ralfate 1g Tablets of M/s Rakaposhi Pharmaceuticals, Peshawar.
Case No.4. Suspension of Drug Manufacturing License of M/s Lawari International,

Swat.
The Central Licensing Board has informed vide their letter no.F.3-6/2008-Lic (Vol-I)
dated 21st Dec, 2017 that the Central Licensing Board, vide its 256th meeting, held on 09th -10th
November, 2017, has decided to suspend the Drug Manufacturing License No. 000658 by way of
formulation, of M/s Lawari International, Valley Road, Gulkada, Swat with immediate effect for
a period of six months.
Decision: Registration Board observed that as a result of declaration of Drug
Manufacturing License suspended by Central Licensing Board, registration of
drugs also become suspended and therefore suspension letters for drugs
registered in favour of the firm shall be issued accordingly.
Case No.5. Correction in Specifications of Ozee Injection of M/s Weather Folds

Pharmaceuticals, Hattar
M/s Weather Folds Pharmaceuticals, Hattar applied for correction of Reg. No. of Ozee Injection
as per following details:
Reg.No. mentioned on letter for Correct Reg.No. as per Brand name & Composition
change of manufacturing from toll Initial Registration
to own premises Letter
052943 052942 Ozee Injection
Omeprazole Powder….…40mg
(Manufacturer’s Specs)
The correction in Reg.No. from 052943 to 052942 has been approved in accordance with the
authorization given to the Chairman Registration Board for this purpose. However, while
processing the case, it was observed the Product specifications also need to be corrected in
accordance with the decisions of M-264 & M-265 of Registration Board.
Decision: Registration Board approved the correction in specifications of Ozee
Injection to “As per Innovator’s Specifications”
Case No.6. Correction In pack size/ Formulation of Safesol NS Infusion Approved By
The Registration Board
Registration Board in its 251st meeting approved Safesol NS Infusion of M/s. Ahad International,
Dera Ismail Khan as per following details:-
Brand Name & Type of Form SRA/ Metoo/ GMP Remarks Decision
Composition Initial date, Status
diary
Fee including
differential fee
Demanded
pack/price
Safesol NS Form 5 FDA Approved Evidence 1. Approved.
Infusion 04/07/2013 Sterifluid NS Of approval 2. Condition will
Each 5ml Dy. No. 510 (FDL Hattar) of section / be mentioned in
contains:- Rs. 20000/- Grant of manufacturing Registration
Sodium As per renewal of DML facility of applied letter that firm
Chloride SRO/100ml and additional drug(Infusion will purchase and
(USP)…45mg. section section)from perform
(Electrolytes Ampoule Licensing section is required. installation and
and Water (General) 2. Undertaking on desired operational
replacement) recommended. format is required. qualifications
(USP Spec.s) (06.09.2014 3. Evidence liquid particle
Of verification counter in six
n of Total Organic Testing months time.
Facility and Liquid article
Counter by area
FID that the said
Instrument are in Functional
Condition is required
Though the pack size was mentioned as 100ml in the minutes, however, the composition
approved was for 5ml so the same pack size was given in the registration letter. The firm later
claimed that they demanded pack size of 100ml and requested to correct the pack size and price
accordingly. The case was again considered in M-262 wherein the Registration Board decided
that the pack size of Safesol NS infusion be corrected as 100ml as per demand in Form-5 and the
formulation may accordingly be mentioned in the composition.
However, the formulation & MRP also need to be revised in accordance with corrected pack size
of "100ml". Therefore, the case was placed in 2nd meeting of PRVC as per following details:
Reg.No. Name of Drug(s) & Name of Drug (s) & Previous Correcte MRP For
Previous formulation Corrected formulation MRP/Pac d Pack Corrected Pack
k size Size Size
079738 Safesol NS Infusion Safesol NS Infusion Rs. 100ml Rs.38.00
Each 5ml contains:- Each 100ml contains:- 9.00/5ml SRO 1219(I)/2017
Sodium Chloride....45mg Sodium Chloride….0.9gm Dated
(USP Specification) (USP Specification) (27-11-2017)
On recommendation of the Committee, the Chairman Registration Board approved the issuance
of the corrigendum in accordance with the aforementioned particulars.
Decision: Registration Board endorsed the issuance of the corrigendum in accordance

with the aforementioned particulars.
Case No.7. Extension in shelf life of registered products & Registration of products of
M/s Unisa, Akora Khattak.
M/s. Unisa Pharmaceuticals, Akora Khattak, was granted increase in shelf life from 2 years to
3 years on the recommendation of experts dated 28th June, 2016. Now the firm has again
requested for increase in shelf life of their following drugs from 3 years to 4 years:-
S. Name of Drug(s) Reg. No. Pack size Registration Remarks
No. and
Renewal
Status
I II III IV V VI
1 Unisol-DS I.V Infusion 073390 500ml 14-9-2012 Dy.No.626 / dated 07-
Each 100ml contains:- 1000ml Renewal 12-2016
Sodium Chloride………… 0.9gm applied on
Glucose Anhydrous….... 5.0gm 13-09-2017 The firm has stated
(BP Specification) with fee of that they are using the
Rs.10,000/- same packaging
2 Unisol-5 I.V Infusion 073391 100ml -do- material LDPE
Each 100ml contains 500ml (container of IV
Glucose Anhydrous……… 5.0gm 1000ml solution) as used by
(BP Specification) other IV manufacturer
3 Unisol-10 I.V Infusion 073392 500ml -do- Medipak, Shazeb, Mac
Each 100ml contains:- 1000ml & Rains who have
Glucose Anhydrous……… shelf life of four and
10.0gm five years. Moreover,
(BP Specification) we have carried out
4 Unisol-RL I.V Infusion 073393 500ml 14-9-2012 stability studies which
Each 100ml contains:- 1000ml Renewal show that our products
Calcium Chloride2H20…..0.02gm, applied on are stable.
Potassium Chloride……0.03gm 13-09-2017
Sodium with fee of
Chloride………….0.60gm Rs.10,000/-
Sodium Lactate………0.31gm
(USP Specification)
5 Unisol-NS I.V Infusion 073394 500ml -do-
Each 100ml contains:- 1000ml
Sodium Chloride………0.9gm
(BP Specification)
The case was considered in 2nd meeting of PRVC, wherein the Chairman Registration Board
directed to evaluate the stability data submitted by the firm. The Committee further noted that
against one registration number multiple packs are approved for the above products as per
previous practice. Since under prevailing practice only one pack size is given against one
registration number for injectables so, on recommendation of the Committee, the Chairman
Registration Board decided to place the matter for consideration of the Registration Board.
Decision: Registration Board decided that the firm shall be directed to furnish separate
application on form-5 along with fee for each pack size which will be
considered on priority by the Registration Board.
Case No.8. Request of M/s Treat Pharma, Bannu for Change of Registration Status from
Contract To Own Manufacturing Facility.
M/s. Treat Pharmaceutical Industry (Pvt) Ltd, Bannu has requested for change of
registration status of following products from toll manufacturing by M/s. Mediate Pharma (Pvt),
Karachi to their own manufacturing unit along with change of brand name :-
S. Regn. Existing Name & Proposed Validity of Diary No. Remarks
# No. Composition Name previously Date / Fee
granted
permission
I II III IV V VI VII
1. 073248 K-Xime Suspension Cefitest Extension Dy.No.88/ -
Each 5ml contains:- Suspension granted on: 23-01-2018
Cefixime Trihydrate 200mg/5ml 30-10-2015 Rs.20,000
≡ Cefixime ……..200mg Valid upto
(USP Specification) 30-06-2020
2. 073247 K-Xime Suspension Cefitest -do- Dy.No.87/ -
Each 5ml contains:- Suspension 23-01-2018
Cefixime Trihydrate 100mg/ Rs.20,000
≡ Cefixime ……..100mg 5ml
(USP Specification)
3. 073246 K-Xime Capsule 400mg Cefitest -do- Dy.No.89/ Specifications
Each capsule contains:- 400mg 23-01-2018 need to be
Cefixime Trihydrate Capsule Rs.20,000 corrected as the
≡ Cefixime ……..400mg formulation is
(USP Specification) not available in
USP/BP
Now the management of the firm has submitted application on form-5 along with fee of
Rs. 20000/- each, and approval of Oral Dry Suspension (Ceph) & Capsule (Ceph) sections from
CLB (19-12-2017). The dossiers have been evaluated accordingly.
Decision: Registration Board acceded to the firm’s request for changing the
manufacturing site along with change of brand name to “Cefitest”, of above
mentioned products, from M/s. Mediate Pharma (Pvt), Karachi to M/s. Treat
Pharma, Bannu on same price, terms and conditions. Furthermore, for
product at S.No.3, specifications shall be corrected to “JP specifications”
Case No.9. Request of M/s. Delta Pharma Pvt Ltd, Nowshera For Grant of Afresh
Registration.
Registration Board in 276th meeting held on 22ND- 25TH November, 2017, declared
registration of all drugs of M/s. Delta Pharma Pvt Ltd, Nowshera invalid due to non renewal of
DML. Management of the firm has now applied for registration of following products on form-5
with fee of Rs.20,000/- each as per details mentioned below:
S# Brand Name, Composition Dy.No./Date Evidence of Section Approval, Remarks
and (Reg.No) & Availability in RRAs Last Inspection
Demanded and Me-too Status Report & DML
Price/ Pack Provided by Firm
1. Excip 250mg Tablet Dy.No.104 TGA Austrialia Section approval Ok
Each film coated tablet 23-01-18 approved Arflox 18-12-2017
contains: - 20,000/- 250 M/s. Arrow
Ciprofloxacin HCl eq. to 22-01-2018 Pharma Last inspection
Ciprofloxacin……250mg report
(USP Specifications) Rs.28/1’s Ciproxin Tablets 15-08-2017
Rs.280/10’s approved by M/s. DML 18-12-2017
Bayer Pharma.
2. Excip 500mg Tablet Dy.No.103 TGA Australia -do- Ok
Each film coated tablet 28-01-18 approved Arflox
contains: - 20,000/- 500 M/s. Arrow
Ciprofloxacin HCl eq. to 22-01-2018 Pharma
Ciprofloxacin……500mg
(USP Specifications) Rs.45/1’s Ciproxin Tablets
Rs.450/10’s approved by M/s.
Bayer Pharma.
3. MB Ron FA Tablet Dy.No.101 TGA approved -do- Provided
Each film coated tablet 23-01-18 MALTOFER SRA
contains: - 20,000/- Tablet by M/s. reference
Iron (III) hydroxide 22-01-2018 VIFOR Pharma does not
Polymaltose complex eq. to Australia comply.
elemental Iron…..100mg Rs.7.33/1’s
Folic Acid……..0.35mg Rs.220/30’s Apofer-F by M/s.
(Manufacturer's Platinum Pharma
Specifications)
4. Ketry 200mg Tablet Dy.No.100 SRA status not -do- Standard
Each film coated tablet 23-01-18 provided formulation
contains: - 20,000/- approved
Ketoconazole….200mg 22-01-2018 Nizoral by M/s. by RRA is
(USP Specifications) Rs.25/1’s Janssen- Cilag not film
Rs.250/10’s coated.
5. Karzole 20mg Capsule Dy.No.91 UK MHRA -do- OK
Each capsule contains: - 23-01-18 approved Losec 20
Omeprazole as Enteric 20,000/- mg capsule
Coated Pellets……20mg 22-01-2018 Manufactured by
(USP Specifications) AstraZeneca.
Rs.230/ Risek 20mg capsule
2x7's by M/s GETZ
6. Levetazet 500mg Tablet Dy.No.90 UK MHRA -do- USP
Each film coated tablet 23-01-18 approved Levo Monograph is
contains:- 20,000/- floxacin Tablet by available for
Levofloxacin hemihydrate 22-01-2018 Sandoz applied
eq. to Levofloxacin Rs.70/ 1’s Cravit by M/s. formulation.
……..500mg Rs.700/10’s Hilton Pharma
(Manufacturer's
Specifications)
7. Levetazet 250mg Tablet Dy.No.92 UK MHRA -do- USP Monograph is
Each film coated tablet 23-01-18 approved Levo available for applied
contains: 20,000/- floxacin tablet by formulation
Levofloxacin hemihydrate 22-01-2018 Sandoz
eq. to Levofloxacin
…....250mg Rs.40/ 1’s Cravit by M/s.
(Manufacturer's Rs.400/10’s Hilton Pharma
Specifications)
8. Loranees 10mg Tablet Dy.No.94 TGA Australia -do- OK
Each tablet contains: 23-01-18 approved Claratyne
Loratadine……10mg 20,000/- Tablet by M/s. Bayer
(USP Specifications) 22-01-2018 Australia.
Histanil by M/s.
Rs.110/ 10’s Wilshire
Laboratories.
9. Faxetine 20mg Tablet Dy.No.96 SRA status not -do- Evidence of SRA
Each film coated tablet 23-01-18 provided approval not
contains: 20,000/- submitted.
Fluoxetine as HCl…..20mg 22-01-2018 Floxac by M/s.
(USP Specifications) Rs.150/20’s Shazoo Pharma.
10. Zoxa-Z 500mg Capsule Dy.No.97 Pacimol Paracetamol -do- Evidence of SRA
Each capsule contains: - 23-01-18 by IPCA Australia & Me too
Paracetamol…300mg 20,000/- approval not
Chlorozoxazone….250mg 22-01-2018 Napadoc by M/s. submitted.
(Manufacturer's Rs.6.66/1’s Atco Pharama
Specifications) Rs.200/30’s
11. Dardnil 75mg Tablet Dy.No.98 TGA approved. Provided SRA
Each film coated tablet 23-01-18 Voltaren Rapid by evidence does not
contains: 20,000/- M/s. Novartis comply.
Diclofenac 22-01-2018 Pharma Australia Decision of M-
potassium….75mg 258 regarding
(USP Specifications) Rs.100/20’s Caflam by M/s. issuance of show
Novartis Pharma cause for de-
registration of
Diclofenac
Potassium 75mg
& 100mg
12. Delmol Extra Tablet Dy.No.99 TGA approved -do- Standard
Each tablet contains: - 23-01-18 BLOOMS THE formulation
Paracetamol…500mg 20,000/- CHEMIST approved by TGA
Caffeine…65mg 22-01-2018 PARACETAMOL is film coated.
(BP Specifications) PLUS CAFFEINE
Rs.2/1’s Film coated Tablet
Rs.200/100’ by Apotex Pty Ltd.
s Panadol Extra by
M/s. GSK Pharma.
13. Delmol CF tablet Dy.No.102 TGA approved. -do- Provided SRA
Each tablet contains: - 23-01-18 Cipla Cold and Flu reference does not
Paracetamol…500mg 20,000/- night by Cipla comply.
Pseudoephedrine…60mg 22-01-2018 Australia Formulation is
Chlorpheniramine…4mg Rs.3/1’s available in USP.
(Manufacturer's Rs.300/ 100’s Panadol CF by M/s.
Specifications) GSK
14. Delvitis Tablet Dy.No.95 TGA approved. -do- Provided SRA
Each film coated tablet 23-01-18 Vitamins for kids and me too
contains: - 20,000/- sports by M/s. Orien reference do not
Vitamin A……..5000IU 22-01-2018 Laboratories comply.
Vitamin D……..400IU Australia
Vitamin C….75mg Rs.5/1’s
Vitamin B1….2mg Rs.150/30’s Surbex T by M/s.
Vitamin B2….5mg Abbott Karachi.
Vitamin B6…2mg
Vitamin B12….2mcg
Calcium d Pentothenate
…5mg
Folic Acid…0.25mg
Nicotinamide…20mg
Vitamin E….10mg
(Manufacturer's Specifications)
15. Nymph Tablets Dy.No.93 TGA approved. -do- Provided SRA
Each film coated tablet 23-01-18 Vitamins for kids and me too
contains: - 20,000/- sports by M/s. Orien reference do not
Vitamin A……..5000IU 22-01-2018 Laboratories comply.
Vitamin D……..400IU Australia
Vitamin C….75mg Rs.4.16/1’s
Vitamin B1….2mg Rs.125/30’s Surbex T by M/s.
Vitamin B2….5mg Abbott Karachi.
Vitamin B6…2mg
Vitamin B12….2mcg
Calcium d Pentothenate
…….5mg
Folic Acid………0.25mg
Nicotinamide……20mg
(Manufacturer's Specifications)
Decision: Registration Board decided as under:

i. Approved the grant of registration for products at S.No. 1,2,6,7 and 8 with USP
Specifications.
ii. Approved the grant of registration for product at S.No.3 with “Innovator’s
Specifications”.
iii. Approved the grant of registration for product at S.No.5 with USP
Specifications and “Vision Pharmaceuticals, Islamabad” as source of
Omeprazole pellets.
iv. Deferred the product at S.No.4, in accordance with the decision taken by the
Registration Board vide its 244th meeting.
v. Approved the grant of registration for product at S.No.10 with “Innovator’s
Specifications” considering that the formulation is approved by the German
Authorities.
vi. The Board was informed regarding item at S.No.12 that the standard
formulation approved by Reference Regulatory Authorities is film coated tablet
and the firm has submitted revised formulation accordingly, before the
commencement of 278th meeting of Registration Board. In view of foregoing
position, the Board approved the grant of registration for product at S.No.12
with film coated tablet and BP Specifications.
vii. Deferred the products at S.No. 9 and 13 for submission of evidence of approval
status in Reference Regulatory Authorities.
viii. Deferred the products at S.No.14-15 for submission of evidence of me too status.
ix. Reject the product at S.No. 11, in accordance with the decision taken by the
Registration Board vide its 258th meeting.
Case No.10: Standard Operating Procedures for approval of post-registration variations.
Registration Board, vide its 240th meeting, has approved following SOPs for approval of post
registration variations. Pharmaceutical Evaluation & Registration Directorate briefed that after
grant of registration, certain variations are required to be approved. The Directoarte has prepared
Standard Operating Procedures for all such variations. These SOPs will serve as guideline for the
applicants and will also facilitate efficient working and timely disposal of cases by the
Directorate.
Decision: Registration Board discussed SOPs and approved following SOPs for implementation.
A. Locally manufactured products:

1. Change in excipients (inactive) including flavor/ colour
a. Application with required fee as per relevant SRO.
b. Copy of registration letter and renewal status.
c. NOC for CRF clearance.
d. Specification of existing and proposed excipients / Flavour / Colour.
e. Document confirming that proposed expcipient / inactive is of pharmaceutical grade.
f. Data for 06 months accelerated stability studies.
g. Undertaking that real time stability studies would be continued till whole of shelf life & in
case of OOS (out of specifications), the applicant will inform PE&R accordingly.
h. In case of additional flavor, Application on Form 5 with full fee will be submitted.
2. Change of source of pellets

d. Real time stability studies of pellets conducted by manufacturer as per conditions of zone IV-
A as per ICH guidelines (Both real time & accelerated studies).
e. Certificate of analysis of manufacturer
f. GMP certificate from regulatory authority of exporting country.
g. Undertaking that shelf life of finished product would be assigned from date of manufacturing
of pellets from manufacturer.
3. Transfer of registration
i) With change in manufacturing site:
a. Application with Form-5 and required fee as per relevant SRO.
d. Copy of approved section by Central Licensing Board.
e. Copy of last inspection report.
f. NOC from existing manufacturer / registration holder permitting for transfer of product.
g. Statement / undertaking that applicant do not have registration of same products. If so, it has to
apply for cancellation of product.
h. Accelerated stability studies of 6 months with undertaking to conduct real time stability
studies up to assigned shelf life & report if any result falls outside shelf life specifications (with
proposed action).
i. Validated method of analysis, master formula and product development data
ii) Change in name / title of manufacturer (site of manufacturing remains the same)
a. Application on Form-5 with required fee as per relevant SRO.
d. Approval of new name / title from CLB.
e. Undertaking that the formulation, API source & Specifications, manufacturing process, release
& shelf life specifications have not changed.
4. Change in storage conditions/shelf life

d. Real time stability data.
5. Change in Prescribing Information (PI)

d. Difference between existing and proposed information in tabulated form.
e. Justification of proposed changes.
f. Reference of prescribing information of brand leader (for me too products).
g. Copy of approval from regulatory agency / authority from country of origin for brand leader.
h. Copy of label outer pack in case of changes indication/ dose/ administration etc.
6. Change in primary packaging.

d. Justification of proposed change.
e. Accelerated stability studies of 6 months with undertaking to conduct real time stability
studies up to assigned shelf life & report if any result falls outside shelf life specifications (with
proposed action).
f. Shelf life of the drug product supported with justification.
7. Change of packaging materials.

e. Existing and proposed packaging materials.
f. Difference between existing and proposed information in tabulated form.
g. Confirmation and undertaking that proposed label complies all provisions of Drugs (Labeling
& Packing) Rules, 1986.
h. An undertaking that the proposed colour scheme / label has no resemble with already
registered Products. In case of resemblance, new label will be changed immediately. Moreover,
no case is pending at any forum / court of law regarding this matter.
i. Dosage, administration, indication & direction for use etc. on the label be in line with
marketing authorization.
8. Registration of drug for export purpose.

a. Application on Form 5 with required fee as per relevant SRO.
b. NOC for CRF clearance.
c. Copy of approved section from CLB.
d. Copy of last inspection report.
e. An undertaking that applied registration is exclusively for export purpose and will not be sold
in Pakistan.
f. If formulation / product is not registered in Pakistan, then export order from importing country.
9. Change of brand name.

a. Application with required fee as per relevant SRO (in case of similarity / resemblance with
already registered drug, fee will not be required).
d. Justification for proposed change.
e. Information regarding previous change of brand name since registration of drug.
f. Details (batch number, date of manufacture, quantity and stock position) regarding last batch
manufactured.
g. An undertaking that the proposed names do not resemble with already registered brands
/similarity with already registered drug, the applicant will be liable to change immediately.
Moreover, at any forum / court of law regarding this matter.
10. Change in shape of tablet / color and size of capsule.

e. Undertaking that other specification of the product would remain the same.
11. Cancellation of registration of drug on firm’s request.

a. Application.
d. Justification
e. List of alternatives brands available in the country.
f. An undertaking that the no case is pending at any forum / court of law regarding this product.
12. Renewal of drugs applied after due date.

b. Copy of registration letter and last renewal status.
d. Reason for not submitting renewal in time.
13. Corrigendum for correction in registration letter.

a. Application with required fee as per relevant SRO, if error is on part of firm.
d. Document in support of proposed correction.
B. Imported products:
1. Change of name of manufacturer of imported drugs
d. Original and legalized Certificate of Pharmaceutical Product as per WHO format for new
manufacturer’s name OR Original and legalized GMP certificate of new manufacturing site with
free sale certificate from regulatory body of country of origin.
2. Change of manufacturing site/source

a. Application on Form 5A with required fee as per relevant SRO.
d. Original and legalized Certificate of Pharmaceutical Product as per WHO format for new
manufacturer’s name OR Original and legalized GMP certificate of new manufacturing site with
free sale certificate from regulatory body of country of origin.
e. Site master file of new manufacturing site.
3. Increase or decrease in shelf life of finished products

e. Approval of regulatory body of country of origin / Original and legalized Certificate of
Pharmaceutical Product as per WHO format.
f. Stability data for Zone IV A or for respective storage condition (in case of products to be
stored at 2-8 0C).
4. Transfer of registration from one importer to other importer

d. Termination letter (original) from manufacturer for previous importer.
e. Authority letter/sole agent letter (original) from manufacturer.
f. NOC from existing registration holder for transfer of registration.
5. Change of packaging materials.

e. Existing and proposed packaging materials.
f. Difference between existing and proposed information in tabulated form.
g. Confirmation and undertaking that proposed label complies all provisions of Drugs (Labeling
& Packing) Rules, 1986.
h. An undertaking that the proposed colour scheme / label has no resemble with already
registered Products. In case of resemblance, new label will be changed immediately. Moreover,
no case is pending at any forum / court of law regarding this matter.
i. Dosage, administration, indication & direction for use etc. on the label be in line with that
authorization.
j. Regulatory approval of change from country of export.
6. Change of brand name.

a. Application with required fee as per relevant SRO (in case of similarity / resemblance with
drug, fee will not be required).
e. Information regarding previous change of brand name since registration of drug.
f. Details (batch number, date of manufacture, quantity and stock position) regarding last batch
imported.
g. An undertaking that the proposed names do not resemble with already registered brands. In
case of resemblance/similarity with already registered drug, the applicant will be liable to change
immediately. Moreover, no case is pending at any forum / court of law regarding this matter.
h. Original and legalized Certificate of Pharmaceutical Product as per WHO format for new
brand name OR Original and legalized GMP certificate of new brand name with free sale
certificate from regulatory body of country of origin.
Decision: Registration Board deferred the case for comments/ reviews of stake holders.
REGISTRATION -V
Case No.1 Change in specification for the Product of M/s. Stallion Pharmaceuticals
(Pvt) Ltd, Lahore.
M/s. Stallion Pharmaceuticals (Pvt) Ltd, Lahore has applied for change of specifications of
already registered product as at the time of initial registration the specs were mentioned as BP
specification. Since applied formulation neither exist in USP nor BP hence firm has requested for
change the specification as given below:
Sr. Reg. Proposed Renewal Remarks
Name of Drug(s) with formulation
No. No. Change status
1 077243 Staclox 250mg Capsule Valid Formulation do
Each capsule contains:- not exist in BP
From BP TO
Ampicillin Trihydrate eq to. or USP or any
Manufacturer’s
Ampicillin……………….125mg other official
specification
Cloxacillin sodium eq to:- monograph
Cloxacillin…………………….125mg
2. 077244 Staclox 500mg Capsule Valid Formulation do
Each capsule contains:- not exist in BP
From BP TO
Ampicillin Trihydrate eq to. or USP or any
Manufacturer’s
Ampicillin……………….250mg other official
specification
Cloxacillin sodium eq to:- monograph
Cloxacillin…………………….250mg
The firm has submitted the following documents.
 Fee Deposit slips Rs. 5,000 for this purpose.
 Standard Analytical Procedure for applied formulations
 Copy of the relevant registration and renewal letters
 Copy of NOC for CRF.
Decision: Registration Board deferred the request of M/s Stallion Pharmaceuticals (Pvt)
Ltd, Lahore for confirmation of formulation in monograph of reference
countries.
Case No.2: Registration of M/s. Fynk Pharmaceuticals, Lahore.

Registration Board in 226th meeting deferred the following product of M/s. Fynk
Pharmaceuticals, Lahore as per detailed below:-
S. No Name of Product Decision (M-226)
1. Ploro-T Tablets Deferred for review
Each tablet contains:- committee
Hydrated Phloroglucinol 80mg Eq. to
anhydrous phloroglucinol…62.233mg
Trimethylphloroucinol………80mg
The case was presented before Registration Board in 270th meeting and decided as follows:
Decision: Registration Board deferred request of M/s Fynk Pharma, Lahore for submission
of GMP report during last one year.
Firm had submitted GMP inspection conducted on 20.09.2017, case was again presented
before Registration Board in 276th meeting and decided as follows:
Decision: Registration Board deferred the product for clarification of coating type of the
product.
Now the firm has clarified that applied formulation is sugar coated.
Decision: Registration Board approved the product Ploro-T Tablet of M/s. Fynk
Pharmaceuticals, Lahore for registration.
Case No.3: Registration of M/s. Fynk Pharmaceuticals, Lahore.
Registration Board in 228th meeting approved the following product of M/s. Fynk
Pharmaceuticals, Lahore as per detailed below:-
Sr.No Name of Product Demanded MRP Decision Remarks
pack size
1. Meglum Injection 5mlx5’s As per Approved The applied
Each 5ml contains:- SRO formulation exists in
Meglumine Antimoniate….1.5gm WHO essential
medicine list.
Last GMP inspection report dated 20.09.2017. The firm has requested for registration letter of
above mentioned product.
Submission of Differential fees of Rs 12000/- not confirmed.
Decision: Registration Board deferred the product for differential fee (Rs 12000/-)
Case No.4: Change in formulation for the product of M/s. A.Z Pharmaceutical co. Ltd.
Lahore.
M/s. A.Z Pharmaceuticals Co.Ltd, Lahore has requested for change in formulation for below
mentioned products as per detailed below:-
S. No Reg.No Name of Product with existing formulation Proposed change in formulation
1. 015329 Immunasol-H IV Infusion Immunasol-H IV Infusion
Each 1000ml contains:- Each 1000ml contains:-
Sodium chloride……………….6.00gm Sodium chloride…………….6.00gm
Potasaium Chloride…………..0.400gm Potasaium Chloride………..0.400gm
Sodium Lactate 50%................6.200gm Sodium Lactate 60%.........6.200gm
Calcium Chloride 2H2O……...0.27gm Calcium Chloride 2H2O…..0.27gm
2. 015332 Immunasol-H IV Infusion Immunasol-H IV Infusion
Dextrose anhydrous……………….50.00gm Dextrose anhydrous……….50.00gm
Potasaium Chloride…………..0.400gm Potasaium Chloride………..0.400gm
Sodium Lactate 50%................6.200gm Sodium Lactate 60%.........6.200gm
 Fee Deposit slips Rs. 20,000 for this purpose.
 Copy of the relevant registration and renewal status (renewal valid)
 Copy of NOC for CRF.
 Accelerated stability data for the duration of 6 month
 Reason for change of formulation (Easy market availability of 60%)
Decision: Registration Board deferred the request of M/s. A.Z Pharmaceutical co. Ltd.
Lahore for confirmation of applied formulation in official monograph as well
as approval by reference regulatory authority.
Case No.5: Contract Manufacturing Permission for the products of M/s. Highnoon
Laboratories Ltd, Lahore.
M/s. Highnoon Laboratories Co. Ltd, Lahore has requested for contract manufacturing
permission for below mentioned products as per detailed below:-
S.No. Applicant Contract Name of Drug (S) & Reg# Date of Valid
Manufacturer Composition Application/ till
Fee
1. Highnoon M/s. Titlis Cyrocin Tablet 250mg 011406 Dy # 3463R&I 26th
Laboratories Pharma, Each film coated tablet 17-04-2017 August,
Ltd. Lahore Lahore contains:- Rs. 50,000/- 2017
Ciprofloxacin (as HCl)
………. 250mg
2 -do- -do- Cyrocin Tablet 500mg 011407 -do- -do-
contains:-
Ciprofloxacin (as HCl)
………. 500mg
3 -do- -do- Oxaquin Tablet 400mg 043660 -do- -do-
Moxifloxacin (as HCl)
……… 400mg
4 -do- -do- Aria Tablet 1mg 014742 -do- -do-
Ketotifen (as Fumarate)
……. 1mg
5 -do- -do- Voxiquin Tablet 250mg 038991 -do- -do-
contains:-
Levofloxacin (as
6 -do- -do- Voxiquin Tablet 500mg 038992 -do- -do-
contains:-
Levofloxacin (as
7 -do- -do- Senegy-OD Tablet 10mg 017672 -do- -do-
Loratadine ………… 10mg
Approval for contract manufacturing was granted in 248th meeting of Registration Board
for the period of two years. The reason for extension of contract manufacturing mentioned by
firm is plan of up gradation/ plant expansion during next 5 years.
The case was presented before the Board in 270th meeting and decided as follows:
Decision: Registration Board advised to place updated status of case for consideration of
Registration Board.
The firm had submitted progress report and renovation, the case was again presented before
Registration Board in 272nd meeting.
Decision: Registration Board deliberated that firm has already availed 30 months time for
renovation of their facility. Firm has also not submitted progress report of 30
months. The Board decided to get details of work done during this time.
The firm’s representatives were called for personal hearing upon their request for deliberating
the matter.
Proceedings: Following representative of firm appeared before Registration Board for
deliberating the matter:
1. Ms. Iram Naila (Head Regulatory Affairs)
2. Dr. Saleem (Director quality operations)
3. Faisal Shahzad (Head of Engineering)
4. Mr. Naveed (G.M operation Titlis pharma)
5. Hassan Masood Naqvi (Manager Regulatory affairs)
Representatives of firm apprised Registration Board that firm launched renovation and expansion
plan to meet growing needs of local as well as export market, to produce quality medicines and
to meet technical demands for enhanced technical efficiency.
The plan was divided into two phases. Phase A was about expansion by adding new areas in
granulation section and Phase B was about Renovation & upgradation of existing granulation
section.
Phase A has been successfully completed. The new area has been validated and operated
successfully. Phase B was postponed and could not installed due to following reasons:
a) Increased growth of highnoon’s product which made it unviable to close the area for
renovation.
b) Due to old technology of existing equipment and non availability of replacement
components, it was not technically feasible to upgrade them.
c) For installation of new equipment some structural changes like increase in room height is
required which need more time for renovation.
The firm requested for extension for contract manufacturing permission by Titlis pharma, Lahore
for further 30 months. The case was again considered by Registration Board in 274th meeting and
decided as follows:
Decision: Registration Board deliberated that firm was granted contract manufacturing
permission as per Rule 20A (1)(c), Drugs (L,R &A) Rules, 1976 for renovation
and up-gradation of tablet section. As per aforementioned provision, maximum
time limit for contract manufacturing is 30 months. As firm has already availed
contract manufacturing permissions for 24 months thus Registration Board
decided to extend contract manufacturing for further period of 6 monthsnder as
permissible under Rule 20A (1)(c), Drugs (L,R &A) Rules, 1976.
Now the firm is requesting for manufacturing of below mentioned products by way of contract
manufacturing from M/s. Titlis Pharma Lahore for period of 5 years, in order to avoid to
shortage of these medicines.
S.No Name of Name contract Reg. Name of product with Fee, Dy No. and
applicant(s) manufacturer No composition date
1. M/s. Highnoon M/s. Titlis 011406 Cyrocin Tablet 250mg Rs.50000/-
Laboratories, Pharma, Lahore Each film coated tablet Dated 23.11.2017
Lahore contains:- Dy No. 22033 dated
Ciprofloxacin (as HCl) 23.11.2017
………. 250mg
2. -do- -do- 011407 Cyrocin Tablet 500mg Rs.50000/-
Each film coated tablet Dated 23.11.2017
contains:- Dy No. 22034 dated
Ciprofloxacin (as HCl) 23.11.2017
………. 500mg
3. -do- -do- 043660 Oxaquin Tablet 400mg Rs.50000/-
Each tablet contains:- Dated 23.11.2017
Moxifloxacin (as HCl) Dy No. 22037 dated
……….. 400mg 23.11.2017
4. -do- -do- 038991 Voxiquin Tablet 250mg Rs.50000/-
Levofloxacin (as 23.11.2017
Hemihydrate)….. .250mg
5. -do- -do- 038992 Voxiquin Tablet 500mg Rs.50000/-
Levofloxacin (as 23.11.2017
Hemihydrate) .500mg
The firm has submitted following documents.

i. Form 5 with fees Rs 50,000/- for each product
ii. Agreement for contract manufacturing (12-10-2017)
iii. Initial Registration letters and renewal status (Renewal valid).
iv. Last GMP inspection report of M/s Titlis Pharma, Lahore (22.11.2016).
v. Copy of last GMP inspection report (dated 06.07 2017)
Decision: Registration Board deliberated on the matter and decided to provide
opportunity of personal hearing to M/s. Highnoon Laboratories, Lahore for
clarification regarding previously granted contract manufacturing
permission under Rule 20A (1)(c), Drugs (L,R&A) Rules, 1976
Case No.6: Registration for the product of M/s. Dr. Sethi (Pharma) Industries,
Chichawatni.
Registration Board in its 272nd meeting approved the following product of Dr. Sethi (Pharma)
Industries, Chichawatni as per below mentioned details:
Sr.No Name of product Demanded MRP Approval status in SRA
/Pack Size
1 Hexa Tulle Sachet. 5cm x 5cm Bactigras Dressing by M/s Smith &
Each Sachet Contains:- 10cm x 10cm Nephew Pty Ltd, TGA confirmed
Chlorohexidine…………..0.5% Rs. 6.06
Rs. 13.33
Previously the product was considered by Registration Board in 212th meeting subject to
confirmation of GMP status.
The firm had submitted the following documents:-
i. Remaining Fee Rs.12,000/- for this product (dated 13.06.2017)
ii. Copy of last GMP inspection report conducted on 03.08.2016.
The case was reconsidered by Registration board in 272 meeting and decided as follows:-
Decision: Registration Board acceded to request of firm for registration of above mentioned
product
While processing registration letter firm was asked to clarify demanded MRP. The firm has
submitted reply that demanded MRP mentioned in minutes was unit price rather than pack.
However, demanded MRP was not found in copy of Form-5.
Decision: Registration Board deferred the request of M/s. Dr. Sethi (Pharma)
Industries, Chichawatni for submission of revised Form 5 alongwith
undertaking.
Case No.7: Registration for the product of M/s. Wilshire Laboratories (Pvt) Ltd, Lahore.
Registration Board in 225th meeting approved the following product of M/s. Wilshire
Laboratories (Pvt) Ltd, Lahore as per detailed below:
S.No. Name of product Demanded Demanded Decision
pack size price
1. Perlita SR Tablet 10,s As per SRO Approved
Each tablets contains:- 20’s
Diltiazem Hydrochloride Extended 30’s
Release pellets 222.222 mg
Containing Diltiazem Hydrochloride
Eq.to Diltiazem………………120mg
The formulation approved in minutes as Perlita SR Tablet instead of Capsule whereas firm has
clarified there was typographic error, the applied formulation was capsule instead of tablet.
The firm has submitted following document
i. Copy of Form-5,
ii. Evidence of fee submission 100,000/-
iii. Documents regarding source of pellets (M/s. Titan Laboratories (Pvt) Ltd, India)
Decision: Registration Board noted the correction in minutes and acceded to request of
M/s. Wilshire Laboratories (Pvt) Ltd, Lahore for granting registration.
Case No.8: Registration of M/s. Saffron Pharma, Faisalabad.
Registration Board considered following product of M/s. Saffron Pharma, Faisalabad in
224th meeting and decided as follows:
S. Name of Name of the Products Demanded Decision of Registration
No Firm MRP/ Pack Board/ meeting no.
size
1. M/s. Angitryl Tablet 2.5mg 30’s Approved subject to the Good
Saffron Each tablet contains:- Rs.157.22 GMP Inspection in last one
Pharma Glyceryl Trinitrate..2.5mg year and first ten molecules
Faisalabad (B.P Specs) per section.
Firm had submitted last GMP inspection report dated 28th Nov, 2016. Differential fee of above
mentioned product was submitted by the firm (dated 18.12.2013) and case was presented before
Registration Board in 276th meeting:
Decision: Registration Board considered the request of M/s Saffron Pharma, Islamabad
For confirmation of approval status in reference countries
Now the applied formulation found approved by Regulatory Authority “Sweeden” @

https://lakemedelsverket.se/english/product/Medicinal-products (date of access 31.01.2018).
Hence the firm has requested for registration letter of above mentioned product.
Decision: Registration Board approved product of M/s. Saffron Pharma Faisalabad,
Lahore.
Case No.9: Registration of M/s. Zeta Pharmaceuticals, Lahore.

Registration Board in 253rd meeting approved the following product of M/s. Zeta
Pharmaceuticals, Lahore as per detailed below:
S. Name of Firm Name of the Products Demanded MRP/ Pack size
No
2. M/s. Zeta Zetamox Tablet Form-5
Pharmaceuticals, Each film coated tablet contains: 28-07-2015 diary
Lahore Moxifloxacin HCl eq to No 4632.
Moxifloxacine….400mg Rs 20,000
Fluroquinolone Manufacturer‟s Rs. 475/10 tablets
specifications
While processing registration letter the firm pointed out that applied pack size was 5’s
instead of 10’s same has been verified by PEC and communicated through letter.
Firm has submitted following documents:-
i. Application for correction and issuance of registration letter
ii. Undertaking on stamp paper regarding authenticity of informaiton.
Now the firm has requested for issuance of registration letter with correct pack size.
Decision: Registration Board noted the correction in minutes regarding pack size i.e
5’s instead of 10’s
Case No.10: Correction in formulation for the product of M/s. Irza Pharma (Pvt) Ltd,
Lahore
M/s. Irza Pharma (Pvt) Ltd, Lahore has requested for correction in formulation of below
mentioned registered product as per detailed below:-
Sr.No Reg. No Name of Drug(s) & Composition Proposed correction
1. 017622 Irazacin Suspension Irazacin Suspension
Erythromycin Estolate eq. to Erythromycin Estolate eq to
Erythromycin…200mg Erythromycin………125mg
 Application for correction with fees (Rs 5000/-)
 Copy of registration letter (dated 7th Dec 1995) and renewal status (last
renewal 10th Nov, 2015)
The firm is submitting renewal as Irzacin suspension (Reg no. 017622) as 125mg/5ml instead of
200mg/5ml. However, Irzacin suspension 200mg/5ml is registered having registration no.
064815 (dated 5th August, 2010)
Decision: Registration Board decided to provide opportunity of personal hearing to M/s.
Irza Pharma (pvt) Ltd, Lahore for deliberating the matter.
Case No.11: Change of Specification of M/s. Arson Pharmaceutical Industries (Pvt) Ltd,
Lahore
a) M/s. Arson Pharmaceutical Industries (Pvt) Ltd, Lahore has applied for change of
specifications of some of their already registered products as at the time of initial
registration the specs were mentioned as Arsons Specs. Now the firm has request for
change the specification as given below:
Sr. Proposed Remarks
Reg. No. Name of Drug(s) with formulation
No. Change
1 071359 Arsozole Capsule Applied
From Arsons
Each capsule contains formulation
Specification to
Fluconazole……………………………150mg exists in BP
BP
(Arsons Specification)
 Application with required fees i.e Rs. 5,000 for this purpose
 Copy of registration letter
 Reference for BP
Submitted for consideration of Registration Board.
b) M/s. Arson Pharmaceutical Industries (Pvt) Ltd, Lahore has applied for change of
specifications of their already registered products as at the time of initial registration
the specs were mentioned as USP . Now the firm has request for change the
specification as given below:
Sr. Reg. Proposed Remarks
Name of Drug(s) with formulation
No. No. Change
1 085208 Moxifon 400mg Tablet From USP Applied
Each film coated tablet contains:- Specification formulation
Moxifloxacin…………………………..400mg to Innovator’s not exists in
(USP Specification) Specification USP

 Application for this purpose (dated 7th November, , 2017)
 Copy of registration letter (19th sep, 2017)
Decision: Registration Board acceded to request of M/s. Arson Pharmaceutical Industries
(pvt) Ltd, Lahore for change in specification for above mentioned products.
Case No.12: Change of Specification of M/s. Masfa Industries (Pvt) Ltd, Lahore
M/s. Masfa Industries (Pvt) Ltd, Lahore has applied for change of specifications of their already
registered products as at the time of initial registration the specs were mentioned as BP
specification. Now the firm has request for change the specification as given below:
No. Change
1 071557 Meofen Oral Suspension Applied
From BP
Each 5ml contains:- formulation
Specification to
Ibuprofen…………….100mg exist in both
USP
(BP Specification) USP and BP

 Application with fee i.e Rs. 5,000 for this purpose
 Copy of registration letter
 Reference for USP
Since API (Ibuprofen) is of USP specification hence firm requested to grant finished product
specification of same pharmacoepia i.e USP
Decision: Registration Board deferred the request of M/s. Masfa Industries (Pvt) Ltd,
Lahore for justification of proposed change as well as latest GMP inspection
report (within one year).
Case No.13: Change of Specification of M/s. Searl Company Ltd, Lahore
M/s. Searle Company Ltd, Lahore has applied for change of specifications oof their already
registered products as at the time of initial registration the specification were mentioned as searle
specification. Now the firm has request for change the specification as given below:
No. Change
1 054506 Lumark-250mg Tablet Applied
From Searle
Each tablet contain:- formulation
Specification to
Levetiracetam…………………….250mg exist in USP
USP
(Searle Specification)
2. 054507 Lumark-500mg Tablet Applied
From Searle
Specification to
USP
From Searle
Specification to
USP
From Searle
Specification to
USP
 Fee Deposit slips Rs. 5,000 per product, for this purpose
 Copy of registration letter and renewal status (products were transferred from
the name of Searl Pakistan Limited, Lahore to Searl Company Limited,
Lahore on 7th May, 2014)
Decision: Registration Board acceded to request of M/s. Searl Company Ltd, Lahore
for change in specification for above mentioned products.
Case No.14: Change of Brand Name for the product of M/s. CCL Pharmaceuticals
(Private) Limited: Lahore.
M/s. CCL Pharmaceuticals (Private) Limited, Lahore has requested for change of brand
name of following products as per details below:-
S. Reg No. Existing Brand Name Proposed Justification/
No Brand Name Reasons
1. 025410 Once A Day Tablet Once A Day As per marketing
Each Tablet contains:- Maximum requirement.
Vitamin A (as acetate and Tablet
betacarotene)……………...…10mg
Vitamin B1 ……………...1.5mg
Niacin.....................................20mg
Vitamin E ……......................30mg
Folic Acid…………….…….0.4mg
Biotin…………………........30mcg
Iron.........................................18mg
Phosphorus …………..…....100mg
Magnesium ……………….100mg
Zinc ………………………..15mg
Selenium …………………..10mcg
Manganese………………...2.5mg
Chloride …………………….34mg
Vitamin C ………………….60mg
Vitamin B2 ………………1.7mg
Vitamin D………………….10mcg
Vitamin B6..............................2mg
Vitamin B12..........................6mcg
Pantothenic acid ……..…….10mg
Calcium ……………….…..130mg
Iodine ………………...…..150mcg
Copper ……………………….2mg
Chromium …………………10mcg
Molybdenum ………………10mcg
Potassium ………………....37.5mg
Following documents have been submitted by the firm as per SOP approved by the Registration
Board in its 240th meeting for the purpose of change of brand name for above product:
S.No. Required documents
a Application with required fee as per relevant SRO (in case of similarity / resemblance with
already registered drug, fee will not be required)
b Copy of registration letters and renewal status.
c CRF clearance certificate
d Justification for proposed change
e Information regarding previous change of brand name since registration of drugs.
f Details (batch number, date of manufacture, quantity and stock position) regarding last batch
manufactured.
g An undertaking that the proposed names do not resemble with already registered brands. In case
of resemblance/similarity with already registered drugs, the applicant will be liable to change
immediately. Moreover, no case is pending at any forum / court of law regarding this matter.
Decision: Since the proposed brand name contains adjective property hence Registration
Board deferred the request of M/s. CCL Pharmaceuticals (Private) Limited,
Lahore and advised firm to propose alternate brand name.
Case No.15: Change of address for the products of M/s. P.D.H Laboratories (Pvt) Ltd,
Lahore
M/s. P.D.H Laboratories (Pvt) Ltd, Lahore has requested for change of address for their
registered products as per details mentioned below:-
S.No. Reg No. Existing brand name of Drug Existing address Proposed Registration and
and composition address as per renewal status
mentioned on
DML
1. 007118 Apoclox Injection M/s. P.D.H M/s. P.D.H Renewal valid
Each vial contains Laboratories Ltd Laboratories
Ampicillin…250mg 42, Nicholson Ltd 9.5km.
(as Ampicillin Sodium) Road, Lahore Sheikhupura
Cloxacillin….250mg Road, Lahore
(as cloxacillin Sodium)
2. 009260 Ephedrine Injection -do- -do- Renewal valid
Each 1ml contains:-
Ephedrine Sulphate……30mg
3. 019691 Clostecin Cream -do- -do- Renewal valid
Clostebol Acetate….500mg
Neomycin Sulphate
USP……..500mg
4. 005660 Belexvit-T Injection -do- -do- Renewal valid
Each ml contains:-
Thamine HCl…10mg
Riboflavin…2mg
Pyridoxine HCl…5mg
Nicotinamide…75mg
D-Panthenol….mg
5. 002593 Amplipen Injection 250mg -do- -do- Renewal valid
Ampicillin……250mg
6. 002589 Amplipen Injection 500mg -do- -do- Renewal valid
Ampicillin……500mg
7. 003551 Apoclox Capsule -do- -do- Renewal valid
Ampicillin (as ampicillin
trihydrate)….250mg
Cloxacillin (as cloxacillin
sodium)….250mg
8. 019692 Ulticomb Ointment -do- -do- Renewal valid
Each gm contains:-
Triamcinolone Acetonide
USP….1mg
Neomycin sulfate USP…2.5mg
Nystatin USP….100000 units
Gramicidin..0.25mg
9. 019693 Ulticomb Cream -do- -do- Renewal valid
Each gm contains:-
Triamcinolone Acetonide
USP….1mg
Neomycin sulfate USP…2.5mg
base
Nystatin USP….100000 units
Gramicidin..0.25mg
10. 002483 Polybiotic Injection 2.5gm -do- -do- Renewal valid
Streptomycin Procaine
Pencillin Injection…2.5mg
11. 000785 Polybiotic Injection 1gm -do- -do- Renewal valid
Streptomycin Procaine
Pencillin Injection…1g
12. 018605 Kaplor Injection -do- -do- Renewal valid
Each 1ml ampoule contains:
Phytonadione (Vitamin K1)
…10mg
13. 018606 Colicin Injection -do- -do- Renewal valid
Each 1cc ampoule contains:-
Hyoscine N-Butyl
Bromide…20mg
14. 016935 Dynacef Injection 250mg -do- -do- Renewal valid
Cethradine…250mg
15. 016936 Dynacef Injection DS 500mg -do- -do- Renewal valid
Cephradine…500mg
16. 007721 Potassium Chloride Injection -do- -do- Renewal valid
7.48% w/v
17. 007722 Diazepam injection 10mg -do- -do- Renewal valid
Existing address i.e. M/s. P.D.H Laboratories Ltd 42, Nicholson Road, Lahore was of their head
office address, firm requests to mention address of manufacturing site rather head office address.
The firm has submitted following documents:-
i. Application for corrigendum with fee of Rs.5000- for each product.
ii. Copy of registration letter and renewal deposit slips.
iii. Copy of DML from year 1988 to 2015.
Firm has requested for issuance of corrigendum with correct address as mentioned above
Decision: Registration Board acceded to request of M/s. P.D.H Laboratories (Pvt) Ltd,
Lahore for correction of address as per DML i.e M/s. P.D.H Laboratories
Ltd 9.5km. Sheikhupura Road, Lahore.
Case No.16: Registration of M/s. Cotton Craft (Pvt) Ltd, Lahore.
Registration Board in 227th meeting approved the following products of M/s. Cotton
Craft (Pvt) Ltd, Lahore as per detailed below:
Sr. Name of Name of product Demanded Demanded Decision of
No firm Pack size MRP registration
Board in 227th
meeting
1. M/s. Cotton Sulphachlor Tulle 10cm x Rs.39.99 Approved
Craft Each contains:- 10cm
Pvt. Ltd Siver Sulphadiazine………..1% USP
Chlorohexidine Acetate….0.5% BP
2. M/s. Cotton Povidone- Tulle 5.0cm x Approved
Craft, Each tulle:- 5.0cm Rs.34.42
Lahore. Povidone Iodine………………10% BP
Firm has submitted the differential fee of Rs. 12000/- for each product on dated 19.09.2016.
Now the firm has requested for registration letter of above mentioned products.
Last GMP inspection conducted on 14.06.2017 concluded GOOD GMP compliance. Now the
firm has requested for registration letter of above mentioned products.
Decision: Registration Board approved the product of M/s. Cotton Craft Pvt. Ltd, Lahore.
Case No.17: Registration of M/s. Irza Pharma (Pvt) Ltd. Lahore
Registration Board in 218th meeting deferred the following product of M/s. Irza Pharma
(Pvt) Ltd. Lahore as per detailed below:
Sr.No Name of firm Name of Product Demanded Demanded Decision
Pack Size MRP
1. M/s. Irza I-Nim Tablets 100mg 2x10’s Rs.95.00 Deferred for
Pharma (Pvt) Each tablet contains:- 3x10’s Rs.130.00 review
Ltd. Lahore Nimesulide ……… 5x10’s Rs.220.00 committee
100mg
Firm has submitted the differential fee Rs. 12000/- for each product on dated 29.12.2017.
The above mentioned formulation has been approved by Registration Board in 269th
meeting as follows:
Decision: Registration Board deliberated the case and decided as follows:
Keeping in view the approval status of Nimesulide 100mg tablet in EMA, the Registration Board
approved the formulation of Nimesulide Tablets 100mg with a pack size of 15 tablets as per
recommendations of EMA only for the following clinical indications as a second line choice.
 Treatment of acute pain
 Primary dysmenorrhea.
Decision: Registration Board approved the product of M/s. Irza Pharma (Pvt) Ltd. Lahore.
Case No.18: Registration of M/s. Reko Pharmacals, Lahore
Registration Board in 228th meeting deferred the following product of M/s. Reko
Pharmacals. Lahore as per detailed below:
Name of Firm Name of Product Demanded Decision Remarks

MRP/
Pack size
M/s. Reko Ruphen-C Tablets Rs.297.00/ 100 Approved MHRA
Pharma, Lahore. Each tablet contains:- Tablets Subject to the approved
Paracetamol BP……500mg Separate
Codeine phosphate section.
BP…..15mg
The firm has submitted Inspection report (for DML renewal) dated 2nd May, 2017 and evidence
of approval of psychotropic section (also verified from Licensing section). The firm is requesting
for issuance of registration letter.
Decision: Registration Board approved the product of M/s. Reko Pharma, Lahore.
Case No. 19: Registration M/s. Chishti Pharmaceutical Industries, Chichwatni.
Registration Board in its 206th meeting approved the following product of M/s. Chishti
Pharmaceutical Industries, Chichawatni as per detailed below:
Sr. No Name of the drugs with Pack Size Proposed Decision
composition Price
1. Imperial Crepe Bandage. -- -- Approved
Contains:-
Crepe Bandage BPC.
The firm had submitted following documents:-

i. Copy inspection report (GMP)
ii. Copy of Bank challan of Rs. 8000/-
iii. Differential fee of Rs. 12000/-as balance fee.
The case was presented before Registration Board in 260th meeting and decided as follows:
Decision: Registration Board deferred the case for submission of new Form-5 and
verification of record regarding issuance of registeration letter, as product was
considered by Registration Board in 2007.
The case was again presented before Registration Board and decided as follows:
Decision: Registration Board deferred the case for submission of new form-5 as per decision
of the board in 260th meeting
Now the firm has again submitted new Form 5, moreover non issuance of registeration letter is
verified from record. Latest GMP inspection report not provided.
Decision: Registration Board deferred the product of M/s. Chishti Pharmaceutical
Industries, Chichwatni for latest GMP inspection report (within one year).
Item No. III Division of Biological Evaluation and Research Division.
Sr. No. Details of application No. of Cases
1. Guidelines for regulatory requirements of Biological Drugs using 1

rDNA technology
2. Requirement of published safety and efficacy data deferred in 275th 1
meeting of Registration Board.
3. Miscellaneous/ Deferred cases of previous meeting 13
4. Dengue Vaccine 4
5. Storage facility verification. 1
6. Inspection exemption applied by M/s AGP Private Limited, Karachi. 1
7. Veterinary Drug Product Specifications. 1
8. Cancellation of registration of Influenza vaccines applied by M/s 1

Novartis Pharma, Karachi and M/s GSK, Karachi.
Total 23
I. Guidelines for regulatory requirements of Biological drugs using rDNA technology.
Two meetings of committee on Biological drugs constituted by Registration Board in its 273rd
meeting were held on20th November, 2017& 16th January, 2017 in the Committee Room, Drug
Regulatory Authority of Pakistan, G-9/4, Islamabad. The meeting was attended by the following:
1. Maj.Gen.Dr. TahirMukhtar Syed Chairman
2. Dr Noor us Saba, Director (Biological) Member
3. Dr.Qurban Ali, Member Registration Board Member
4. Dr. Obaidullah, Director (PE&R)/Chairman Registration Co-Opted Member
Board
5. Mr. Abdullah Add. Director (PE&R) / Secretary Registration Co-Opted Member
Board (2nd meeting)
6. M. Akhtar Abbas Khan, Dy Director Biological Secretary
Mr. ZubairMasood AD (Bio), Mr. Muneeb Ahmad Cheema AD (Bio) Mr. Muhammad Sarfraz
Nawaz AD (Bio), Mr. Khurrum Khalid AD (Bio) and Mr.Saadat Ali Khan, AD (Bio) assisted
with relevant agenda. Mr. Hamid Raza & Mr. Muhammad Imran in first meeting while Mr.
Farooq Mustafa & Dr.Syed Salman A Zaidi represented PPMA in 2nd meeting, Mr. Abdul Samad
and Dr.Ali Shehzad reperesented PharmaBeauru and PCDA respectively in both meetings.
Mr.Ajmal Nasir (BF Bioscience) was called for 2nd meeting on his request as the firm is not
member of PPMA.
In the 1st meeting PPMA was asked by committee to provide the details of the testing facilities
available in the reference countries for the complete testing of bio-similar products. After many
verbal reminders the information was not provided by the PPMA. Later on bio-similar testing
Labs who have online contact details were contacted to get the information on availability of
tests and their cost for analytical characterization. It is submitted that there are labs available in
the Europe, USA and other countries that provide the bio-similar testing services at different
negotiable rates. A list of the required tests for analytical characterization was also searched.
There are various guidelines which provide details of the Physicochemical and Biological
characterization methods to be used for r-DNA derived products however the Guideline on
similar biologics India have outlined the list of routine analytical tests to be included for
comprehensive quality comparability exercise of Critical and Key Quality Attributes is given in
Annexure-II of Guidelines. The list from a testing lab of a Europe/USA was also placed for
further consideration of the committee.
The committee discussed regulatory requirements in Pakistan and deliberated on the Registration
Board’s previous decision of data requirements for issuance of registration of locally
manufactured biological drugs. In DRAP’s Act, 2012 there are four categories of Biological
drugs, Finished Form, Ready to fill form, concentrated form and naked vials.
The committee gave its recommendations as follows: -
1. Biological Drugs (Concentrated Form/Ready to fill Form).
a) The firms shall provide legalized GMP certificate of biological drug substance
manufacturer abroad (who will provide concentrate / ready to fill bulk of biological drug
to Pakistani manufacturers for further processing) as an evidence that the manufacturer is
an authorized manufacturer of biological drug in the country of origin.
b) The firms shall provide legalized free sale certificate/CoPPeither from country of origin
or by any reference regulatory authority as adopted by Registration Boardof finished
product as evidence that the final product has been manufactured by same
concentrate/ready to fill bulk after submission of data to the concerned regulatory
authority.
c) The firm shall provide the open part of DMF of Drug Substance (Concentrate/Ready to
fill).
d) The firm shall provide the complete Bio-similarity studies of the finished product of same
source (bulk concentrate or ready to fill) manufactured either from country of origin or by
any reference regulatory authority as adopted by Registration Board to demonstrate the
bio-similarity.
e) The firm shall provide the lot release certificate of the finished product manufactured by
same bulk concentrate/ ready to fill from country of export (If applicable).
f) The firm shall provide the 6 months accelerated and real time stability studies for drug
substance.
g) The local manufacturer shall be authorized to manufacture the finished biological product
and then perform analytical studies(Physicochemical and biological) including protein
content, appearance, pH, Osmolarity, composition of key excipients including stabilizers
(if formulation is same), visible/subvisible particles, identity testing to parent molecule,
purity testing, in vitro biological activity, sterility, Pyrogen content, safety, potency and
toxicity with support of iso-electro focusing data, gel electrophoresis, Western-Blot and
other analytical techniques).
h) The firm shall also provide the list of finished products being manufactured from same
bulk concentrate or ready to fill form in any country of the world (if available).
i) The manufacturer shall perform all tests locally as detailed on Certificate of analysis.
j) The firm shall provide the agreement with the source (of bulk concentrate/ready to fill)
that if there shall be any critical change in manufacturing process, biological systems
used to manufacture, etc. the firm shall inform DRAP immediately along with relevant
documents.
k) Regular monitoring through pharmacovigilance reporting system shall be observed
through proper pharmacovigilance cell of the manufacturer and report will be forwarded
to the National Pharmacovigilance Centre, Division of Pharmacy Services and Biological
Division of DRAP. In case of any severe adverse event, immediate mandatory reporting
procedure shall be followed.
l) The firm shall inform DRAP if there shall be any adverse event or ADR reporting from the
country of manufacture of concentrate/ready to fill bulk and finished product as required
vide Rules 30 of Drug (LR&A) Rule.
m) If any of the conditions is not fulfilled or public health risk reported at any stage, the drug
registration shall stand cancelled with immediate effect.
n) All the provisions as contained in the Drugs Act, 1976 and rules made there under
including provisions of Lot Release certification from National Control Laboratory for
Biologicals shall be strictly adhered to.
o) For the already registered drugs for local manufacturing the current guidelines shall
apply.
2. Biological Drugs, finished form/ Naked Vials

a) The importer shall provide the analytical studies (Physicochemical, Biological), animal
studies and clinical studies (immunogenicity studies, PK, PD) of the finished product
from the exporter.
b) The firm shall provide the open part of DMF of Drug Substance (Concentrate/Ready to
fill).
c) The importer shall provide the guidelines for evaluation of biotherapeutics in the country
of export as evidence that the submitted data is in accordance with the said guidelines.
d) The importer shall provide the lot release certificate of the country of export for the same
drug (if applicable).
3. Other manufacturing processes: For products where process other than listed above
(Finished Form, Ready to fill form, concentrated form and naked vials) is done locally
likePEGylation, then complete clinical data shall be required by the manufacturer.
Above recommendations are submitted for the consideration of the Registration Board with the
suggestion that the firms must first produce at least three trial batches to finalize the formulation
and testing protocols as mentioned above and submit results to the RB before they are issued
Decision: Registration Board appreciated the work of committee for drafting guidelines
for registration of Biological drugs and decided to adopt the following guidelines
as regulatory requirements for the registration of rDNA therapeutic proteins:
1. Biological Drugs (Concentrated Form/Ready to fill Form).
a) The firms shall provide legalized GMP certificate of biological drug substance
manufacturer abroad (who will provide concentrate / ready to fill bulk of biological
drug to Pakistani manufacturers for further processing) as an evidence that the
manufacturer is an authorized manufacturer of biological drug in the country of
origin.
b) The firms shall provide legalized free sale certificate/CoPP either from country of
origin or by any reference regulatory authority as adopted by Registration Board of
finished product as evidence that the final product has been manufactured by same
concentrate/ready to fill bulk after submission of data to the concerned regulatory
authority.
c) The firm shall provide the complete Bio-similarity studies of the finished product of
same source (bulk concentrate or ready to fill) manufactured either from country of
origin or by any reference regulatory authority as adopted by Registration Board to
demonstrate the bio-similarity.
d) The firm shall provide the lot release certificate of the finished product manufactured
by same bulk concentrate/ ready to fill from country of export (If applicable).
e) The firm shall provide the 6 months accelerated and real time stability studies for drug
substance.
f) The local manufacturer shall manufacture three trial batches of the finished biological
product to finalize the formulation and then perform analytical
studies(Physicochemical and biological) including protein content, appearance, pH,
Osmolarity, composition of key excipients including stabilizers (if formulation is same),
visible/subvisible particles, identity testing to parent molecule, purity testing, in vitro
biological activity, sterility, Pyrogen content, safety, potency and toxicity with support
of iso-electro focusing data, gel electrophoresis, Western-Blot and other analytical
techniques). The firm shall submit the results for processing of registration
application.
g) The manufacturer shall perform all tests locally as detailed on Certificate of analysis.
h) The firm shall also provide the list of finished products being manufactured from same
bulk concentrate or ready to fill form in any country of the world (if available).
i) The firm shall provide the agreement with the source (of bulk concentrate/ready to fill)
that if there shall be any critical change in manufacturing process, biological systems
used to manufacture, etc. the firm shall inform DRAP immediately along with relevant
documents.
j) Regular monitoring through pharmacovigilance reporting system shall be observed
through proper pharmacovigilance cell of the manufacturer and report will be
forwarded to the National Pharmacovigilance Centre, Division of Pharmacy Services
and Biological Division of DRAP. In case of any severe adverse event, immediate
mandatory reporting procedure shall be followed.
k) The firm shall inform DRAP if there shall be any adverse event or ADR reporting from
the country of manufacture of concentrate/ready to fill bulk and finished product as
required vide Rules 30 of Drug (LR&A) Rule.
l) If any of the conditions is not fulfilled or public health risk reported at any stage, the
drug registration shall stand cancelled with immediate effect.
m) All the provisions as contained in the Drugs Act, 1976 and rules made there under
including provisions of Lot Release certification from National Control Laboratory for
Biologicals shall be strictly adhered to.
n) For the already registered drugs for local manufacturing the current guidelines shall
apply.
2. Biological Drugs, finished form/ Naked Vials
a) The importer shall provide the complete bio similarity studies including analytical
studies (Physicochemical, Biological), animal studies and clinical studies
(immunogenicity studies, PK, PD) of the finished product from the exporter.
b) The importer shall provide the guidelines for evaluation of biotherapeutics in the
country of export (Non-reference authorities) as evidence that the submitted data is in
accordance with the said guidelines.
c) The importer shall provide the lot release certificate of the country of export for the
same drug (if applicable).
3. Other manufacturing processes:
For products where process like PEGylation are performed locally, then complete
clinical data shall be required by the manufacturer.
II. Requirement of published safety and efficacy data deferred in 275th meeting
of Registration Board.
As per DRAP Act, 2012 Schedule-I 1(8): Pharmaceutical dossier includes a set of document
submitted by a Person for the registration of a therapeutic good, containing complete information
about: …(e)clinical trial data and published reports about the safety and efficacy of the drug.
Division of Biological Evaluation & Research in 274th meeting requested guidance from the
Registration Board in this matter so as to have across the board fair application of these statutory
requirements.
Registration Board advised DBER to prepare a proposal on the requirement of published safety
and efficacy data of the drug as per DRAP Act, 2012 for next Registration Board meeting as to
have across the board fair application of these statutory requirements.
It is submitted that the most of the time published safety and efficacy data of Human biological
products is available for products applied from reference countries while it is not available
generally from non reference countries. Furthermore, in majority of cases the published safety
and efficacy data of veterinary biological products is not available from reference, non reference
countries and locally manufactured drugs.
The committee recommended that as Registration Board is only approving the formulations
which have already been approved by the nineteen reference regulatory authorities to rely upon
their quality, safety and efficacy data. When a proposed formulation is approved in reference
countries it is not mandatory to ask for the published safety and efficacy data of the drug.
Decision: On the recommendation of the committee, Registration Board decided that

Board is only approving the formulations which have already been approved
by the reference regulatory authorities to rely upon their quality, safety and
efficacy data. When a proposed formulation is approved in reference
countries, published safety and efficacy data of the drug is not required.
III. Miscellaneous/ deferred cases of previous meeting.
Case No.1: Zytux applied by M/s CCL Pharmaceuticals, Lahore

Following applications of M/s CCL Pharma, Karachi applied for registration as per
following details:
Name of Importer & Brand Name & Composition Type of Form Document details
Manufacturer Dy. No & Date of (CoPP)
application Reference agencies
Fee submitted availability
Pack size/ Locally registered
Demanded Price product
M/s CCL ZYTUX Injection Form-5A CoPP issued
Pharmaceuticals (Pvt) 100mg/ 10ml Dy. No 688(R&I) dated 06-04-2014
Limited, Lahore (Concentrate solution for dated 30-01-2015
Injection) 50000/- dated FSC issued
M/s AryogenZistDarou 30-01-2015 dated 06-04-2014
Co. Each vial contains: As per brand
140Corner Tajbaksh Rituximab...….100mg leader/ Pack of 2 MabThera 100mg of
street, 24 vials Roche products (UK)
KmMakhsuous Road, Antineoplastic
AlborzIran,Iran agent/ Monoclonal Mabthera of Roche
Antibody Pakistan Ltd.
Manufacturer’s Specs
Shelf life: twoyears
M/s CCL ZYTUX Injection Form-5A CoPP issued
Pharmaceuticals (Pvt) 500mg/ 50ml Dy. No 687(R&I) dated 06-04-2014
Limited, Lahore (Concentrate solution for dated 30-01-2015 FSC issued
Injection) 50000/- dated dated 06-04-2014
M/s AryogenZistDarou 30-01-2015
Co. Each vial contains: As per brand MabThera 500mg of
140Corner Tajbaksh Rituximab…...500mg leader/ Pack of 1 Roche products (UK)
street, 24 vial
KmMakhsuous Road, Antineoplastic Mabthera of Roche
AlborzIran,Iran agent/ Monoclonal Pakistan Ltd.
Antibody
Shelf life: two years
Case History
258th meeting:
The case was initially considered in 258th meeting of Registration Board and Board decided as
follows:
“Deferred for expert’s opinion of following experts:
a. Brig (R), MuzamilHussainNajmi, Member Registration Board.
b. Brig. Amir Ikram, AFIP Rawalpind
c. Dr. Masud-ur-Rehman, DDG, DRAP,”
The experts Brig. Amir Ikram, AFIP, Rawalpindi &Dr. Masud-ur-Rehman, DDG, DRAP have furnished
their opinion which are taken up in the 263rd board meeting:
263rd Meeting:
The case was again placed before the board in 263rd meeting along with the opinion furnished by
the experts. Which are as under:
a. Expert opinion of Brig. Amir Ikram, AFIP, Rawalpindi
1. Product safety:
The provided literature shows that the preparations are safe. Trials have been conducted in the country of
origin with satisfactory outcome. The manufacturer is following GMPs.
2. Efficacy:
The clinical trials conducted in the country of origin indicate that the preparations are efficacious, however
further evaluation if requisite may be done.
The molecular description seems satisfactory. The provided material indicates that the preparations are
comparable to published literature. The preparations are required and if probably not incorrect not much of
preparations are easily available within the country. Its transportation under requisite parameters especially
temperature has to be guaranteed by the company at all levels.
b. Expert opinion of Dr. Masud-ur-Rehman, Additional Director, DRAP, Islamabad

Evaluation of dossier of Zytux Injection 100mg & 500mg (Rituximab)
Rituximab is genetically engineered chimeric human-mouse monoclonal antibody produced by

Chinese Hamster Ovary (CHO) cells in suspension and purified by affinity chromatography and ion
exchange, including specific viral inactivation and removal procedures. It is a fusion of the light and heavy
chain variable regions of a murine monoclonal anti-CD 20 antibody and human kappa light chain and
gamma-1 heavy chain constant regions. Rituximab binds specifically to antigen CD20, a hydrophobic
transmembrane protein located on normal pre-B and mature B lymphocytes. Antigen CD20 also is
expressed on greater than 90% of B-cell non Hodgkin's lymphomas. It is not found on hematopoietic stem
cells, pro-B cells or normal plasma cells.
Administrative documents elucidation:

Legalized GMP certificate of Zytux Injection 100mg (Rituximub) has evidence that the manufacturer is an
authorized manufacturer of that particular biological drug (Zytux Injection 100mg, 500mg Rituximab) in
its country of origin i.e. Iran.
GMP certificate dated 06.04.2014 by M/s AryoGenBiopharma Co is legalized by embassy of Pakistan.
GMP Certificate by regulatory body of Iran is annexed.
Manufacturing license baring No. 665/7940 dated 12.06.2012 of AryoGenZistDarou, Co., Iran confirms
that manufacturer is licensed to manufacture Monoclonal Antibodies Rituximab (100mg0. Manufacturing
License is legalized by embassy of Pakistan.
Structural similarly of Zytux Injection 100mg (Rituximab) with reference biological product (innovator
Mabthera of M/s Roche, USA)
Photocopy of document issued by Aryozen Pharmed Ltd for product characterization report of
Zytux in comparison with monoclonal antibody Mabthera of M/s Roche, USA.
As per documents Rituximab, prepared by manufactureing process and finalized for PCS stage was
used in product characterization studies, as follows:
Identity has been done on SDS-page, RP-HPLC, Ion-exchange chromatography.
Purity is by Gel Electrophoresis, SE HPLC.
Biological activity has been done through antibody dependent cell cytotoxicity (ADCC) assay and
complement-dependent cytotoxicity (CDC) assay).
Free Sale Certificate and Authorization letter form manufacturer has been provided. Importer shall be
authorized to import the finished biological product.
Bio-comparability studies including identity testing to parent molecule, purity testing and in virto
biological activity with support of gel electrophoresis, SE-HPLC, glycan analysis and other analytical
techniques) and stability studies of finished biological product. Toxicity studies has been done by Human
PD/PK study.
Clinical Comparability Studies for comparison of safety and efficacy with reference product:
There is Phase 3, double blind, randomized and controlled study to evaluate the efficacy and safety
of Zytux in patients with chronic lymphocytic leukemia (CLL) Clinical Data (Annexure XIV, Volume-I
Clinical data) Non-clinical study reports (Annexure-II, Volume-II) Clinical study reports (Annexure-III,
Voloume-II)
There is comparison of the patient’s percentage of decrement in CD20 marker from the pre-
treatment baseline value after four months’ comparison of adverse events was wll tolerated and safety was
similar to that of reference product.
Clinical study Phase III trial (Annexure-IV, Volume-II) Human PD/PK study reports (Annexure-
V, Volume-II)
Real time stability for 24 months, Stability Profile (Annexure XV, Volume-II)
Presentation /Containers:
Vial of 10ml (10 mg/ml) 2 in each small package and vial of 50 ml (10 mg/ml) 1 in each small package
respectively. Shelf life is 2 years.
Recommendation:
In the light of evaluation of submitted documents, the product is of safe to be registered for the
availability to suffering and poor patients, and hence recommended. The submitted data should be
evaluated by the inspecting panel of manufacturing site for the correctness and on spot cGMP compliance.
The expert opinion of Gen. Muhammad Aslam, Member Registration Board is has not furnished opinion
despite letter issued on dated 09-07-2016 and reminder on dated 08-08-2016.Board decided as follows:
“Registration Board deferred the above products for submission of biosimilarity data”
Remarks of division:
As per Schedule I of DRAP Act, 2012: “Biosimilarity” means Similar Biotherapeutic Product which is
similar in terms of quality, safety and efficacy to an already licensed reference biotherapeutic product.
The biosimilarity studies were submitted by the firm in terms of safety and efficacy performed in
comparative clinical trials whereas, for quality lab tests Innovator product was used.
The firm provided the biosimilarity data as per following details:
WHO Biosimilarity Guidelines Data Submitted by CCL (Rituximab)
Quality Comparison i. Molecular size, Integrity and purity.

1. Physicochemical Characterization Gel Electrophoresis (SDS-PAGE)
ii. Primary structure/Identity
Peptide mapping.
iii. Variation in monomer, dimmer and aggregation form.
Size exclusion HPLC
iv. Charge variant
Ion exchange chromatography
v. Glycan analysis
NP-HPLC
vi. Biological activity
In vitro bioassay (Antibody-dependent cell
cytotoxicity (ADCC) assay & Complement-
dependent cytotoxicity (CDC) assay
2. Biological Activity Comparative In vitro Biological activity is provided.
3. Immunochemical properties Comparative studies related to:
i. Binding affinity with FcγR receptors
ii. Binding affinity with FcγRn receptors
4. Impurities Impurities related data is provided
5. Stability Studies Stability studies are provided.
Non-clinical Comparison Pre-clinical Studies
i. In-vitro Studies In-vitro Studies
ii. In-vivo Studies Primary pharmacodynamics data provided.
a. Biological/ Pharmacodynamic In-vivo Studies
activity If the quality biosimilar comparability exercise and the
b. Non- clinical toxicity as nonclinical in vitro studies are considered satisfactory and
determined in one repeat dose no issues are identified which would block direct entrance
toxicity study into humans, an in vivo animal study may not be
considered necessary. (Guidelines on evaluation of
monoclonal antibodies as similar biotherapeutic products
(SBPs) (World Health Organization 2016).
i) Toxicology studies
a. Single dose IV toxicity study in rodents.
b. Single dose intraperitoneal toxicity study in non-
rodent.
c. Repeated dose intravenous toxicity study.
d. Local tolerance study
Clinical Comparison a. Phase-III Studies
i) A comparative analysis of safety and efficacy of
AryoGen-made Rituximab (ZytuxTM, AryoGen, Iran,
n=35) with (MabThera®, n=35) in patients with chronic
lymphocytic leukemia: a randomized, double blind, phase
3, clinical trial.
ii) A comparative, parallel, randomized, double-blind,
multiple-dosing study in 53 chemo-naive male patients
diagnosed with stage II, III, IV CD20 positive Diffuse
Large B-cell lymphoma (DLBCL).

Registration Board referred the instant application to the committee constituted in 273rd meeting of
Registration Board. The committee has asked the division of biological drugs to place cases in the
Board which have submitted complete data.
Decision:Keeping in view the biosimilarity data and submitted CoPP indicating that the products
are available for sale in the country of origin, Registration Board approved the above
products as per valid legalized CoPPs subject to price fixation by Federal Government and
compliance of current Import Policy for Finished drugs.
Case No. 2: Aryoseven applied by M/s CCL Pharmaceuticals Lahore.

Following application of M/s CCL Pharma, Karachi applied for registration as per
following details:
Sr. Name of Importer Brand Name & Type of Form Document details
No. & Manufacturer Composition Dy No & Date of (CoPP)
Pack size/ Demanded Locally registered
Price product
1. M/s CCL AryoSeven 1.2mg Form-5A Valid Legalized CoPP
Pharmaceuticals (Lyophilized Powder) Dy. No 4470(R&I) dated 11-04-2014
Lahore dated 03-09-2014
Each vial contains: Legalized Free
M/s AryogenZist Activated Eptacog 50000x2 dated 03- sale certificate
Darou Co. 140 Alfa (human activated 09-2014 dated 06-04- 2014
CornerTajbaksh Recombinant coagulation Copy of GMP
street,24 Km factor VII) Pack size: 1’s vial submitted dated
MakhsuousRoad, ….1.2mg(60KIU) Price: As per brand 18-05-2014
AlborzIran, Iran leader.
Sterile Water for NOVOSEVEN 60KIU
Injection…..2.2ml (1.2MG) POWDER
NovoNordisk Pakistan
Shelf Life: 2 years
Case History
257th meeting:
The case was initially considered in 257th meeting of Registration Board and Board decided as
follows:
“Deferred for expert opinion of following:
a. Gen. Muhammad Ayub. Comdt, AFIP, RWP.
b.Maj. Gen Muhammad Aslam, Member Registration Board.”
One of the expert i.e.General Muhammad Ayub, AFIP Rawalpindi has furnished his opinion:
Patients are not available for trail of subject drug. It is advised that the opinion of subject drug
may please be asked from hospitals which deal with the product and have patients. However the
institute is willing to provide all the required lab testing and facilities in this regard.
The other expert has not furnished the opinion despite letter issued on dated 09-07-2016 and reminder on
dated 08-08-2016. Accordingly the case was taken up in the 263rd Registration Board meeting and board
decided as under:
“Registration Board deferred above product for the submission of clinical trial data”
As per Schedule I of DRAP Act, 2012: “Biosimilarity” means Similar Biotherapeutic Product which is
similar in terms of quality, safety and efficacy to an already licensed reference bio therapeutic product.
comparative clinical trials whereas, for quality lab tests Innovator product was used which requires in-
depth evaluation by the Division and the expert if required.
The firm has submitted bio-similarity as per following details:

WHO Biosimilarity Data Submitted by the firm
Guidelines
Quality Comparison i. Intact Mass
1. Physicochemical ii. Peptide Mapping
Characterization Reverse phase HPLC analysis with UV detection
iii. Secondary structure analysis of proteins
Circular Dichroism (CD) spectrometry
iv. Structure characterization of proteins
NMR spectroscopy
v. Glycan Analysis
RP-HPLC
vi. SDS-gel capillary electrophoresis for both reduced and non-reduced
form of drug
vii. Molecular profiling using surface-enhanced laser desorption ionization
(SELDI)
viii. Evaluation of protein composition
SDS-PAGE Analysis
2. Biological Biological activity measurement by Parallel Line Assay (PLA)
Activity
3. Immunochemical Immunoblotting study (Western blot)
properties
4. Impurities Impurities data is provided
5. Stability Studies Stability data is provided
Non-clinical Pre-clinical Studies
Comparison In-vitro Studies
i. In-vitro Studies Primary Pharmacodynamics not provided
ii. In-vivo Studies Secondary Pharmacodynamics not provided
a. Biological/ Safety Pharmacology not provided
Pharmacodynamic In-vivo Studies
activity i. According to WHO 2009 Guidelines on Evaluation of Similar
b. Non- clinical Biotherapeutic Products (Sbps) (In vivo evaluation of biological/
toxicity as pharmacodynamic activity may be dispensable if in vitro assays are
determined in one available, which have been validated to reliably reflect the clinically
repeat dose toxicity relevant pharmacodynamic activity of the RBP)
study ii. Comparative Pharmacokinetic/ Pharmacodynamics studies
To compare the circulating levels of factor VIIa antigen and procoagulant
activity following administration of AryoSevenTM and NovoSeven® to
primates
iii. Toxicology
a. Toxicity after a single dose administration
b. Toxicity after repeated administration
c. Local Tolerance (non-comparative)
Clinical Comparison i. Comparative analysis between safety and efficacy of AryoGen Pharmed
recombinant activated factor VII (AryoSeven™, n=35) in comparison
with (NovoSeven®, n=31) in patients with congenital Factor VII
deficiency: A randomized, multicenter, double blind clinical trial.
(Phase-3)
Study IRCT201104266302N1
ii. Comparative analysis of safety and efficacy of recombinant activated
factor VII (AryoSevenTM, AryoGen Pharmed, Iran, n=31) in
comparison with (NovoSeven® n=35) in patients with congenital
Haemophilia A or B with inhibitors: A randomized, double blind, phase
III clinical trial.
Study IRCT201202106302N2
iii. Published Comparative Biochemical and Functional Studies on a
Branded Human Recombinant Factor VIIa (NovoSeven) and a
Biosimilar Equivalent Product (AryoSeven)
Evaluator Remarks Firm compare the data of AryoSeven 1.2mg with innovator 1mg.
Registration Board referred the instant application to the committee constituted in 273rd meeting
of Registration Board. The committee has asked the division of biological drugs to place cases in
the Board which have submitted complete data.
Decision: Keeping in view the biosimilarity data and submitted CoPP indicating that the product is
available for sale in the country of origin, Registration Board approved the above product
as per valid legalized CoPP subject to price fixation by Federal Government and
Case No.3: Altebrel injection applied by M/s CCL Pharmaceuticals (Pvt) Ltd, Lahore.
Following applications of M/s CCL Pharma, Karachi applied for registration as per
following details:
S. Name of Importer & Brand Name & Type of Form Document details
NO Manufacturer Composition Dy No & Date of (CoPP)
. application Reference agencies
1. M/s CCL ALTEBREL Injection Form-5A CoPP issued
Pharmaceuticals (Pvt) 25mg Dy. No 686(R&I) 11-04-2014
Limited, dated 30-01-2015 FSC issued
Lahore Each 0.5ml prefilled 50000/- dated on 11-04-2014
Syringe contains: 30-01-2015
M/s AryogenZistDarou Etanercept……25mg Enbrel by Pfizer
Co. 140 Corner Tajbaksh As per brand USA
street, 24 KmMakhsuous Tumor necrosis factor leader/ Pack of 1
Road, AlborzIran, blocking agent PFS Enbrel in vial of
Iran Wyeth Pakistan
Manufacturer’s Specs Karachi
Shelf life: twoyears
2. M/s CCL ALTEBREL Injection Form-5A CoPP issued
Pharmaceuticals (Pvt) 50mg Dy. No 685(R&I) 11-04-2014
Limited, dated 30-01-2015 FSC issued
Lahore Each ml prefilled 50000/- dated on 11-04-2014
syringe contains: 30-01-2015
M/s AryogenZistDarou Etanercept……50mg As per brand Enbrel by Pfizer
Co. 140 Corner Tajbaksh leader/ Pack of 1 USA
street, 24 KmMakhsuous Tumor necrosis factor PFS
Road, AlborzIran, blocking agent. Enbrel of Wyeth
Iran Pakistan Karachi
Shelf life: two years
Case History
258th meeting:
The case was initially considered in 258th meeting of Registration Board and Board decided as follows:
“Deferred for experts opinion of following experts:
a. Brig (R), MuzamilHussainNajmi, Member Registration Board.
b. Brig. Amir Ikram, AFIP Rawalpind
c. Dr. Masud-ur-Rehman, DDG, DRAP,.”
The experts Brig. Amir Ikram, AFIP, Rawalpindi &Dr. Masud-ur-Rehman, DDG, DRAP have furnished
their opnion which are taken up in the 263rd board meeting:
Expert opinion of Brig. Amir Ikram, AFIP, Rawalpindi

1. Product safety:
The provided literature shows that the preparations are safe. Trials have been conducted in the country of
origin with satisfactory outcome. The manufacturer is following GMPs.
2. Efficacy:
The clinical trials conducted in the country of origin indicate that the preparations are efficacious,
however further evaluation if requisite may be done.
The molecular description seems satisfactory. The provided material indicates that the preparations are
comparable to published literature. The preparations are required and if probably not incorrect not
much of preparations are easily available within the country. Its transportation under requisite
parameters especially temperature has to be guaranteed by the company at all levels.
b. Expert opinion of Dr. Masud-ur-Rehman, Additional Director, DRAP, IslamabadEvaluation of

dossier of Etanercept (Altebrel 25, 50mg).
Introduction:
Etanercept (Altebrel) is a dimeric fusion protein consisting of the extra cellular ligand-
binding portion of the human immunoglobulin 75 kilo Dalton (p75) tumor necrosis facor (TNFR) linked to
the Fc portion of human immunoglobulin (IgG1). Etanercept is produced by rDNA technology in a
Chinese Hamster ovary (CHO) mammalian cell expression system for use as a therapeutic inhibitor of
tumor necrosis factor (TNF), a pro-inflammatory cytokine. Etanercept is composed entirely of human
amino acid sequence. The Fc portion of Etanercept contains the CH2 and CH3 domains but not the CH1
domain of IgG1. It consists of 934 amino acids and has molecular weight of approximately 150 Kilo
Daltons.
Administrative Documents Elucidation
The legalized GMP certificate of Ertanercept (Alterbrel Injection 25, 50 mg) submitted is as evidence that
the manufacturer is an authorizaed manufacturer of biological drug in its country of origin. GMP
certificate date 06.04.2014 by M/s AryoGenBiopharma Co., Iran is legalized by embassy of Pakistan.
GMP compliance is evident from GMP.
Manufacturing Licensebaring No. 665/7940 dated 12.06.2012 is by ArygenZistDarou, Co., Iran confirms
atha manufacturer is licensed to manfacture recombinant humabn tumor necrosis is Legalized by embassy
of Pakistan.
Free Sale Certificate and CoPPhas been annexed, confirming that the product is available in the market in
Iran. Importer shall be authorized to import the finished biological product.
Authorization Letter confirms that the manufacturer is authorized manufacturer.
Structural Similarity Studies:

Structural smimlarity of subject biological drug product with reference biological product (innovator brand
in Enbrel, M/s Pfizer, USA). As per documents, recombinant human tumor necrosis factor receptor fusion
protein Etanercept (25mg and 50mg) prepared by company specific manufacturing process (finalized for
PCS stage) was used in product characherization studies:
i) Identity has been done b ycoomassie Blue Stain SDS-page, Silver Stain SDS-page, Ion-Exchange
chromatography, RP-HPLC and by UV spectrophotometry.
ii) Purity has been done by SDS page, SE HPLC, HIC and HPLC.
iii) Biological activity is done through anti-proliferation assay.
Bio-Comparability Studies:
Bio-comparability studies including identity testing to parent molecule has beenb done by SDS page, Ion-
exchage chromatography, purity testing by SDS page, SE HPLC, HIC HPLC ans in vitro biological
activity and potency by gel filtration chromatography and anti-proliferation assay.
Clinical Comparability Studies:
Clinical Data Annexure-XIV, Volume-I, Clinical Studies Annexure-IV, Volume-II is for comparision of
safety and efficacy with rederence product, prospective, randomized, double blind clinical trial to compare
the efficacy with reference product, comparison of baseline ACR components is as:
i) Comparison of the patient’s percentages who met 20%^ improvement in each of 7 components of
ACR criteria for three and six months
ii) Comparison of percentages of the changes which occurred in each of 7 components of ACR
criteria for three and six months.
iii) Comparison of the patient’s percentages who met ACR 20,50 and 70 after three and six months.
iv) Comparison of adverse events which occurred during the treatment is annexed.
Stability Studies:
Stability Studies is done for real time stability of twenty four months of COA-Altebrel 25mg/50 mg
respectively.
Presentation/Container:
Altebrel is supplied as pre-filled syringe containing a clear, pale yellow solution for injection.
Each pack contains 4 pre-filled syringes and with alcohol swabs. Shelf life is 2 years.
Recommendation:
In the light of evaluation of submitted documents, the product is recommended to be registered for
the availability to suffering poor patients. The submitted data should be evaluated by the inspecting panel
on site correctness and cGMP compliance.
The third expertGen. Muhammad Aslam, Member Registration Boardhas not furnished the opiniond
despite letter issued on dated 09-07-2016 and reminder on dated 08-08-2016. Accordingly, the case was
taken up in 263rd board meeting and decided as under:
“Registration Board deferred the above products for submission of biosimilarity data”
As per Schedule I of DRAP Act, 2012: “Biosimilarity” means Similar Biotherapeutic Product
which is similar in terms of quality, safety and efficacy to an already licensed reference biotherapeutic
product.
comparative clinical trials whereas, for quality lab tests Innovator product was used which requires in-
depth evaluation by the Division and the expert if required.
268th Meeting:
The case was again placed in 268th meeting of Registration Board wherein the Board decided as follows:
“Registration Board deferred above products for evaluation by Division of Biological Evaluation
&Research”

WHO Biosimilarity Guidelines Data Submitted by the firm
Quality Comparison i. Molecular Size, Integrity and Purity
1. Physicochemical a. SDS-PAGE scanning densitometry (Coomassie
Characterization staining SDS-PAGE)
b. Silver staining SDS-PAGE
ii. Analysis of higher order Structure
iii. Primary Structure
Peptide Mapping by Reverse Phase HPLC
iv. Post translational Modification
a. N-glycan Analysis
b. Glycopeptide Analysis
c. N-Glycopeptides
d. O-Glycopeptides
e. Fragmentation analysis of N- & O-glycopeptides
v. Peptide Mapping
vi. Protein Quantification
vii. Biological Activity In-vitro Biological activity (Protection from cell lysis by
TNFα)
viii. Immunochemical properties Fc Gamma Receptor Binding
SPR (Biacore)
ix. Impurities i. Process-Related Impurities and contaminants
a.Cell substrate-derived
b.Cell culture-derived
c.Downstream-derived
d.Contaminants
ii. Product-Related Impurities
a. Truncated forms
b. Aggregates
Stability Studies Stability studies are provided.
i. In-vitro Studies In-vitro Studies
ii. In-vivo Studies Comparative Primary pharmacodynamics
a. Biological/ Pharmacodynamic Evaluating the biological activity and in vitro potency of
activity Enbrel® and Altebrel by Parallel Line Assay (PLA)
b. Non- clinical toxicity as In-vivo Studies
determined in one repeat dose i) According to WHO 2009 Guidelines on Evaluation Of
toxicity study Similar Biotherapeutic Products (Sbps) (In vivo evaluation
of biological/ pharmacodynamic activity may be
dispensable if in vitro assays are available, which have
been validated to reliably reflect the clinically relevant
pharmacodynamic activity of the RBP)
ii) Toxicology studies
a. Single Dose intravenous toxicity study in Wistar
rat.
b. Single dose subcutaneous toxicity study in Swiss
albino mice
c. Repeated-Dose intravenous toxicity study in
Wistar rats
d. Local Tolerance
Clinical Comparison a. The comparison of efficacy and safety of a weekly
subcutaneous biosimilarEtanercept, Altebrel (n=32) with
the reference drug, Enbrel® (n=27) in the treatment of
patients with active Rheumatoid Arthritis: A double-blind
randomized clinical trial. (Phase 3)
b. A Post-marketing surveillance for safety and efficacy of
Altebrel in adults with Rheumatic disorders in Iran
(n=358).
c. Published study
Effect of TNF-α Blockade in Gingival CrevicularFluid on
Periodontal Condition of Patients with Rheumatoid
Arthritis. In this study, the periodontal health of 128
Iranian patients with active Rheumatoid Arthritis, treated
with Altebrel® was examined in a randomized clinical trial
(code no= IRCT201206266302N3)
Registration Board referred the instant application to the committee constituted in 273rd meeting of
Registration Board. The committee has asked the division of biological drugs to place cases in the
Board which have submitted complete data.
Decision: Keeping in view the biosimilarity data and submitted CoPP indicating that the products
are available for sale in the country of origin, Registration Board approved the above
products as per valid legalized CoPPs subject to price fixation by Federal Government and
Case No.4: Mabthera 1600mg applied by M/s Roche Pakistan Limited, Karachi approved
in 276th meeting of Registration Board.
Following products of M/s Roche Pakistan Limited, Karachi was approved in 276th
meeting of Registration Board as per following details:
Name of Importer M/s Roche Pakistan Limited, Karachi
Name of Manufacturer Product License Holder:
M/s Roche Registration Limited, 6 Falcon Way, Shire Park,
Welwyn Garden City AL7 1TW, United Kingdom
Manufacturer:
M/s F. Hoffmann- La Roche Ltd., Wurmisweg, 4303
Kaiseraugst, Switzerland.
Brand Name +Dosage Form +Strength Mabthera Solution for Injection
Rituximab……….120mg
Finished product specifications In-house Specs.
Approval status of this product in Reference USA, UK, Netherlands, Germany, France, etc.
countries
Pharmacological Group Monoclonal antibody
Shelf life 30 months(2-80C)
International Availability of this product Argentina, Greece, Hungary, Italy, Korea, Cyprus etc.
Similar Product already registered in Not Applicable
Pakistan
Type of Form Form-5A
Dy No & Date of application, Dy. No. 727
Fee submitted 19-09-2017
Rs. 50000/- dated 18-09-2017
Demanded Price/ Pack size 1’s Vial/ Price not provided.
General documentation Valid legalized CoPP No. 15/17/111871 dated 21-08-2017
issued by EMA.
(Muhammad Zubair AD)
In this context, it is submitted that while recording the minutes of 276th meeting the strength of
Mabthera was inadvertently missed and written as “Mabthera Solution for Injection” instead of
“Mabthera Solution for Injection (Rituximab 1600mg/vial)”. Moreover, pack size was mentioned
as “1’s vial” instead of “1’s vial (1600mg/13.4ml)”.
Decision: Registration Board approved the following correction in minutes of 276th meeting
of Registration Board:
a. Brand Name as Mabthera Solution for Injection (Rituximab 1600mg/vial)
b. Pack Size as 1’s vial (1600mg/13.4ml).
Case No.5: Request of M/s Sanofi-Aventis Pakistan, Karachi for Registration of new
strength of his already registered product Enterogermina.
M/s Sanofi-Aventis Pakistan applied for Registration of a new strength of their already
registered product and the case was placed before the board in its 268th and 275th meeting. The
Board decided as under;
Manufacturer Brand Name & Type of Form, Documents Decision of 275th
Composition Fee submitted, Details meeting of RB
Pack Size/Price
M/s Sanofi- Enterogermina Form-5A Legalized CoPP Registration Board
aventisS.p.AV 4 billion / 5ml oral Dy. No. 645 dated No.CPP/2016/504 decided to refer the
iale suspension 04-07-16 & CPP/2016/181 matter to DRAP's
Europe,11- Fee Rs.100000 dated 14-03-2016 authority with
Origgio (VA), One vial of 4 billion dated 22-06-16 GMP No.IT/54- Complete
Italy contains: Pack size: 1x20 4/h/2015 dated background of case
4 billion spores of Vials 1x10 Vials 03/06/2015 in light of its earlier
multi-antibiotic- Price: As per DPC decision in 39th
resistant Bacillus meeting held on 03rd
clausiiPurified water qs November,2016.
5ml.
Shelf life: 2 years
It is worth noting that the same product in different strength (2 billion) is registered vide
Registration No.069588. It is submitted that DRAP’s authority in its 39th meeting dated 3rd
November, 2016 has decided that Brand name registered under the Drug Act.1976 cannot be
enlisted under Alternative medicines / Health & OTC (non-drug) products. The decision was
reproduced as under for ready reference
“The Authority decided that:-
1. No nutraceutical product or alternative medicines already registered as drugs under the
Drugs Act, 1976 shall be allowed for switch over from drug category to alternative
medicines or Health & OTC (non-drug) category. Therefore, those who want to switch
for price de-registration due to such switching will not arise.
2. Those who are interested in enlistment under alternative medicines enlistment rules
where applicable may apply fresh under new brand names. Brand names even registered
as drug will not be allowed to be registered under Alternative medicines / Health & OTC
(non-drug) products. It was further decided that brand names already registered under
the Drugs Act, 1976 will not be allowed by the Health & OTC (non-drug) Division for
enlistment purpose. Even already registered name with some suffix or prefix shall also
not be allowed to avoid any confusion, misinterpretation or misleading patient and
prescriber, so as to avoid any confusion or risk to patient. So use of same or similar
name or similar sonic (sound alike or look alike) can create problems and legal
complications for the DRAP and risk to patient.
3. For future, it was decided that nutraceutical products with therapeutic claims and using
ingredients above RDI shall continue to be registered as drugs while rest shall be
enlisted by the Health & OTC (non-drug) Division under their respective rules.”
Therefore, as per above decision of the DRAP authority in its 39th meeting, the product i.e.
Enterogermina 4 billion/ 5ml cannot be enlisted under Alternative medicines / Health & OTC
(non-drug) products.
Decision: Keeping in view the decision of 39th meeting of DRAP’s authority that the
brand names already registered under the Drugs Act, 1976 will not be
allowed by the Health & OTC (non-drug) Division for enlistment purpose,
Registration Board referred the application back to DBER for evaluation
and further processing.
Case No. 6: Deferred in 262nd meeting of Registration Board 3Fluart Suspension for
Injection of M/s Amson Vaccines &Pharma. Islamabad, Pakistan.
Following product of M/s Amson Vaccines &Pharma, Pakistan was deferred in 262nd
meeting of Registration Board held on 20-21st, October, 2016 for following:
a. Under composition the quantities of excipients is not provided.
b. Specimen labels need to be submitted in English language
c. Stability data is required as merely protocols are submitted by the firm.
d. Verification of WHO recommended influenza strain
Name of Brand Name & Composition Type of Form Dy Document
Importer & No & Date of details
Manufacturer application Fee (CoPP)
submitted Pack
size/Demanded
Price
M/s FLUART 3Fluart Suspension for Injection Form 5A Legalized
Innovative Infuenza vaccine (whole virion, inactivated, CoPP No.
Vaccines Kft. adjuvated) Dy No. OGYEI/656
(FluartInnovativ 3458/2016 (R&I) 01-2/2017
e Vaccines Ltd), One dose of vaccine (0.5ml) contains: 04-08-2016 dated
2097 A/Michigan/45/2015 (H1N1) pdm09–like strain Rs. 100000 20/11/2017
Pilisborosjeno, (A/Michigan/45/2015, NYMC X-275) 16-06-2016
Fo u 7. Hungary. ………….6 mcg HA
A/Hong Kong/4801/2014 (H3N2)–like strain Glass ampoule of
(A/Hong Kong/4801/2014, NYMC X-263B) ... 20x0.5ml & 1x0.5
……6mcg HA ml/ As per DPC
B/Brisbane/60/2008 – like strain
(B/Brisbane/60/2008, NYMC BX-35)
………….…6 mcg HA
Shelf life: 15 months
The firm submitted the following documents:
a. Composition of the product (Including quantities of excipients)
b. Specimen labels are submitted in English language
c. Stability data
d. The strains as per submitted CoPP are as per WHO recommendation for use the 2017-18
northern hemisphere influenza seasons.
Decision: Keeping in view valid legalized CoPP; Registration Board approved the product
subject to price fixation by the Federal Government and compliance of current
Import Policy for Finished Drugs.
Case No. 7: Registration of products for EPI/ Govt. Supply.

Division of biological evaluation & research come across that many cases where initially
the products were approved by the Registration Board but price was not yet fixed by the Federal
Government. Meanwhile, the firms apply for issuance of registration letters for EPI/ Govt
Supplies and the letters are issued with the approval of Chairman Registration Board as per
request of the firm.
After the price fixation by the Federal Government, there is a possibility of misuse of
registration letter (without price) for Government supplies only. Therefore, the case was referred
to Chairman Registration board for his opinion as Chairman Registration board is authorized.
The following opinion of Chairman Registration Board referred to Legal Affairs Division for
their comments:
a. Issuance of new registration lettermentioning MRPwith cancellation of previous
registration letter
b. Issuance of letter mentioning MRP of the product in continuation to already
issued registration letter.
The response of Legal Affairs Division is as under:
“Option ‘b’ is more reasonable in which the element of delay is excluded. In fact any
delay in issuance of registration letter were on presumption of misuse of the former registration
letter is not justified. Moreover, in case of any misuse of registration letter it is the duty of
Authority under section 7(t) of the DRAP Act, 2012 to ensure safety, efficacy and quality of
therapeutic goods with rational use at reasonable price”
Therefore, if all the requirements have been fulfilled by the firm then option ‘b’ is more
suitable”
Decision: Registration Board deliberated the matter of cases where initially the
registration letters are issued for EPI/ Govt Supplies and MRP is fixed
afterwards by the Federal Government for sale in the market and thus
decided as follows:
a. The initial registration letter for EPI/ Govt Supplies will be issued with the
condition that the price will be communicated after price notification by
Federal Government.
b. After MRP fixation, letter mentioning MRP of the product in continuation to
already issued registration letter will be issued.
Case NO. 8: Imported veterinary biologicals applied by M/s Vet Pharma Trading
Company, Gujranwala deferred in 273rd meeting of Registration Board.
Following veterinary biological drug of M/s Vet Trading Company, Korea was considered in
273rd meeting of the Registration Board wherein the board decided as under;
Name of Importer M/s Vet Pharma Trading Company, New steel market, near regent
cinema, G.T road, Gujranwala-Pakistan
Name of Manufacturer M/s KBNP, INC
254-18, Dugok-Ri, Senam, Yesan, Chungnam, Korea
235-9, Chusaro, Senam, Yesan, Chungnam, Korea.
Brand Name HimmvacDalguban N Plus Live Vaccin
Composition Each dose contains:
Live attenuated virus NDV strain “KBNP-C4152R2L”……..Min. 106.0
EID50/dose
Pharmacological Group Poultry Vaccine
Specification In-house Specs
Approval status in reference New Castle Disease Vaccine (La Sota ) by Merial Select Inc USA
countries
International Availability None
Products already registered in Inmugal V.P La Sota Live Vaccine By M/S Rock Way Karachi. Reg.
Pakistan No. 021293
Dy No & Date of application Dy. No. 7957(R&I) Date: 07-07-2017
Fee submitted Rs. 1,00,000/- Date: 06-07-2017
Pack size 2000 doses /Bottles
General documentation Legalized GMP issued on 24-04-2017.
Legalized Free Sale Certificate issued on 24-04-2017.
Remarks of Evaluator  Scientific literature shows “KBNP-C4152R2L” is a “Recombinant
La Sota strain”.
 Accelerated stability data is not provided.
 Long term stability data reveals initial virus content of 107.1 which
gradually decreases up to 106.4 till 27th month and remain more than
Min. 106.0 EID50/dose throughout stability profile.
 Sole Agency Certificate is not provided.
 The applied formulation is included in official monograph Ph. Eu
while firm has provided specs without any reference.
Decision: Registration Board decided to defer the application and advised the firm to submit the following
documents/clarification.
i. Accelerated stability data.
ii. Sole Agency Certificate.
iii. Justification for the use of KBNP-C4152R2L strain of Newcastle Disease virus.
Above mentioned decision of the Registration Board was communicated to the firm and the firm
replied with following document;
1. Original legalized Certificate of Sole Agent Authorization.
2. For Strain Justification, the firm has submitted that “as the instant applied registration is for
Recombitek La Sota strain (KBNP-C4152R2L), and we already have registered vaccine
named “Himmvac ND LaSota (Reg. No. 052303)”.
It is submitted that the already registered vaccine is also with the same strength i.e. Newcastle
disease virus LaSota strain……. At least 106.0 EID50/dose”.
Furthermore, the firm has submitted published safety and efficacy of “KBNP-C4152R2L-
Recombinant La Sota strain” which is summarised as under;
“A recombinant La Sota strain (KBNP-C4152R2L) in which fusion (F) and hemagglutinin-
neuraminidase (HN) genes were replaced with those of a contemporary genotype VIId virus,
KBNP-4152, has been developed. To attenuate the virulence of the recombinant strain, the F
cleavage motif was mutated from 112RRQKR116 to 112GRQAR116, and to reduce pathogenic
instability, a codon which does not allow changes to basic amino acids by single point mutation
was inserted at codon 115. In addition a six-nucleotide sequence was inserted into the intergenic
region between matrix protein and F genes for attenuation without breaking the “rule-of-six.”
The HN protein length was increased from 571 to 577 as a marker. Serological tests revealed that
the antigenicity of KBNP-C4152R2L was similar to that of KBNP-4152 but distinct from that of
the La Sota strain. KBNP-C4152R2L was avirulent (intracerebral pathogenicity index, 0.0; mean
death time, >168 h) and stable in pathogenicity through in vivo passages. The killed oil emulsion
of and live KBNP-C4152R2L were completely protective against mortality and egg drop caused
by virulent strains, and KBNP-C4152R2L was applicable to in ovo vaccination. Therefore,
KBNP-C4152R2L is a promising vaccine strain and viral vector in terms of antigenicity,
productivity, safety, and pathogenic stability.”
3. For accelerated stability study the firm has reply is as under;

“Through our study in the below regulations, it seems that the requested stability data is not
necessary.
Please refer to the page 9 of attached ICH Q5C regulation first. Please see the below clause.
Although the tripartite guideline on stability describes the conditions of the accelerated and
stress study, the applicant should note that those conditions may not be appropriate for
biotechnological/biological products. Conditions should be carefully selected on a case-by-
case basis.
Actually, Accelerated test (25+2◦C), for 6months) of biological product like vaccine is no
meaning because vaccine should be stored in cool condition.
According to International CTD guideline, the above test is required for ointment and
eye drop etc.”
Decision: Registration Board deferred the application for following:

a. Submission of clarification by the firm regarding the high temperature
exposure affects on the product.
b. The case shall be evaluated on the basis of ICHQ5C guidelines by DBER.
Case No. 9: Freclot Injection applied by M/s RG Pharmaceutica (Pvt.) Ltd., Lahore
deferred in 273rd meeting.
M/s RG Pharmaceutica (Pvt.) Ltd., Lahore applied for the registration of Freclot Injection. The
case was deferred in 273rd meeting of Registration Board as per following details:
Name of Importer RG Pharmaceutica (Pvt.) Ltd. Suit #703 progressive square block 6,
P.E.C.H.S Shahrah-e-Faisal, Karachi-75400, Pakistan
Name of Manufacturer Ms/ North China Pharmaceutical Co. Ltd. No. 115 Hainan Road,
Economic & Technological Development Zone, Shijiazhuang, China
Brand Name Freclot Injection 25000IU/5ml
Heparin sodium ….5000 IU
Finished product USP Specs
specifications
Approval status in Reference Heparin 5000IU/ml, solution for injection by Panpharma UK Ltd.
countries
Products already registered in Heptar 5000IU/ml (063936)
Pakistan Heparin Regalab (066083)
International Availability Philippines
Type of Form Dy No. 2524/2017(R&I) 25-01-2017
Dy. No & Date of Rs.100,000/- Date: 11-01-2017
application. Fee submitted
Demanded price /Pack size Not provided/10 x 5ml vials
General documentation Valid Legalized CoPP No. 20170178 dated 22-03-2017.
Decision of Registration Registration Board deferred the application for submission of clinical
Board in 273rd meeting. trial data and clarification from firm as previous CoPP does not confirm
market availability status in China whereas later CoPP shows it
available.
Remarks of Evaluator The firm has submitted the following:
Justification on Clinical Data: As per SFDA China guidelines, Heparin
Sodium Injection 25000IU/5ml belongs to supplementary applications.
According to provision for Drug registration, the clinical study
requirement for supplementary applications are to submit clinic using
reports or literatures.
Clarification on CoPP: We hereby inform you that at the time of
submission of the dossier of Freclot injection (Heparin Sodium
25000IU/5ml) the same was not registered by SFDA China and
accordingly, the new CoPP has been updated and revised CoPP has been
submitted for your consideration.
Decision: Keeping in view the availability of product in country of origin as per submitted CoPP
and Heparin injection being non-rDNA pharmacopoeial product, Registration Board approved the
Freclot Injection 25000IU/5ml as per valid legalized CoPP subject to price fixation by Federal
Government and compliance of current Import Policy for Finished drugs.
Case No. 10: Rilast applied by M/s GenixPharma Karachi.
Following applications of M/s Genix Pharma, Karachi applied for registration as per
following details:
Sr. Name of Importer & Brand Name & Type of Form Document details
No. Manufacturer Composition Dy No & Date of (CoPP)
1. M/s GenixPharma Rilast (Rituximab) Form 5-A Legalized valid CoPP
(Pvt)Ltd., 44 45-B infusion 100mg/10ml. Dy No. No:
Korangi Creek Road, 618/2016(R&I) DI/SAN/KTR/CoPP/2
Karachi Each 10 ml vial contains 27-04-2016 2.08.2015-13 dated
M/s Hetero Drugs Limited Rituximab(rDNA origin) 453-ADC(BD) 22-08-2015
Unit-III, TSIIC- In-house……100mg 27-04-2016
Formulation SEZ, Sy Rs.100,000/- MabThera 100mg of
No.458(pert), Anti neoplastic 18-04-2016 Roche products (UK)
Polepally(Vi), Jadecheria Pack of 1’s/
(Md), In-house Specs Rs. 17,250/- Ristova of Roche
Mahaboobnagar(Dt)—509 Pakistan Ltd.
301, Telangana, India. Shelf Life: 2 years
2. M/s GenixPharma Rilast (Rituximab) Form 5-A Legalized valid CoPP

(Pvt)Ltd., 44 45-B infusion 500mg/50ml. Dy No. No:
Korangi Creek Road, 619/2016 (R&I) DI/SAN/KTR/CoPP/2
Karachi Each 50 ml vial contains 27-04-2016 2.08.2015-11 dated
M/s Hetero Drugs Limited Rituximab(rDNA origin) 452-ADC(BD) 22-08-2015
Unit-III, TSIIC- In-house……500mg 27-04-2016
Formulation SEZ, Sy Rs.100,000/- MabThera 500mg of
No.458(pert), Anti neoplastic 18-04-2016 Roche products (UK)
Polepally(Vi), Jadecheria Pack of 1’s/
(Md), In-house Specs Rs. 85,500/- Ristova of Roche
Mahaboobnagar(Dt)—509 Pakistan Ltd.
301, Telangana, India. Shelf Life: 2 years
Case History
In 263rdRegistration Board meeting the case was initially considered and Board:“Deferred due to paucity of
time”
In 264thMeeting:The case was again placed before the board in 264th meeting and Board “Deferred the
product for evaluation of biosimilarity data”
The firm has submitted the biosimilarity data which requires in-depth evaluation by the
Division and the expert if required. Further the Innovator has already gone to court against the previous
Board decision to consider similar molecule and has obtained a stay order against the issuance of registration
letter to M/s Macter Karachi.

WHO Biosimilarity Guidelines Data Submitted by the firm
Quality Comparison i. Peptide Mapping
1. Physicochemi For identity testing targeting the primary sequence.
cal Characterization ii. Concentration by Absorbance 280 method
To determine the concentration of the sample.
iii. UV-Absorption Spectra
To determine and compare the UV absorption spectra of product with
that of reference.
iv. Sodium dodecyl sulphate polyacrylamide gel
electrophoresis (Non-reducing and Reducing)
To determine the purity of product with respect to molecular weight
impurities.
v. Size Exclusion Chromatography (SEC-HPLC)
To determine the product aggregates / multimers.
vi. Cation Exchange Chromatography (CEX)
For purity determination in terms of charge variants.
vii. Reduced reverse phase chromatography (RPC)
For purity determination in terms of hydrophobic related substances
including light and heavy chain
viii. Capillary Electrophoresis SDS-PAGE (Reducing)
For quantitation of non-glycosylated heavy chain and relative
percentages of light and heavy chains
ix. Capillary Electrophoresis SDS-PAGE (Non-
Reducing)
For quantitative determination of the degradation products (LMW
impurities).
x. Capillary IEF
For Isoelectric point determination
xi. Intrinsic Fluorescence
For tertiary structure elucidation.
xii. Extrinsic Fluorescence
For tertiary structure elucidation
xiii. Hydrophilic (HILIC) Chromatography
For Glycan forms determination.
xiv. Bioassay (CDC)
For relative biological efficacy.
2. Biological Comparative In vitro Biological activity is provided.
Activity
3. Immunochemi i) Receptor Binding Activity
cal properties ELISA test
ii) Affinity Analysis
4. Impurities i. RPC method was performed to check the purity in
terms of hydrophobic related impurities.
ii. CE-SDS PAGE was performed at both reducing and
non-reducing condition (Low molecular weight impurities).
5. Stability Stability study provided
Studies
i. In-vitro in-vivo Studies
Studies If the quality biosimilar comparability exercise and the nonclinical in
ii. In-vivo vitro studies are considered satisfactory and no issues are identified
Studies which would block direct entrance into humans, an in vivo animal
a. Biological/ study may not be considered necessary. (Guidelines on evaluation of
Pharmacodynamic activity. monoclonal antibodies as similar biotherapeutic products (SBPs)
b. Non- clinical (World Health Organization 2016).
toxicity as determined in one i) Safety Pharmacology
repeat dose toxicity study. Toxicology
a. Single Dose Toxicity
b. Repeated Dose Toxicity
c. Local Tolerance
6. Clinical i. A Randomized, Multiple-dose, Multicenter,
Comparison Comparative Parallel Study to Evaluate the Efficacy, Safety and
Pharmacokinetic Characteristics of Intravenous Infusion of Rituximab
(Hetero) and Reference Medicinal Product (Rituximab, Roche) in
Indian Patients of Non-Hodgkin's Lymphoma (Sample size of 52 per
arm 104 completers for two arms was required for this study
ii. An Observational, Non-Interventional, Multi-Centric
Postmarketing Surveillance Study Evaluating The Safety and
Tolerability of The Labeled Usage Of Hetero - Rituximab In
Prescribed Patients.
iii. Published study
A Randomized, Multiple-dose, Multicenter, Comparative Parallel
Study To Evaluate The Efficacy, Safety And Pharmacokinetic
Characteristics Of Intravenous Infusion Of Rituximab (Hetero)
And Reference Medicinal Product (Rituximab, Roche) In Indian
Patients Of Non-Hodgkin's Lymphoma (HERILY Study)
(http://adisinsight.springer.com/trials/700237414)
Registration Board referred the instant application to the committee constituted in 273rd
meeting of Registration Board.
The committee has asked the division of biological drugs to place cases in the Board which have submitted
complete data.
Decision: Registration Board deferred the product for submission of valid legalized CoPP or GMP &
FSC.
Case No. 11: Approval of Intradermal route of administration of Rabio Vaccine (Reg. No.
059094) applied by M/s Atlantic Pharmaceutical, Karachi.
M/s Atlantic Pharmaceutical, Karachi applied for the approval of Intradermal
route of administration of their already registered Rabio Vaccine (Reg. No. 059094). The firm
has submitted following documents:
i. Copy of initial registration letter
ii. Copy of application of last renewal
iii. Copy of GMP certificate issued by Ministry of Public Health, Thailand
iv. Notarized copy of Drug renewal registration certificate
v. Notarized copy of certificate of product registration of Purified Rabies Vaccine issued by
FDA, Philippines
The firm provided the reason for the said change that WHO recommended in 1995, multisite
intradermal route of administration for cell culture rabies vaccine to decrease the cost of
administration of vaccine, therefore it is requested to kindly allow Intradermal route to be
mentioned on label and unit carton and leaflet of Rabio. Previously DRAP has approved in 241st
meeting same for M/s Novartis Pharma product name “Rabipur” Reg. No. 018238 and M/s
Hospital Sales & Services for “Indirab” Reg. No. 053814. The firm further submitted that as
WHO recommended the route of administration therefore in order to reduce the cost of treatment
the firm requested the same for Rabio vaccine (Reg. No. 059094).
The firm has not provided the legalized approval of Intradermal route of administration of Rabio
Vaccine (Reg. No. 059094) from country of origin.
The firm on 18-01-2018 submitted a letter wherein the firm requested for the issuance of an
acknowledgement of aforementioned application. The firm further submitted that there is a
tender floated and in process of finalization by Health Department Government of Sindh where
the government wants an assurance from DRAP that the product can be used Intradermal.
Decision: Keeping in view the WHO recommendation and already granted approval of
Intradermal route to Rabies vaccine of M/s NIH, Islamabad, Registration Board
approved the Intradermal route of administration of Rabio Vaccine (Reg.No.
059094).
Case.No.12: Change of Manufacturing Site for the following products by M/S. Novo
Nordisk Pharma (Pvt.) Limited, Karachi.
M/s. Novo Nordisk Pharma (Pvt) Limited, Karachi has requested for change of
manufacturing site for their already registered imported human product as per following details:-
Brand Name Composition & Reg. Current Manufacturing New Manufacturing Site
No Site
Actrapid HM Penfill M/s. Novo Nordisk Novo Nordisk A/s, Novo Allé,
(Reg. No. 010344) Production SAS 45 Avenue 2880 Bagsvæd, Denmark (also
100IU/ml,3ml X 5’s Pack d’ Orleans 28002 Chartres responsible for batch release in
Each ml solution contains France the EU and primary packaging
Insulin human (rDNA)….100 IU
Insulatard HM Penfill M/s. Novo Nordisk Novo Nordisk A/s, Novo Allé,
(Reg. No. 010341) Production SAS 45 Avenue 2880 Bagsvæd, Denmark (also
100IU/ml,3ml X 5’s Pack d’ Orleans 28002 Chartres responsible for batch release in
Each ml solution contains France the EU and primary packaging)
Insulin human (rDNA)….100 IU
The firm submitted the following documents;

Sr. Brand Documents provided by the firm Remarks
No Name,
1. Actrapid HM i) Application on Form 5A along with annexures. Brand name
Penfill ii) Fee of Rs. 50,000/- in the initial
iii) Original & legalized CoPP issued by EMA. Registration
iv) Legalized GMP issued by Danish Medicines Agency. letter &
v) Site master plan of the manufacturer subsequent
vi) Stability data. letters are
vii) Copy of initial registration letter vide brand Name of different as
InsulinActrpid HM Penfill 100IU/mlin the name of M/s mention
Worldwide Trading Co Karachi dated 28-02-1990 against each
viii) Copy of Transfer letter into the name of M/s Norvins in the
International Karachi dated 24-04-1991 without mentioning the column#3
brand name.
ix) Copy of Additional Packs approval letter vide brand Name of
Insulin Actrpid HM Penfill 100IU/ml
x) Copy of Transfer letter vide brand Name of Actrpid HM
Penfill5x3ml into the name of M/s. Novo Nordisk Pharma (Pvt)
Limited, Karachi dated 11-11-2005.
xi) Last renewal application was submitted on 16-04-2015 to this
division.
2. Insulatard i) Application on Form 5A along with annexures. Brand name
HM Penfill ii) Fee of Rs. 50,000/- in the initial
iii) Original & legalized CoPP issued by EMA. Registration
iv) Legalized GMP issued by Danish Medicines Agency. letter &
v) Site master plan of the manufacturer subsequent
vi) Stability data. letters are
vii) Copy of initial registration letter vide brand Name of different as
InsulinProtaphanHM Penfill 100IU/mlin the name of M/s mention
Worldwide Trading Co Karachi dated 28-02-1990 against each
viii) Copy of Transfer letter into the name of M/s Norvins in the
International Karachi dated 24-04-1991 without mentioning the column#3
brand name.
ix) Copy of Additional Packs approval letter vide brand Name of
Insulin InsulatardPenfill100IU/ml
x) Copy of Transfer letter vide brand Name of Insulatard HM
Penfill5x3ml into the name of M/s. Novo Nordisk Pharma (Pvt)
Limited, Karachi dated 11-11-2005.
xi) Last renewal application was submitted on 16-04-2015 to this
division.
Decision: Keeping in view valid legalized CoPP and approval of EMA (Reference
Regulatory Authority/country); Registration Board approved the change of
manufacturing site from M/s. Novo Nordisk Production SAS 45 Avenue d’
Orleans 28002 Chartres France to M/s Novo Nordisk A/s, Novo Allé, 2880
Bagsvæd, Denmark subject to compliance of current Import Policy for
Finished Drugs.
Case No. 13: Product applied by M/s Matrix Pharma Pvt. Ltd. Karachi approved in 270th
meeting of Registration Board for exemption of foreign inspection of
imported finished products from Korea.
Following product of M/s Matrix Pharma Pvt. Ltd. Karachiwas approved
in 270th meeting of Registration Board. The details are as under:
Name of Brand Name & Composition Document details Decision of RB in 270th meeting
Manufacturer (CoPP)
M/s Dong-A ST Gonadopin NF Injection Valid Legalized As per clinical trial data and
Co., Ltd, 493, Prefilled Syringe CoPP No. 2013- CoPP submitted by the firm
Nongong-ro, 225IU/0.75ml A1-1375 dated 02- indicating that above product is
Nongong-eup, Each 0.75ml contains: 07-2013 licensed and available for sale in
Dalseong-gun, Recombinant human follicle the country of origin,
Daegu (N-dong, Stimulating Hormone (Host Registration Board approved the
B-dong Section Cell: CHO dhfr- cell, Vector: above products as per Import
2), Korea. Rc. CMV-dhfr-TPL-FSH) ... Policy for Finished Drugs and
225IU valid legalized CoPP. The same
Gonadotropin formulations have already been
For the treatment of infertility registered by the Registration
Shelf Life: 24 months Board from non-reference
In-house Specs countries.
Before foreign inspection the firm request that Gonadopin NF Injection Prefilled Syringe
225IU/0.75ml which is line extension of the products included in panel inspection list, but it was
not included.
The above manufacturing site has recently been inspected on 04-05th December 2017 by panel of
inspectors Dr. Noor-us-Saba and Mr. Abid Hayat for same category of following products
approved by the Registration Board in its 268th meeting i.e.
i. Gonadopin NF Injection Prefilled Syringe 75IU/0.25ml.
ii. Gonadopin NF Injection Prefilled Syringe 150IU/0.5ml.
iii. Gonadopin NF Injection Prefilled Syringe 300IU/ml.
The panel rated the facility as “Very GOOD” and recommended the facility but it was pointed
out that product applied strength for exemption is not mentioned in foreign inspection report.
Therefore, in light of above panel inspection report and decision of Registration Board in its
262nd meeting, the exemption of inspection of above products may be granted.
It was further discussed in the meeting that there are many cases where the firms, who have not
made arrangements for the inspection abroad, apply for the foreign inspection exemption on the
basis of already conducted inspection exemption arranged by some other firm.
Decision: Keeping in view the inspection report of panel of inspectors dated 04 th-05th
December, 2017 as recorded above, reflecting that facility was inspected at
that time for same category of products and falls within the time span of five
years in accordance with procedure adopted in 262nd meeting of Registration
Board, hence the Board acceded to the request of the firm for exemption of
inspection of manufacturing facility i.e. M/s Dong-A ST Co., Ltd, 493,
Nongong-ro, Nongong-eup, Dalseong-gun, Daegu (N-dong, B-dong Section 2),
Korea for above product as per current Import Policy for Finished Drugs.
The Board also advised the DBER to bring proposal for grant of foreign inspection
exemption to the firms who has not made arrangements for the inspection abroad.
IV. DENGUE VACCINE.
Case No. 1 Price Fixation of Dengue Vaccine.

The case of price fixation of Dengvaxia Powder for Injection &Dengvaxia MD
Powder for Injection was considered in meeting of DPC held on 6th-7th December, 2017 wherein
following is decided:
“In the light of reports from Department of health Govt of Philippine with respect to
temporarily halting dengue vaccination program due to safety concern, the committee
considered it appropriate to refer back the matter to Registration Board for reconsideration
of safety profile”
Case No. 2 Philippines Food and Drug Administration (FDA) latest updates:
M/s Sanofi-Aventis Pakistan Limited, Karachi submitted the latest update on
Dengvaxia wherein it has been stated that the Philippines Food and Drug Administration (FDA)
notified Sanofi Pasteur of a one-year suspension of Dengvaxia® Marketing Authorization.
Furthermore, the firm narrated that according to the notification, this suspension is linked to an
alleged failure to comply with post-marketing requirements and is not linked to the product
profile. The statement submitted by the firm has been reproduced as under:
“This is with reference to the subject cited above.
We would like to inform you that on December 29th, 2017 the Philippines Food and Drug
Administration (FDA) notified Sanofi Pasteur of a one-year suspension of Dengvaxia®
Marketing Authorization. According to the notification, this suspension is linked to an alleged
failure to comply with post-marketing requirements and is not linked to the product profile.
As part of our standard company practices, Sanofi routinely conducts post-approval
commitments to continuously evaluate the safety and effectiveness of our vaccines in the
countries where they are in use, and we have done so in the Philippines with Dengvaxia®.
Sanofi Pasteur confirms that in accordance with international and local laws, regulations and
company standards, post-approval commitments for Dengvaxia®, as described in the
pharmacovigilance plan submitted to the Philippines FDA and other national regulatory
authorities, have been – and will continue to be - fulfilled.
Sanofi Pasteur will continue to cooperate in full transparency with the Philippines FDA and
is committed to comply with the Philippines laws and regulations.
The global risk management and pharmacovigilance plan for Dengvaxia® is the same for all
countries where the product has been approved, and periodic reports are submitted to the
national regulatory authorities (NRAs) where Dengvaxia® is approved. No other requests of
market withdrawal or license suspension have been received from other NRAs where the
vaccine is approved.
As of today, Dengvaxia® is registered in following 19 countries:
Argentina, Bolivia, Brazil, El Salvador, Costa Rica, Guatemala, Honduras, Mexico, Peru,
Venezuela, Philippines, Paraguay, Australia, Cambodia, Malaysia, Thailand, Bangladesh,
Singapore, Indonesia.”
Case No. 3 Exemption of labeling text on Dengvaxia vaccine approved in 275th meeting
of Registration Board.
M/s Sanofi Aventis Pakistan Limited requested for the grant of exemption in
labeling text (Urdu Text, MRP and Registration Letter) for the following vaccines at the time of
importation into Pakistan.
S. Manufacturer Reg. No Product
No.
1. Sanofi Pasteur Parc 082506 Dengvaxia,
Industrial Incarville, (Dengue tetravalent vaccine) Powder and solvent
27100 Val de Reuil for suspension for injection
France.
2. -do- 082507 Dengvaxia MD,
(Dengue tetravalent vaccine) Powder and solvent
for suspension for injection
The case was considered in 275th meeting of Registration Board wherein the board decided as
follows:
“Registration Board acceded to the request of the firm for import of Dengvaxia (Powder and
solvent for suspension for injection) Reg. No. 082506 and Dengvaxia MD (Powder and solvent
for suspension for injection) Reg. No. 082507 without MRP, registration number and urdu text
and printing the same at licensed premises of M/s Sanofi Aventis, plot 23, sector 22, Korangi
Industrial area, Karachi before sale. Other terms and conditions shall remain same.”
Under the current circumstances regarding Dengue vaccine, DBER seeks guidance of the
Registration Board whether exemption approval letter should be issued or otherwise.
Case No. 4: Communication of decision of 277th meeting of Registration Board to EPI,

Provincial governments including ICT, AJK & Gilgit Baltistan Health
Department to get their recommendation under the present scenario
regarding Dengue Vaccine.
The case of Dengue Vaccine recent scenario was included in the agenda of 277th
meeting of Registration Board and the firm was called for personal hearing in the same meeting.
Registration Board deliberated the matter in detail and decided as follows:
 “Use of dengue vaccine (Dengvaxia) is indicated / recommended only in individuals with
a documented past dengue infection (seropositive persons), confirmed either by a
diagnostic test or by a documented medical history of past dengue illness. Moreover,
vaccine is not indicated for a mass vaccination program as it is indicated for use in
seropositive individuals as this vaccine is the only remedy for already exposed patients.
In case of not using the vaccine, possibility of mortality can be high as observed in
previous years.
 Registration Board, DRAP will review case further as soon decision of WHO Strategic
Advisory Group of Experts (SAGE) on immunization becomes available in April 2018
and/ or new findings become available in the meantime based upon either post
marketing safety surveillance data obtained domestically/ internationally or new
findings from clinical trials.
 To issue an advisory to EPI, Provincial Health Departments including ICT, AJK and
Gilgit-Baltistan Health Department regarding use of dengue vaccine (Dengvaxia) only
in individuals with a documented past dengue infection (seropositive persons), either by
a diagnostic test or by a documented medical history of past dengue illness which is in
line with latest WHO guidelines for use of Dengue vaccine. Moreover, they will also
share pharmacovigilance data with DRAP.
 Registration Board advised to coordinate with EPI, provincial governments including
ICT, AJK and Gilgit-Baltistan Health Department to furnish their recommendations
under present scenario as registration letter was issued for government purpose only
based on bidding documents (for procurement of vaccine, anti-dote and immunoglobulin
for year 2017-18, Government of Punjab) that would be presented before Registration
Board in next meeting.
 M/s Sanofi Aventis, Pakistan is also advised to follow course of action:
 To share any new information regarding use of Dengvaxia with Registration Board,
DRAP without any delay.
 To share complete pharmacovigilance data / AEFI as per standard procedure defined
under ICH and WHO guidelines and DRAP's letter Nos. F.1-1/2014/DDG(PV) dated
05.06.2014 and F.9-3/2017-DD(PS)Pt dated 31.10.2017.
 To educate medical practitioners regarding indicated / recommended use of Dengvaxia.
 To take measures for awareness of general public regarding recommended use of dengue
vaccine (Dengvaxia) under medical supervision only.
 To inform DRAP when the firm is supplying vaccine to any provincial
Government/institution”.
Accordingly, the letter was processed for communication of decision to EPI, Provincial
governments including ICT, AJK & Gilgit Baltistan Health Department to get their
recommendation under the present scenario. DBER is of the opinion that the letter to secretaries
of all provinces including ICT, AJK & GB may be signed by the head of department i.e. CEO,
DRAP or Chairman Registration Board. Chairman Registration Board is of the opinion that the
letter may be signed by the head of the division as per practice.
DBER requests the guidance of the Board regarding this matter.
Decision: Registration Board discussed the decision of Philippines Food and Drug
Administration for suspension of market authorization of Dengvaxia vaccine
and reference from Pricing Division. The Board asked the representative of
Punjab Government about the current status of procurement of Dengvaxia
vaccine. The representative of Punjab Government informed that the Punjab
Government has not issued any supply orders of said vaccine. Registration
Board advised DBER to issue a show cause notice to M/s Sanofi Aventis
Pakistan Limited, Karachi to explain why not the registration/ permission of
Dengvaxia vaccine is withdrawn as the circumstances under which the said
registration was granted no longer exist.
V. STORAGE FACILITY VERIFICATION.
Verification of the cold storage facility/ room temperature storage facility is one of the
prerequisites for grant of registration to imported products. As per practice, the inspection reports
of cold storage facilities for biological drugs are taken as valid for five years and for room
temperature biologicals only valid Drug sale license is considered while for locally manufactured
drugs GMP reports of inspections conducted within one year are accepted. The provincial
governments issue the licenses for 2 years.

a. For products stored at 2-80C, cold storage facility verification report shall be
valid for 5 years provided that the address of Drug Sale License remains the
same.
b. For products stored at room temperature, storage facility verification shall be
conducted once provided that the address of Drug Sale License remains the
same.
VI: INSPECTION EXEMPTION APPLIED BY M/S AGP (PVT) LTD, KARACHI.
Following products of M/s AGP (Pvt.) Limited, Karachi were approved in 270th meeting
of Registration Board held on 25-26th May 2017 as per details below:
Sr.# Name of Brand Name & Type of Form Document details Decision of RB in
Manufacturer Composition Dy No & Date (CoPP) its 270th meeting
of application Reference
Fee submitted agencies
Pack size/ availability
Demanded Locally registered
Price product
1. M/s Biocon HERTRAZTM 440 Form 5-A Legalized CoPP Keeping in view
Limited Plot NO. No. DCD/CR- the biosimilarity
2-4, Phase-IV (TRASTUZUMAB) Dy No. 1990 1249/Spl. Cell-
data and submitted
Bommasandra- R&I dated I/2013-14 dated CoPP indicating
Jigani Link road, Each vial contains: 25-5-2016 11-08-2016 valid that the product is
bommasandra Trastuzumab for up to 30-11-2016 available for sale
Post, Bangalore- injection (r-DNA Fee deposited from Government in the country of
560 099, India origin) 440mg/vial :Rs. 100000/- of Karnataka,
origin,
( Multiple use vial) dated 19-5- India Registration
For M/s Mylan Combi pack 2016 Board approved
Pharmaceuticals 100000 dated Herceptin (FDA the product as per
Private Limited, Antineoplastic agents, 03-08-2016 Approved import policy for
Plot No. 1-A/2, monoclonal antibodies molecule) finished drugs and
MIDC, Industrial Pack size: as per valid
Area, Taloja, Intravenous infusion Single vial Herceptin of legalized CoPP.
Panel Raigad Indications: Metastatic with water for Roche Karachi
(Dist.), Breast cancer and injection.
Maharashtra- Metastatic gastric
410208, India cancer Unit price:
130,000/ vial
Shelf life: 2 years
In house Specs
2. M/s Biocon HERTRAZTM 150 Form 5-A Legalized CoPP Keeping in view
Limited Plot NO. No. DCD/CR- the biosimilarity
2-4, Phase-IV (TRASTUZUMAB) Dy No. 1991 1249/Spl. Cell-data and submitted
Bommasandra- Each vial contains: R&I dated I/2013-14 dated CoPP indicating
Jigani Link road, Trastuzumab for 25-5-2016 11-08-2016 valid that the product is
bommasandra injection (r-DNA up to 30-11-2016 available for sale
Post, Bangalore- origin) 150mg/vial Fee deposited from Government in the country of
560 099, India (Multiple use vial) :Rs. 50000/- of Karnataka,origin,Registration
Combi pack dated 19-5- India Board approved
For M/s Mylan 2016 the product as per
Pharmaceuticals Antineoplastic agents, 100000 dated Herceptin (FDA import policy for
Private Limited, monoclonal antibodies 03-08-2016 Approved finished drugs and
Plot No. 1-A/2, molecule) as per valid
MIDC, Industrial Intravenous infusion Pack size: legalized CoPP.
Area, Taloja, Indications: Metastatic Single vial
PanvelRaigad Breast cancer and with water for
(Dist.), Metastatic gastric injection.
Maharashtra- cancer
410208, India Shelf life: 2 years Unit price:
In house Specs 44,318/ vial
2. The firm has also filed a constitutional Petition no. D3059/ 2017 in the High Court of
Sindh at Karachi on 13-05-2017 regarding the registration of above products. The parawise
comments have already been filed in the Honorable court on 12-10-2017.
M/s Ali GoharPharma Pvt. Ltd., Karachi on 27-07-2016 submitted a letter indicating that
USFDA inspected above facility however evidence of said inspection was not submitted. The
inspection report was submitted on 18-07-2017 along with the request for exemption of
inspection of manufacturing facility by DRAP. The said inspection was conducted by USFDA on
March 27 to April 7, 2017. In which, USFDA listed many serious observations, which are as
under:
i. Discrepancies between the information submitted and the manufacturing process
performed at M/s Biocon Limited India.
ii. The Quality Assurance Unit has approved and implemented documents that do not
assure appropriate production testing and deviation review a release of commercial
material.
iii. Handling of in process samples in inadequate
iv. There is lack of quality oversight in the review of procedures followed in quality
control testing of drug substance and product.
v. Out of Specification procedure for non- conforming materials and drug products
does not ensure satisfactory conformance to batch release specifications.
vi. Solutions used for drug substance formulation do not have adequate microbial
control.
vii. Bio burden sampling during manufacturing of drug product is inadequate esp.
sampling.
viii. Deviations are not initiated and/ or closed in time, and do not include appropriate
justification for delays.
4. After this, M/s AGP did not provided any updates on the inspection conducted by the
USFDA. It is pertinent to mention that another inspection of the firm was conducted by
USFDA on 25-05-2017 to 01-06-2017 & 03-06-2017 and according to this report 2017,
various other serious observations pertaining to the GMP of sterile manufacturing facility are
reported. Brief of them is as under:
i. Inadequate investigation in to visible particulates observed in injection, no risk
assessment has been performed after updates to determine, how the previous
versions of documents affected products on market.
ii. Procedure designed to prevent microbiological contamination of drug products do
not include adequate validation of sterilization procedure.
iii. Aseptic processing area is deficient regarding the system for monitoring
environmental conditions.
iv. Procedures to prevent microbiological contamination of drug products are not
established written and followed.
v. Laboratory records do not include complete data of al tests examinations and
assays
vi. Procedures for cleaning and maintenance of equipment are deficient.
vii. Quality Control unit lacks the responsibility and authority to approve and reject
all components of drug products.
viii. Employees engaged in manufacturing process lack training and experience
ix. Laboratory controls do not include establishment of scientifically sound and
appropriate specifications and tests.
x. Procedures describing insufficient details the controls employed for the issuance
of labeling are not followed.
4. The said report is available on USFDA website
(https://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/cderfoiaelectr
onicreadingroom/ucm569851.pdf). M/s AGP Pvt. Limited, Karachi has not informed to the
respondents about the latest inspection and above serious observations.
5. In the light of above and current Import Policy, DRAP submitted in the Honorable court
that recommendations of USFDA will be considered by the DRAP Registration Board for grant
of Registration of Hertraz 150mg and 440mg, therefore:
i. If the manufacturing facility is rejected by the USFDA, the Registration board of
DRAP will not consider its registration due to quality and safety concerns.
ii. If the manufacturing facility is approved by the USFDA, the Registration Board of
DRAP will consider the product for issuance of registration.
6. The firm on 22-12-2017 submitted a letter wherein they have enclosed a copy of BLA
(Biologic License Application) approval issued by USFDA to Mylan GmbH, Switzerland to
manufacture the product Ogivri (Trastuzumab-dkst) 420mg/ vial for injection, wherein its is
mentioned that Under this license you are pproved to manufacture Ogivri (Trastuzumab-dkst) at
--------------------------, the final formulated product and Bacteriostatic water for injection USP
will be manufactured, filled, labeled and packaged at M/s Biocon Limited (FEI: 3003981475) in
Bangalore, Karnataka, India. However, there was a difference in the address, which is addition of
Plot no. 5, available at USFDA Drug Establishment Current Registration Site for above FEI no.
and the address submitted by the firm in Form-5A and CoPP. The firm on 10-01-2018 submitted
a letter wherein they submitted valid legalized CoPPs vide no. DCD/CR-1849/ Spl cell-I/2015-
16 dated 26-12-2016 for Hertraz 440mg and Hertraz 150 mg indicating the same address i.e. M/s
Biocon Limited, Special Economic Zone, Plot No. 2, 3, 4 & 5, Phase IV, Bommasandra-Jigani
Link Road, Bommasandra post, Bengaluru, Karnataka 560099, India as available at USFDA
Drug Establishment current Registration site for above FEI and USFDA Approval of Ogivri
Injection.
FEI No. Manufacturing Address Activities Available USFDA Link
Details of 3003981475 M/s Biocon Limited, Manufacturing, https://www.accessdata.fd
USFDA BLA Bangalore, Karnataka, filling, labeling a.gov/drugsatfdadocs/appl
Approval India and packaging. etter/2017/761074Orig1s0
00ltr.pdf
Details of 3003981475 M/s Biocon Limited, Analysis; https://www.accessdata.fd
USFDA Special Economic Zone, Manufacture; a.gov/scripts/cder/drls/get
Current Plot No. 2, 3, 4& 5, Phase Pack; drls.cfm
Establishment IV, Bommasandra-Jigani Repack;
Registration link road, Bommasandra
Site post, Bengaluru,
Karnataka 560099, India.
7. Moreover, the DRAP on 17-01-2018 has submitted a reply to court order dated 13-11-
2017 that above documents submitted by the firm will be placed before the Registration Board in
its forthcoming meeting scheduled to be held on 29th-31st January, 2018 for discussion and
decision for grant of inspection exemption. The court now ordered to submit the minutes of the
meeting before next date of hearing which is 15-02-2018.
Decision:
Keeping in view the USFDA BLA approval of Ogivri 420mg Vial (Trastuzumab-
dkst) available at www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/761074
Orig1s000ltr.pdf (accessed on 30-01-2018) wherein it is mentioned for Ogivri 420mg
Vial (Trastuzumab-dkst) that the final formulated product and Bacteriostatic water
for injection USP will be manufactured, filled, labeled and packaged at M/s Biocon
Limited (FEI: 3003981475) in Bangalore, Karnataka, India which is the same site
where Hertraz 440mg and Hertraz 150mg are manufactured. Therefore,
Registration Board exempted the inspection of M/s Biocon Limited, Special
Economic Zone, Plot No. 2, 3, 4 & 5, Phase IV, Bommasandra-Jigani link road,
Bommasandra post, Bengaluru, Karnataka 560099, India (manufacturing facility of
Hertraz 440mg and Hertraz 150mg) as per current Import Policy for Finished drugs
and as per valid legalized CoPP.
VII: VETERINARY DRUG PRODUCT SPECIFICATIONS.
Registration Board’s decision of 267th meeting:

Registration Board deliberated matter for Drug product specifications in its 264th and
266th meetings. The Board further discussed the matter in detail especially for generic
manufacturer’s specifications and further decided as follows:
a. The product quality depends upon its standards and specifications. For ensuring safety,
efficacy and quality of products, pharmacopoeial specifications are the most reliable, safe
and accepted worldwide and same is required and shall be followed as per Drug
Specification Rules, 1978. Moreover, Registration Board has specified reference
countries including USFDA, Health Canada, EMA, TGA Australia, PMDA Japan, United
Kingdom, Germany, France, Switzerland, Netherlands, Austria, Denmark, Sweden and
Norway and thus pharmacopoeial specifications approved by pharmacopeias of
aforementioned countries are accordingly acceptable for their relevant products.
b. In case a drug product is not yet available in pharmacopeia of reference countries as
specified by Registration Board, then innovator products specifications as approved by
regulatory authority of reference country shall be followed. The innovator’s
specifications, however, shall be valid only till inclusion of the product in the official
pharmacopoeia of reference countries as specified by the Registration Board. being
official specifications as approved by authorities of reference countries and same can be
adopted by the generic manufacturer / importers.
c. In case product is still not available in any pharmacopeia and a generic applicant prefer to
manufacture with its own (manufacturer’s) specifications, then firm shall submit
following data for review and approval by Registration Board as manufacturer’s
specifications as per international practices.
i. Product and formulation development data.
ii. Manufacturing method development and process validation.
iii. Analytical method development and validation (accuracy, precision, specificity,
linearity, ruggedness and robustness) against innovator’s analytical method and
innovator’s product.
iv. Comparative pharmaceutical equivalence against innovator’s product including
comparative dissolution profiling and preferably bio-equivalence.
v. Stability study data of the product for accelerated and real time period against
innovator’s product as a reference.
Current practices:
The specifications are asked as per following details:
a. Pharmacopoeial (Biological products included in the pharmacopoeia of reference
countries).
b. In house/ manufacturers specifications/ Innovator specs
c. As per Innovator
As most of the human biological products are easily available as one of the above mentioned
specifications but, mostly, specification issue is associated with veterinary biological products
(locally manufactured and imported). For veterinary biological products, following problems are
being faced regarding above mentioned specifications:
a. Most of the veterinary biological products are unavailable in any pharmacopoeia.
b. Those firms demanding in house/ manufacturers specifications for their veterinary
products, are unable to provide most of the data as per requirements mentioned in
267th meeting of the Registration Board.
c. Those firms demanding “as per innovator” specifications, the required criteria
which must be followed is as under:
i. Proof of getting specification from innovator
ii. Same Composition
iii. Same Strength
iv. Same Container closure
Moreover, for majority of the veterinary biological products above mentioned criteria from
reference countries or already registered products are unavailable.
The World Organization for Animal Health (OIE).

OIE is an intergovernmental organization responsible for improving animal health
worldwide. Its creation stemmed from the “Office International des Epizooties (OIE)” to fight
animal diseases at global level through an international Agreement signed on January 25th 1924.
In May 2003 the Office became the World Organization for Animal Health but kept its historical
acronym OIE. It is recognized as a reference organization by the World Trade Organization
(WTO) and in 2017 has a total of 181 Member Countries. The OIE maintains permanent
relations with 71 other international and regional organizations and has Regional and sub-
regional Offices on every continent. The organization is placed under the authority and control of
a World Assembly of Delegates consisting of Delegates designated by the Governments of all
Member Countries. The OIE serves for the following objectives:
 Ensure transparency in the global animal disease situation
 Collect, analyse and disseminate veterinary scientific information
 Encourage international solidarity in the control of animal diseases
 Encourage international solidarity in the control of animal diseases
 Safeguard world trade by publishing health standards for international trade in animals
and animal products
 Improve the legal framework and resources of national veterinary services
 Provide a better guarantee of food of animal origin and to promote animal welfare
through a science-based approach
The OIE is the WTO reference organization for standards relating to animal health and
zoonoses. It regularly updates its international standards as new scientific information comes to
light, following its established transparent and democratic procedures. The only pathway for
adoption of a standard is via approval of the World Assembly of Delegates meeting in May each
year at the OIE General Assembly, at Paris.
The Manual of Diagnostic Tests and Vaccines for Terrestrial Animals (Terrestrial
Manual) aims to facilitate international trade in animals and animal products and to contribute to
the improvement of animal health services world-wide. The principal target readership is
laboratories carrying out veterinary diagnostic tests and surveillance, plus vaccine manufacturers
and regulatory authorities in Member Countries. The objective is to provide internationally
agreed diagnostic laboratory methods and requirements for the production and control of
vaccines and other biological products.
In case, the product is still not available in any pharmacopeia and an applicant prefer to
manufacture with its own (manufacturer’s) specifications, then the manufacturer shall submit the
documents as per above decision of 267th meeting of Registration Board for review and approval
of Registration Board as manufacturer’s specifications.
Decision: Registration Board deferred the case for deliberation in next meeting
with veterinary expert.
VIII: CANCELLATION OF REGISTRATION OF INFLUENZA VACCINES
APPLIED BY M/S NOVARTIS PHARMA, KARACHI AND M/S GSK,
KARACHI.
Chief Drugs Controller Punjab on 08-09-2017 asked various importer of Influenza

Vaccine, that influenza Vaccine, registered in their name is not available in the local market
(Medical Stores and Pharmacies) in the Province of the Punjab which is a clear violation of the
conditions of drug registration. Furthermore, non-availability of the product increases the
suffering of the patients and is detrimental to public interest. The Chief Ddrug Controller Punjab
has instructed them to ensure the market availability of product on all medical stores and
Pharmacies etc. immediately. Wherein in case failure DRAP will be approached for
suspension/cancellation of registration. The copy of above letter was made to the Chief
Executive Officer and Director Registration of DRAP.
In this context the BE&R Division on 18-09-2017 advised M/s Sanofi-aventis Pakistan
Ltd Karachi, M/s Abbott Laboratories (Pakistan) Limited Karachi, M/s GSK Pakistan Limited
Karachi and Novartis Pharma (Pakistan) Limited Karachi to insure the availability of their
registered Influenza vaccine with their current import status.
The responses submitted by the above firms/importers are reproduced as under:
M/s Sanofi-aventis Pakistan Limited, Karachi.
This is in reference to your letter No. 6-1/2016-DDC(BD) dated 18th September 2017 on the
subject shortage of influenza Vaccine in the Market of Punjab.
We would like to inform you that so far Sanofi-aventis Pakistan limited has imported 290,000
doses of Vaxigrip (Reg. No. 025266) in the year 2017, details of which mentioned below.
Batch Number Number of Doses Importation Month
P3A534V 65,287 July
P3A433V 77,726 July
P3A731V 46,987 July
P3F971M 100,000 August
Total 290,000
Please be informed that this year we have supplied
i) 190,000 doses of Varigrip to the Ministry of Religious Affairs and
ii) 25,000 doses to the DGHS Punjab
Below you will find the month wise Sales in data for the year 2017 (excluding supplies made to
Ministry of Regilous Affairs and DGHS Punjab).
Month Sales-In Unit
Jan-17 11,910
Feb-17 1,632
Mar-17 700
Apr-17 200
May-17 -
Jun-17 -
Jul-17 -
Aug-17 14,000
M/s Abbott Laboratories (Pakistan) Limited, Karachi
This is with reference to your letter F. No. 6-1/2016-DDC(BD) dated September 18, 2017 and
letters from Primary and Secondary Healthcare Department No. DVC/SURV/01-2017 & No. PA
to DS (Drugs)/9-1/2017 dated September 8, 2017 regarding above cited subject.
The shipment of Influenza Vaccine has arrived in Pakistan for which we have received the Lot
Release Certificate from National Control Laboratory for Biologicals Dated 20-09-2017 and it is
now available for sale from September 21, 2017. Our distributor Muller & Phipps can be
contacted for the availability of the product.
The detail of our distributor’s depot is mentioned below.
Contact person: M. NasirAsim
Lahore-1 depot
10Km, main Multan Road, Near Sessi Hospital, Lahore.
Tel. No.042-37492203-05
M/s GSK Pakistan Limited, Karachi.

Please refer to your letter No. F. No. 6-1/2016-DDC(BD) dated 18th September, 2017 on the
above subject. We would like to kindly inform you that Fluarix - that is a TIV version of flu
vaccine, is no longer supplied to Pakistan since this version of the vaccine is getting obsolete
globally and being replaced with advanced WHO recommended quadrivalent Flu vaccine (QFV)
by GSK. Accordingly, we had communicated this information to the Secretary Registration
Board about discontinuation and license cancellation of Fluarix vaccine in Pakistan in January
2016. Copy is enclosed for your kind reference.
We also wish to inform you that regarding the mentioned newer version of Flu vaccine i.e.,
Fluarix Tetra (Quadrivalent Flu vaccine), we are in discussion with our global offices for filing
registration application in Pakistan. We sincerely hope that above information would clarify the
matter however; if DRA requires any further discussion/information in this regard we would be
available for the same.
M/s Novartis Pharma Limited, Karachi.

We would like to inform you that Commonwealth Serum Laboratories (bioCSL) has globally
acquired Marketing Authorization / Registration rights from Novartis for Influenza Vaccines
including Agrippal S1 Vaccine for their division, Seqirus (http://www.csl.com.au/Seqirus.htm).
In this regard, we are enclosing a brief letter on transition of the merger of bioCSL, the vaccine
and pharmaceutical business of CSL, with acquired Novartis Influenza Vaccines.
Therefore, we request you to kindly cancel the registration of Agrippal S1 Vaccine (Reg. No.
016383) from the name of Novartis Pharma (Pakistan) Limited.
It is submitted that the availability of registered drugs/market surveillance come under the
purview of QA&LT Division. However, keeping in view the request of M/s GSK Pakistan and
M/s Novartis Pharma Limited for cancellation of registration of influenza, the case is placed
before the board for discussion please.
Decision: Registration Board directed M/s GSK Pakistan Limited, Karachi and M/s
Novartis Pharma Limited, Karachi for personal hearing before Registration
Board to explain their position regarding their applications for cancellation
of registrations of their Influenza vaccines.
Item No. IV: Quality Assurance & Lab Testing Division:
Case No. 1: Manufacture & Sale of Sub-Standard “Cetzi Syrup” Batch No. 2476
Manufactured by M/S. Jawa Pharmaceuticals (Pvt) Ltd. Lahore.
The sample of Cetzi Syrup, Registration No.042613, Batch No.2476, Mfg. Date 12-15
and Exp. Date 12-17 manufactured by M/S Jawa Pharmaceuticals (Pvt) Ltd., Lahore, has been
declared “Substandard” by Federal Government Analyst, CDL Karachi vide test report No.
IP.71/2016 dated 11th January 2017. The sample of above mentioned drug was taken by FID
Islamabad-I from the premises of M/s Main Pharmacy, Federal Government Hospital, OPP NIH,
Islamabad on 18-11-2016.
The result on the basis of which the drug is declared substandard is reproduced as under.
Sub-Standard with regard to pH Determination:
(With protocols of test applied BP 2016)
pH. Determined: 7.60
Limits: 4.5 to 5.5 Does not comply
Remarks: - The sample is of “Sub-Standard” quality under the Drugs Act 1976.
The Federal Government Hospital management provided the bill/invoice with warranty No. 65
dated 15-01-2016 of M/s Al-Rayyan Health Services, Rawalpindi.
M/s Al-Rayyan Health Services, Rawalpindi provided the bill invoice warranty of the
manufacturer, M/s Jawa Pharmaceuticals (Pvt) Ltd, Lahore.
The manufacturer of the drug M/s Jawa Pharmaceuticals (Pvt) Ltd, Lahore was served
explanation letter from FID-I for confirmation of warranty, in reply of which M/s Jawa
Pharmaceuticals (Pvt) Ltd, Lahore confirmed that the drug in question was manufactured and
sold by them to the distributor, Al Rayyan Health Services, Rawalpindi.
In response of explanation letter from FID, the firm M/s Jawa Pharmaceuticals (Pvt) Ltd, Lahore
submitted its reply vide Ref No. JPPL/W/4721 dated 30-03-2017 which is reproduced as under:
i. The variation of pH can shift under adverse storage condition
ii. pH have no role in the standard as is apparent from the active ingredient determined
as 99.61% stated in the above referred test report which is well within BP limit i.e.
95-105%.
iii. That negative remarks about standard on the basis of physical appearance, when the
active content is up to the mark, cannot be constructed as misbranded by any stretch
of imagination.
iv. That the Federal Inspector of Drugs has no jurisdiction to proceed with substandard
drug cases Authority relied there for your record, ready reference and for your kind
perusal.
In spite of FID’s letter to the firm to furnish the names of responsible management, the
firm has not given names of responsible persons. The Licensing Division, DRAP, Islamabad
furnished the names of management and approved qualified persons of the firm as under;
M/s Jawa Pharmaceuticals, Lahore.
i. Mr. Sajid Ali Jawa, Chief Executive
ii. Mr. Shoukat Hayat, Manager QC
iii. Mr. Abid Hussain Production Incharge
The firm, M/s Jawa Pharmaceuticals (Pvt) Ltd, Lahore was served with a show-cause
notice dated 05-06-2017, in response of which the Firm submitted its written defense / reply to
show cause notice dated 15/06/2017 from Muhammad Baqir Jawa, M/s Jawa Pharmaceuticals
(Pvt.) Ltd., Lahore, the main points of which state as under;
i. The out of labeled prescribed storage conditions adversely affect the potency as well as
physical characteristics and state of drugs. The storage conditions have not been
mentioned anywhere on any document.
ii. The number of portions of sample has not been made as per requirement under section 18
which requires that Inspector shall make five portions of samples sampling from premises
other than licensed manufacturing unit. The manufacturer and warrantor portions have
not been received within statutory period of seven days as prescribed under Section 19(3)
of the Drugs Act 1976.
iii. The FID committed an illegality as he delivered the sample to CDL Karachi within 28
days instead of statutory period of seven days prescribed under section 18 of the Drugs
Act 1976.
iv. The assay of Cetzi Syrup is determined as 99.61%. The drug could not be declared
substandard on the basis of physical specification like pH without calculating the impact
of pH on the formulation.
v. The report of Government analyst simply states the result of the test but does not give the
protocols.
They have been called for personal hearing.
Decision of the 274th Meeting of Registration Board:

The Board decided to defer the case and give the firm last opportunity of personal hearing in the
next meeting of Registration Board.
Proceedings and Decision of 278th Meeting.
Mr. Khwaja M.Tahir advocate appeared on behalf of M/s Jawa Pharma Lahore to defend the
case of substandard drug. He argued that assay of active contents is OK and product has been
declared substandard on the basis of pH which is not so much important. He also said that they
have recalled the batch from the market. The advocate presented the judgment to defend his case.
Members of the RB deliberated and held that the cage in pH of the solution from the standard
4.5-5.5 to 7.6 reflects, this is problem in the formulation and it is the responsibility of the product
registration holder to identify root cause analysis and take correction action as well as preventive
action to ensure that the product remains within its specifications through out to shelf life.
Decision: The Board decided as under:

 The product registration holder shall conduct Root Cause Analysis of the
product failure.
 Take corrective and preventive measures to ensure stability of
formulation.
 Conduct accelerated stability studies as per WHO/ICH guidelines
 Submit the investigation report and preventive action taken by the firm
and stability data for verification of DRAP expert panel.
 Meanwhile, the Registration of the product shall remain suspended till the
final assessment report forward by the expert panel, is consigned by the
DRB and final orders as passed in this respect.
Case No. 02: Manufacture & Sale of Sub-Standard Drug Zeboxil 500mg Capsules Batch
No. 614C01 Reg. No. 031010 manufactured by M/S Medicaids Pakistan (Pvt)
Ltd. Karachi.
The Federal Inspector of Drugs FID-I, Karachi, on 22-06-2016, drew samples of Zeboxil
500 mg Capsule Batch No. 614C01, manufactured by M/s Medicaids Pakistan (Pvt) Ltd, Karachi
from manufacturer’s premises for test/analysis. The samples were declared substandard by the
F.G Analyst vide Test Report No.KQ.239/2016 dated 19-08-2016. The remarks of Government
Analyst, CDL, Karachi are as under: -
Dissolution Test Result:
Stage-1
Capsule No. (%)age
01. 56.475
02. 129.109
03. 86.87
04 87.19
05. 37.27
06. 76.259
Limits for (Stage-1):- Each unit is not less than Q+5% i.e. 80+5=85%
Stage-2
Capsule No. (%)age
01. 102.139
02. 51.631
03. 104.704
04 79.049
05. 105.346
06. 65.741
Average of 12 units= 981.783/12=81.815%

Limits for (Stage-2):- Average of 12 units (S1+S2) is equal to or greater than Q (80%) and
no unit is less than Q-15% (80-15=65%)
Limits for (stage-3):- Average of 24 units (S1+S2+S3) is equal to or greater than Q (80%). Not
more than 2 Units are less than Q-15 (80-15=65%) & no units is less than Q-25% (80-25=55%)
Since, 01 capsule is already below 55% therefore, the sample does not comply with USP 37.
In response to FID explanation letter the firm did not agree with the CDL’s test report
and has pointed out that the test report of CDL suffers from patent faults, errors and obvious
deviations from the prescribed method of testing given in USP for Cefadroxil Capsule. But the
firm did not request for re-testing by the Appellate Laboratory as per Section 22(5) of Drugs Act
1976 within prescribed time period.
As per procedure show-cause notices were issued to the firm on 10-01-2017 as

recommended by the FID-I Karachi, and accused persons, offering opportunity of personal
hearing before the Drug Registration Board.
The firm has submitted its reply in response to Show Cause notice on 23-01-2017. They
submitted that they detected and observed three basic, crucial and vital flaws and errors in such
report which tended to invalidate and nullify the same and the declaration of substandard
declared on such flawed test report.
They highlighted the following three errors which are as follows;
1. Use of paddle instead of dissolution basket;
2. Absorbance shown at 363nm instead of 263nm; and,
3. Vessel operated at speed of 50 rpm instead of 100 rpm.
The firm did not agree with the CDL test report and want to appear for personal hearing
before Registration Board.
They were called for personal hearing in 274th Meeting of RB, but no person appeared before the
Board.

The Board decided to defer the case and give last opportunity of personal hearing to the firm in
the next meeting of Registration Board.
278th Meeting of Registration Board held on 29th, 30th & 31st January 2018:
The accused persons were again called for personal hearing but no person appeared before the
Board due to delayed dispatch of personal hearing letter.
Decision: The Board decided to defer the case and give last opportunity of personal
hearing to the firm in the next meeting of Registration Board.
Case No. 03: Manufacture & Sale of Sub-Standard Ei-Ram 10mg Tablets Batch No. C-018
By M/S Iceberg Pharmaceuticals, Risalpur, KPK.
The Federal Inspector of Drugs FID Peshawar on 27-05-2016 drew sample of Ei-Ram
tablets Batch No. C-081, manufactured by M/s Iceberg Pharmaceuticals, Risalpur, KPK from
manufacturer’s premises for test/analysis. The samples were declared substandard by the F.G
Analyst vide Test Report No.IP.38/2016 dated 29-07-2016. The remarks of Government Analyst,
CDL, Karachi are as under:-
Assay for: Determined Stated Percentage
Amount/Tablet Amount/Tablets
Escitalopram 8.037mg 10.0mg 80.37%
Limits: 90.0% to 110.0% Does not comply

The Federal Inspector of Drugs, Peshawar in the light of CDL’s test report, served an
explanation letter dated 24-08-2016 to the firm. In response, the firm did not accept the CDL test
report vide their reply dated 06-11-2016 which was received in the office of FID on 08-12-2016.
As per procedure show-cause notice was issued to the firm on 25-04-2017. In response
to show cause notice the firm submitted its reply on 28-04-2017 and submitted that the recalling
process was time bearing due to which appeal for retesting of sample in Appellate Board was
delayed.
They were called for personal hearing in 274th Meeting of DRB.
Board.
Case No. 04 Manufacture & Sale of Sub-Standard “Tincture Benzoin Co” Batch No.
Mf84 Manufactured by M/S. Prime Laboratories (Pvt) Ltd. Lahore
The sample of Tincture Benzoin Co, Reg. No.028164, Batch No.MF84, manufactured
by M/S Prime Laboratories (Pvt) Ltd. Lahore has been declared Sub-Standard by Federal
Government Analyst, CDL Karachi vide test report No. LHR.359/2016 dated 05th October, 2016.
The sample of failed drug was taken by FID Lahore-V on 25-07-2016 from the premises of M/S
Prime Laboratories (Pvt) Ltd. 9.5-k.m Sheikhupura Road, Lahore for test/analysis. The results on
the basis of which the drug is declared substandard are reproduced as under.
Sub-Standard with regard to Non Volatile Residue:
Acceptance Criteria: 525.0 mg to 675.0 mg
Findings: Determined/3ml: 396.3 mg

Sub-Standard with regard to Specific Gravity:
Acceptance Criteria: 0.870 to 0.885

Findings: Determined: 0.8479
On explanation letter issued by FID Lahore-V on 20-10-2016, M/s Prime Laboratories
(Pvt) Ltd. Lahore did not challenge the CDL test report for retesting at Appellate Lab, NIH,
Islamabad. The firm stated that Government Analyst applied fictitious protocols i.e.
Manufacturer’s specifications, while their prescribed specifications are of 3(Z) (i) of the Drugs
Act, 1976 as claimed on label. In his complete case, FID stated that the firm has not submitted
any information/document regarding details of technical staff which is violation of section 23(i)
(f) of Drugs Act 1976 and Section A(1) (f) of Schedule II of DRAP Act 2012. Firm is also
involved in manufacturing of Sub-standard drug which is violation of section 23(i) (a) (v) of
Drug Act 1976 and section A(1) (a) (v) of Schedule II of DRAP Act 2012. These offences are
punishable under section 27 of Drugs Act 1976 read with Schedule III of DRAP Act 2012.
Hence the FID submitted the case to Registration Board as required under Schedule V of the
DRAP Act 2012 to seek further orders as to the actions to be taken in respect of contraventions
of the provisions of DRAP Act 2012.
Area FID was requested to take and submit the names of responsible persons form
Licensing Division, DRAP, Islamabad. FID submitted the names of responsible persons as per
available record of his office and the information provided by the Licensing Division, DRAP,
Islamabad. Names are as below;
M/s Prime Laboratories through its CEO (Mr. Zaheer Iqbal Sheikh)
Mr. Asad Ali Khan, Incharge Production
Mr. Muhammad Umar, Incharge Quality Control
The firm M/s Prime Laboratories (Pvt) Ltd. Lahore was served with show-cause notice
dated 17-08-2017. In response to show cause notice, the firm submitted its reply and stated that
their prescribed specification is that of USP 19 and Government Analyst is bound to apply the
same. Firm also stated that the FID is not competent to initiate the case of substandard drugs.
The firm has also attached the recall documents of their product Tincture Benzoin Co, Batch No.
MF-084.
The responsible persons have been called for personal hearing.
Board.
Case No. 05: Manufacture & Sale of Misbranded Drug Pixicam 20mg Injection Batch No.
I.077, Reg. No. 073407 Manufactured by M/s City Pharmaceutical
Laboratories, Karachi.
The sample of Drug Pixicam 20mg injection batch no. I.077, reg. no. 073407
manufactured by M/s City Pharmaceutical Laboratories, Karachi was drawn by Federal Inspector
of Drugs-II Karachi from the premises of M/s City Pharmaceutical Laboratories, Karachi on 29-
8-2017 for test/analysis. The Federal Government Analyst, CDL, Karachi declared the sample
Misbranded vide test report No. R.KQ.464/2017 dated 25-9-17. The result of CDL on the basis
of which sample under reference has been declared misbranded is reproduced as under:-
Remarks: The label carries USP product whereas Piroxicam injection is not included in
USP 40. Hence, sample is declared Misbranded under section 3(s) (i) of the
Drugs (Labeling & Packing) Rules 1986 under the Drugs Act, 1976.
The sample is “Misbranded” under the Drug Act 1976.
On explanation letter issued by the FID Karachi to the firm dated 27-9-17, the firm
submitted their unsatisfactory reply vide their letter to FID-Karachi dated 27-11-17 and claimed
that they have written USP with the generic (raw material) in compliance to the Registration
letter issued to them for this product and it is mentioned in USP too.
As per procedure show-cause notice was issued to the firm and accused persons, offering
opportunity of personal hearing before the Drug Registration Board.
The firm replied that they are in compliance of the directions started to test the API as per USP
specification. They further added that they had submitted the In House Specifications for their
subject product in their registration dossier.
The accused persons were called for personal hearing but no person appeared before the Board.
Case No. 6: Manufacture & Sale of Adulterated & Sub-Standard “Oxytocin Injection
(for vet only)” Batch No. 2876 Manufactured by M/S. Elko Organization Pvt,
Ltd, Karachi.
The matter of Adulterated and Substandard Oxytocin Injection Batch no 2876
manufactured by M/s Elko organization, Karachi, by CDL, Karachi vide report no. KQ.
461/2014(B) dated 26th November, 2014, was placed before the Registration Board in its 248th
meeting and RB decided as under:
I. Suspended the registration of oxytocin injection, registration no. 011122 of M/s
Elko Organization (Pvt), Ltd, Karachi for a peroid of six months.
II. Investigation through a Product Specific inspection (PSI) by a panel comprising
of director DTL Quetta, Chief Drug Inspector, Sindh and Area FID karachi.
III. The panel will also witness the destruction of the recalled/withheld stocks of the
drug under reference.
That the letter regarding PSI was conveyed to panel members vide letter no. 3-56/2014-
QC dated 22nd April, 2015. It was requested to conduct PSI by the panel members as under:
i. Dr. Amanullah Khan, Director, Drug Testing Laboratory, Quetta.
ii. Syed Kalb-e- Hasan Rizvi, Chief Drug Inspector, Sindh.
iii. Abdul Rasool sheikh, Area FID, Karachi.
That the reminders were issued to Additional Director, DRAP, Karachi to conduct PSI
and submit the report by panel vide letter no. 3-56/2014-QC dated 9th October, and 26th October,
2017.
PSI report received from Additional Director, DRAP, Karachi vide F. no. 01-04/2017-
DRAP(K)(Insp) dated 15th November, 2017 received on 23rd November, 2017 wherein he
enclosed the detailed PSI report (duly signed) conducted by panel vide f. ARS.000245/2015-
FID-III(k) dated 15th November, 2017.The panel members are as under:
i. Dr. Amanullah Khan, Director, Drug Testing Laboratory, Quetta.
ii. Syed Kalb-e- Hasan Rizvi, Chief Drug Inspector, Sindh.
iii. Abdul Rasool sheikh, Area FID, Karachi.
That the points in the report submitted by Additional Director, DRAP, Karachi are as under:
 Good practices in production: The root cause of failure was rubber
stoppers which were not washed properly as rubber stoppers were being washed
manually. Factors triggering such incidents were reviewed in detail. Keeping in
view the instant failure stringent checking was found in place to avoid the
occurance and recurrence of such failures in future.
 QA system: with respect to the subject case their SOPS regarding failures and
controlling the deviation were reviewed in detail. After receiving the report, the
firm had started to find out the root cause of the problem and total three batches
were also investigated. The firm was found capable enough to investigate their
failures as per SOPs. Appropriate in process checks were noted in place.
That the conclusion of the report submitted by panel is reproduced as under:
After investigating the root cause analysis (RCA) of the failure and subsequent rectification of
the problem the firm had resumed the manufacturing of oxytocin injection after the lapse of
suspension period and keeping in view the current status of their compliance the panel
recommends that the firm may be allowed to continue the manufacturing of oxytocin injection.
The panel further observed that the retained stocks in quarantine were destructed as per their
appr oved SOP on 01.11.2016.
 Meanwhile, it is pertinent to mention that FIA Karachi is conducting enquiry 22/2017 on
the complaint of Provincial Inspector of Drugs, Karachi about illegal import of oxytocin
and manufacturing of oxytocin injections manufactured by M/s Elko organization, Karachi
during suspension period. (page 66-67/corr) The FIA raised the following queries in this
respect as under:
 Copies of minutes of meeting of 248th Drug Registration Board where registration no.
011122 of M/s Elko organization Pvt ltd was suspended.
 Import details of oxytocin by M/s Elko Organization during 2015 to till date.
 Procedure/ DRAP regulations to import oxytocin (in any form) into Pakistan by
manufacturers of oxytocin for human and Vetanry usage.
 Details of importers viz name of company, quantity imported, etc.
 Details of any ban imposed on manufacturing or importing (in any form) of oxytocin
by DRAP.
Similarly, NAB is also conducting an enquiry.
Proceeding and Decision of 278th Meeting of RB:

Product Specific Inspection report and import data forwarded by AD (I&E) DRAP
Karachi about import of oxytocine raw material was contained by the DRB and discussed
in details.
 The queries of the FIA Karachi and NAB were also brought in the knowledge of the
Board members. The DRB after through deliberation decided as under:
 That the company violated the orders of the Registration Board and continued
import of raw material during the suspension period as per detail are given below.
 The company resumed production of oxytocin vials without approval of the
Registration Board.
 The Board decided to issue show cause notice & personal hearing letter to the firm
for their violation in the forthcoming meeting.
 It was also decided that the Registration of the oxytocin shall remain suspended till
final decision by the Registration Board in the forthcoming meeting.
 Registration Board advised PE&R Division to present case regarding alleged use of
oxytocine multidose vials for enhancement of milk production in the animals.
The Board agreed to issue show cause notice of multidose vials on the same lines which
have been adopted by India. They allow only one mL oxytocine ampoule for human use
only.
Item No. V: ADDITIONAL AGENDA
Pharmaceutical Evaluation Cell
S.No. Detail
Case No. 01 Registration applications for local manufacturing of (Human) drugs
c) New Cases
d) Deferred Cases
Case No. 02 Registration applications of newly granted DML or New section (Human)
a) Deferred cases
Case No. 03 Registration applications of newly granted DML or New section
(Veterinary)
Case No. 04 Registration applications of import cases
d. Import Deferred cases (Human)
Case No. 05 Registration applications of drugs for which stability study data is
required to be verified
e. New cases
f. Verification of stability study data
g. Exemption from onsite verification of stability data
Registration applications of categories to be considered on priority
Case No. 06
a) Applications for registration of drugs for Local Manufacturing
Case No. 07 Import of Active Pharmaceutical Ingredients (APIs) / Drug Substances
Case No. 01: Registration applications for local manufacturing of (Human) Drugs.
a) New Cases
1. Name and address of manufacturer / M/S Tabros Pharma, Pvt Ltd, Factory :L-20/B, Sector -
Applicant 22,Federal B Industrial Area, Karachi
Brand Name +Dosage Form + Strength Sodium chloride 0.9% injection
Composition Each 10 ml ampoule contains:
Sodium chloride……….0.9%
Pharmacological Group Parentral electrolyte
Type of Form Form 5
Pack size & Demanded Price 10 ml ;Diluent of Misonate injection (Artesunate 120mg)
Approval status of product in Recommended in WHO list, as separate ampoule of
Reference Regulatory Authorities 0.9% sodium chloride solution diluent for Artesun 120 mg
injection.
Me-too status (with strength and Diluent for Gen-M injection of M/s Genix pharma
dosage form)
report concludes that overall GMP status firm is GOOD.
Remarks of the Evaluator  The official monograph of the product is available
in USP. While in BP infusion is available.
 The firm applied for the liquid Injectable for which
evidence of TOC (total Organic Count)of and LPC
(Liquid Particle Counter) is required in the light of
decision of Registration Board and they provide
commercial invoices dated 26-09-2017 & 08-11-
2015 for LPC (Liquid Particle Counter and TOC
(total Organic Count) respectively.
Decision: Approved.
2. Name and address of manufacturer / M/S Tabros Pharma, Pvt Ltd, Factory :L-20/B, Sector -
Applicant 22,Federal B Industrial Area, Karachi
Brand Name +Dosage Form + Strength Sodium bicarbonate 5.0% injection
Composition Each 2 ml ampoule contains:
Sodium bicarbonate……….5.0%
Pharmacological Group Irrigating Solution
Type of Form Form 5
Pack size & Demanded Price 2 ml ;Diluent of Misonate injection (Artesunate 120mg)
Approval status of product in Recommended in WHO list, as separate ampoule of 5%
Reference Regulatory Authorities sodium bicarbonate solution diluent for Artesun 120 mg
injection.
Me-too status (with strength and Diluent for Gen-M injection of M/s Genix pharma
dosage form)
report concludes that overall GMP status firm is GOOD.
Remarks of the Evaluator The firm applied for the liquid Injectable for which
evidence of TOC (total Organic Count)of and LPC
(Liquid Particle Counter) is required in the light of
decision of Registration Board and they provide
commercial invoices dated 26-09-2017 & 08-11-2015 for
LPC (Liquid Particle Counter and TOC (total Organic
Count) respectively.
Decision: Approved as diluent for Artesuante injection.
3. Name and address of manufacturer / M/s Medizan Laboratories Pvt. Ltd. Plot No. 313,
Applicant Industrial Triangle, Kahuta Road, Islamabad.
Brand Name +Dosage Form + Strength Fluvin-50mg tablet
Fluvoxamine……………50mg
Type of Form Form-5
Pack size & Demanded Price 10’s, 30’s and 60’s; As decided by the Ministry of Health
Approval status of product in Reference Luvox 50mg film coated tablets of M/s Ani Pharms
Me-too status (with strength and dosage Flevox Tablets of M/s Schazoo Laboratories (Reg.#
form) 042803)
Remarks of the Evaluator  In response to query regarding submission of
accelerated stability studies data before production
the firm has submitted that
“During a recent investigation of our records we
discovered that accelerated stability data of the drug
(Fluvin 50mg tablets) applied for registration has
been mistakenly attached into the file more over the
quality control staff has been changed so we
apologize for the subject. You are requested to accept
the post registration commitment of stability data.”
Decision: Registration Board deferred the case for personal hearing regarding submission of
accelerated stability studies data before production.
4. Name and address of manufacturer / M/s Medizan Laboratories Pvt. Ltd. Plot No. 313,
Applicant Industrial Triangle, Kahuta Road, Islamabad.
Brand Name +Dosage Form + Strength Fluvin-100mg tablet
Fluvoxamine……………100mg
Type of Form Form-5
Pack size & Demanded Price 10’s, 30’s and 60’s; As decided by the Ministry of Health
Approval status of product in Reference Luvox 100mg film coated tablets of M/s Ani Pharms
Me-too status (with strength and dosage Flevox Tablets of M/s Schazoo Laboratories (Reg.#
form) 042804)
operating at reasonably acceptable compliance with GMP
guidelines as of today.
Remarks of the Evaluator  In response to query regarding submission of
the firm has submitted that
“During a recent investigation of our records we
discovered that accelerated stability data of the drug
(Fluvin 100mg tablets) applied for registration has
been mistakenly attached into the file more over the
quality control staff has been changed so we
apologize for the subject. You are requested to accept
the post registration commitment of stability data.”
Decision: Registration Board deferred the case for personal hearing regarding submission of
5. Name and address of manufacturer / M/s Faas Pharmaceuticals (Pvt.) Ltd. F-748L, S.I.T.E.,
Applicant Karachi.
Brand Name +Dosage Form + Strength Osmofaas sachet
Sodium chloride………………..…1.3g
Potassium chloride……………...…0.75g
Trisodium citrate dihydrate………..1.45g
Glucose anhydrous……………...…6.75g
Pharmacological Group Oral rehydration salt formulation
Type of Form Form-5
Finished product Specifications International pharmacopoeia
Approval status of product in Reference WHO recommended formulation
Me-too status (with strength and dosage Osmolar of M/s Atco
form)
GMP status Last GMP inspection dated 24-07-2017; the report
concludes that based on the above facts their current level
of compliance is rated satisfactory.
Remarks of the Evaluator Initially, the firm has applied for formulation containing
Sodium chloride……………..…1.3g
Potassium chloride…………...…0.75g
Trisodium citrate dihydrate……..1.45g
Glucose anhydrous………....…6.75g to be reconstituted
with 1 liter of water, which is not as per WHO approved
low osmolality ORS formulation.
Now the firm has revised volume of water for
reconstitution to 500ml.
Decision: Approved.
6. Name and address of Manufacturer / M/s Wilson’s Pharmaceuticals, 387-388,I-9 Industrial

Brand Name+DosageForm+Strength Nicowil tablet 10mg
Nicorandil…10mg
Type of Form Form-5
Approval status of product in Reference Approved in MHRA
GMP status GMP inspection conducted on 24-01-2018 with
conclusive remarks that firm was operating at very good
level of GMP compliance at the time of inspection.
Decision: Approved with BP specifications.
Brand Name+DosageForm+Strength Nicowil tablet 20mg
Nicorandil…20mg
Type of Form Form-5
Decision: Approved with BP specifications.
Brand Name+DosageForm+Strength Parawil tablet 500mg/65mg
Paracetamol…500mg
Caffeine…65mg
Pharmacological Group Analgesic/Antipyretic, CNS Stimulant
Type of Form Form-5
Me-too status Alenmol Tablets of Alen Pharmaceuticals (Pvt.) Ltd.,
Brand Name+DosageForm+Strength Metwil plus tablet 1mg/500mg
Glimeperide(as immediate release)…1mg
Type of Form Form-5
Remarks of Evaluator Evidence of approval status of applied formulation in
reference agencies.
10. Name and address of Manufacturer / M/s Wilson’s Pharmaceuticals, 387-388, I-9 Industrial
Brand Name+DosageForm+Strength Metwil plus tablet 2mg/500mg
Glimeperide (as immediate release)…2mg
Type of Form Form-5
reference agencies.
11. Name and address of Manufacturer / M/s Crystolite Pharmaceuticals, Plot No. 1 & 2, Street S-
Applicant 2 National Industrial Zone, Rawat,
Brand Name+DosageForm+Strength Clindalite cream 2%w/w
Clindamycin (as phosphate)….20mg
Type of Form Form-5
Pack Size & Demanded Price 40gm tube; As per SRO
Me-too status Climed-V cream 2% of Medera pharmaceuticals
Decision: Approved
12. Name and address of Manufacturer / M/s Crystolite Pharmaceuticals, Plot No. 1 & 2, Street
Applicant S-2 National Industrial Zone, Rawat,
Brand Name+DosageForm+Strength Clindamax lotion 1%w/v
Clindamycin (as phosphate)….10mg
Type of Form Form-5
Pack Size & Demanded Price 30ml; As per SRO
Me-too status Austaclin-T Lotion 1% of Bloom Pharmaceuticals
Decision: Approved
13. Name and address of Manufacturer / M/s Crystolite Pharmaceuticals, Plot No. 1 & 2, Street
Applicant S-2 National Industrial Zone, Rawat,
Brand Name+DosageForm+Strength Daskil lotion 1%w/v
Terbinafine(as hydrochloride)….10mg
Type of Form Form-5
Pack Size & Demanded Price 30ml; As per SRO
Me-too status Cutis Lotion 1% of Tabros Pharma(drug infosis)
(Reg#067109)
reference agencies.
Decision: Deferred for evidence of approval of applied formulation by reference regulatory
authorities/agencies which were declared/approved by the Registration Board, since reference
submitted by firm is not verifiable.
14. Name and address of Manufacturer / Kanel Pharmaceuticals. Plot # 6-Road Ss-3. National
Applicant Industrial Zone. Rawat. Rawalpindi.
Brand Name + Dosage form + Strength K-Pride 50 Mg Tablets
Itopride hydrochloride…50mg
Pharmacological Group Gastroprokinetics
Type of Form FORM-5
Packed Size and Demanded Price 3 x10’s: As per SRO
Approval status of product in Reference Approved in PMDA
Me-too Status Xepride Tablets 50mg of USAWA
GMP Status Panel Inspection dated 20-12-2017 recommends renewal
of DML by the way of formulation of following sections.
Tablet section(general)
Capsule section(general )
Decision: Approved
Brand Name + Dosage Form + Strength Arip 10mg Tablets
Aripiprazole….10mg
Diary No. Date Of R&I & Fee Dy No.19; 02-02-2017; Rs. 20,000/-
Type Of Form Form-5
Packed Size And Demanded Price 3 X 10’s: As per SRO
Approval Status Of Product In Approved in US-FDA
Reference Regulatory Authorities Abilify (Teva Pharmaceuticals,USA)
Me-Too Status Apify 10mg Tablet of Akhai Karachi.
Remarks Of Evaluator
Decision: Approved
Brand Name + Dosage Form + Strength Arip 15mg Tablets
Aripiprazole….15mg
Diary No. Date Of R&I & Fee Dy No.14; 02-02-2017; Rs. 20,000/-
Type Of Form Form-5
Packed Size And Demanded Price 3 X 10’s: As per SRO
Approval Status Of Product In Approved in US-FDA
Reference Regulatory Authorities Abilify (Teva Pharmaceuticals,USA)
Me-Too Status Apify 10mg Tablet of Akhai Karachi.
Remarks Of Evaluator
Decision: Approved
Brand Name + Dosage form + Strength Dompy 10 Mg Tablets
Domperidone (as maleate)…10mg
Pharmacological Group Antiemetic
Type of Form FORM-5
Packed Size and Demanded Price 5 X 10’s; As per SRO
Me-too Status Veldom 10mg Tablet of Well & Well Pharma
Remarks of Evaluator Reference product is approved as Domperidone (as
maleate)…10mg uncoated tablet while firm has applied
with coating.
uncoated tablet whereas firm has applied for film coated tablet
18. Name and Address of the Kanel pharmaceuticals. Plot # 6-road ss-3. National
Manufacturer/Applicant industrial zone. Rawat. Rawalpindi.
Brand Name + Dosage form + Strength Fenac-K 75 Mg Tablets
Diclofenac Potassium… 75mg
Pharmacological Group Phenyl acetic acid; Cyclo-oxygenase inhibitor; NSAIDs
Type of Form FORM-5
Packed Size and Demanded Price 2 x10’s , 5 x 10’s; As per SRO
Me-too Status Dicgesic-K Tablets 75 mg of Alen Pharmaceuticals.
reference agencies.
Decision: Registration product rejected the application since applied formulation is not
approved by any reference regulatory authority
19. Name and Address of the Kanel Pharmaceuticals. Plot # 6-Road Ss-3. National
Manufacturer/Applicant Industrial Zone. Rawat. Rawalpindi.
Brand Name + Dosage form + Strength Fenac-P 100mg Tablets
Composition Each extended release, film coated tablet contains:
Diclofenac Potassium… 100mg
Pharmacological Group Phenyl acetic acid; Cyclo-oxygenase inhibitor; NSAIDs
Type of Form FORM-5
Packed Size and Demanded Price 1 x10’s , 3 x 10’s: As per SRO
Me-too Status ARTIMOV K (BARRETT HODGSON)
reference agencies.
Evidence of Me Too with registration number.
Decision: Registration product rejected the application since applied formulation is not
approved by any reference regulatory authority
Brand Name + Dosage form + Strength Klarit 500 Mg Tablets
Clarithromycin…. 500mg
Pharmacological Group Macrolide antibiotic
Type of Form FORM-5
Packed Size and Demanded Price 1 x10’s: as per SRO
Approval status of product in Reference Approved in US-FDA
Me-too Status Claramet 500mg Tablets of Metro Pharmaceuticals
Remarks of Evaluator Firm has shifted from uncoated to coated tablet without
submission of fee.
Brand Name + Dosage form + Strength Klarit 500mg Tablets
Clarithromycin…. 500mg
Diary No. Date of R&I & Fee Dy No.24; 02-02-2017; Rs. 20,000/-
Type of Form FORM-5
Packed Size and Demanded Price 1 x5’s: as per SRO
Me-too Status E-Clar XL 500mg Tablet (extended release film coated
tablet )of Tabros Pharma
Remarks of Evaluator Firm has shifted from extended release uncoated tablet to
extended release film coated tablet without submission
of fee.
Brand Name + Dosage form + Strength No-uric 40 mg tablets
Febuxostat ….40 mg
Pharmacological Group Xanthine oxidase inhibitor
Type of Form Form-5
Packed Size and Demanded Price 2 x10’s, 3 x 10’s
Regulatory Authorities Uloric (Takeda Pharmaceuticals,USA)
Me-too Status Febuxin 40mg Tablet of AGP
Brand Name + Dosage form + Strength No-Uric 80mg Tablets
Febuxostat ….80 mg
Pharmacological Group Xanthine oxidase inhibitor
Type of Form FORM-5
Packed Size and Demanded Price 2 x10’s, 3 x 10’s
Regulatory Authorities Uloric (Takeda Pharmaceuticals,USA)
Me-too Status Febuxin 80mg Tablet of AGP
Brand Name + Dosage form + Strength Rifagut 550 Mg Tablets
Rifaximin…. 550mg
Type of Form FORM-5
Packed Size and Demanded Price 1 x10’s: As per SRO
Me-too Status Nimixa 550 mg tablet by Getz Pharma
Remarks of Evaluator Applied formulation is not present in available USP and
BP.
Firm has shifted from uncoated to coated tablet without
submission of fee.
Decision: Deferred for submission of fee for change of formulation
Brand Name + Dosage form + Strength Zipraside 20 mg Capsules
Ziprasidone (as hydrochloride)… 20mg
Pharmacological Group Atypical Antipsychotic
Type of Form FORM-5
Approval status of product in Reference Approved in Ireland
Regulatory Authorities Geodon (PFIZER,IRELAND)
Me-too Status PRAZIP (SHROOQ PHARMA)
Remarks of Evaluator Firm has claimed USP specifications but applied
formulation is not present in USP.
Reference product is approved as Ziprasidone (as
hydrochloride monohydrate)… 20mg capsule which
different from the applied formulation i.e. Ziprasidone
(as hydrochloride)…20 capsule.
Decision: Deferred for clarification of salt form of API.
Brand Name + Dosage form + Strength Zipraside 40 MG Capsules
Ziprasidone (as hydrochloride)… 40mg
Pharmacological Group Atypical Antipsychotic
Type of Form FORM-5
Approval status of product in Reference Approved in Ireland
Regulatory Authorities Geodon (PFIZER,IRELAND)
Me-too Status PRAZIP (SHROOQ PHARMA)
Remarks of Evaluator Firm has claimed USP specifications but applied
formulation is not present in USP.
Reference product is approved as Ziprasidone (as
hydrochloride monohydrate)… 40mg capsule which
different from the applied formulation i.e. Ziprasidone
(as hydrochloride) 40mg capsule.
Decision: Deferred for clarification of salt form of API.
Brand Name + Dosage form + Strength Rovastin 10 Mg Tablets
Rosuvastatin (as calcium)….10mg
Diary No. Date of R&I & Fee Dyno.13; 02-02-2017; Rs. 20000/-
Pharmacological Group Lipid Lowering Agent
Type of Form Form-5
Packed Size and Demanded Price 1 X 14’s, 2 X 14’s; As per SRO
Regulatory Authorities Crestor (Astra Zeneca Pharma,Usa)
Me-too Status Xovat 10mg Tablet of AGP Pharma
BP.
Brand Name + Dosage form + Strength Rovastin 20 mg Tablets
Rosuvastatin (as calcium)….20mg
Pharmacological Group Lipid Lowering Agent
Type of Form Form-5
Packed Size and Demanded Price 1 X 14’s, 2 X 14’s; As per SRO
Regulatory Authorities Crestor (Astra Zeneca Pharma,Usa)
Me-too Status Xovat 20mg Tablet of AGP Pharma
BP.
29. Name And Address Of The Kanel Pharmaceuticals, Plot # 6-Road SS-3, National
Manufacturer/Applicant Industrial Zone, Rawat, Rawalpindi.
Brand Name + Dosage Form + Strength K-PRIDE SR 150 MG TABLETS
Composition Each extended release film coated tablet Contains:
Itopride Hydrochloride…150mg
Diary No. Date Of R&I & Fee Dy No.18; 02-02-2017; Rs. 20000/-
Pharmacological Group Gastroprokinetics
Type Of Form FORM-5
Packed Size And Demanded Price 1 x10’s: As per SRO
Approval Status Of Product In Not confirmed
Me-Too Status ITOPLEX (WINSFIELD)
Remarks Of Evaluator Evidence of approval status of applied formulation in
reference agencies.
30. Name And Address Of The Sawan pharmaceuticals 11-E Industrial triangle Kahuta
Manufacturer/Applicant Road, Islamabad.
Contract manufactured by: Bio labs pharmaceuticals plot
No. 145 Industrial triangle Kahuta Road, Islamabad.
Brand Name + Dosage Form + Strength S-Zole Injection 40mg
Composition Each vial contains omeprazole (as sodium)…40mg
Pharmacological Group Poton Pump inhibitor
Type Of Form Form-5
Finished Product Specification Not claimed
Packed Size And Demanded Price 1’s vial; As per PRC.
Approval Status Of Product In MHRA approved.
Me-Too Status Loprot injection 40mg by Nabiqasim
GMP Status
Remarks Of Evaluator Firm has claimed Innovator specs and applied
formulation does not exist in Available USP and B.P.
Decision: Deferred for clarification of submitted manufacturing method for applied
formulation.
Brand Name + Dosage Form + Strength S-Eso Injection 40mg
Composition Each vial contains Esomeprazole (as sodium)…40mg
Type Of Form Form-5
Approval Status Of Product In MHRA approved.
Me-Too Status Esopep by Global Pharmaceuticals.
GMP Status
Remarks Of Evaluator i.
Applied formulation does not exist in Available
USP and B.P.
formulation.
Brand Name + Dosage Form + Strength Pantozole Injection 40mg
Pantoprazole (as sodium sesquihydrate)lyophilized
powder…40mg
Type Of Form Form-5
Approval Status Of Product In MHRA approved
Me-Too Status Lesprot of Nabiqasim Industries
GMP Status
Remarks Of Evaluator i. Applied formulation does not exist in Available
USP and B.P.
formulation.
b) Deferred Cases
33. Name and address of manufacturer / M/s Linear Pharma, Plot # 18, Street S-4, National
Applicant Industrial Zone, Rawat.
Brand Name +Dosage Form + Strength Unigab Capsules 150mg
Composition Dy No. 4370, 03-09-2014, Rs.20000/-
Diary No. Date of R& I & fee Each capsule contains:-
Pregabalin ….150mg
Pharmacological Group Antiepileptics
Type of Form Form-5
Finished product Specifications Mfg. Specifications
Pack size & Demanded Price 14’s (alu/alu blister); As per PRC
Me-too status Hilin capsules 150mg by Highnoon
GMP status Last GMP Inspection of M/s Linear Pharma conducted
on 19-01-2016 with conclusive remarks of good level of
cGMP compliance.
Remarks of the Evaluator i. Firm has claimed Mfg. Specifications but has not
submitted the data as required by decision taken in
267th R.B meeting, & the applied formulation does
not exist in available USP & B.P.
ii. Firm has tablet (general) section.
inspection report conducted within a period of last one
year
Evaluation by PEC Inspection conducted on 30-11-2017, the firm was
operating at fair level of GMP compliance. The firm was
granted GMP certificate.
Decision: Approved with Innovators specifications.
Pregabalin ….75mg
Pharmacological Group Gaba analogue
Type of Form Form-5
on 19-01-2016 with conclusive remarks of good level of
cGMP compliance.
ii. Firm has tablet (general) section.
year
Decision: Approved with Innovators specifications
Pregabalin ….50mg
Pharmacological Group Gaba analogue
Type of Form Form-5
on 19-01-2016 with conclusive remarks of good level
of cGMP compliance.
ii. Firm has capsule (general) section.
year
36. Name and address of manufacturer / M/s. Medella Pharma (Pvt) Ltd, Plot No. 569-570,
Applicant Sunder Industrial Estate, Lahore contract manufactured
from Medisave Pharmaceuticals, Plot No. 578-579,
Sundar Industrial Estate Lahore
Brand Name +Dosage Form + Strength Mede-C Capsule 400mg
Cefixime as trihydrate…400mg
PKR 50,000/-: 22-09-2015
Type of Form Form 5
Approval status of product in Reference Suprax capsule by Lupin
Me-too status Cef-OD by CCL
GMP status Last inspection report of M/s Medisave Pharma dated
09-05-2016 confirms satisfactory status of the firm
Remarks of the Evaluator Firm has claimed in house specification while the
product monograph is present in JP
 GMP report is older than 1 year
Previous Decision Deferred in 273rd meeting for submission of GMP
Evaluation by PEC Panel inspection conducted on 11-12-2017 and 10-1-
2018 recommends renewal of DML.
Brand Name +Dosage Form + Strength Mede-C Suspension
Composition Each 5ml reconstituted contains:-
Cefixime (as trihydrate)…….100mg
Diary No. Date of R& I & fee Dy. No. 821: 22-09-2015 PKR 50,000/-:22-09-2015
Type of Form Form 5
Pack size & Demanded Price 60ml: As per SRO
Approval status of product in Reference Suprax by Lupins
Me-too status Cef-OD by CCL
Remarks of the Evaluator GMP report is older than 1 year
Decision: Approved.
Brand Name +Dosage Form + Strength Medecif Injection 250mg IM
Ceftriaxone sodium eq.to ceftriaxone…..250mg
Diary No. Date of R& I & fee Dy. No. 822: 22-09-2015 PKR 50,000/-: 22-09-2015
Type of Form Form 5
Approval status of product in Reference Rocephin Injection by Roche
Me-too status Rocephin by Martin Dow
Remarks of the Evaluator  GMP report is older than 1 year
 Firm has applied for both IM/IV injection in single
application.
and clarification whether the firm want to retain this
application for IM or IV use.
The firm has specified IM route of administration.
Decision: Approved
Brand Name +Dosage Form + Strength Medecif Injection 500mg IV
Ceftriaxone sodium eq.to ceftriaxone…500mg
Diary No. Date of R& I & fee Dy. No. 823: 22-09-2015
PKR 50,000/-: 22-09-2015
Type of Form Form 5
inspection report conducted within a period of last 1
year.
2018 recommends renewal of DML to M/s. Medisave
Pharma, Lahore.
Decision: Approved
Brand Name +Dosage Form + Strength Medecif Injection 1g IV
Ceftriaxone sodium eq.to ceftriaxone…1gm
Diary No. Date of R& I & fee Dy. No. 819: 22-09-2015 PKR 50,000/-: 22-09-2015
Type of Form Form 5
inspection report conducted within a period of last 1
year.
Decision: Approved.
41. Name and address of manufacturer / M/s NabiQasim Industries (Private) Limited, 17/24,
Applicant Korangi Industrial Area, Korangi, Karachi
Brand Name +Dosage Form + Strength Orbimet 50mg/ 500 mg tablet
Vildagliptin….50 mg
Metformin hydrochloride….. 500 mg
Diary No. Date of R& I & fee Dy. No.410, 23-06-2015, Rs.20,000/- (23-06-2015). Fee
challan is duplicate.
Pharmacological Group Oral hypoglycemic
Type of Form Form 5 (Duplicate)
Pack size & Demanded Price 30‟s ; As per PRC
Approval status of product in Reference Galvumet tablet, TGA-Australia approved
Me-too status Galmet 50mg/500mg Tabletof M/s Visison
Pharmaceuticals (Pvt,) Ltd, (Reg.#081905)
GMP status GMP status Last inspection conducted on 03-08-2017
and 02-11-2017 reports conclude that firm is found
GMP compliant.
Remarks of the Evaluator  Submitted dossier is duplicate.
 No USP or BP monograph is available for applied
formulation.
 Several cases of the firm has been deferred in 269th
meeting of Registration Board for observations related
to GMP made by panel of inspection for the product
SOVIR-C 400mg tablet and as recorded in inspection
report (dated: 01-04-2017).
Previous Meeting (M-272) Deferred for following:
i. Submission of rectification report of
observations related to GMP made by panel of
inspection for the product SOVIR-C 400mg
tablet and as recorded in inspection report
ii. Verification of fee challan as per decision of
Registration Board in 264th meeting.
Evaluation by PEC QA Division vide letter No.F.4-4/89-QA dated 18-01-
2018 clarified that as per panel Inspection Reports Dated
03-08-2017 and 02-11-2017, the firm Nabiqasim
Industries (Pvt) Ltd., Plot No. 17, Sector 24, Korangi
Industrial Area, Karachi was considered to be operating
at acceptable level of compliance of GMP requirements.
Decision: Approved with 18 months’ specifications. Reference will be sent to Budget &
challan is duplicate
GMP compliant.
formulation.
i. Submission of rectification report of observations
related to GMP made by panel of inspection for the
product SOVIR-C 400mg tablet and as recorded in
inspection report
challan is duplicate.
GMP compliant.
formulation.
i. Submission of rectification report of observations
inspection report
Brand Name +Dosage Form + Strength Zelocal 4mg Injection
Composition Each vial contains: Zoledronic acid monohydrate eq. to
Zoledronic acid (lyophilized)…4mg
Diary No. Date of R& I & fee Dy. No. 124: 27-7-2015Rs. 20,000/-: 27-7-2015.
Pharmacological Group Bisphosphonate
Type of Form Form 5
Finished product Specifications Firm has claimed innovator specifications
Pack size & Demanded Price 1’s ; As per PRC
Approval status of product in Reference Zometa injection by Novartis (USFDA Approved) but
Regulatory Authorities discontinued for reasons other than safety and efficacy
Me-too status Zometa Injection by Novartis
GMP compliant.
Remarks of the Evaluator -
Registration Board was apprised of the observations
inspection report (dated: 01.04.2017). The observations
in the GMP inspection report of area FID, dated
03.08.2017 was also considered. Registration Board
deferred the case for clarification from QA Division
regarding GMP status of the firm in the light of
observations made by the panel of inspection for the
product SOVIR-C 400mg tablet and those recorded by
area FID in inspection report dated 03-08-2017.
Brand Name +Dosage Form + Strength Loprot 40 Capsule
Composition Each capsule contains: Omeprazole enteric coated
pellets eq. to Omeprazole (12.5%)..……..40 mg
Diary No. Date of R& I & fee Dy. No. 125: 27-7-2015; Rs. 20,000/-: 27-7-2015
Pharmacological Group (Proton Pump Inhibitor)
Type of Form Form 5
Pack size & Demanded Price 14‘s: As per PRC
Approval status of product in Reference Omeprazole capsule by Actavis (USFDA Approved)
Me-too status Risek capsule by Getz Pharma
GMP compliant.
Remarks of the Evaluator Source of pellets: M/s Surge Laboratories
deferred the case for clarification from QA< Division
Brand Name +Dosage Form + Strength Oseban 50mg Tablet
Composition Each film coated tablet contains: Ibandronate sodium
monohydrate eq. to. Ibandronic acid………50 mg
Diary No. Date of R& I & fee Dy. No. 168: 03-8-2015Rs. 20,000/-: 03-8-2015
Pharmacological Group (Nitrogen containing bisphosphonate)
Type of Form Form 5
Finished product Specifications Firm has claimed innovator‘s specifications
Pack size & Demanded Price 28‘s: As per PRC
Approval status of product in Reference Ibandronic acid by Actavis (MHRA Approved)
Me-too status Bondronat tablets by Roche
GMP compliant.
Brand Name +Dosage Form + Strength Oseban 150mg Tablet
Composition Each film coated tablet contains: Ibandronate sodium
monohydrate eq. to. Ibandronic acid……… 150 mg
Diary No. Date of R& I & fee Dy. No. 167: 03-8-2015 Rs. 20,000/-: 03-8-2015
Pharmacological Group (Nitrogen containing bisphosphonate)
Type of Form Form 5
Finished product Specifications Firm has claimed innovator‘s specifications
Pack size & Demanded Price 1‘s, 3‘s: As per PRC
Approval status of product in Reference Ibandronic acid by Actavis (MHRA Approved)
Me-too status Bronheal tablets by Novamed
GMP compliant.
Brand Name +Dosage Form + Strength Loprot Plus Capsule
Omeprazole ……..20mg
Sodium Bicarbonate .1100mg
Diary No. Date of R& I & fee Dy.1530, 03-08-2010 Rs.8000 + Rs.12,000/-(14-5-2013)
Pharmacological Group Anti Ulcerant
Type of Form Form 5
Finished product Specifications Manufacturer specifications
Pack size & Demanded Price 7‘s, 10‘s, 14‘s;As per PRC
Approval status of product in Reference (USFDA Approved)
Me-too status Zoltar Insta by Pharmaevo
GMP compliant.
Remarks of the Evaluator Firm has submitted copy of inspection report conducted
on 03-08-2017 concluding acceptable of GMP
compliance.
Brand Name +Dosage Form + Strength Loprot Plus Capsule
Omeprazole …….40 mg
Sodium Bicarbonate……..…1100 mg
Diary No. Date of R& I & fee Dy.1333, 14-7-2010 Rs.8000/- +
Rs.12,000/-(14-5-2013) (Photo copy)
Type of Form Form 5
Pack size & Demanded Price 7‘s, 10‘s, 14‘s;As per PRC
Approval status of product in Reference (USFDA Approved)
Me-too status Zoltar Insta by Pharmaevo
GMP compliant.
compliance.
Decision: Approved with Innovator’s speicfications.
Brand Name +Dosage Form + Strength Loprot Insta Sachet
Omeprazole ………..20 mg
Sodium Bicarbonate (as Buffer)……1680 mg
Diary No. Date of R& I & fee Dy.1332, 14-7-2010 Rs.8000/- +
Rs 12,000/- (14-5-2013) (Photo copy)
Type of Form Form 5
Pack size & Demanded Price 7‘s, 10‘s; As per PRC
Approval status of product in Reference Zegerid (USFDA Approved)
Me-too status Omega rapid (Ferozesons)
GMP compliant.
compliance.
inspection report (dated: 01-04-2017). The observations
Moreover, clarification shall be obtained from firm
regarding use of sodium bicarbonate as buffer..
Decision: Deferred for clarification of use of Sodium bicarbonate as buffer in the applied
formulation.
Brand Name +Dosage Form + Strength Loprot Insta Sachet
Omeprazole ………..40 mg Sodium
Bicarbonate (as Buffer)….1680 mg
Diary No. Date of R& I & fee Dy.No.1331, 14-7-2010 Rs.8000/- + Rs 12,000/- (14-5-
2013) (Photo copy)
Type of Form Form 5
Pack size & Demanded Price 7‘s, 10‘s; As per PRC
Approval status of product in Reference Zegerid (USFDA Approved)
Me-too status Risek Insta by Getz
GMP compliant.
compliance.
Moreover, clarification shall be obtained from firm
regarding use of sodium bicarbonate as buffer..
Decision: Deferred for clarification of use of Sodium bicarbonate as buffer in the applied
formulation.
Brand Name +Dosage Form + Strength Keptiron Oral Solution
Levetiracetam …………..500mg
Diary No. Date of R& I & fee Dy. No. 1063, 26-06-2014, Rs.20,000/- (26-06-2014)
Type of Form Form 5
Pack size & Demanded Price 60 ml; As per PRC
Approval status of product in Reference Keppra 100mg/ml oral solution USFDA approved
Me-too status Lumark oral solution by searle
GMP compliant.
compliance.
in the GMP inspection report of area FID, dated 03-08-
2017 was also considered. Registration Board deferred
the case for clarification from QA< Division regarding
GMP status of the firm in the light of observations made
by the panel of inspection for the product SOVIR-C
400mg tablet and those recorded by area FID in
inspection report dated 03-08-2017.
Decision: Approved
Brand Name +Dosage Form + Strength Zonitec 50mg capsule
Zonisamide ………...50 mg
Type of Form Form 5
Pack size & Demanded Price 14‘s and 28‘s; As per PRC
Approval status of product in Reference Zonegran 50mg Capsule (MHRA approved)
Me-too status Zonisa capsules by Hilton pharma
GMP compliant.
compliance.
Brand Name +Dosage Form + Strength Zonitec 100mg capsule
Zonisamide ………... 100 mg
Type of Form Form 5
Pack size & Demanded Price 14‘s and 28‘s; As per PRC
Approval status of product in Reference Zonegran 100mg Capsule (MHRA approved)
Me-too status Zonisa capsules by Hilton pharma
GMP compliant.
compliance.
Brand Name +Dosage Form + Strength Vortex 200mg Powder for Injection

Voriconazole………..… 200 mg
Type of Form Form 5
Finished product Specifications Innovator specifications
Pack size & Demanded Price 20ml x 1‘s and 5‘s ; As per PRC
Approval status of product in Reference Vfend 200mg powder for solution for injection MHRA
Regulatory Authorities approved
Me-too status Vivid 200mg/vial injection
GMP compliant.
Remarks of the Evaluator  Firm has submitted copy of inspection report
conducted on 03-08-2017 concluding acceptable
of GMP compliance.
 Inspection reports mentions availability of
―Small volume lyophilized injectables‖ section
Decision: Approved.
Brand Name +Dosage Form + Strength Vortex Dry Suspension 200 mg
Composition Each 5ml of reconstituted suspension contains:
Voriconazole ….200 mg
Diary No. Date of R& I & fee Dy. No. 996 ,16-6-14, Rs.20000/-
Type of Form Form 5
Finished product Specifications Innovator specifications
Pack size & Demanded Price 60 ml, 70 ml; As per PRC
Approval status of product in Reference VFEND by Pfizer (USFDA)
Me-too status Vorizole suspension by CCL pharma
GMP compliant.
Brand Name +Dosage Form + Strength Fluderm Oral Suspension 50mg/5ml
Fluconazole…..50 mg
Diary No. Date of R& I & fee Dy. No.79, R&I Dated 21-10-14, Rs: 20,000/-
Pharmacological Group Antifungal triazole
Type of Form Form 5
Pack size & Demanded Price 35ml amber glass bottle, As per PRC
Approval status of product in Reference Diflucan.USFDA
Me-too status Fluren by Regal Pharmaceuticals(R. No. 081984)
GMP compliant.
Decision: Approved.
Brand Name +Dosage Form + Strength Migrina film coated tablet (85 mg+500mg)
Sumatriptan succinate USP eq. to sumatriptan…85 mg
Naproxen sodium USP…500mg
Diary No. Date of R& I & fee Dy. No.80,R&I Dated 21-10-14,Rs. 20,000
Pharmacological Group Selective 5 HT1 receptor agonists, Analgesic,
Type of Form Form 5
Finished product Specifications As per Innovator Specs.
Pack size & Demanded Price 2's,6's,10's Alu Alu Formable Foil ,As per PRC
Approval status of product in Reference Treximet By GSK,USFDA
Me-too status Imtaxen by Shaigan Pharmaceuticals(081678)
GMP compliant.
the case for clarification from QA Division regarding
Brand Name +Dosage Form + Strength Preka 25mg Capsule
Pregabalin……. 25mg
Diary No. Date of R& I & fee Dy. No. 385: 10/09/2015,Rs 20,000/-: 10/09/2015
Type of Form Form 5
Finished product Specifications In House
Pack size & Demanded Price Pack Size: 10‘s 14‘s, 30‘sPrice: As per PRC
Approval status of product in Reference Lyrica capsule (USFDA Aprroved)
Me-too status Dygab capsule 25mg by M/s Dyson Pharma (Reg #
079155)
GMP compliant.
compliance.
Diary No. Date of R& I & fee Dy. No. 383: 10/09/2015,Rs 20,000/-: 10/09/2015
Type of Form Form 5
Me-too status Nergab capsule 200mg by M/s AGP (Reg #076696)
GMP compliant.
compliance.
Diary No. Date of R& I & fee Dy. No.387, 10/09/2015, Rs 20,000/= 10/09/2015
Type of Form Form 5
Me-too status Nergab capsule 200mg by M/s AGP (Reg # 074884)
GMP compliant.
 Evidence of approval of applied formulation in reference regulatory
status) alongwith registration number, brand name and name of firm.
Diary No. Date of R& I & fee Dy. No. 386, 10/09/2015, Rs 20,000/= 10/09/2015
Type of Form Form 5
Me-too status Xilica capsule 300mg by M/s PhamEvo (Reg# 080634)
GMP compliant.
compliance.
Brand Name +Dosage Form + Strength ES-Pramcit Oral Drops 20mg/ml
Composition Each ml of solution contains:
Escitalopram as oxalate…..20mg
Pharmacological Group Antidepressant (Selective Serotonin Inhibitor)
Type of Form Form 5
Pack size & Demanded Price 15ml, 30ml : As per PRC
Approval status of product in Reference Anisdis 20 mg/ml oral drops by Pharmacare
Me-too status Cipralex by Lundbeck
GMP compliant.
Remarks of the Evaluator Registration Board was apprised of the observations
inspection report (dated: 01-04-2017).
The observations in the GMP inspection report of area
FID, dated 03-08-2017 was also considered. Registration
Board deferred the case for clarification from QA&LT
area FID in inspection report dated 03-08-2017
Previous Meeting (M-274) Registration Board deferred the case for clarification
from QA&LT Division regarding GMP status of the
firm in the light of observations made by the panel of
inspection for the product SOVIR-C 400mg tablet and
those recorded by area FID in inspection report dated
03-08-2017.
Decision: Approved
Brand Name +Dosage Form + Strength ES-Pramcit Oral Drops 10mg/ml
Composition Each ml of solution contains:
Escitalopram as oxalate…..10mg
Pharmacological Group Antidepressant (Selective Serotonin Inhibitor)
Type of Form Form 5
Pack size & Demanded Price 15ml, 30ml : As per PRC
Approval status of product in Reference SEROPLEX 10 mg / ml, oral solution ANSM
Me-too status Depsit by Genix
GMP compliant.
Remarks of the Evaluator (M-274) Registration Board was apprised of the observations
inspection report (dated: 01-04-2017).
The observations in the GMP inspection report of area
FID, dated 03-08-2017 was also considered. Registration
Board deferred the case for clarification from QA&LT
area FID in inspection report dated 03-08-2017
Previous Meeting Deferred for the following reasons:
 Clarification from QA&LT Division regarding GMP
status of the firm in the light of observations made by
the panel of inspection for the product SOVIR-C 400mg
tablet and those recorded by area FID in inspection
report dated 03-08-2017.
 Submission of evidence of approval of applied
formulation in reference regulatory authorities / agencies
in its 249th meeting.
Decision: Approved
Brand Name +Dosage Form + Strength Neutop 100mg tablets
Topiramate……….100mg
Type of Form Form 5
Pack size & Demanded Price 30’s and 60’s; As per PRC
Approval status of product in Reference Topamax (MHRA approved)
Me-too status Tics 100mg tablets of M/s Genix pharma
GMP compliant.
Remarks of the Evaluator ---
Previous Meeting (M-274) Registration Board deferred the case for clarification
from QA&LT Division regarding GMP status of the
firm in the light of observations made by the panel of
inspection for the product SOVIR-C 400mg tablet and
those recorded by area FID in inspection report dated
03-08-2017.
Decision: Approved
Sr. Name of the Brand Name Dy No. International Decision of Evaluation by
No Firm Composition Date availability Previous PEC
Finished Pack Size Me-too status meetings
Product Specs and Price GMP Status
and date
66. M/s. Linear Litrozole Tablets Form-5 GMP Deferred for
Inspection
Pharma, Plot 2.5mg Fast track inspection of clarification for
conducted on 30-
No 18, Stret Each film coated As Per last 1 year requirement of
11-2017 concluded
No. S-4 tablet contains:- SRO per could not be manufacturing for
that the firm was
National Letrozole(U.S.P) 10’s/ 30’s confirmed product (M-242).
operating at fair
Industrial ……..2.5mg 31/10/13, level of GMP
Zone Enzyme 6806 Deferred in 275th compliance. The
(RCCI) inhibnitor (Non- (R&I) meeting for firm was granted
Rawat, steroidal 31/10/13 submission of GMP certificate.
Islamabad Aromatase Rs. latest GMP
inhibitor) / Anti- 60,000/- inspection report
cancer conducted within a
period of last 1
year by DRAP.
67. M/s Global Vorzol 200mg Vfend Infusion  Firm changed The
Form 5-D firm has
Pharmaceuti Injection 16-6-2011
by PF Prism the form from 5- submitted me-too
cals, (USFDA D to form 5 reference as
Islamabad Each vial Dy.2120 Approved)  Firm claimed “Vivid Injection of
contains:- Manufacturer S.J. & G. Fazul
Voriconazole… Rs.15000/- Vorif by Specification, Ellahie, Karachi
….…..200mg Rs.5000/- ferozsons and the product (Reg # 070582)”.
26-3-2015 is not present in
(Antifungal) Last inspection available
1’s report versions of
As Per 23-24-08-2016 pharmacopeia
SRO Overall cGMP (BP 2013 and
compliance is USP 39)
considered as  Deferred in
good. 265th meeting
for confirmation
of me too status
as reported
reference is in-
correct.
Moreover, firm
has applied on
Form5D.
Decision: Deferred for evidence of approval of manufacturing facility of “Dry powder Lyophilized
injection” by Central Licensing Board.
Case No. 02: Registration applications of newly granted DML or New section (Human)
a) Deferred Cases
68. Name and address of manufacturer / M/s. Aries Pharmaceuticals (Pvt) Ltd. 1-W, Industrial
Applicant Estate, Hayatabad Peshawar.
Brand Name +Dosage Form + Strength Phenobar Elixir 20mg/5ml
Phenobarbital…20mg (0.4% w/v)
Diary No. Date of R& I & fee Diary No:24292 , 13/12/2017, Rs: 20,000/-
Pharmacological Group Barbiturates
Type of Form Form-5
Pack size & Demanded Price 60ml, 90ml, 120ml, 240ml, 300ml / As per SRO.
Approval status of product in Reference Phenobarbital Elixir 20mg/5ml by M/s Qualitest
Regulatory Authorities. Pharmaceuticals (USFDA)
https://www.accessdata.fda.gov/scripts/cder/ndc/dsp_se
archresult.cfm
Market category: Unapproved Drug Other
Me-too status Phenomed Elixir 20mg/5ml by M/s Medicraft
Grant of Additional Sections
Panel recommends grant of Additional Sections
Previous Remarks of the Evaluator.  Approval status of product in Reference Regulatory
 According to FDA:
https://www.fda.gov/AboutFDA/Transparency/Bas
ics/ucm213030.htm
What are unapproved drugs and why are they on the
market?
Generic drugs have been evaluated and approved by
FDA to demonstrate bioequivalence to a brand name
reference drug. Healthcare professionals and
consumers can be assured that FDA-approved generic
drug products have met the same quality, strength,
purity and stability as brand name drugs. Additionally,
the generic manufacturing, packaging, and testing sites
must meet the same quality standards as those of brand
name drugs. Unapproved drug products have not been
evaluated and approved by FDA. Unapproved drugs
are not generic medications, and neither their safety
nor their efficacy can be assured.
Decision: Registration Board in its 277th meeting deferred for
evidence of approval of applied formulation by
Reference Regulatory Agencies.
Evaluation by PEC
Firm has referred to section 1308.22 (Excluded substances) of part 1308 (Schedules of Controlled
Substances) of Chapter II of title 21 of CFR (United States Code of Federal Regulations) stating
as under:
The following nonnarcotic substances which may, under the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 301), be lawfully sold over the counter without a prescription, and are excluded
from all schedules pursuant to section 201(g) (1) of the Act (21 U.S.C. 811(g) (1)):
Company Trade name NDC code Form Controlled substance (mg or
mg/ml)
Aphena Pharma Nasal Decongestant IN Levmetamfetamine 50.00
Solutions—New York, Inhaler/Vapor Inhaler (l-Desoxyephedrine)
LLC
Bioline Laboratories Theophed 00719-1945 TB Phenobarbital 8.00
Goldline Laboratories Guiaphed Elixir 00182-1377 EL Phenobarbital 4.00
Goldline Laboratories Tedrigen Tablets 00182-0134 TB Phenobarbital 8.00
Hawthorne Products Choate's Leg Freeze LQ Chloral hydrate 246.67
Inc
Parke-Davis & Co Tedral 00071-0230 TB Phenobarbital 8.00
Parke-Davis & Co Tedral Elixir 00071-0242 EX Phenobarbital 40.00
Parke-Davis & Co Tedral S.A. 00071-0231 TB Phenobarbital 8.00
Parke-Davis & Co Tedral Suspension 00071-0237 SU Phenobarbital 80.00
Parmed Pharmacy Asma-Ese 00349-2018 TB Phenobarbital 8.10
Procter & Gamble Co., Vicks VapoInhaler 37000-686-01 IN Levmetamfetamine 50.00
The (l-Desoxyephedrine)
Rondex Labs Azma-Aids 00367-3153 TB Phenobarbital 8.00
Smith Kline Consumer Benzedrex 49692-0928 IN Propylhexedrine 250.00
Sterling Drug, Inc Bronkolixir 00057-1004 EL Phenobarbital 0.80
Sterling Drug, Inc Bronkotabs 00057-1005 TB Phenobarbital 8.00
White Hall Labs Primatene (P-tablets) 00573-2940 TB Phenobarbital 8.00
 The above statement has been verified form following web-link as accessed on 30-01-2018:
“https://www.ecfr.gov/cgi-bin/text-
idx?SID=184dc03c78c520a8b1618288bc58551e&mc=true&node=se21.9.1308_122&rgn=div8”
(current as of January 26, 2018)
 The record of NDC code of the product as referred in above CFR regulation i.e. 00182-1377,
is not available in the On-line NDC (National Drug Code) Directory as accessed on
30.1.2018, from following website link:
https://www.accessdata.fda.gov/scripts/cder/ndc/ (Current through: 1/30/2018)
 The marketing status of product referred by Firm i.e. Phenobarbital Elixir 20mg/5ml by M/s
Qualitest Pharmaceuticals, is declared as “Unapproved Drug”.
 The term “Unapproved Drug” is described by USFDA as under:
“Federal law generally requires that prescription drugs in the U.S. be shown to be both safe and
effective prior to marketing. The FDA's evidence-based system of drug approval and the OTC
monograph system play essential roles in ensuring that drugs are both safe and effective. For
instance, during the drug approval process the applicant must demonstrate that its manufacturing
processes can reliably produce drug products of expected identity, strength, quality, and purity.
Furthermore, FDA's review of the applicant's labeling insures that health care professionals and
patients have the information necessary to understand a drug product's risks and its safe and
effective use.
The Agency has serious concerns that drugs marketed without required FDA approval may not
meet modern standards for safety, effectiveness, quality, and labeling. Physicians and other
healthcare practitioners, along with consumers, cannot assume that all marketed drugs have been
found by the FDA to be safe and effective. For a variety of historical reasons, some drugs, mostly
older products, continue to be marketed illegally in the U.S. without required FDA approval. The
manufacturers of unapproved drug products have not received FDA approval and do not conform
to a monograph for making over-the-counter (OTC) drugs. The lack of evidence demonstrating
that these unapproved drugs are safe and effective is a significant public health concern.”
(Ref.
https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesb
yFDA/SelectedEnforcementActionsonUnapprovedDrugs/default.htm) accessed on 30.1.2018
Decision: RegistrationBoard deferred the case for further dliberation.
Case No. 03: Registration applications of newly granted DML or New section (Veterinary)
M/s. Majestic Pharma., Plot # 21, Phase-1A, M-3, Industrial City, Faisalabad.
The Central Licensing Board in its 256th meeting held on 9-10th November, 2017 has considered and
approved the grant of Drug Manufacturing License by way of Formulation.
Accordingly, firm has applied following registration applications, the section wise details are as follows
 Oral Liquid (General) Section
 Oral Powder (General) Section
The firm did not mention product names on fee challans of applied formulations. So the reference was
sent to Budget and Accounts Division to confirm fee deposited for applications to be considered by the
Board. The B & A division replied that “this office may only verify this amount in accordance of the
original record”. They further commented that “Already mentioned in this office letter as well as on the
application deposit fee slips and amount which may be accordingly processed.”
Oral Liquid (General) Section (10molecules / 10 products)
69. Name and address of manufacturer / M/s. Majestic Pharma., Plot # 21, Phase-1A, M-3,
Applicant Industrial City, Faisalabad.
Brand Name +Dosage Form + Strength M-FCO Liquid
Florfenicol……………… 250 mg
Colistin Sulphate…………0.5MIU
Diary No. Date of R& I& fee 1410, 16-01-18, 20,000/-, 08-01-2018
Type of Form Form-5
Pack size& Demanded Price 100 ml,250ml, 500 ml, 1 Liter,5Liter; Decontrolled
Me-too status Poliflor Liquid of M/s. Hawk Biopharma (Reg # 078383)
GMP status CLB in 256th meeting approved the grant of new DML to
M/s. Majestic Pharma, Faisalabad
Remarks of the Evaluator.  Fee challan of Rs. 20,000/ could not be verified.
Decision: Deferred for verifivation of Fee challan of Rs. 20,000/- for applied formulation.
Brand Name +Dosage Form + Strength TILMICO-N Liquid
Tilmicosin…………..250mg
Type of Form Form-5
Pack size& Demanded Price 100 ml, 500 ml, 1 Liter,5Liter; Decontrolled
Me-too status Micotil 250 oral Liquid of M/s. Vantage Pharma (Reg #
081699)
Brand Name +Dosage Form + Strength PRO CHICK Oral Liquid
Enrofloxacin………………..75mg
Sulphamethoxypiridazine …………75mg
Sulphamethzine……………..50 mg
Trimethoprim……………… 25 mg
Type of Form Form-5
Pack size& Demanded Price 100 ml, 500 ml, 1 Liter,5Liter; Decontrolled
Me-too status Cenatin Oral Liquid of M/s Hawk Biopharma (Reg#
078379)
Brand Name +Dosage Form + Strength M FLOX-C Liquid
Enrofloxacin……………….. 20g
Colistin Sulphate…………….50 MIU
Type of Form Form-5
Pack size& Demanded Price 100 ml, 250ML, 500 ml, 1 Liter,5Liter; Decontrolled
Me-too status Floxa-C Oral Solution of M/s. Baariq pharma
(Reg#071094)
Brand Name +Dosage Form + Strength BROCHLIN Oral Liquid
Tylosin Tartrate………………… 200 mg
Doxycyclin HCL ………………… 250mg
Colistin Sulphate ………………… 0.5 MIU
Bromhexine HCL……………………12mg
Type of Form Form-5
Pack size& Demanded Price 100 ml, 250ML, 500 ml, 1 Liter,5Liter; Decontrolled
Me-too status Tylotar Forte Solution of M/s. Evergreen Pharma (Reg #
071094)
Brand Name +Dosage Form + Strength MAJI LIVO P Liquid
Inositol……………………7mg
Betain………………….. 20mg
Choline Chloride ………………100mg
Magnesium Sulphate…………… 10mg
Sorbitol…………………………. 200mg
L-Carnitine…………………….. 50mg
Pharmacological Group vitamin-like/Amino acid derivative/ Anticholinergics/
nutritional suppliments
Type of Form Form-5
Pack size& Demanded Price 100 ml, 250ML, 500 ml, 1 Liter, 5Liter; Decontrolled
Me-too status Liver Mall Liquid of M/s. Mallard Pharma (Reg # 075631)
Remarks of the Evaluator. The applied product falls under the category of H & OTC
Division so may be referred to respective division.
Brand Name +Dosage Form + Strength DIARRINE-M Oral Suspension
Sulphadiazine……………………3.350g
Sulphadimidine………………….. 2.840 g
Neomycine sulphate ……………… 0.18 g
Hyoscine Methyl bromide……………..0.004 g
Pectin…………………………………. 0.710 g
Kaolin………………………………..10.33 g
Vitamin B1……………………….. 0.015 g
Vitamin B2………………………..0.022 g
Pharmacological Group Antibacterial, Anti-toxins, Anti-spamodic and vitamins
Type of Form Form-5
Me-too status Scour-X oral suspension of Selmore Pharma (Reg #
029661)
Brand Name +Dosage Form + Strength WARFAX-SC Oral Liquid
Oxfendazole……………………. 34 mg
Oxyclozanide………………….. 94 mg
Sodium Selenite……………….. 0.5 mg
Cobalt Sulphate………………… 3.82mg
Pharmacological Group Anthelmintic/Mineral supplement
Type of Form Form-5
Me-too status Combiox Drench of Selmore Pharma (Reg # 057004)
Brand Name +Dosage Form + Strength I TRIC Oral Suspension
Triclabendazole …………… 120mg
Ivermectin………………. 2mg
Pharmacological Group Anthelmintic
Type of Form Form-5
Me-too status Endoplus 12.2% Oral suspension of M/s. Hawk Bio (Reg
# 079123)
Brand Name +Dosage Form + Strength TRICLAMIN SC Oral Liquid
Composition Contains:
Levamisole HCl…………….. 7.5%w/v
Triclabendazole…………….. 12%w/v
Sodium Selenite…………….. 0.035%w/v
Cobalt Chloride………………. 0.075%w/v
Pharmacological Group Antianthelmentic/ Mineral suppliment
Type of Form Form-5
Me-too status Tenex Plus 19.5 suspension of Vety-Care pharma (Reg #
031470)
Oral Powder (General) Section (molecules / products)
Brand Name +Dosage Form + Strength H-Plus Powder
Paracetamol…………………20 g
Vitamin C………………….. 5g
Potassium Carbonate………….12.5 g
Sodium Bicarbonate………….. 12.5 g
Vitamin E …. 12.5 g
Pharmacological Group Analagesic/Mltivitamines/ Salt solution
Type of Form Form-5
Pack size& Demanded Price 100 g, 250g, 500g, 1 Kg, 5Kg; Decontrolled
Me-too status Para CE oral Powder of Biogen Pharma (Reg # 063812)
Brand Name +Dosage Form + Strength FLOTOX Powder
Composition Each Kg contains
Sodium Benzoate………………..500 g
Ethanol B Aminophosphoric acid ………. 100 g
Vitamin A…………………….. 10000000 IU
Vitamin E……………………. 2500 mg
Vitamin K3…………………. 1000mg
Vitamin C………………….. 2500 mg
Pharmacological Group Antibacterial/Multivitamine
Type of Form Form-5
Me-too status Diurizone powder of M/s. Mylab (Reg # 073908)
Remarks of the Evaluator. The applied product falls under the category of H & OTC
Division so may be referred to respective division.
Brand Name +Dosage Form + Strength TYCODIN-M Oral W/S Powder
Composition Each Kg contains:
Tylosin Tartrate ……………….. 200 gm
Doxycycline HCL……………… 400 g
Colistin Sulphate ……………… 500 MIU
Bromhexine HCL………………. 10 g
Pharmacological Group Antibiotic/ Mucolytics
Type of Form Form-5
Me-too status MEXIN PLUS WSP of M/s. Mylab (Reg # 073908)
Remarks of the Evaluator. The submitted me-too reference contains Doxycycline and
Bromhexine bases while the applied formulation states salt
forms of these molecules.
Brand Name +Dosage Form + Strength ERITIN Oral W/S Powder
Erythromycin Thiocyanate………… 100 g
Trimethoprim ………………. 20 g
Sulphadiazine ………………. 100 g
Type of Form Form-5
Me-too status Erysul-T oral Powder of M/s. Bio-Oxime (Reg # 080135)
Brand Name +Dosage Form + Strength MAJI FLUSH Powder
Hexamethylen Tetramine ……….. 95.5 gm
Riboflavin ……………………… 1 gm
Calcium Pantothenate …………… 0.5 gm
Nicotinamide…………………….. 2.5 gm
Pharmacological Group Urinary antiseptic/Multivitamine
Type of Form Form-5
Me-too status Solo Flush Oral Powder of Biogen Pharma (Reg #
049722)
Brand Name +Dosage Form + Strength MOXY-N Oral W/S Powder
Oxytetracycline HCL ………….300 g
Neomycin Sulphate…………… 250 g
Colistin Sulphate………………500 MIU
Type of Form Form-5
Me-too status Oxyneoriq-C WSP of Baariq Pharma (Reg # 073952)
Brand Name +Dosage Form + Strength M-RESCURE Powder
Oxytetracycline HCL…………. 300 g
Neomycin Sulphate …………….150 g
Florfenicol……………………… 100 g
Type of Form Form-5
Me-too status E-Col Powder of Evergreen pharma (Reg # 081733)
Brand Name +Dosage Form + Strength LSBEE Oral W/S Powder
Lincomycin HCL ……………… 5 g
Spectinomycin HCL…………… 7.5g
Spiramycin Adipose …………… 2.5 g
Bromhexine HCL …………………. 0.5 g
Pharmacological Group Antibacterial/ Mucolytics
Type of Form Form-5
Me-too status Speclinx oral powder of M/s. Vantage Pharma (Reg #
081714)
Brand Name +Dosage Form + Strength MBOOSTER-V Oral W/S Powder
Vitamin B3………………… 2 g
L-Lysine …………………. 25 g
Vitamin E…………………. 5 g
DL- Methionine…………….. 50 g
Choline chloride……………….. 100g
Virginiamycin…………………. 12g
Pharmacological Group Multivitamins
Type of Form Form-5
Me-too status Supercine-TM Powder of M/s. Leads (Reg # 019946)
Case No. 04: Registration applications of import cases

a) Import Deferred cases (Human)
88. Name and address of Applicant M/s. Amtul Pharmaceuticals, 251-Sikandar Block
Allama Iqbal Town, Lahore
Name and address of manufacturer M/s REYOUNG PHARMACEUTICAL CO., No.6,
Erlangshan Road, Yiyuan County, Shandong Province,
P.R. China.
Brand Name+Dosage Form + Strength Piptaz 4.5 g powder for injection
Piperacillin Sodium……….4.03gm
Tazobactum Sodium ……………… 0.536mg
Finished product Specification Firm has claimed in house specification
Diary No. & Date of R& I Dy. # 966 dated 25-07-2012
Fee including differential fee Rs. 15000/- (25-07-2012) + Rs. 85000/- (29-03-2013)
Pack size one vial
Demanded Price Rs. 1350/-
International Availability MHRA approved product of Sandoz
Me-too status Piptazo-Regent
Detail of certificates attached Legalized CoPP dated 02-07-2012.
 Deferred for evaluation of CoPP (M-258)
th
Decision of 258 Board meeting:
Evaluation by PEC The firm has submitted Following embassy attested
documents
1. Free sale issued dated
2. GMP valid upto 17.2.2019
Decision of 261st Board meeting: Deferred for the clarification of composition of
formulation on free sales certificate as on free sales only
brand name is mentioned.
Fresh Evaluation:
The firm has submitted notarized copy of CoPP (issued on 17th May 2012) according to which the
composition is as follows:
Piperacillin…. 4.0 g (Piperacillin sodium: 4.03g)
Tazobactum… 0.5g (Tazobactam sodium: 0.536 g)
Decision: Deferred for submission of valid original & legalized CoPP
Case No. 05: Registration applications of drugs for which stability study data is required
to be verified.
a) New cases:
Sr. Name & Address Brand Name Type of Form, International Previous DRB Decision
No of Manufacturer / (Proprietary Name + Initial Diary Availability / Local / Remarks
. Applicant Dosage Form + & Date, Fee Availability (if any)
Strength), (including
Composition, differential GMP Inspection
Pharmacological fee), Report Date &
Group, Demanded Remarks
Finished Product Price / Pack
Specification size
89. M/s Weatherfolds WIFODEX Capsule Form 5-D DEXILANT by The firm has claimed
Pharmaceuticals 60mg M/s Takeda Manufacturer’s
Dairy No. 154Pharms, USFDA. Specifications.
Plot no. 69/2 Each capsule dated Fee Challan as
phase II, contains: 27-05-2016. Not applicable. submitted with the
Industrial Estate, Enteric coated dossier was for
pellets 22.5% eq. to Rs.50,000/- GMP compliant Dexlansoprazole 60mg
Hattar. Dexlansoprazole dated dated 04-08-2016. Tab. Now the firm has
……..60mg 25-01-2018. submitted Rs. 50,000/-
dated 25-01-2018 for
(Proton Pump As per SRO Dexlansoprazole 60mg
Inhibitor) for 2 x 7’s. Capsules.
Drug WIFODEX Capsule 60mg (Dexlansoprazole)
Name of Manufacturer M/s Weatherfolds Pharmaceuticals, Hattar.
Manufacturer of API M/s Vision Pharmaceuticals, Islamabad.
API Lot No. DLP156T
Description of Pack Plastic jar.
(Container closure
system)
Stability Storage Accelerated: 40°C ± 2°C &75±5%RH
Condition Real Time: 30°C ± 2°C &65±5%RH
Time Period Accelerated: 26 Weeks
Real Time: 26 Weeks
Frequency Accelerated: 1,2,3,4,6,8,12,16,20,24,26 (Week)
Real Time: 1,2,3,4,6,8,12,16,20,24,26 (Week)
Batch No. T – 04 T – 05 T – 06
Batch Size 1,650 Capsules 1,650 Capsules 1,650 Capsules
Manufacturing Date 01 – 2017 01 – 2017 01 – 2017
Date of Initiation 01 – 2017 01 – 2017 01 – 2017
No. of Batches 03
Date of Submission 09-01-2018 (Dy. No. 1263), 25-01-2018 (Dy. No. 1858 PEC), 25-01-2018 (Dy.
No. 1869 PEC)
No.
1. COA of API Photocopy of COA for Batch No. DLP156T is
submitted.
2. Approval of API by regulatory authority of Photocopy of GMP Certificate No. F.8-1/2016-DDG
country of origin or GMP certificate of API (E&M) issued by DDG (E&M) Islamabad, valid till
manufacturer issued by regulatory authority 08th February 2017 is submitted.
of country of origin.
3. Protocols followed for conduction of stability Yes
4. Data of 03 batches will be supported by The firm has submitted supporting Chromatograms
attested respective documents like for Assay Results for 03 batches. However, the UV /
chromatograms, laboratory reports, data Visible Spectra supporting dissolution results for all
sheets etc. 03 batches are not included in the submission.
5. Documents confirming import of API etc. Not applicable since the API is purchased from a
local source (M/s Vision Pharmaceuticals,
Islamabad).
Rules, 1978.
 The Firm has submitted 26 Weeks Accelerated and 26 Weeks Real Time Stability Study Data for 03
Batches.
 The results for initial testing of all 03 Batches are not included in the submission.
 The firm has clarified that they had submitted wrong method of analysis in dossier mistakenly and
requested to proceed with the method of analysis submitted with the stability study data.
 For Batch T-06 (Accelerated): Significant Change 5.84% was observed between Week 1 (97.96%) and
Week 26 (103.8%) Assay Results for Dexlansoprazole. Limits of Specifications as specified by the
manufacturer are 90%-110%.
 The firm has submitted supporting Chromatograms for Assay Results for 03 batches. However the UV
/ Visible Spectra supporting dissolution results for all 03 batches are not included in the submission.
 The Dissolution Testing has been performed on Finished Product (Capsules) at Acid Stage (0.1N HCl),
Buffer Stage 1 (pH 5.5) and Buffer Stage 2 (pH 7.0). USFDA recommends dissolution testing at Acid
Stage (0.1 N HCl) and Buffer Stage (pH 7.0 Phosphate Buffer with 5 mM SLS) only.
 In 276th meeting of Registration Board, wherein after detailed deliberation and personal hearings of
relevant firms, the Registration Board directed all applicants whom cases of Dexlansoprazole capsules
have been previously considered by registration Board and were deferred for any reason to submit their
own analysis record of dissolution testing on pellets confirming their dual delayed release profile at pH
5.5 & pH 6.75 / 7.
The case is hereby presented for perusal and further necessary action please.
Sr. Name & Address Brand Name Type of Form, International Previous DRB
No. of Manufacturer (Proprietary Name + Initial Diary & Availability / Decision /
/ Applicant Dosage Form + Date, Fee Local Availability Remarks
Strength), Composition, (including (if any)
Pharmacological Group, differential fee), GMP Inspection
Finished Product Demanded Price / Report Date &
Specification Pack size Remarks
90. M/s WIFODEX Capsule Form 5-D DEXILANT by The firm has
Weatherfolds 30mg M/s Takeda claimed
Pharmaceuticals Dairy No. 155 Pharms, USFDA. Manufacturer’s
Each capsule contains: dated 27-05-2016. Specifications.
Plot no. 69/2 Not applicable.
phase II, Enteric coated pellets Rs.50,000/- dated
Industrial Estate, 22.5% eq. to 27-05-2016. GMP compliant
Dexlansoprazole…….. dated 04-08-
Hattar. 30mg As per SRO for 2 2016.
(Proton Pump x 7’s.
Inhibitor)

Drug WIFODEX Capsule 30mg (Dexlansoprazole)
Name of Manufacturer M/s Weatherfolds Pharmaceuticals, Hattar.
Manufacturer of API M/s Vision Pharmaceuticals, Islamabad.
API Lot No. DLP156T
Description of Pack Plastic jar.
(Container closure
system)
Stability Storage Accelerated: 40°C ± 2°C &75±5%RH
Condition Real Time: 30°C ± 2°C &65±5%RH
Time Period Accelerated: 26 Weeks
Real Time: 26 Weeks
Frequency Accelerated: 1,2,3,4,6,8,12,16,20,24,26 (Week)
Real Time: 1,2,3,4,6,8,12,16,20,24,26 (Week)
Batch No. T – 01 T – 02 T – 03
Batch Size 1,650 Capsules 1,650 Capsules 1,650 Capsules
Manufacturing Date 01 – 2017 01 – 2017 01 – 2017
Date of Initiation 01 – 2017 01 – 2017 01 – 2017
No. of Batches 03
Date of Submission 09-01-2018(Dy. No. 1263), 25-01-2018 (Dy. No. 1858 PEC)
Documents / Data Provided by the Applicant
1. COA of API Photocopy of COA for Batch No. DLP156T is
submitted.
2. Approval of API by regulatory authority Photocopy of GMP Certificate No. F.8-1/2016-DDG
of country of origin or GMP certificate of (E&M) issued by DDG (E&M) Islamabad, valid till 08th
API manufacturer issued by regulatory February 2017 is submitted.
authority of country of origin.
3. Protocols followed for conduction of Yes
stability study and details of tests.
4. Data of 03 batches will be supported by The firm has submitted supporting Chromatograms for
attested respective documents like Assay Results for 03 batches. However the UV / Visible
chromatograms, laboratory reports, data Spectra supporting dissolution results for all 03 batches
sheets etc. are not included in the submission.
5. Documents confirming import of API etc. Not applicable since the API is purchased from a local
source (M/s Vision Pharmaceuticals, Islamabad).
7. Commitment to continue real time Yes
stability study till assigned shelf life of the
product.
Rules, 1978.
 The Firm has submitted 26 Weeks Accelerated and 26 Weeks Real Time Stability Study Data for 03
Batches.
 The results for initial testing of all 03 Batches are not included in the submission.
 The firm has clarified that they had submitted wrong method of analysis in dossier mistakenly and
requested to proceed with the method of analysis submitted with the stability study data.
 For Batch No. T-01 (Real Time): Significant Change 5.5% was observed between Week 1 (103%) and
Week 26 (97.5%) Assay Results for Dexlansoprazole. Limits of Specifications as specified by the
manufacturer are 90%-110%.
 The firm has submitted supporting Chromatograms for Assay Results for 03 batches. However the UV
/ Visible Spectra supporting dissolution results are not included in the submission.
 The Dissolution Testing has been performed on Finished Product (Capsules) at Acid Stage (0.1N HCl),
Buffer Stage 1 (pH 5.5) and Buffer Stage 2 (pH 7.0). USFDA recommends dissolution testing at Acid
Stage (0.1 N HCl) and Buffer Stage (pH 7.0 Phosphate Buffer with 5 mM SLS) only.
 The firm has submitted supporting Chromatograms for Assay Results for 03 batches. However, the UV
/ Visible Spectra supporting dissolution results for all 03 batches are not included in the submission.
 In 276th meeting of Registration Board, wherein after detailed deliberation and personal hearings of
5.5 & pH 6.75 / 7.
The case is hereby presented for perusal and further necessary action please.
In response to above observations conveyed to the firm, the firm has submitted that “Results of all 03
batches are included in BMR (at filled capsule report) in Annexure F. Further since dissolution scan/data
will be provided at the time of inspection since it is too much lengthy and practically impossible to attach
this with dossier”.
Therefore, they have requested to verify the same by the panel at their premises during inspection.
The Chairman, Registration Board approved the following panel for on-site investigation to confirm
genuineness/authenticity of stability data and associated documents, import of API, quality, specification,
test analysis, facilities etc:
i. Additional Director (E&M), DRAP, Peshawar
ii. Area Federal Inspector of Drugs, Peshawar
iii. Assistant Director, DRAP, Peshawar
The Chairman, Registration Board also directed the panel to verify the data pertaining to following
observations noticed in submitted data:
a. The results for initial testing of all 03 Batches are not included in the submission.
b. You have submitted supporting Chromatograms for Assay Results for 03 batches. However, the UV /
Visible Spectra supporting dissolution results have not been included in the submission.
c. In 276th meeting of Registration Board, wherein after detailed deliberation and personal hearings of
5.5 & pH 6.75 / 7.
The constituted panel conducted detailed inspection of the firm as follows:

Firm Name& Address: Weatherfolds Pharmaceutical Hattar Plot No 69/2, Phase 2 Industrial Estate Hattar
Audit Format for PSI (Dexlansoprazole 30mg and 60mg)
Q.No.1 Do you have documents confirming the import Locally Purchased (M/s VISION
of Dexlansoprazole API? Pharmaceutical Islamabad)
Q.No.2 What was the rationale behind selecting the GMP compliant and easily availability.
particular manufacturer of API?
Q.No.3 Do you have documents confirming the import Supplied by M/s Vision pharmaceuticals
of Dexlansoprazole reference standard and Islamabad
impurity standards? No impurities available
Q.No.4 Do you have certificate of Analysis of the API, Yes, Impurities not available
reference standards and impurity standards?
Q.No.5 Do you have any approval of API or GMP Yes
certificate of API manufacturer issued by
regulatory authority of country of origin?
Q.No.6 Do you use API manufacturer method of Yes
testing?
Q.No.7 Do you have stability studies reports on API? Yes
Q.No.8 If yes, whether the stability testing has been Not available
performed as per SIM method and degradation
products have been quantified?
Q.No.9 Do you have method for quantifying the Method available
impurities in the API?
Q.No.10 Do you have some remaining quantities of the Yes, No impurities available
API, its reference standard and impurities
standards?
Q.No.11 Have you used pharmaceutical grade Ready to fill pellets
excipients?
Q.No.12 Do you have documents confirming the import Ready to fill pellets
of the used excipients?
Q.No.13 Do you have test reports and other records on Ready to fill pellets
the excipients used?
Q.No.14 Do you have written and authorized protocols Yes
for the development of Dexlansoprazole
capsules?
Q.No.15 Have you performed Drug-excipient Ready to fill pellets
compatibility studies?
Q.No.16 Whether firm has performed comparative Not Performed
dissolution studies?
Q.No.17 Do you have product development (R&D) No
section
Q.No.18 Do you have necessary equipments available Not Applicable
in product development section for
development of Dexlansoprazole capsules?
Q.No.19 Are the equipments in product development Not Applicable
section qualified?
Q.No.20 Do you have proper maintenance / calibration / Not Applicable

re-qualification program for the equipment
used in PD section?
Q.No.21 Do you have qualified staff in product Yes
development section with proper knowledge
and training in product development?
Q.No.22 Have you manufactured three stability batches Yes
for the stability studies of Dexlansoprazole
capsules as required?
Q.No.23 What was the criteria for fixing the batch size The criteria for fixing the batch size of the
of stability batches? stability batches is the quantity required for
testing frequency and number of testing
frequencies.
Q.No.24 Do you have complete record of production of Yes
stability batches?
Q.No.25 Do you have protocols for stability testing of Yes
stability batches?
Q.No.26 Do you have developed and validated the Supplier method validated by the firm
method for testing of stability batches?
Q.No.27 Do you have method transfer studies in case Not applicable
when the method of testing being used by your
firm is given by any other lab?
Q.No.28 Do you have documents confirming the Calibration record maintained.
qualification of equipments / instruments being
used in the test and analysis of
Dexlansoprazole API and the finished drug?
Q.No.29 Do your method of analysis stability Yes, method validated
indicating?
Q.No.30 Do your HPLC software is 21CFR compliant? NO (Nova chrome)
Q.No.31 Can you show Audit Trail reports on Not available, manual log books for
Dexlansoprazole testing? performance of tests at reported intervals were
checked and found ok
Q.No.32 Do you have some remaining quantities of Degradation products not available.
degradation products and stability batches? Stability batches available
Q.No.33 Do you have commitment batches kept on Yes
stability testing?
Q.No.34 Do you have valid calibration status for the Yes
equipments used in Dexlansoprazole capsules
production in analysis?
Q.NO.35 Do proper and continuous monitoring and Manual records maintained.
control are available for stability chamber?
Q.No.36 Do related manufacturing area, equipment, Yes
personnel and utilities be rated as GMP
compliant?
(a) The results for initial testing were checked as provided in the BMR of stability batches and found
Satisfactory.
(b) The UV/Visible spectra for dissolution test result for all three batches have been checked and found
satisfactory.
(c) Analysis record of dissolution testing on pellets confirming their dual delayed release profile at pH 5.5
& pH 7 have been checked and found available.
(d) The firm has 100KVA electric backup generator.
Decision: Registration Board deliberated the inspection report in detail and considered the report to
be at minimum level of acceptance hence Board decided to approve registration of “WIFODEX
Capsule 30mg (Dexlansoprazole 30 mg)” & “WIFODEX Capsule 60mg (Dexlansprazole 60 mg)” by
M/s Weatherfolds Pharmaceuticals, Hattar. Manufacturer will place first three production batches
on long term stability studies throughout proposed shelf life and on accelerated studies for six
months.
b) Verification of stability study data:
VERIFICATOIN OF GENUINENESS / AUTHENTICITY OF STABILITY DATA AND

ASSOCIATED DOCUMENTS
M/s Scotmann Pharmaceuticals – 03 Products
91. Report on investigation of authenticity / genuineness of data submitted for registration of
DASCOT (Daclatasvir) 30mg Tablet by M/s Scotmann Pharmaceuticals, 5-D, I-10/3, Industrial
Area, Islamabad.

DASCOT (Daclatasvir) 60mg Tablet by M/s Scotmann Pharmaceuticals, 5-D, I-10/3, Industrial
Area, Islamabad.
Investigation Date and Time: 26th January, 2018 (11:00 AM till 4:30 PM)
Investigation Site: Factory premises of M/s Scotmann Pharmaceuticals, 5-D, I-10/3, Industrial
Area, Islamabad.
Background:
Registration Board in its 277th meeting considered the registration application of M/sScotmann
Pharmaceuticals, 5-D, I-10/3, Industrial Area, Islamabad for DASCOT 30 and 60mg Tablet along with 24
weeks accelerated and real time stability study data. Since as per 251 st meeting 26-week data of both
accelerated and real time stability study is required for consideration, therefore Registration Board deferred
the case for provision of complete 26-week data. The firm has submitted complete 26 week accelerated and
real time stability study data and the chairman Registration Board has approved a three-member panel for
on-site investigate to confirm the authenticity / genuineness of stability data and associated documents,
import of API, quality, specification, test analysis and facilities etc for further consideration by the
Registration Board.
1. Mr. Abid Hayat, Director DTL, Peshawar, Member Registration Board
2. Dr.Muhammad Fakharuddin Amir, Additional Director (QA & LT Division) DRAP, Islamabad
3. Mr. Muhammad Haseeb Tariq, Assistant Director, PEC, DRAP
Scope of Investigation:
Investigation of the authenticity / genuineness of the data, manufacturing of stability batches and stability
studies on these batches.
Tool for investigation:

The investigation was conducted by using a structured questionnaire of DRAP. For objective
evidence physical inspection of the facilities for manufacturing and quality control, material used and
retained, personnel involved, ongoing studies, printed data and integrity and security of data in respective
databases were also audited. The details of investigation may be summarized as under:
Detail of investigation for DASCOT 30mg & 60mg Tablet
Sr. Description Observation by panel

No.
1. Do you have documents confirming the import Firm has imported Daclatasvir dihydrochloride (Lot
of API including approval from DRAP? No. ADLTC0517001) from M/s Virupuksha Organics
Limited, India
2. Do you have any rationale behind selecting the Firm has informed that they have selected the supplier
particular manufacturer based on their previous experience.
The supplier is GMP certified.
3. Do you have documents confirming the Import Firm has informed that the reference standard was
of Reference standard and Impurities present along the shipment package of import of API.
standards? The firm has certificate of analysis of the reference
standard
4. Do you have certificate of analysis of the API Firm have certificate of analysis of API reference
reference standard and impurities standards? standard specifying the impurity contents as well
5. Do you have any approval of API or GMP Firm has provided copy of GMP certificate No.
certificate of manufacturer issued by 7947/E(G)/TS/2017 issued by Drugs Control
regulatory authority of country of origin? Administration (Telangana), India
6. Do you use API manufacturer method of The firm has used API manufacturer’s method of
Testing for testing of API? testing for carrying out tests of API.
7. Do you have stability Studies Report on API? The firm has real time and accelerated stability study
data sheets provided by the API manufacturer
8. If Yes, whether the stability testing has been The stability studies have been performed as per SIM
performed as per SIM method and degradation method and the degradation products have been
products have been quantified? quantified.
9. Do you have method for quantifying the The firm have used the method provided by API
impurities in the API? manufacturer for quantification of impurities
10. Do you have some remaining quantities of the Firm has some remaining quantities of reference
API, Its reference standard and impurities standard and 345gram of API
standard?
11. Have you used pharmaceutical grade Firm has used pharmaceutical grade excipients in the
excipients? manufacturing of stability batches
12. Do you have documents confirming the import Firm has necessary documents confirming import /
of the used excipients? purchase of used excipients
13. Do you have test reports and other records on The firm has test reports and other records of the
the excipients? excipients used
14. Do you have written and authorized protocols The firm has written and authorized protocols for the
for the development drug product? development of DASCOT 30 & 60mg Tablet
15. Have you performed Drug-Excipient The firm has performed drug-excipient compatibility
compatibility studies? studies
16. Have you performed comparative dissolution Firm has performed comparative dissolution profile
studies? against Mydekla Tablets India, and their producthas
demonstrated comparable dissolution profile
17. Do you have Product Development / R&D Firm has dedicated area for product development
Section?
18. Do you have necessary equipment’s available Firm has necessary equipment for manufacturing and
in product development section for testing of DASCOT 30 & 60mg Tablet
development drug product?
19. Are the equipment’s in product development The equipment present in product development area
qualified? are qualified
20. Do you have proper maintenance / calibration / The firm has proper maintenance and calibration for
re-qualification program for the equipment the equipment used in product development section.
used in PD?
21. Do you have qualified staff in product Firm has qualified staff with proper knowledge in
development section with proper knowledge product development section
and training in product development?
22. Have you manufactured three stability batches The firm has manufactured three stability batches for
for the stability studies of drug product? the stability studies of DASCOT 30 & 60mg tablet
23. Do you have any criteria for fixing the batch The firm has informed that their criteria for fixing
size of stability of batches? batch size is based on number of testing frequencies
and number of tablets used in each test.
24. Do you have complete record of production of The firm has complete batch manufacturing record of
stability batches? all the batches of DASCOT 30 and 60mg tablet
25. Do you have protocols for stability testing of Firm have protocols for stability testing of the stability
stability batches? batches.
26. Do you have developed and validated the The firm has developed and validated the method for
method for testing of stability batches? the testing of DASCOT 30 and 60 mg tablet
27. Do you have method transfer studies in case The firm has not conducted method transfer studies,
when the method of testing being used by your however, they have validated their method
firm is by any other lab?
28. Do you have documents confirming the Firm has complete record of qualification of
qualification of equipment / instruments being equipment / instruments used in the test and analysis
used in the test and analysis of the product’s of API and DASCOT 30 & 60mg tablet
API and drug product?
29. Do your method of analysis Stability The method of analysis is stability indicating and the
indicating? firm has performed studies of degradation products.
30. Is your HPLC software 21CFR compliant? The HPLC software of the firm is 21 CFR compliant
31. Can you show audit trail reports on drug Firm has demonstrated all audit trail reports for the
product testing? DACOT 30 & 60mg tablet
32. Do you have some remaining quantities of The firm has remaining quantities of stability batches
degradation products and stability batches? which are kept in stability chamber for ongoing real
time stability study
33. Do you have batches kept on stability testing? The firm has kept the remaining quantities of all
batches in stability chamber for on-going real time
stability study
34. Do you have valid calibration status for the The firm has valid calibration status of all equipment
equipment’s used in drug product’s production used in production and analysis of DASCOT 30 &
and analysis? 60mg tablet
35. Do Proper and Continuous monitoring and The firm has stability chambers for carrying out
control are available for stability chamber? accelerated and real time stability studies provided
with uninterrupted power supply and data loggers,
which are set for recording temperature and humidity
after each hour.
36. Do related manufacturing area, equipment, Firm has dedicated area for product development, and
personnel and utilities be rated as GMP all manufacturing area, equipment, personnel and
compliant? utilities are as per cGMP compliance
CONCLUSION:
On the basis of risk-based approach the genuineness / authenticity of stability data submitted by the firm for
registration of DASCOT (Daclatasvir) 30mg and 60 mg Tablets is verifiable to satisfactory level. Related
manufacturing area, equipment, personnel & Utilities are rated as GMP Compliant to satisfactory level.
Decision: Registration Board decided to approve registration of “DASCOT 30 mg Tablets

(Daclatasvir 30 mg)” & “DASCOT 60 mg Tablets (Daclatasvir 60 mg)” by M/s Scotmann
Pharmaceuticals, 5-D, I-10/3, Industrial Area, Islamabad. Manufacturer will place first three
production batches on long term stability studies throughout proposed shelf life and on accelerated
studies for six months.
VELSCOT400 mg / 100mg (Sofosbuvir + Velpatasvir) Tablet by M/s Scotmann Pharmaceuticals,
5-D, I-10/3, Industrial Area, Islamabad.
Investigation Date and Time: 26th January, 2018 (11:00 AM till 4:30 PM)
Investigation Site: Factory premises of M/s Scotmann Pharmaceuticals, 5-D, I-10/3, Industrial
Area, Islamabad.
Background:
Registration Board in its 277th meeting considered the registration application of M/sScotmann
Pharmaceuticals, 5-D, I-10/3, Industrial Area, Islamabad for VELSCOT400mg / 100mg Tablet and decided
to constitute a three-member panel for on-site investigate to confirm the authenticity / genuineness of
stability data and associated documents, import of API, quality, specification, test analysis and facilities etc.
Moreover, Registration Board advised the panel to investigate the performance of both stability studies data
that submitted initially (i.e. dated 02-11-2017)& that submitted subsequently (i.e. dated 21-12-2017) as per
above mentioned details.
1. Mr. Abid Hayat, Director DTL, Peshawar, Member Registration Board
2. Dr. Muhammad Fakharuddin Amir, Additional Director (QA & LT Division) DRAP, Islamabad
3. Mr. Muhammad Haseeb Tariq, Assistant Director, PEC, DRAP
Scope of Investigation:
Investigation of the authenticity / genuineness of the data, manufacturing of stability batches and stability
studies on these batches.
Tool for investigation:

The investigation was conducted by using a structured questionnaire of DRAP. For objective
evidence physical inspection of the facilities for manufacturing and quality control, material used and
retained, personnel involved, ongoing studies, printed data and integrity and security of data in respective
databases were also audited. The details of investigation may be summarized as under:
Detail of investigation for VELSCOT 400mg / 100mg Tablet

Sr.
Description Observation by panel
No.
Do you have documents confirming the Firm has imported Velpatasvircopovidone (1:1) from M/s
import of API including approval from Virupuksha Organics Limited, India
1.
DRAP? Firm has purchased Sofosbuvir from Pharmagen Ltd,
Lahore
Do you have any rationale behind Firm has informed that they have selected the suppliers
2. selecting the particular manufacturer based on their previous experience.
Both suppliersare GMP certified
Do you have documents confirming the Firm has informed that the reference standard of
Import of Reference standard and velpatasvirwas present along the shipment package of
Impurities standards? import of API. The firm has certificate of analysis of the
3. reference standard for both API’s. The firm is already
purchasing sofosbuvir from the same source for
manufacturing of another product therefore the firm
already had reference standard for sofosbuvir
Do you have certificate of analysis of the Firm have certificate of analysis of API reference
4. API reference standard and impurities standard specifying the impurity contents as well for both
standards? velpatasvir and sofosbuvir
Do you have any approval of API or GMP Firm has provided copy of GMP certificate No.
certificate of manufacturer issued by 7947/E(G)/TS/2017 issued by Drugs Control
5. regulatory authority of country of origin? Administration (Telangana), India for Velpatasvir and
copy of GMP certificate of M/s Pharmagen Ltd, Lahore
for sofosbuvir.
Do you use API manufacturer method of The firm has used API manufacturer’s method of testing
6. Testing for testing of API? for carrying out tests of both APIs
Do you have stability Studies Report on The firm has real time and accelerated stability study data
7. API? sheets for both velpatasvir and sofosbuvirprovided by the
API manufacturers
If Yes, whether the stability testing has The stability studies have been performed as per SIM
been performed as per SIM method and method and the degradation products have been
8.
degradation products have been quantified
quantified?
Do you have method for quantifying the The firm have used the method provided by both API
9. impurities in the API? manufacturer for quantification of impurities
Do you have some remaining quantities of Firm has some remaining quantities of reference standard
10. the API, Its reference standard and for sofosbuvir
impurities standard?
Have you used pharmaceutical grade Firm has used pharmaceutical grade excipients in the
11. excipients? manufacturing of stability batches
Do you have documents confirming the Firm has necessary documents confirming import /
12. import of the used excipients? purchase of used excipients
Do you have test reports and other records The firm has test reports and other records of the
13. on the excipients? excipients used
Do you have written and authorized The firm has written and authorized protocols for the
14. protocols for the development drug development of VELSCOT Tablet
product?
Have you performed Drug-Excipient The firm has performed drug-excipient compatibility
15.
compatibility studies? studies
Have you performed comparative Firm has performed comparative dissolution profile
dissolution studies? against VELPANAT Tablets India, and their producthas
16. demonstrated comparable dissolution profile. Firm has
selected VELPANAT tablets because it has the same
source of API as approved by Gilead Sciences, USA
Do you have Product Development / R&D Firm has dedicated area for product development
17. Section?
Do you have necessary equipment’s Firm has necessary equipment for manufacturing and
18. available in product development section testing of VELSCOT Tablet
for development drug product?
Are the equipment’s in product The equipment present in product development area are
19.
development qualified? qualified
Do you have proper maintenance / The firm has proper maintenance and calibration for the
20. calibration / re-qualification program for equipment used in product development section.
the equipment used in PD?
Do you have qualified staff in product Firm has qualified staff with proper knowledge in product
development section with proper development section
21. knowledge and training in product
development?
Have you manufactured three stability The firm has manufactured three stability batches for the
22. batches for the stability studies of drug stability studies of VELSCOT tablet
product?
Do you have any criteria for fixing the The firm has informed that their criteria for fixing batch
23. batch size of stability of batches? size is based on number of testing frequencies and
number of tablets used in each test.
Do you have complete record of The firm has complete batch manufacturing record of all
24. production of stability batches? the three batches of VELSCOT tablet
Do you have protocols for stability testing Firm have protocols for stability testing of the stability
25. of stability batches? batches
Do you have developed and validated the The firm has developed and validated the method for the
26.
method for testing of stability batches? testing of VELSCOT tablet
Do you have method transfer studies in The firm has not conducted method transfer studies,
27. case when the method of testing being however, they have validated their method
used by your firm is by any other lab?
Do you have documents confirming the Firm has complete record of qualification of equipment /
qualification of equipment / instruments instruments used in the test and analysis of API and
28.
being used in the test and analysis of the VELSCOT tablet
product’s API and drug product?
Do your method of analysis Stability The method of analysis is stability indicating and the firm
29. indicating? has performed studies of degradation products.
Is your HPLC software 21CFR compliant? The HPLC software of the firm is 21 CFR compliant. The
firm has informed that previously they had Schimadzu
HPLC system LC-Solution version 1.10 which was old
30.
and they have upgraded their CFR system along with
hardware upgradation now to version 1.25 CFR 21 part-II
compliance on 15-11-2017.
Can you show audit trail reports on drug Firm has demonstrated audit trail reports for the data
product testing? submitted subsequently (i.e. dated 21-12-2017)
31. forVELSCOT tablet.
Audit trail reports for the data submitted initially (i.e.
dated 02-11-2017) could not be verified
Do you have some remaining quantities of The firm has remaining quantities of stability batches
32. degradation products and stability which are kept in stability chamber for ongoing real time
batches? stability study
Do you have batches kept on stability The firm has kept the remaining quantities of all batches
33. testing? in stability chamber for on-going real time stability study
Do you have valid calibration status for The firm has valid calibration status of all equipment
34. the equipment’s used in drug product’s used in production and analysis of VELSCOT tablet
Do Proper and Continuous monitoring and The firm has stability chambers for carrying out
control are available for stability chamber? accelerated and real time stability studies provided with
35. uninterrupted power supply and data loggers, which are
set for recording temperature and humidity after each
hour.
Do related manufacturing area, equipment, Firm has dedicated area for product development, and all
36. personnel and utilities be rated as GMP manufacturing area, equipment, personnel and utilities are
compliant? as per cGMP compliance
Conclusion:
1. On the basis of risk-based approach the genuineness / authenticity of stability data submitted
subsequently by the firm (dated 21-12-2017) for registration of VELSCOT 400 mg / 100mg
(Sofosbuvir + Velpatasvir) Tabletfor following batches is verifiable to satisfactory level from the
batch manufacturing record and HPLC audit trail reports
a. Trial batch No. 01: (Manufactured on 13-06-2017 and placed in stability chamber on 23-06-2017)
b. Trial batch No. 02: (Manufactured on 14-06-2017 and placed in stability chamber on 17-06-2017)
c. Trial batch No. 03: (Manufactured on 15-06-2017 and placed in stability chamber on 22-06-2017)
2. Related manufacturing area, equipment, personnel & Utilities are rated as GMP Compliant to
satisfactory level.
3. The genuineness / authenticity of stability data submitted initially by the firm (i.e. dated 02-11-2017)
could NOT be verified from batch manufacturing record, HPLC audit trail reports, log book of
stability chambers and other associated documents. The firm has informed that previously the CFR
system was showing wrong dates on the chromatograms as their system was partially CFR
compliant, after the up gradation of the HPLC CFR21 system from version 1.10 to version 1.25 and
the hardware up gradation on 15-11-2017, the system has now shifted all data to correct dates.
Decision: Registration Board decided to approve registration of “VELSCOT 400 mg / 100mg

(Sofosbuvir 400mg + Velpatasvir 100 mg)” by M/s Scotmann Pharmaceuticals, 5-D, I-10/3, Industrial
Area, Islamabad. Manufacturer will place first three production batches on long term stability studies
throughout proposed shelf life and on accelerated studies for six months.
c) Exemption from onsite verification of stability data:
Sr. Name & Address Brand Name Type of Form, International Availability /
No. of Manufacturer / (Proprietary Name + Initial Diary & Local Availability
Strength), Composition, (including GMP Inspection Report
Pharmacological Group, differential fee), Date & Remarks
Finished Product Demanded Price /
Specification Pack size
94. M/s Crystolite SEPAVIR Tablets Form 5-D EPCLUSA by M/s Gilead
Pharmaceuticals, Diary No. dated Sciences, (USFDA Approved)
Plot # 1 & 2, Street Each film coated tablet 27-07-2016 GMP compliant dated
S-2, National contains: Rs. 50,000/- dated 17-10-2017
Industrial Zone, Sofosbuvir …..…400mg 27-07-2016
Rawat, Islamabad Velpatasvir……..100mg (DUPLICATE)
(Anti-viral) 28’s: As per SRO.
Remarks of Evaluator:
The firm has submitted stability study data along with required documents as per checklist approved in
276th meeting of Registration Board for exemption from “On site investigation of submitted stability
data”. Detailsof submitted data are as under:
(Dy.# 24297 dated 13-12-2017)
Drug SEPAVIR Tablets
Name of Manufacturer M/s Crystolite Pharmaceuticals, Islamabad.
Manufacturer of API Sofosbuvir: M/s M/s Suli Pharmaceutical Technology Jiangyin Co. Ltd.
No. 2, Runhua Road, Harbour Economic Development District,
Jiangyin, Jiangsu Province, China
Velpatasvir (Copovidone): M/s Nantong Chanyoo Pharmatech Co., Ltd.
No. 2 Tonghai Si Road, Yangkou Chemical Industrial Park, Rudong
Coastal Economic Development Zone, Nantong, Jiangsu Province P.R.
China
API Lot No. Sofosbuvir: (1kg): Imported on 31-05-2017
17SLZY019SC (As per commercial invoice)
SLZY059-FORM 6-170403 (As per COA and license to import)
Velpatasvir (Copovidone): 201704001
(100gram): imported on 11-05-2017
(300gram): imported on 31-5-2017
Description of Pack
4 x 7’s: Alu-Alu blister pack
Stability Storage Condition Real time : 30°C ± 2°C / 65% ± 5%RH
Accelerated: 40°C ± 2°C / 75% ± 5%RH
Time Period Real time: 6 months
Accelerated: 6 months
Frequency Accelerated: Initial, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24 (week)
Real Time: Initial, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24 (week)
Batch No. 007T17 008T17 009T17
Batch Size 600 Tablet 600 Tablet 600 Tablet
No. of Batches 03
Date of Submission 13-12-2017 (Dy No. 24297)
Documents / Data Provided by the Applicant
1. COA of API Yes
2. Approval of API by regulatory Sofosbuvir: Firm has submitted copy of GMP certificate
authority of country of origin or GMP of M/s Suli Pharmaceutical Technology Jiangyin Co. Ltd.
certificate of API manufacturer issued China (The certificate is not issued byr relevant
by regulatory authority of country of regulatory authority i.e. Jiangsu FDA)
origin. Velpatasvir (Copovidone): Firm has submitted the
decision of Registration Board taken in its 275th meeting
regarding confirmation of GMP status of M/s Nantong
Chanyoo Pharmatech Co. Ltd.
3. Protocols followed for conduction of
Yes
4. Data of 03 batches will be supported by
Yes
sheets etc.
5. Documents confirming import of API Sofosbuvir: Copy of license to import issued by ADC
etc. Islamabad confirming import of Sofosbuvir invoice #
17SLZY019 dated 19th May 2017.
Velpatasvir (Copovidone): Copy of license to import
issued by ADC Islamabad confirming import of
Velpatasvir
 100gram through invoice # CY117166 dated 28th April
2017.
 300gram through invoice # CY117169 dated 1st May
2017.
6. All provided documents will be attested
(name, sign and stamp) for ensuring Yes
7. Commitment to continue real time
stability study till assigned shelf life of Yes
the product.
8. Commitment to follow Drug
Yes
Specification Rules, 1978.
 The batch number of API of sofosbuvir mentioned in commercial invoice and COA is different from
that mentioned in license to import.
 The GMP certificate of manufacturer of sofosbuvir is issued by Jiangsu Changzhou Drug
Administration which is not relevant regulatory authority (the relevant authority is Jiangsu Food and
Drug Administration)
 Both API’s i.e. sofosbuvir and velpatasvir have λmax at 280nm. The protocol for testing of finished
product do not specify retension time for testing of both sofosbuvir and velpatasvir.
 Firm has tested the product on in-house specification, while no documents were submitted which shows
analytical method validation data in the light of ICH Q2 guidelines, since two API’s having same λmax
were analyzed in this formulation.
 The detailed procedure for carrying out dissolution is not provided.
 The final dilution for assay of finished product per standard analytical procedure and final testing was
different in folloiwng regards
Drug Dilution
Standard analytical Actual
procedure (Protocol) testing
Sofosbuvir 0.20 mg/ml 0.16 mg/ml
Velpatasvir 0.05 mg/ml 0.04mg/ml
 The retention time for velpatasvir at 16th week i.e. 13th October 2017 is carried out at 12 and then 10
minutes which shows significant difference.
Data for exemption from On site investigation of submitted stability data
1. Reference of last onsite panel inspection Firm has referred to onsite inspection report of their product
for instant dosage form conducted “Daclavir (Daclatasvir 30 and 60mg) Tablets”, which was
during last two years. conducted on 19th April, 2017 and was presented in 269th
meeting of Registration board. Registration Board decided to
approve registration of Daclavir (Daclatasvir 30 and 60mg)
Tablets by M/s. Crystolite Pharma Islamabad. According to
the report following points were confirmed
 The firm has 21 CFR compliant HPLC software
 The firm has audit trail reports available
 The firm possesses stability chambers with continuous
power supply and digital data loggers
2. Documents for the procurement of API Firm has submitted following documents
with approval from DRAP (in case of  copy of commercial invoice and license to import for
import). Velpatasvir co povidone, attested by AD (I&E), DRAP
Islamabad on 11-05-2017 and 31-05-2017 foe 100 gram
and 300 gram respectively.
 Copy of commercial invoice and license to import signed
by ADC Islamabad on 31-05-2017 for 1 kg.
3. Documents for the procurement of Firm has not submitted any evidence for procurement of
reference standard and impurity reference standards and impurity standards
standards.
4. Approval of API/ DML/GMP certificate Firm has submitted following:
of API manufacturer issued by i. Copy of GMP certificate issued to M/s Nantong
regulatory authority of country of Chanyoo Pharmatech by by Nantong Chemical &
origin. Medical Industry Association, valid upto 05-12-
2019. Firm has also submitted copy of certificate of
GMP issued by Agency for medicinal products and
medical devices of the republic of Slovenia
ii. Copy of GMP Certificate issued to M/s Suli
Pharmaceutical Technology Jiangyin by Jiangsu
Changzhou Drug Administration. This GMP
certificate is not issued by relevant regulatory
authority in China
qualification i. Vendor Registration Form filled and signed by the
manufacturer (M/s Nantong Chanyoo Pharmatech in
China). The document was signed on 20th December
2017 while the material was imported on 11-05-
2017.
ii. Vendor Registration form for M/s Suli
Pharmaceutical Technology, Jiangyin Co. Ltd China.
The Document is unsigned and contains no details
regarding GMP certificates
The mechanism or SOP for vendor pre-qualification is not
provided.
reference standards and impurity iv. COA of Velpatasvir copovidone (Batch#
standards 201704001) from M/s Nantong Chanyoo
Pharmatech along with COA of all the related
substances mentioned in the Certificate of analysis
of velpatasvir copovidone
v. COA of Sofosbuvir Form-6 (Batch# SLZY059-
FORM6-170403) from M/s Suli Pharmaceutical
Technology, Jiangyin Co. Ltd China.
vi. Firm has submitted qualification report of reference
standard (Requalification) of Sofosbuvir for Batch
No. PRS-15069 by HEC. The reference standard
from HEC is used while the API was purchased from
M/s Suli Pharmaceutical
7. Documents for the procurement of Firm has submitted commercial invoice and license to import
excipients used in product issued by ADC Islamabad only for following excipients:
development? Name of Name of Manufacturer
Excipient
Microcrystalline M/s Hangzhou Maytime Bio
cellulose Tech Co Ltd. China
Titanium dioxide M/s Hangzhou Zhongbao Imp &
Exp Corp. Ltd. China
Magnesium M/s Hangzhou Zhongbao Imp &
stearate Exp Corp. Ltd. China
Talcum M/s Hangzhou Zhongbao Imp &
Exp Corp. Ltd. China
 Commercial invoice of only 4 excipients is attached while
evidence for procurement of crosscarmellose sodium,
polyvinyl alcohol, polyethylene glycol, iron oxide red and
IPA is not provided.
 The excipients titanium dioxide, magnesium stearate and
talcum is procured from import and export corporation
firm while no evidence of the manufacturer of these
excipients is attached.
 Certificate of anlysis of excipients is not provided
 Specifications of excipients procured could not be verified
8. List of qualified staff involved in Firm has provided list of technical staff directly supervising
product development with relevant product development section with following details and
experience. discrepencies with the list of staff submitted in dossier
Name Designation as Designation as
provided in provided in data for
dossier exemption
Zahoor Illahi Production Production Manager
Manager
Amir Raza QC Manager QC Manager
Ayesha QA Inspector Quality Assurance
Mumtaz Manager
M. Touseef Production R & D Pharmacist
Pharmacist
Ahmed Hayat - R & D QA Inspector
Khan
Sidra Naseer - R & D QC Analyst
Production Data
9. Authorized Protocols/SOP for the Firm has not provided authorized protocols/SOPs for the
development & stability testing of trial development & testing of trial batches.
batches.
10. Complete batch manufacturing record Firm has provided Batch Manufacturing Record, including
of three stability batches. Dispensing sheets, Master formulation & Standard
Manufacturing procedure, for all the three batches
11. Record of remaining quantities of Firm has provided following
stability batches.  copy of stock book balance sheet for both API i.e.
sofosbuvir and velpatasvir
 Manual stability chamber log book for real time and
accelerated stability study for all the three batches
Firm has not provided remaining quantities of tablets for each
batch.
QA/QC DATA
temperature and humidity monitoring of Printed unsigned sheets for temperature & humidity record
stability chambers (real time and of Accelerated & real time conditions for the time period of
accelerated) June to December 2017.
13. Method used for analysis of API along Firm has submitted following documents
with COA.  COA for Velpatasvir copovidone from M/s Nantong
Chanyoo Pharmatech Co., Ltd.
 Method of analysis & COA for Sofosbuvir from M/s Suli
Pharmaceutical.
14. Method used for analysis of FPP & Firm has submitted following for both accelerated & real
complete record of testing of stability time stability studies of all three stability batches:
iv. HPLC Chromatograms (for Assay analysis) & for
Dissolution analysis)
However, the complete method for conducting dissolution
test is not provided.
15. Reports of stability studies of API from Firm has submitted both accelerated (40°C ± 2°C &
manufacturer. 75±5%RH) stability studies & long term (30°C ± 2°C &
65±5%RH) stability studies reports of three batches of
Valpatasvir co povidone from M/s Nantong Chanyoo
Pharmatech Co., Ltd.
Batch 1: 201611001: 6 months accelerated and 9 months
relatime data
relatime data
relatime data
The submitted stability data sheets are unsigned
16. Analysis reports for excipients used. Firm has submitted analysis reports for following excipients
 Titanium dioxide (COA provided by supplier)
 Mg. stearate (COA provided by supplier)
 HPMC E5 (COA provided by supplier) This excipient is
not mentioned in the master formulation submitted in
dossier
 Microcrystalline cellulose PH102 (COA provided by
manufacturer)
 Crosscarmellose sodium (COA provided by CRODA
Singapore)
The analysis reportes for excipients of coating is not
provided.
17. Drug-excipients compatibility studies. Firm has not provided evidence of drug-excipient studies
18. Record of comparative dissolution data.  Firm has submitted Comparative dissolution study
protocol & results. The details of reference product &
Sample product are as follows:
Feature Reference product Product of
Crystollite
Brand name Velpanat Tablets Sepavir tablets
Batch No. 408298 007T17
Mfg. date 06-2017 06-2017
Expiry date 05-2019 06-2019
 Comparative study dissolution study has been performed
in following mediums:
iv. pH 5.0 Buffer (50mM sodium acetate buffer with
0.5% w/v Cetyltrimethyl ammonium bromide
(CTAB)
 Dissolution testing is only performed at 30 mins in
which both products complied with specifications
 Comparative dissolution profile is not performed as per
FDA recommended sampling times/frequencies.
 The comparative dissolution study is not performed
against innovator product, moreover the evidence of
purchase of reference product is also not provided
19. Compliance Record of HPLC software Firm has submitted audit trail reports for HPLC analysis for
21CFR & audit trail reports on product all the three batches.
testing.
Decision of 277th meeting of Registration Board:
Registration Board deferred the case for clarifications of following observations:
i. The batch number of API of sofosbuvir mentioned in commercial invoice and COA is different from
that mentioned in license to import.
ii. The GMP certificate of manufacturer of sofosbuvir is issued by Jiangsu Changzhou Drug
Administration which is not relevant regulatory authority (the relevant authority is Jiangsu Food and
Drug Administration)
iii. Both API’s i.e. sofosbuvir and velpatasvir have λmax at 280nm. The protocol for testing of finished
product do not specify retention time for testing of both sofosbuvir and velpatasvir, furthermore the
firm has tested the product on in-house specification, while no documents were submitted which
shows analytical method validation data.
iv. The detailed procedure for carrying out dissolution is not provided.
v. The final dilution for assay of finished product as per standard analytical procedure and final testing
was different in following regards
Drug Dilution
Standard analytical procedure (Protocol) Actual testing
vi. The retention time for velpatasvir at 16th week i.e. 13th October 2017 is carried out at 12 and then
10 minutes which shows significant difference.
vii. Firm has not submitted any evidence for procurement of reference standards and impurity standards
viii. Vendor Registration Form for Valpatasvir was signed on 20th December 2017 while the material
was imported on 11-05-2017.
ix. The mechanism or SOP for vendor pre-qualification is not provided.
x. The Certificate of Analysis (COA) for reference standard of sofosbuvir was provided from HEC,
while the API was purchased from M/s Suli Pharmaceuticals.
xi. Commercial invoice of only 4 excipients is attached while evidence for procurement of
crosscarmellose sodium, polyvinyl alcohol, polyethylene glycol, iron oxide red and IPA is not
provided. Furthermore, the excipients titanium dioxide, magnesium stearate and talcum is procured
from import and export corporation firm while no evidence of the manufacturer of these excipients
and certificate of analysis is provided.
xii. Firm has not provided authorized protocols/SOPs for the development & testing of trial batches.
xiii. Firm has not provided record of remaining quantities of tablets for each batch.
xiv. The submitted stability data sheets of API are unsigned
xv. Firm has not provided evidence of drug-excipient studies
xvi. Comparative dissolution profile is not performed as per FDA recommended sampling
times/frequencies. Moreover, the comparative dissolution study is not performed against innovator
product and the evidence of purchase of reference product is also not provided.
Evaluation by PEC:
Reasons for deference Reply by the firm and evaluation remarks
The batch number of API of sofosbuvir mentioned in Firm has submitted that batch number is not
commercial invoice and COA is different from that mentioned on Sofosbuvir invoice, rather it is
mentioned in license to import. Purchase Order Number. The batch numbers are
mentioned on COA, Form 3 and Form 7.
The batch number is same on COA, Form 3 and
Form 7
The GMP certificate of manufacturer of sofosbuvir is Firm has submitted that they have purchased
issued by Jiangsu Changzhou Drug Administration sofosbuvir from Jiangsu Yongda Pharmaceutical
which is not relevant regulatory authority (the relevant Co, Ltd. Through Suli Pharmaceuticals. The
authority is Jiangsu Food and Drug Administration) documents Form 3, Form 7, COA and GMP
contains the same manufacturer name i.e. Jiangsu
Yongda Pharmaceutical except on invoice and
DRAP has given us ADC clearance with name Suli
Pharma. The firm has therefore requested to
consider Jiangsu Yongda as manufacturer of
Sofosbuvir rather than Suli Pharma.
Firm has initially submitted Form 3 and Form 7
dated 8th May 2017 specifying Suli Pharmaceutical
as the manufacturer. Firm has again submitted
another copy of Form 3 and Form 7 dated 6th May
2017 specifying Jiangsu Yongda as manufacturer
of Sofosbuvir. Similarly the same COA which was
previously submitted from Suli pharmaceutical is
again submitted with header from Jiangsu Yongda
Pharmaceutical.
Both API’s i.e. sofosbuvir and velpatasvir have λmax Firm has provided SOPs and complete data results
at 280nm. The protocol for testing of finished product of analytical method validation.
do not specify retention time for testing of both
sofosbuvir and velpatasvir, furthermore the firm has
tested the product on in-house specification, while no
documents were submitted which shows analytical
method validation data
The detailed procedure for carrying out dissolution is Firm has provided detailed procedure of dissolution
not provided. test.
i. The final dilution for assay of finished product Firm has provided revised assay reports and
as per standard analytical procedure and final standard analytical procedure specifying the
testing was different in following regards dilutions of actual testing of both sofosbuvir and
Drug Dilution velpatasvir.
Standard analytical Actual
procedure (Protocol) testing
The retention time for velpatasvir at 16th week i.e. 13th The firm has submitted revised testing results along
October 2017 is carried out at 12 and then 10 minutes with chromatograms with retention time at 12
which shows significant difference. minutes along with audit trail reports of the specific
period.
Firm has not submitted any evidence for procurement Firm has submitted undertaking from Suli Pharma
of reference standards and impurity standards and Nantong chanyoo Pharma that working
standard was supplied along with shipment.
Firm has submitted that the reference standards
were purchased along with the API and the
reference standard was present along with the
shipment of API. The firm has provided COA of
reference standard.
Vendor Registration Form for Valpatasvir was signed Firm has submitted vendor registration form which
on 20th December 2017 while the material was was filled before the purchase of material from Suli
imported on 11-05-2017. Pharma
The mechanism or SOP for vendor pre-qualification is Firm has provided complete mechanism and SOP
not provided. for vendor pre-qualification.
The Certificate of Analysis (COA) for reference Firm has provided COA of sofosbuvir from Suli
standard of sofosbuvir was provided from HEC, while Pharmaceuticals
the API was purchased from M/s Suli Pharmaceuticals.
Commercial invoice of only 4 excipients is attached  Firm has provided certificate of analysis of
while evidence for procurement of crosscarmellose Crosscarmellose sodium from Croda Singapore.
sodium, polyvinyl alcohol, polyethylene glycol, iron  Firm has provided Certificate of analysis of
oxide red and IPA is not provided. Furthermore, the Polyvinyl alcohol from Croda Singapore, and sales
excipients titanium dioxide, magnesium stearate and tax invoice from A.M. Yousaf & Co.
talcum is procured from import and export corporation  Firm has provided Certificate of analysis of
firm while no evidence of the manufacturer of these Polyethylene Glycol from Croda Singapore, and
excipients and certificate of analysis is provided. sales tax invoice from A.M. Yousaf & Co.
 Firm has now provided invoice of purchase of IPA
from Kanny chemicals Rawalpindi along with
Goods Declaration GD-I specifying export from
LCY Chemicals Taiwan.
 Firm has provided certificate of analysis of
Titanium dioxide from Hangzhou Maytime Bio-
Tech Co., Ltd.
 Firm has provided certificate of analysis of
Magnesium stearate from Hangzhou Maytime
Bio-Tech Co., Ltd.
Firm has not provided authorized protocols/SOPs for Firm has provided authorized protocols/SOPs for
the development & testing of trial batches. the development & testing of trial batches
Firm has not provided record of remaining quantities of Firm has submitted record of remaining tablets of
tablets for each batch. all the three batches as per following details
Batch-I: 007T17 100 Tablets
Batch-II:008T17 100 Tablets
Batch-III: 009T17 115 Tablets
The submitted stability data sheets of API are unsigned The copy of signed stability data sheets of
velpatasvir copovidone has been provided.
Firm has provided signed stability data sheets of
sofosbuvir from the API manufacturer.
Firm has not provided evidence of drug-excipient Firm has submitted that they are following
studies innovator’s formulation so they do not required
compatibility studies for their product.
Comparative dissolution profile is not performed as per Firm has submitted data of comparative dissolution
FDA recommended sampling times/frequencies. profile of Sepavir against Velpanat at 5, 10, 15, 20
Moreover, the comparative dissolution study is not and 30 minutes and the FDA recommended
performed against innovator product and the evidence dissolution time frequencies is 10, 20, 30 and 45
of purchase of reference product is also not provided. mins. All the samples show more than 85%
dissolution at 30 mins therefore study at 45 mins is
not required.
Based upon the evaluation a letter was issued to the firm on 25th January, 2018 and the firm has submitted
response which is mentioned below.
You have initially submitted (on 15-01-2018) Form 3 Firm has responded that at the time of ADC
and Form 7 issued 8th May 2017 specifying M/s Suli clearance they have received Form 3 and Form 7
Pharmaceuticals as the manufacturer. You have again on 6th May 2017 and we have submitted all the
submitted (on 23-01-2018) another copy of Form 3 and documents to ADC and those documents could also
Form 7 issued 6th May 2017 specifying M/s Jiangsu be verified from AD I(&E). They have received
Yongda as manufacturer of Sofosbuvir. Form 3 and Form 7 on 8th May 2017 through email
with the manufacturer name Suli Pharma.
Therefore we accept that documents with different
dates and manufacturer name are present.
The same COA which was previously submitted from The firm informed that basically the COA is from
M/s Suli pharmaceutical is again submitted from the manufacturer i.e. Jiangsu Yongda Pharma but
Jiangsu Yongda Pharmaceuticals. as we have purchased the material through Suli
Pharma, that’s why they have also provided the
same COA on Suli Pharma letter head. We have
submitted both COA at the time of ADC clearance,
which could also be verified from record.
You have submitted a request to consider Jiangsu The firm has informed that they have purchased
Yongda Pharmaceutical Co. Ltd as manufacturer of sofosbuvir from Jiangsu Yongda pharma through
sofosbuvir instead of Suli Pharmaceuticals on 23-1- Suli Pharma. All documents Form 3, Form 7, COA
2018, while in all the previously submitted documents and GMP contains the same name i.e. Jiangsu
like GMP, commercial invoice, COA, stability study Yongda except on invoice and submitted
data of API the manufacturer of API was specified as documents for ADC. But DRAP has given us ADC
Suli Pharmaceuticals. with manufacturer name Suli.
You have submitted a declaration from Suli The firm has submitted that the declaration from
Pharmaceuticals dated 27-01-2016 that their API Suli Pharma that their API products are customized
products are customized manufactured in Jiangsu manufactured by Jiangsu Yongda Pharma can also
Yongda Pharmaceuticals Co. Ltd. While the site master be verified from Suli Pharma. Regarding the site
file of M/s Suli Pharmaceuticals submitted with the master file, we have asked the concerned person
exemption data further specify that their premises has for not mentioning the contract manufacturer in the
never been inspected for GMP and that they do not file. According to Suli, they do not mention such
have any contract manufacturer. kind of data in site master file.
Decision: I&E section, DRAP, Islamabad confirmed firm’s stance and accordingly the Registration
Board decided to approve registration of “SEPAVIR 400 mg / 100mg (Sofosbuvir 400mg +
Velpatasvir 100 mg)” by M/s Crystolite Pharmaceuticals, Plot # 1 & 2, Street S-2, National Industrial
Zone, Rawat, Islamabad. Manufacturer will place first three production batches on long term stability
studies throughout proposed shelf life and on accelerated studies for six months.
Sr. Name & Address Brand Name Type of Form, International REMARKS
No of Manufacturer / (Proprietary Name + Initial Diary & Availability / Local (IF ANY)
. Applicant Dosage Form + Date, Fee Availability
Strength), Composition, (including
Pharmacological differential fee), GMP Inspection
Group, Demanded Price / Report Date &
Finished Product Pack size Remarks
Specification
95. M/s Helix SOFOVEL Tablets Form 5-D EPCLUSA by M/s The firm has
Pharma (Pvt.) 100mg / 400mg Diary No. 1506 Gilead Sciences claimed
Ltd. dated 27/07/2016 Inc. USA. Manufacturer’s
Each film coated tablet Specifications.
Hakimsons contains: Rs. 50,000/- Not applicable.
House, A-56, Velpatasvir...100mg
S.I.T.E. Sofosbuvir…400mg As per PRC for GMP compliant
10’s, 20’s and dated 9-2-2016.
Karachi. (Anti-viral) 30’s.
STABILITY STUDY DATA SUBMITTED INITIALLY
Drug SOFOVEL Tablets 100mg / 400mg (Sofosbuvir + Velpatasvir)
Name of M/s Helix Pharma (Pvt.) Ltd. Karachi.
Manufacturer
Manufacturer of API Sofosbuvir:M/s Ruyuan HEC Pharm Co., Ltd. China.
Velpatasvir:M/s Anhui Yellen Pharmaceutical Co., Ltd. China.
API Lot No. Sofosbuvir: YAK-EM201602201W1
Velpatasvir: 170402
Description of Pack Alu/Alu Blister Pack
(Container closure
system)
Time Period Accelerated: 06 Months Real Time: 06 Months
Frequency Accelerated: 0,1,2,3,6 (Month)
Real Time: 0,3,6 (Month)
Batch No. TF 001 TF 002 TF 003
Batch Size 1,000 Tablets 1,000 Tablets 1,000 Tablets
No. of Batches 03
DOCUMENTS / DATA PROVIDED BY THE APPLICANT INITIALLY
Sr Documents To Be Provided Status
1. COA of API Yes
2. Approval of API by regulatory authority of M/s Ruyuan HEC Pharm Co., Ltd. China:
country of origin or GMP certificate of Copy of GMP Certificate for Pharmaceutical Products
API manufacturer issued by regulatory issued by Shaoguan Food and Drug Administration, China
authority of country of origin. is submitted.
M/s Anhui Yellen Pharmaceutical Co., Ltd. China:
Copy of GMP Certificate issued by Food and Drug
Administration (Lingbi), China is submitted.
sheets etc.
5. Documents confirming import of API etc. Sofosbuvir:ADC (Karachi) attested Commercial Invoice is
submitted.
Velpatasvir:ADC Karachi attested Commercial Invoice
No.YL-20161020-1 dated 20161020 contains Quantities
And Description of Velpatasvir Co-Povidone and
Ledipasvir Co-Povidone having the same Batch Number
(170402), Mfg. Date (2016.08.16) and Expiry Date
(2018.08.15).
stability study till assigned shelf life of the
product.
Rules, 1978.
PREVIOUS REMARKS OF EVALUATOR1
 The firm has provided 06 Months Accelerated and 06 Months Real Time Stability Data for 03 Lab Scale
Batches.
 Documents confirming import of API (Velpatasvir Co-Povidone):
ADC Karachi attested Commercial Invoice No.YL-20161020-1 dated 20161020 contains Quantities
And Description of Velpatasvir Co-Povidone and Ledipasvir Co-Povidone having the same Batch
Number (170402), Mfg. Date (2016.08.16) and Expiry Date (2018.08.15).
 Significant Change (5.86%) was observed between initial (104.05%) and 6th Month (98.19%) Assay
Results for Accelerated Stability Study of Velpatasvir Co-Povidone (Batch No. TF-002). However the
Assay Results are within specified limits (90%-110%).
DECISION 274TH RB MEETING

Registration Board was apprised of following Regulations for Implementation of the Drug Administration
Law of the People’s Republic of China:
Chapter I General Provisions; Article 5:

The drug regulatory department of the people’s government at or above the provincial level shall organize
inspections of drug manufacturers in accordance with the Good Manufacturing Practice for Pharmaceutical
Products (GMP) and the measures and schedule for implementing the GMP formulated by the drug
regulatory department under the State Council, and issue a certificate to the manufacturer that complies with
the GMP. For the manufacturer producing injections or radioactive pharmaceuticals and for that producing
biological products specified by the drug regulatory department under the State Council, the inspection of
which shall be conducted by the drug regulatory department under the State Council. The format of GMP
certificate shall be uniformly provided for by the drug regulatory department under the State Council.
Decision: Registration Board deferred the case for submission / clarification of the following:
 GMP Certificates as it is not issued by respective province / state in the light of above regulations.
 According to the submitted SOP for ‘Management Procedures for Batch Number and Period of
Validity’, batch number 170402 shall be produced on 2nd of April 2017; whereas the Mfg. Date on
COA and Commercial Invoice is mentioned as 16th of August 2016.
In response to above, the firm vide letter Ref: RGN-487-12/2017 dated 13-12-2017 has stated as follows:
“We have conducted stability of our applied product by using API (Velpatasvir copovidone) from 02
different sources, one is from M/s Anhui Yellen Pharmaceutical Co., Ltd. China and other is from M/s
Ruyuan HEC Pharm Co., Ltd. China. We have placed stability from Anhui Yellen source in Jan – 2017
whose 06 Months stability data was submitted in 08 – 17, parallel we have placed stability of our applied
product from another source of API (Velpatasvir copovidone) by Ruyuan HEC in Feb – 2017”.
The firm further clarified as follows:
“On our query, the supplier Anhui Yellen is unable to provide the Authentic GMP so by fortune we have
conducted stability studies from another GMP compliance source of API (Velpatasvir copovidone) i.e
Ruyuan HEC whose API data has been approved by DRAP for other companies”.
The firm has requested to consider the re-submitted stability study data and ignore the previous submitted
stability study data:
DETAIL OF NEW SUBMISSION OF STABILITY STUDY DATA
Drug SOFOVEL TABLET 400mg/100mg
Name of Manufacturer M/s Helix Pharma (Pvt.) Ltd. Karachi.
Manufacturer of API RUYUAN HEC PHARM CO., LTD. Xiaba development zona, Ruyuan
county, Shaoguan City, Guandong Province for both APIs.
API Lot No. Sofosbuvir: (imported on 17/11/2016 as per invoice)
YAKBII-RD201610201
RD-SFB2015102201
Velpatasvir and copovidone solid dispersion: (imported on 13/11/2016)
VEPII-201609001
Description of Pack
Alu/Alu Blister Pack
Stability Storage Condition Accelerated: 40°C ± 2°C & 75±5%RH
Real Time: 30°C ± 2°C & 65±5%RH
Time Period Real Time: 06 Months
Frequency Real Time:0,3,6,9 (Month)
Accelerated: 0,3,6 (Month)
Batch No. TF 001 TF 002 TF 003
Batch Size 1,000
1,000 Tablets 1,000 Tablets
Tablets
No. of Batches 03
1. COA of API Sofosbuvir: Photocopy of COAs of batch no. YAKBII-
RD201610201 and RD-SFB2015102201 are submitted.
Velpatasvir Copovidone: Photocopy of COA of batch no.
VEPII-201609001 is submitted.
2. Approval of API by regulatory M/s Ruyuan HEC Pharm Co., Ltd. China:
authority of country of origin or Photocopy of GMP Certificate for Pharmaceutical Products
GMP certificate of API issued by Shaoguan Food and Drug Administration, China is
manufacturer issued by regulatory submitted.
authority of country of origin.
The firm has also provided a copy GMP Declaration endorsed
by QA Director: Zhang Junshan from M/s Ruyuan HEC
Pharm Co., Ltd. China dated Oct 17, 2017 which states as
follows:
“We, Ruyuan HEC Pharm. Co., Ltd herewith confirm that we
have not got the cGMP of Anti Virus Products (Including
Sofosbuvir, Ledipasvir and Copovidone Solid Dispersion,
Daclatasvir & Velpatasvir and Copovidone Solid Dispersion)
and Empagliflozin issued by Site Food and Drug
Administration. The reasons are given below:
1. Chinese Site FDA would not issue any GMP for any
products which are still under patent.
2. Chinese Site GMP would take at least 5 years since
the plant start production. While Ruyuan HEC Pharm
Co., Ltd is a very young manufacturer who started
production in 2011.
4. Data of 03 batches will be supported Yes
by attested respective documents
like chromatograms, laboratory
5. Documents confirming import of Sofosbuvir: Photocopy of ADC (Karachi) attested
API etc. commercial invoice No. PI160086 dated 17-11-2016 issued
by M/s WIS Pharmtech Co., Ltd China is submitted. Detail of
Manufacturer is mentioned as M/s Ruyuan HEC Pharm Co.,
Ltd. China. Batch details are not mentioned on invoice.
Velpatasvir and Copovidone Solid Dispersion: Photocopy of
ADC (Karachi) attested commercial invoice No. WIS170169
dated Nov 13, 2016 issued by M/s WIS Pharmtech Co., Ltd
China for batch no. VEPII-201609001 is submitted. Detail of
Manufacturer is mentioned as M/s Ruyuan HEC Pharm Co.,
Ltd. China.
6. All provided documents will be Yes
attested (name, sign and stamp) for
ensuring authenticity of data /
documents.
stability study till assigned shelf life
of the product.
8. Commitment to follow Drug Yes
Specification Rules, 1978.
 The firm has submitted Revised Stability Study Data of 06 Months Accelerated and 09 Months Real
Time for 03 Lab Scale Batches using different source of Velpatasvir Copovidone Solid Dispersion i.e.
M/s Ruyuan HEC Pharm Co., Ltd. China in lieu of M/s Anhui Yellen Pharmaceutical Co., Ltd. China.
 The firm has requested to consider the re-submitted stability study data for evaluation and to ignore the
previously submitted stability study data.
Furthermore, the firm has also requested for Exemption from On-site Investigation of their submitted
stability data vide Letter No. 1858 (R&I) dated 15-01-2018 and provided the following documents in
conjunction with the checklist approved by the Registration Board in its 276th Meeting:
20. Reference of last onsite panel inspection  Registration Board approved RAMELTON Tablets
for instant dosage form conducted during 8mg (Ramelteon) in its 273rd Meeting. Date of
last two years. Inspection: 18-08-2017.
o The HPLC is 21CFR Compliant.
o Audit trail on the testing reports of ―Ramelton
(Ramelteon) Tablets 8mg were available.
21. Documents for the procurement of API Sofosbuvir: Photocopy of ADC (Karachi) attested
with approval from DRAP (in case of commercial invoice No. PI160086 dated 17-11-2016 issued
import). by M/s WIS Pharmtech Co., Ltd China is submitted. Detail
of Manufacturer is mentioned as M/s Ruyuan HEC Pharm
Co., Ltd. China. Batch details are not mentioned on
invoice.
Velpatasvir and Copovidone Solid Dispersion: Photocopy
of ADC (Karachi) attested commercial invoice No.
WIS170169 dated Nov 13, 2016 issued by M/s WIS
Pharmtech Co., Ltd China for batch no. VEPII-201609001
is submitted. Detail of Manufacturer is mentioned as M/s
Ruyuan HEC Pharm Co., Ltd. China.
22. Documents for the procurement of  Not provided.
reference standard and impurity  The firm has clarified that the reference standard and
standards. impurity standards are procured along with the APIs’
consignment and not separately.
23. Approval of API/ DML/GMP certificate M/s Ruyuan HEC Pharm Co., Ltd. China:
of API manufacturer issued by Photocopy of GMP Certificate for Pharmaceutical Products
regulatory authority of country of origin. issued by Shaoguan Food and Drug Administration, China
is submitted.
The firm has also provided a copy GMP Declaration

endorsed by QA Director: Zhang Junshan from M/s
Ruyuan HEC Pharm Co., Ltd. China dated Oct 17, 2017
which states as follows:
“We, Ruyuan HEC Pharm. Co., Ltd herewith confirm that
we have not got the cGMP of Anti Virus Products
(Including Sofosbuvir, Ledipasvir and Copovidone Solid
Dispersion, Daclatasvir & Velpatasvir and Copovidone
Solid Dispersion) and Empagliflozin issued by Site Food
and Drug Administration. The reasons are given below:
1. Chinese Site FDA would not issue any GMP for
any products which are still under patent.
2. Chinese Site GMP would take at least 5 years since
the plant start production. While Ruyuan HEC
Pharm Co., Ltd is a very young manufacturer who
started production in 2011.
24. Mechanism for Vendor pre-qualification  The firm has submitted copy of vender evaluation
questionnaire for vender pre-qualification.
25. Certificate of analysis of the API, The firm has submitted copy of their Working Standards
reference standards and impurity qualified against the reference material (Sofosbuvir and
standards Velpatasvir) provided by the API Manufacturer M/s
Ruyuan HEC Pharm Co., Ltd. China.
26. Documents for the procurement of Firm has submitted copy of commercial invoices for the
excipients used in product development? excipients used in the applied formulation. However ADC
Clearance is missing on the invoices.
27. List of qualified staff involved in Firm has submitted copy of R&D staff list comprising of
product development with relevant 02 members. Asst. Manager Production, 08 Years and
experience. Production Pharmacist, 06 Months.
Production Data
28. Authorized Protocols/SOP for the The firm has submitted copy of generalized SOP with the
development & stability testing of trial title ‘Protocol for Development of New Product’.
batches. Effective date 01-03-2017.
29. Complete batch manufacturing record of The firm has submitted copy of Trial batch manufacturing
three stability batches. record. Details are as under:
Batch No. Bach size Mfg. Started Mfg.Completed
TF001 1,000 Tabs 03-02-2017 04-02-2017
TF002 1,000 Tabs 03-02-2017 04-02-2017
TF003 1,000 Tabs 03-02-2017 04-02-2017
30. Record of remaining quantities of  TF001: Yield 989 Tablets, 03 Packs used for testing
stability batches. method validation. 32 Packs placed on stability out of
which 11 packs are remaining.
 TF002: Yield 992 Tablets, 03 Packs used for testing
method validation. 32 Packs placed on stability out of
 TF003: Yield 989 Tablets, 03 Packs used for testing
method validation. 32 Packs placed on stability out of
QA / QC DATA
31. Record of Digital data logger for  Previously Reported in panel inspection:
temperature and humidity monitoring of The firm has installed software for recording the
stability chambers (real time and temperature/Humidity of the chamber (for real time
accelerated) stability software V5.7T Thermo, India & for Accelerated
Stability studies, software is Logit Chrt; Technoman;
Pakistan) & the data can been verified for 01 years.
Now the firm has submitted copy of record of digital data
logger for temperature and humidity monitoring of stability
chambers from 20-Jan-2017 to 07-Aug-2017.
32. Method used for analysis of API along  The firm has submitted copy of method used for
with COA. analysis of APIs (Sofosbuvir and Velpatasvir
Copovidone) along with COAs.
33. Method used for analysis of FPP &  The firm has submitted copy of Specifications and
complete record of testing of stability Testing Method of Finished Goods for SOFOVEL
batches (i.e. chromatograms, lab reports, Tablets. Effective date 30-08-2016.
raw data sheets etc.)  Complete record of testing of stability batches (i.e.
chromatograms, lab reports, raw data sheets etc.) are
submitted with the revised stability data submission as
discussed earlier.
34. Reports of stability studies of API from The firm has submitted copy of accelerated, 06 Months
manufacturer. (40°C ± 2°C & 75±5%RH) & long term,12 Months (25°C
± 2°C & 60±5%RH) stability study reports of 03 batches
each of Sofosbuvir and Velpatasvir and Copovidone solid
dispersion from M/s Ruyuan HEC Pharm Co., Ltd. China.
35. Analysis reports for excipients used. The firm has submitted copy of COAs for the excipients
used in the applied formulation.
36. Drug-excipients compatibility studies.  The firm has not submitted Drug-excipients
compatibility studies and has referred to the Innovator
Product (EPCLUSA).
37. Record of comparative dissolution data. Firm has submitted Comparative dissolution study of their
product with VELPANAT of M/s Nacto Pharma, India
conducted on 18-01-2018. The details are as follows:
Feature Reference Product of
Product HELIX Pharma
Brand name VELPANAT SOFOVEL
Batch No. 408298 TF001
Mfg. date Not Mentioned 02-2017
Expiry date Not Mentioned NA
 Comparative dissolution studies have been performed
in following media:
i. pH 1.2 HCl solution.
ii. pH 4.5 Acetate buffer solution.
iii. pH 5.0 Sodium Acetate buffer with 0.5% CTAB.
iv. pH 6.8 phosphate buffer solution.
 Copy of Calculation Sheets and HPLC chromatograms
has been submitted for Comparative dissolution
studies.
38. Compliance Record of HPLC software The firm has submitted copy of Audit Trail for 0, 3rd and
21CFR & audit trail reports on product 6th Month Testing Intervals dated 2/6/2017, 5/6/2017 and
testing. 8/7/2017.
Decision: Registration Board decided to constitute the following panel for onsite
investigation to confirm genuineness/ authenticity of stability data and
associated documents, import of API, quality, specification, test analysis,
facilities etc. Moreover, Registration Board also directed the panel to confirm
the performance of stability data submitted earlier (dated 10-08-2017).
 Dr. Rafeeq Alam Khan, Meritorious Professor (Member Registration Board)
 Dr. Saif ur Rehman Khattak, FGA, CDL, Karachi
 Mr. Affan Ali Qureshi (Assistant Director, CDL, Karachi)
Case No. 06: Registration applications of categories to be considered on priority
a. Applications for registration of drugs for Local Manufacturing
96. Name and address of manufacturer / M/s Winbrains Research laboratories, Hattar
Applicant
Brand Name +Dosage Form + Strength Letrobrain 2.5mg tablet
Letrozole….2.5mg
Type of Form Form-5
GMP status Panel Inspection conducted on 03-02-2017 recommends
renewal of DML and grant of four additional sections.
97. Name and address of manufacturer / M/s Siam Pharmaceuticals, Islamabad
Applicant
Brand Name +Dosage Form + Strength Cellzol tablet 2.5mg
Composition Each film coating tablet contains:
Letrozole….2.5mg
Type of Form Form-5
GMP status Last inspection report
Remarks of the Evaluator. Inspection report is not provided.
Case No. 07: Import of Active Pharmaceutical Ingredients (APIs) / Drug Substances
Registration Board in its 264th meeting deliberated that APIs/drug substances used in
registered drug product manufacturing are required to be of pharmaceutical grade only. It has
been noticed that some manufacturers are not complying to the requirement of Drug Act, 1976
and drug importation provisions as specified in current edition of Import Policy Order. Thus,
pharmaceutical manufacturers are required to import APIs/drug substances of pharmaceutical
grade only from sources/manufacturers having valid API manufacturing licenses and GMP
certificates by respective drug regulatory authority. The Board further advised to ensure
compliance to aforementioned requirement to be observed by DRAP’s field offices at time of
clearance of APIs/drug substances. Accordingly all pharmaceutical manufacturers were advised
(Letter No. F.1-10/2016-Add:Dir (R.I)/M-264 dated 30th March 2017) to comply the
aforementioned directions of Registration Board to ensure availability of quality finished
pharmaceutical products. Moreover, DRAP’s field offices were also advised to circulate to all
manufacturers/importers in area of their jurisdiction and also to ensure compliance to the above
directions at the time of clearance of API/drug substances.
Registration Board in subsequent meetings observed that pharmaceutical manufacturers

continue to import API/drug substances either from non GMP / licensed sources or provide GMP
of suppliers / exporters of the material. It is pertinent to mention that in India GMP certificates
are issued by states Drugs Control Administration (DCA) while in China only provincial Food
and Drug Administration or China Food and Drug Administration (CFDA) has been permitted to
issue GMP / license to API pharmaceutical manufacturers (Article 5 of Chapter I of Drug
Administration Law of People’s Republic of China; Accessed at
http://eng.sfda.gov.cn/WS03/CL0766/61638.html#01 on 12-02-2018).
Registration Board in its instant meeting discussed this matter in detail and again
reiterated as follows:
a) All pharmaceutical manufacturers should only use pharmaceutical grade Active
Pharmaceutical Ingredients (API) manufactured by firms having valid
manufacturing license and Good Manufacturing Practice (GMP) certificate issued
by relevant regulatory authority.
b) For the APIs/drug substances imported from China, the GMP certificate of the
manufacturer should be issued by drug regulatory department of the people’s
government at or above the provincial level. Chamber of Commerce,
Manufacturer’s Association and District Drug Regulatory Departments are not
authorized to issue GMP certificate and thus not acceptable.
c) GMP certificates, certificate of analysis (COA) and stability studies of API should
be of the manufacturer which is involved in API/drug substances manufacturing,
while aforementioned documents if provided by distributors / suppliers / import and
export corporation etc. are neither required nor acceptable.
d) Above decision will be communicated to Pakistan Pharmaceutical Manufacturer
Association (PPMA), Pharma Bureau and DRAP’s field offices and will also be
notified on DRAP website for the information with aim to ensure availability of safe,
effective and quality drugs.
B. Biological Evaluation & Research Division
CASE Details of application No. of Cases

No.
I. Imported Human Biologicals applied by M/s Getz Pharma, Karachi deferred 4
th
in 274 meeting of Registration Board.
II. Imported Human Biologicals from Non-reference countries. 1
III. Response of Representation Submitted by Representative of M/S Macter 1
th
International Ltd., Karachi regarding Momentum Injection approved in 254
Meeting.
Total 6
Case No. 1: Imported Human Biologicals applied by M/s Getz Pharma, Karachi deferred
in 274th meeting of Registration Board.
Following products of M/s Getz Pharma, Karachi were deferred in 274th meeting of
Registration Board as per following details:
1. Name and address of Importer M/s Getz Pharma (Pvt.) Ltd, 29-30, Sector-27, Korangi
Industrial area, Karachi.
Name and address of Manufacturer M/s Biocon Limited, Special Economic Zone, Plot Nos. 2,3,4
& 5 Phase-IV, Bommasandra-Jigani Link Road, Bommasandra
Post,Bangalore-560099,India
Brand Name +Dosage Form + TRAVIA 150MG (SINGLE USE VIAL)
Strength Trastuzumab for Injection (rDNA Origin) 150mg/vial
Diary No. Date of R& I & fee Dy No. 646/2017(R&I) Date: 17-03-2017
Rs.100,000/- Date: 12-03-2017
Trastuzumab(rDNA Origin)…150mg
Pharmacological Group Anti-neoplastic
Finished Product Specification Manufacturer’s Specs.
Shelf Life 4 years
Document Details CoPP No. DCD/CR-1849/Spl.Cell-I/2015-16
dated 07-12-2016
Pack size & Demanded Price Pack Size: 1’s vial(150mg)/ Rs.50,000
International Availability Herceptin by Roche Products Limited, UK.
Products already registered in New Strength.
Pakistan
Remarks of the evaluator 1. Product is registered with the name of CanMabTM 150 in
country of origin with product license no.: KTK/28D/7/2006
dated 28-04-2006 Permission letter no. DCD/CR-
634/MFG/13-14 Dated 10-04-2014.
2. Brand name applied by the firm on Form-5A is Travia while
as per submitted CoPP Brand Name is CanMab.
3. Letter of Authorization is for Trastuzumab and not for
applied brand name.
Brand Name +Dosage Form + TRAVIA 440MG VIAL (Multiple use vial) Combipack
Rs.100,000/- Date: 12-01-2017
Shelf Life 4 years
dated 07-12-2016
Pack size & Demanded Price Pack Size: 1s vial(440mg)/ Rs.100,000
International Availability Herceptin by Genetech Inc., USA
Products already registered in Herceptin of Roche Pakistan Limited.
Pakistan
country of origin with product license no.:
KTK/28D/7/2006 dated 28-04-2006 Permission letter no.
DCD/CR-634/MFG/13-14 Dated 10-04-2014.
2. Brand name applied by the firm on Form-5A is Travia
while as per submitted CoPP Brand Name is CanMab.
applied brand name.
Brand Name +Dosage Form + TRAVIA 150 MG VIAL (Multiple use vial) Combipack
Rs.100,000/- Date: 23-02-2017
Shelf Life 4 years
Document Details CoPP No. DCD/CR-1849/Spl.Cell-I/2015-16 dt: 07-12-2016
Pack size & Demanded Price Pack Size: 1s vial(150mg)/ Rs.50,000
International Availability Herceptin by Roche Products Limited, UK.
Products already registered in New Strength.
Pakistan
country of origin with product license no.
KTK/28D/7/2006 dated 28-04-2006 Permission letter no.
DCD/CR-634/MFG/13-14 Dated 10-04-2014.
2. Brand name applied by the firm on Form-5A is Travia
while as per submitted CoPP Brand Name is CanMab.
applied brand name.
Brand Name +Dosage Form + BACTERIOSTATIC WATER FOR INJECTION
Strength 15ML VIAL
Rs.100,000/- Date: 02-06-2017
Bacteriostatic Water for Injection…....10ml
Finished Product Specification USP Specs
Shelf Life 02 years.
dated 07-12-2016
Pack size & Demanded Price Pack Size: 1s vial(10ml)/ Diluent in combipack.
Remarks of the evaluator  The firm has submitted that the diluent will be used in
combipacks of Travia 440mg and 150mg (Multiple use
vial).
The firm has submitted biosimilarity data as per following details:
Data Submitted Remarks
Quality Comparison a. Mass spectrometry – Intact (LC-MS)
1. Physicochemical Characterization b. Carbamidomethylated light and heavy chain Mass Analysis
by LC-MS
c. Mass spectrometry – Reduced
d. Peptide mapping: Tryptic peptide mass fingerprinting by
LC-ESI-MS
e. Peptide mapping: Glu-C peptide mass fingerprinting by
LC-ESI-MS
f. N and C-terminal confirmation: By peptide mass
fingerprinting LC-ESI-MS
g. Disulfide mapping: Non-reduced Tryptic peptide mass
fingerprinting by LC-ESI-MS
h. CD Tertiary: By Near UV Circular dichorism
i. CD Secondry: By Near UV Circular Dichorism
j. Extrinsic Fluorescence Analysis-ANS Fluorescence Assay
k. Intrinsic Fluorescence Analysis- Fluorescence Assay
l. N-Glycan analysis by NPHPLC
m. Sialic Acid Content by RP-HPLC
n. Methionine oxidation: By peptide mass fingerprinting and
ESI-MS analysis
2. Biological Activity  ADCC: Antibody Dependent Cell-mediated Cytotoxicity
 Potency assay-Inhibition of Proliferation of SKBr3 cells
 Affinity assay – Binding to SKBr3
 FcγRIa Biacore kinetic assay
 FcγRIIa Biacore kinetic assay
 FcγRIIb Biacore kinetic assay
 FcγRIIIb Biacore kinetic assay
 C1q Enzyme-linked immunosorbent assay(ELISA)
3. Immunochemical Properties  SKBR3 Inhibition of proliferation assay
 SKBR3 binding assay
4. Impurities  Process related impurities
 Host Cell Protein by ELISA
 Host cell DNA by Quantitative-PCR
 Leached protein A by ELISA
 Product related impurities
 Size variants (Reduced and Non-reduced CE-SDS)
 Charge Variants Estimation by Ion Exchange
chromatography
 Glycation: By Boronate affinity chromatography
 Free cystein analysis-UV spectroscopy
5. Stability Studies Comparative force degradation studies of Herceptin and
Bmab-200RPF drug products in reconstituted state.
Non-clinical Comparison  Primary Pharmacodynamics - Biological/ Binding activity
iii. In-vitro Studies  Bioactivity by Sk-Br3 cell lines
iv. In-vivo Studies  Binding by Surface plasmon resonance (Biacore)
 Safety Pharmacology
 Mitochondrial impact of Trastuzumab monoclonal
antibodies on cultured human cardiomyocytes
 The impact of Trastuzumab on mitochondria in
cultured primary Neonatal rat cardiomyocytes
 Invivo pharmacokinetic comparability profile in the
cynomolgus monkeys
 Comparative Toxicity and Toxicokinetic Profile of Hercules
vs Herceptin after Weekly Intravenous Infusion Doses to
Cynomolgus monkeys.
 Four Weeks Comparative Repeat Dose Toxicity Study in
Swiss Albino Mice by Intravenous Route with two weeks’
recovery period.
 90 days Repeat Dose Toxicity Study in New Zealand White
Rabbits by Intravenous Route.
Clinical Comparison  A randomized, double-blind, Phase I study to assess the
Bioequivalence of Hercules vs. Herceptin® administered as
a single Intravenous infusion to healthy male volunteers.
(Sample Size=22)
 A Single-Center, Randomized, Double Blind, Three-Arm,
Parallel-Group Phase I Study to Compare the
Pharmacokinetic Profiles of Hercules, EU approved
Herceptin® and US Licensed Herceptin® Administered as a
Single Intravenous Infusion to Healthy Male Volunteers.
(Sample Size=132)
 A multicenter, double-blind, randomized, parallel-group,
phase III study of the efficacy and safety of Hercules Plus
Texane versus Herceptin® Plus Texane as First Line
therapy in patients with HER2-Positive metastatic breast
cancer. (Sample Size=410)
 Comparative PK, Efficacy, Safety and Immunogenicity
evaluation of Bmab-200 versus Herceptin®, both in
combination with Docetaxel in patients with Her2- positive
Metastatic Breast Cancer: A Double Blind, Randomised,
Active Control, Parallel assignment, Comparative Phase 3
Clinical Trial. (Sample size=135)
Registration Board in its 270th meeting approved the same formulation from same manufacturer
with different brand name for another importer i.e. M/s AGP (Pvt.) Ltd., Karachi. Furthermore,
both products are manufactured by M/s Biocon Ltd., India and are freely sold in India with
different brand names. Moreover, distribution rights of Hertraz are with M/s Mylan Laboratories
Limited, India which has also submitted same application in EMA and USFDA which is under
consideration. M/s Mylan Laboratories, India authorized M/s AGP, Karachi as their sole agent
for Hertraz in Pakistan while M/s Biocon Ltd., India directly appointed M/s Getz Pharma,
Karachi as sole distributor of their product CanMab in Pakistan. The case of import of same
formulation with different brand names from same manufacturer was considered in 274th
meeting of Registration Board wherein the Board decided as follows:
“Registration Board deferred the case of registration of two different brands of same
formulation from same manufacturer for the opinion of Legal Affairs Division.”
The case was referred to Legal Affairs Division for their opinion. The response of Legal Affairs
Division is as follows:
“CoPPs of both the importers i.e. Getz Pharma and M/s AGP have been examined. After perusal
of record, it has been found that the product Trastuzumab is available in the market of exporting
country India with two different names and registration numbers as per rules and regulations of
exporting country. In addition, application for registration of imported drug is made on Form-5A
under Rule 26(1) of Licensing Registration and Advertising Rules, 1976. Registration Board in
its 240th meeting under agenda item no. 2 approved certain requirements for registration of
imported drugs including requirement of sole agency agreement. Therefore, Registration Board
may grant registration to the said product to any firm which produces the sole agency agreement
and fulfill the requirement of Form-5A.”
Proceedings:
Registration Board called up Deputy Director, Legal Affairs Division to further elaborate their
opinion regarding the sole agency agreement. Deputy Director, Legal Affairs Division apprised
the Board that Registration Board may grant registration of said product to any firm which
produces sole agency agreement from the manufacturer, product license holder or authorized
distributor of the product license holder and fulfill the requirements of Form-5A.
Decision: Keeping in view the opinion of Legal Affairs Division, biosimilarity data and
submitted CoPP indicating that the products are available for sale in the
country of origin, Registration Board approved the above products as per
valid legalized CoPP subject to price fixation by Federal Government and
Case No. 2: Imported Human Biologicals from Non-reference countries.
1. Name of Importer M/s Medi Mark Pharmaceuticals Liaqat chowk sahiwal, Pakistan.
Name of Manufacturer M/s Changzhou Qianhong Bio-pharma Co., Ltd.
Address 1: No.192 Huanghe West Road, Xinbei District,
Changzhou, Jiangsu, China.
Address 2: No.128 Xueye Road, Xinbei District, Changzhou,
Jiangsu, China
Brand Name +Dosage Form Mediren Inj. 25000IU/5ml
+ Strength
Composition Each 5ml Vial contains: Heparin Sodium……… 25000IU/5ml
Finished product USP Specs
specifications
Approval status in Reference Panpharma UK Ltd
countries
International Availability China, Philippines
Products already registered in Epsoclar (Noble Pharma)
Pakistan
Shelf life 3 years (≤250C)
Type of Form Form 5-A,
Dy No & Date of application, Dy. No. 743 (R&I) Date: 09-02-2017
Fee submitted Rs. 100,000/- Date: 09-02-2017
Demanded Price/ Pack size Rs. 800/Injection, 1 vial of 5ml
General documentation Legalized CoPP No.201700 issued on 01-03-2017,
Legalized GMP No.JS20160588 issued on 28-06-2016,
Legalized Letter of Authorization for exclusive sole agent valid up
to 02-01-2022.
Remarks of Evaluator Two addresses are mentioned in CoPP i.e.
Address 1: No.192 Huanghe West Road, Xinbei District,
Changzhou, Jiangsu, China
Address 2: No.128 Xueye Road, Xinbei District, Changzhou,
Jiangsu, China.
The firm has clarified that Address-1 is of API manufacturing site
while Address-2 is of finished dosage form manufacturing site.
Decision: Keeping in view the availability of product in country of origin as per submitted
CoPP and Heparin injection being non-rDNA pharmacopoeial product, Registration Board
approved the Mediren Inj. 25000IU/5ml as per valid legalized CoPP subject to price fixation by
Federal Government and compliance of current Import Policy for Finished drugs.
CaseNo.03: Response of Representation Submitted by Representative of M/S Macter

International Ltd., Karachi Regarding Momentum Injection approved in 254th
Meeting.
Sr. Representation Reply
1. We represent M/s Macter International Ltd (our Para 1 needs no comments.
“Client”) and have been instructed to send the
instant representation/notice to highlight the
inordinate delays in the issuance of Registration
Letter despite the completion of all other formalities
involved in the registration process for the biological
product Etanercept (Recombinant Human Tumor
Necrosis Factor) a Receptor II IgG fusion protein
25mg lyophilized powder for injection (the
“Product”)
2. It may be noted that the application for the Denied. As per available record, M/s Macter
registration of the Product was initially submitted International Ltd., Karachi applied for the
on 11th February, 2011 at which time the registration of Etanercept (Recombinant
registration of biological drugs was being carried Human Tumor Necrosis Factor) on 17-10-
out under Schedule VIII of the Drugs Act, 1976 (the 2011. Moreover, in July, 2011 after 18th
“Act”), Form 5 whereof prescribed the only amendment Ministry of Health was devolved
requirements that had to be complied with for the and DRAP Act was promulgated on 13-11-
purposes of registration. At the time of filing of the 2012. In DRAP Act, Biologicals are defined in
aforesaid application, there was no requirement or Schedule-I. After the promulgation of DRAP
compliance needed for bio-similarity studies on the Act, 2012, Registration Board in its 246th
Product. However, the same was introduced meeting held on 10th-11th December, 2014
subsequently and fresh conditions were imposed on gave the opportunity to local manufacturers
our Client whilst the Product was pending approval including M/s Macter International Limited,
from the Board for the past four and a half years. Karachi for appraising their views regarding
Furthermore, our Client also met all the prevalent the local manufacturing of Biological Drugs. It
requirements and conditions as required were is evident from the minutes of meeting that
further the imposed by the biological drugs division two representatives of M/s Macter
of the Authority for the evaluation of the International Ltd., Karachi i.e. Dr. Salman
Application for Registration of the Product.” Ahmed and Mr. Farooq Mustafa also attended
the meeting. Keeping in view the arguments
presented by the representatives of the local
manufacturers, Registration Board decided as
follows:
“a. The firms shall provide legalized
GMP certificate of biological drug
manufacturer abroad (who will provide
concentrate / ready to fill bulk of biological
drug to Pakistani manufacturers for further
processing) as an evidence that the
manufacturer is an authorized manufacturer
of that particular biological drug in its
country of origin.
b. The firm shall provide studies
conducted by manufacturer abroad (dully
verified with statement for correctness /
genuineness of data) regarding structural
similarity of subject biological drug product
(concentrate/ ready to fill bulk for further
processing) with reference biological
product (innovator).
c. The local manufacturer shall be
authorized to manufacture the finished
biological product and then perform bio-
comparability studies including identity
testing to parent molecule, purity testing, in
vitro biological activity, potency and toxicity
with support of iso-electro focusing data, gel
electrophoresis, Western-Blot and other
analytical techniques) and stability studies
of finished biological product. Data
provided by the local manufacturer shall be
evaluated by the Expert Committee on
Biological drugs. Recommendation of the
committee shall be considered by the
Registration Board for issuance of
d. The firms shall conduct parallel bio-
similarity studies as per WHO guidelines
immediately after grant of registration and
shall submit complete studies with in two (2)
years in any case. Manufacturer will provide
progress report to this effect to Directorate
of Biological Drugs on quarterly basis.
e. Regular monitoring through
pharmacovigilance reporting system shall be
observed through proper pharmacovigilance
cell of the manufacturer and report will be
forwarded to the National
Pharmacovigilance Centre, Division of
Pharmacy Services and Biological Division
of DRAP. In case of any severe adverse
event, immediate mandatory reporting
procedure shall be followed.
f. If any of the conditions is not fulfilled
or public health risk reported at any stage,
the drug registration shall stand cancelled
with immediate effect.
g. All the provisions as contained in the
Drugs Act, 1976 and rules made there under
including provisions of Lot Release
certification from National Control
Laboratory for Biologicals shall be strictly
adhered to.
2. Already registered biological drugs
shall be reviewed in the same manner.
3. New applications for registration of
biological drugs shall be considered after
compliance of above point.”
As per the above decision of Registration
Board, M/s Macter International Ltd., Karachi
provided the legalized GMP certificate for
aforementioned product on 08-08-2015. The
case was then placed in 251st meeting of
Registration Board held on 12th-13th August,
2015 wherein the Board decided as follows:
“The case was deferred for the product
specific requirement for manufacturing and
testing of the particular product by the
firm.”
The firm submitted the required documents as
per decision of Board on 01-10-2015.
Accordingly, the case was placed in 253rd
meeting of Registration Board held on 05th-
06th October, 2015 and the case was deferred
due to paucity of time. The case was again
placed in 254th meeting held on 11th-12th
November, 2015 and the Board approved the
product.
3. Consequently, vide Registration Board meeting of Agreed. The product was approved in 254th
11th of November, 2016, after fulfillment of all the meeting of Registration Board after
requirements and conditions, the pending fulfillments of requirements formulated in
registration of our Clients Product was approved. 246th meeting of Registration Board.
This was based on the framework of biosimilar
registration agreed between the industry and Board
in its 246th meeting.
4. After approval of registration by the Registration Agreed to the extent that as per policy, after
Board, the Product was duly sent to Drug Pricing approval the products are referred to Pricing
Committee (the “Committee”) who was pleased to Division for Price fixation. The Federal
approve the pricing of the product in its 17th Government vide SRO 905(I)/2017 dated 7th
meeting held on the 17th of May 2016. Our Client September, 2017 notified the price of
kept following the concerned offices for issuance of aforementioned product. It is pertinent to
Registration Certificate as after approval from the mention that various local manufacturers
pricing section, issuance of a registration letter is a including M/s Macter International Ltd.,
mere formality and there is no reason to restrain or Karachi have already been granted
delay the same to the detriment of our Client. registrations for local manufacturing of
Furthermore, and S.R.O. 905 (I)/2017 dated 7th of Biological drugs as per the decision of
September, 2017, was also issued to confirm the Registration Board with the condition that the
price of the Product. firms shall conduct parallel bio-similarity
studies as per WHO guidelines immediately
after grant of registration and shall submit
complete studies with in two (2) years in any
case. Manufacturer will provide progress
report to this effect to Directorate of
Biological Drugs on quarterly basis.
None of the firms including M/s Macter
International Ltd., Karachi provided any data.
M/s Macter International Ltd., Karachi
submitted the following response:
They have two molecules registered, Pegylated
Interferon and Interferon with 5 & 4 strengths
of each molecule. After the imports of APIs
and manufacturing of batches we could launch
products in market in November 2015.
However, on the first day of product launch
they found that standard therapy was changed
in international treatment guidelines (US FDA,
WHO, EU). Before the launch of their product
one DAA (Direct Acting Antiviral) Sovaldi
(Sofobuvir) was registered in Pakistan in
March 2015. In October of 2015, other 11
generic products of Sofodbuvir were approved
by DRB. They developed a clinical trial
protocol 16CT01 as per Interferon based
therapy comprised of Pegylated
Interferon/Interferon & Ribavirin. They started
study immediately after the registration of
product. After a few patients recruited key
Hepatologists start disagreeing to recruit
patients in a comparability trial based on
Interferon/Peg Interferon & Ribavirin therapy.
They were of opinion that standard clinical
protocols for the Hepatitis treatment include
DAA‘s. Interferon can only prescribed for a
triple therapy (Pegylated Interferon +
Sofosbuvir + Ribavirin as per Hep c clinical
guidelines AASLD & EASL. If comparative
trial done on triple therapy it is difficult to
evaluate comparability of – Peg Interferon/
Interferon as efficacy and side effects are
result of combined effect of DAA‘s
(Sofosbuvir) plus Interferon/ Peg Interferon
plus ribavirin.
They requested that due to such complexity
involved and very slow recruitment of patients
on Interferon/Peg Interferon comparative
clinical trial, they requested that biosimilarity
of Peg Interferon/Interferon may be allowed to
be proven by bioequivalence studies. The
results of comparative clinical trials will not be
applicable to future therapy as it will be
possible only in combination with DAA‘s.
Keeping in view the positions explained by all
the firms regarding the aforementioned
condition, Registration Board in its 273rd
meeting held on 28th-29th August, 2017
decided as follows:
“Registration Board deliberated the matter
and constituted following committee to make
guidelines for the evaluation of different
classes/categories of Biological Drugs
(Human & Veterinary) keeping in view the
statutory requirements as well as the current
scenario of Pakistan.
i. Maj. Gen. Tahir Mukhtar Commandant
AFIRM. (Chairman)
ii. Dr. Noor Us Sabah, Director
Biological Drugs (Member)
iii. Dr. Qurban Ali, DG NVL (Member)
iv. M. Akhtar Abbas Khan, Dy. Director
Biological (Secretary)
v. Representative of Pharma Bureau,
PPMA and PCDA (Observer)
vi. The committee can co-opt any expert as
a member for its technical assistance.”
The committee after its two meetings, in
which the representatives of M/s Macter
International Ltd., Karachi were also present,
drafted guidelines which are included in the
agenda of 278th meeting. After the
finalization of guidelines, all the local
manufacturers which fulfill the said
requirements shall be granted registrations.
5. Despite the completion of all the formalities As already explained in para-3&5/n above.
involving the Registration Process spanning over
almost 7 years, the Registration letter is still not
being issued.
6. It may be noted the due to the continued delay in the DBER has performed its duties as per law.
issuance of Registration Letter our Client has been
suffering from huge financial losses of billions of
rupees in regards to the Product. The delay in
issuance of the Registration Letter being a minor
formality without any rationale, is not reflective of
how a public entity is supposed to act and is in
violation of the due process rights of our Client
guaranteed under the Constitution of Islamic
Republic of Pakistan, 1973 as well as Section 24-A
of the General Clauses Act of 1987, as the
continuous failure to issue the Registration letter
violates the duty and obligations cast upon the
relevant officials being public functionaries.
7. Furthermore, the failure to issue the Registration Para 8 needs no comments.
Letter violates Article 18 of the Constitution, which
guarantees the rights to practice lawful trade,
business or profession. Needless to say, our Client
is suffering huge financial losses due to the inaction
on part of the Authority.
8. In this regard, the learned Wafaqi Mohtasib vide Para 9 needs no comments.
order dated 2 December 2014 also issued clear
directions to the Authority to expeditiously proceed
with the registration of Products of our Client. A
copy of the decision has already been
communicated to your good office.
9. It is implored that your good office may act in DBER has performed its duties as per law.
accordance with law and address the instant
representation immediately and rectify our Client’s
legitimate grievances by providing them with the
Registration Letter for the biological product
Etanercept (Recombinant Human Tumor Necrosis
Factor) a Receptor II Ig G fusion protein 25mg
lyophilized powder for injection, without further
delay. Failure to adhere towards our Client’s
genuine request shall leave our Client with no
avenues but to approach the appropriate legal forum
to adjudicate the unabashed abuse of our Client’s
due process rights.
10. In order to address the grievances, your good office Registration Board may give a personal
is also requested to give a right of hearing to our hearing to M/s Macter International Ltd.,
Client so that a conclusive adjudication of the Karachi.
subject matter can be made.
Decision: Registration Board referred the case back to DBER for processing at their
end as per prescribed procedure and previous practice.
Meeting ended with a vote of thanks to and from the chair.
End of Document

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Minutes of 278th Meeting of Registration Boardffhbcvvvh

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Minutes for 278th Meeting of Registration Board

held on 29-31st January, 2018.

Item No. Detail of Item Page No.

Drug Regulatory Authority of Pakistan

Mr. Zaheer-ud-Din M. Babar (Deputy Director R.I/R.IV), Tehreem Sara (Deputy

Chairman, Registration Board.

Decision: Registration Board confirmed the minutes of 277th meeting.

Total Cases: 848

12. Mst. Mehwish Javed Khan Evaluator PEC-XIII

Pack size & Demanded Price 1’s / As Per SRO

Pack size & Demanded Price 1’s / As Per SRO

Pack size & Demanded Price 60 g /As per Policy

Pack size & Demanded Price As per SRO

Pack size & Demanded Price As per SRO

Pack size & Demanded Price As per SRO

Pack size & Demanded Price As per SRO

Pack size & Demanded Price As per SRO

Pack size & Demanded Price As per SRO

Pack size & Demanded Price As per SRO

Pack size & Demanded Price As per SRO

Pack size & Demanded Price As per SRO

Pack size & Demanded Price As per SRO

Composition Each ml contains:

187. Name and address of Manufacturer / M/s Werrick Pharmaceuticals, 216-217,I-10/3,

Decision: Approved with innovator’s specification

Decision: Approved with box warning

339. Name and address of manufacturer / M/s Sami Pharma, karachi

Diluents and water for Injection (Human)

Me-too status Dantron 4mg/5ml syrup by M/s Shrooq

Decision: Deferred for confirmation whether manufacturing facility of L Liquid Injection

Each vial contains 1 million International Units (IU)

Liquid Ampoules (General) (Human)

GMP status 13-07-2017; Grant of new DML,

GMP status 13-07-2017; Grant of new DML,

Pack size & Demanded Price 3’s(1ml) /As per SRO

Previously considered Products/Molecules:

Dry Vial (Cephalosporin): Products: 02, Molecules: 01

Sr.No. Section No. of No. of

Decision: Approved with change of brand name

Decision: Approved with Innovator’s specification.

Type of Form Form-5

b) Deferred cases (Veterinary Drugs)

Application received against letter No.F.1-3/2017-Reg-I (Vet).

Section Approved Deferred New Request of the firm

Liquid Injection Penicillin vet (molecules 8/ products 18)

740. Name and address of manufacturer / M/s Regal Pharmceuticals, Islamabad

766. Name and address of manufacturer / M/s Rotex Pharma, Islamabad

771. Name and address of manufacturer / M/s Epharm Laboratories, Karachi

777. Name and address of manufacturer / M/s Olive laboratories, Rawalpindi

783. Name and address of manufacturer / M/s Highnoon Labs, Lahore

Decision: Approved as per Imort Policy for Finished Pharmaceutuical Products.

Decision: Approved as per Imort Policy for Finished Pharmaceutuical Products.

Decision: Approved as per Imort Policy for Finished Pharmaceutuical Products

Decision: Approved as per Imort Policy for Finished Pharmaceutuical Products

Decision: Approved as per Imort Policy for Finished Pharmaceutuical Products

The firm has provided following documents;

1. Thiamphenicol is an analogue chloramphenicol in which P-nitro group of

1. I am interested to ask whether this product (drug; Thiamphenicol) is registered already

1. The product under consideration contains thiamphenicol as active ingredient with

1 gram of product contains : Thiamphenicol 200mg

Dissolution parameter USFDA Recommendations Hepgard Plus Test method

 Dr. Rafeeq Alam Khan, Meritorious Professor (Member Registration Board)

Pack size & Demanded Price 10’s, 14’s, 20’s, 28’s

Feature Reference product Product of Hilton