LIST OF COMPARATOR PRODUCTS FOR BIOEQUIVALENCE STUDIES (JUNE 2013) Comparator Products Trade Mark/Registration No./ Reference No.

GLUCOBAY TABLET 50MG MAL19940745A GLUCOBAY TABLET 100MG MAL19940746A SECTRAL CAPSULE 100MG (MAL19870251A) SECTRAL CAPSULE 200MG (MAL19870052A) SECTRAL TABLET 400MG (MAL19870053A) SECTRAL 200MG CAPSULE MAL19920620A Manufacturer BAYER SCHERING PHARMA AG, LEVERKUSEN, GERMANY MAY & BAKER LTD, MAY & BAKER LTD, DAGENHAM, ESSEX, RM107XS, ENGLAND

Bil. 1.

TEST PRODUCTS (Pharmaceutical name) Acarbose

2.

Acebutolol hydrochloride

3.

Acemetacin

RANTUDIL CAPSULE 60MG (MAL19986936A) RANTUDIL RETARD 90MG CAPSULE (MAL19992054A) DIAMOX TABLET 250MG DIAMOX TABLET 250MG

RHONE-POULENC RORER, JL LAWANG GINTUNG, BOGUR, WEST JAVA, INDONESIA BAYER AG, WEST GERMANY BAYER SCHERING PHARMA AG, GERMANY AMERICAN CYANAMID CO.,US LEDERLE LABS DIV CYANAMID, UNITED KINGDOM PHARMACIA S.P.A, ITALY PATHEON INC, CANADA

4.

Acetazolamide

5. 6.

Acipimox Acitretin

7.

Acrivastine

OLBETAM CAPSULE 250 MG (MAL19900589A) NEOTIGASON CAPSULE 10 MG (MAL06091392AC) NEOTIGASON CAPSULE 25 MG (MAL06091393AC) NEOTIGASON HARD GELATIN CAPSULE 10MG (MAL19921411A) NEOTIGASON HARD GELATIN CAPSULE 25* (MAL19921412A) SEMPREX CAPSULE 8MG (MAL19900013A)

ROCHE PRODUCTS LTD, UNITED KINGDOM

SMITHKLINE BEECHAM PHARM, UNITED KINGDOM

LIST OF COMPARATOR PRODUCTS FOR BIOEQUIVALENCE STUDIES (JUNE 2013) TEST PRODUCTS (Pharmaceutical name) Adefovir Comparator Products Trade Mark/Registration No./ Reference No. HEPSERA TABLET 10MG MAL20040907A ZYLORIC 100MG TABLETS MAL19973571AS ZYLORIC TABLET 300MG MAL19972499AS Manufacturer GLAXOSMITHKLINE (TIANJIN) CO. LTD., CHINA ASPEN PORT ELIZABETH (PTY) LTD CNRS FAIRCLOUGH ROAD AND GIBAUD ROAD, KORSTEN PORT ELIZABETH, 6020 REPUBLIC OF SOUTH ARICA , SOUTH AFRICA. ORGANON LABS LTD, SCOTTLAND LABORATOIR BELLON, FRANCE NOVARTIS PHARMA STEIN AG, SWITZERLAND MERZ PHARMA GMBH & CO. KGAA,GERMANY SANOFI WINTHROP INDUSTRIE, FRANCE SANOFI WINTHROP INDUSTRIE, FRANCE

Bil. 8.

9.

Allopurinol

10. 11.

Allyoestrenol Alverin citrate

GESTANIN TABLET 5MG MAL19870680A SPASMAVERINE TABLET 0.04G MAL19871806A

12.

13. 14. 15.

16. 17.

SYMMETREL SOFT GELATIN CAPSULE 100* 1986040644A Amantadine sulphate PK-MERZ TABLET 100MG MAL19860850A CORDARONE 200MG Amiodarone MAL19987968AR hydrochloride SOLIAN 100MG SCORED TABLET Amisulpride MAL20032239A SOLIAN 400MG SCORED FILMCOATED TABLET MAL20032240A CAMOQUIN Amodiaquine Amantadine hydrochloride Anastrozole ARIMIDEX TABLET 1MG MAL19987960AR EMEND 80MG CAPSULE MAL20040905AR EMEND 125MG CAPSULE MAL20040906AR STRATTERA 60MG CAPSULE MAL20051406A STRATTERA 40MG CAPSULES MAL20051405A STRATTERA 25MG CAPSULES

18.

Aprepitant

PFIZER, UNITED KINGDOM ASTRAZENECA PHARMACEUTICALS LP, UNITED STATES MERCK SHARP & DOHME CORP.*, UNITED STATES

19.

Atomoxetine

LILLY S.A, MADRID, SPAIN

LIST OF COMPARATOR PRODUCTS FOR BIOEQUIVALENCE STUDIES (JUNE 2013) TEST PRODUCTS (Pharmaceutical name) Comparator Products Trade Mark/Registration No./ Manufacturer Reference No. MAL20051004A STRATTERA 18MG CAPSULES MAL20051403A STRATTERA 10MG CAPSULES MAL20051402A LIORESAL 10MG TABLET NOVARTIS FARMA S.P.A., MAL20000748AC ITALY As agreed upon in Mesyuarat Jawatankuasa Kerja Bioekuivalens Kebangsaan 1/2012 13 September 2012, the following requirement to be submitted in place of bioequivalence report :i) Validation process report for 3 consecutive batches ii) Comparative dissolution profile for 3 consecutive batches (time points : 0, 5, 15, 30 & 45 minutes ) 22. 23. LES LABS SERVIER INDUSTRIE, FRANCE AMERICAN CYANAMID Benzhexol CO, UNITED STATES CYANAMID OF GREAT BRITAIN, UNITED KINGDOM This product can be obtained from Nagoya, Japan (Information updated from Pfizer on 25th January 2013 via a letter) MERCK SHARP & DOHME Benztropine mesylate COGENTIN TABLET 2MG MAL19870343AR INT, UNITED STATES BETASERC 24MG TABLET ABBOTT HEALTHCARE Betahistine MAL07061394A SAS, FRANCE dihydrochloride BETASERC 16MG TABLETS MAL19972468A EISAI CO LTD, JAPAN Betahistine mesylate MERISLON TABLET 6MG MAL19861236A BETNELAN TABLET 0.5MG, GLAXO WELLCOME Betamethasone MAL19870589A OPERATIONS UNITED KINGDOM As agreed upon in Mesyuarat Jawatankuasa Kerja Bioekuivalens Kebangsaan 1/2013 13 March 2013, the following requirement to be submitted in place of bioequivalence report :Benfluorex i) ii) Validation process report for 3 consecutive batches Comparative dissolution profile for 3 consecutive batches (time points : 0, 5, 15, 30 & 45 minutes ) MEDIAXAL TABLET 150MG MAL19870176A ARTANE TABLET 2MG PBKD861498A ARTANE TABLET 2MG PBKD861497A

Bil.

20. 21.

Baclofen Bacampicillin

24. 25.

26. 27.

LIST OF COMPARATOR PRODUCTS FOR BIOEQUIVALENCE STUDIES (JUNE 2013) TEST PRODUCTS (Pharmaceutical name) Betaxolol Bezafibrate Bicalutamide Comparator Products Trade Mark/Registration No./ Reference No. KERLONE TABLET 20MG MAL19872264A BEZALIP COATED TABLET 200MG 1993010002A CASODEX TABLET 50MG MAL19990958ACR CASODEX 150MG TABLET MAL20040082AR CONCOR 2.5MG TABLET MAL20020792A CONCOR 5 FILM COATED TABLET MAL19890389A CONCOR 10 FILM-COATED TABLET MAL19890390A TRACLEER TABLET 62.5 MG MAL20041084ACR TRACLEER TABLET 125 MG MAL20041085ACR DIMETANE TABLET 4MG 1986041234A LONGIFENE TABLET 25MG MAL19861193A BURINEX TABLET 1MG MAL19913216A MYLERAN TABLETS 2MG MAL05051050AC COLIOPAN TABLET 5MG MAL19910111A DOSTINEX TABLET 0.5MG MAL19971775A ATACAND TABLET 16MG MAL2001219AR ATACAND TABLET 4MG MAL20001217A ATACAND TABLET 32MG MAL09042471A XELODA TABLET 150MG MAL20000001A XELODA TABLET 500MG MAL20000002A Manufacturer SANOFI WINTHROP INDUSTRIE, FRANCE ROCHE DIAGNOSTICS GMBH, GERMANY CORDEN PHARMA GMBH, GERMANY. ASTRAZENECA GMBH , GERMANY MERCK KGAA, GERMANY

Bil. 28. 29. 30.

31.

Bisoprolol fumarate

32.

Bosentan monohydrate

PATHEON INC., CANADA

33. 34.

Brompheniramine maleate Buclizine hydrochloride Bumetanide Busulphan Butropium bromide Cabergoline Candesartan Cilexetil Tablet

35. 36. 37. 38. 39.

40.

Capecitabine

A.H.ROBINS PTY LTD, AUSTRALIA UCB S.A. SECTOR PHARMA, BELGIUM LEO PHARM PRODUCTS, DENMARK EXCELLA GMBH, GERMANY EISAI TAIWAN INC, TAIWAN PFIZER ITALIA S.R.L., ITALY ASTRAZENECA AB, SWEDEN ASTRAZENECA AB, SWEDEN ASTRAZENECA AB, SWEDEN PRODUCTOS ROCHE S.A DE C.V, MEXICO

LIST OF COMPARATOR PRODUCTS FOR BIOEQUIVALENCE STUDIES (JUNE 2013) TEST PRODUCTS (Pharmaceutical name) Carbimazole Comparator Products Trade Mark/Registration No./ Reference No. NEOMERCAZOLE TABLET 5 MG MAL05092230AC DISTACLOR CAPSULE 250MG MAL19962114A DISTACLOR CAPSULE 500MG MAL19962115A DURICEF CAPSULE 500MG MAL19860523A DURICEF TABLET 1GM MAL19940665A OMNICEF CAPSULE 100MG MAL19991688AC PROCEF TABLET 250MG MAL19940487A PROCEF TABLET 500MG MAL19940483A CEDAX CAPSULE 200MG MAL19950228A CEDAX CAPSULE 400MG MAL19950227A CELEBREX CAPSULE 100MG MAL20000004AR CELEBREX CAPSULE 200MG MAL20000005AR CELEBREX 400MG CAPSULES MAL08051748AR VELOSEF CAPSULE 500MG MAL19920468A NIVAQUINE TABLET 200MG MAL19912313A CHLOTRIDE TABLET 500MG REF.NO1986040263A PIRITON TABLET 4MG MAL07082871AC DIABENESE TABLET 250MG MAL19986461A DIABINESE TABLET 250MG MAL19870382A Manufacturer APTUIT (EDINBURGH) LIMITED, UNITED KINGDOM ELI LILLY &C0 (TAIWAN) INC, TAIWAN

Bil. 41.

42.

Cefaclor

43.

Cefadroxil monohydrate

44.

Cefdinir

45.

Cefprozil

BRISTOL-M BARCELONETA INC, PUERTO RISO, UNITED STATES UPHA PHARMACEUTICAL MFG. (M) SDN BHD, MALAYSIA BRISTOL-M BARCELONETA INC, UNITED STATES SIFI S.P.A., ITALY

46.

Ceftibuten

47.

Celecoxib

PFIZER PHARMACEUTICAL LLC, PUERTO RICO

48. 49. 50. 51.

Cephradine Chloroquine Chlorothiazide Chlorpheniramine maleate Chlorpropamide

52.

BRISTOL-MYERS SQUIBB AEBE, GREECE MAY & BAKER LTD, UNITED KINGDOM MERCK SHARP & DOHME INT, UNITED STATES HAUPT PHARMA WULFING GMBH, GERMANY PFIZER AUSTRALIA PTY. LTD., AUSTRALIA PFIZER PHARM DIV., PHILIPINES

LIST OF COMPARATOR PRODUCTS FOR BIOEQUIVALENCE STUDIES (JUNE 2013) TEST PRODUCTS (Pharmaceutical name) Chlortetracycline Comparator Products Trade Mark/Registration No./ Reference No. AUREOMYCIN CAPSULE 250MG MAL19871950A Manufacturer INTERTHAI PHARMACEUTICAL MANUFACTURING LTD, THAILAND NOVARTIS PHARMA STEIN AG, SWITZERLAND

Bil. 53.

54.

Chlorthalidone

55.

Chlorzoxazone

HYGROTON TABLET 25MG PBKD870184A HYGROTON TABLET 50MG PBKD870185A SOLAXIN TABLET 200MG EISAI CO. LTD, JAPAN PBKD861510A As agreed upon in Mesyuarat Jawatankuasa Kerja Bioekuivalens Kebangsaan 1/2013 13 March 2013, the following requirement to be submitted in place of bioequivalence report :iii) iv) Validation process report for 3 consecutive batches Comparative dissolution profile for 3 consecutive batches (time points : 0, 5, 15, 30 & 45 minutes ) KOREA OTSUKA PHARMACEUTICAL CO LTD, KOREA

56.

Cilostazol

57. 58. 59.

Cinnarizine Clemastine fumarate Clenbuterol hydrochloride Clodronate Clomiphene Clonazepam

PLETAAL 50MG TABLETS MAL20061476A PLETAAL 100MG TABLETS MAL20061475A STUGERON 25MG TABLET MAL19871481A TAVEGYL TABLET 1MG PBKD861195A SPIROPENT TABLET 0.01MG MAL19870785A OSTAC CAPSULE 1989120003A CLOMID TABLET 50MG MAL19950686A RIVOTRIL ROCHE TABLET 0.5MG MAL19860961A RIVOTRIL ROCHE TABLET 2MG MAL19860962A DIXARIT TABLET 25MCG MAL19870080A DIXARIT SUGAR-COATED TABLET 0.025MG

60. 61. 62.

JANSSEN CILAG SPA, ITALY NOVARTIS PHARMA AG, SWITZERLAND BOEHRINGER INGELHEIM INTERNATIONAL GMBH, GERMANY ROCHE DIAGNOSTICS GMBH, GERMANY PATHEON FRANCE S.A., FRANCE ROCHE FARMA S.A., SPAIN

63.

Clonidine

BOEHRINGER INGELHEIM INTERNATIONAL GMBH, GERMANY. BOEHRINGER INGELHEIM FRANCE, FRANCE.

LIST OF COMPARATOR PRODUCTS FOR BIOEQUIVALENCE STUDIES (JUNE 2013) TEST PRODUCTS (Pharmaceutical name) Comparator Products Trade Mark/Registration No./ Manufacturer Reference No. MAL19986979A CATAPRES TABLET 0.15MG BOEHRINGER INGELHEIM MAL19861621A LTD, SOUTH KOREA TRANXENE CAPSULE 5MG SANOFI WINTHROP PBKD861331AR INDUSTRIE, FRANCE TRANXENE CAPSULE 10MG PBKD861332AR ANDROCUR 50MG TABLET DELPHARM LILLE S.A.S., MAL19993023AR FRANCE LADOGAL CAPSULE 50MG NYCOMED PUERTO RICO PBKD870433A INC, PUERTO RICE LADOGAL CAPSULE 100MG NYCOMED PUERTO RICO PBKD870434A INC, PUERTO RICE LADOGAL CAPSULE 200MG NYCOMED PUERTO RICO PBKD870435A INC, PUERTO RICE Product is available in Taiwan & Philliphines (Information obtained via an email from Sanofi Aventis (M) Sdn. Bhd dated 22 May 2013) AVLOSULFON TABLET 0.1G ASTRAZENECA UK 1986043833A LIMITED, UNITED KINGDOM SPRYCEL 20MG TABLET BRISTOL-MYERS SQUIBB MAL20071695AR COMPANY, UNITED SPRYCEL 50MG TABLET STATES MAL20071696AR SPRYCEL 70MG TABLET MAL20071697AR FERRIPROX 500MG TABLET APOTEX INC CANADA MAL20033480AC AERIUS TABLET SCHERING PLOUGH SPA, MAL20020876AR ITALY AERIUS TABLET 5MG SCHERING-PLOUGH MAL10053655AS LABO N.V., BELGIUM POLARAMINE 2MG TABLET SCHERING-PLOUGH MAL09072776A LABO N.V., BELGIUM KETESSE 25MG FILM COATED A. MENARINI TABLET MANUFACTURING MAL20061602A LOGISTIES AND SERVICES S.R.L, ITALY ARTRODAR TRB PHARMA S.A, MAL20041211A ARGENTINA

Bil.

64.

Clorazepate dipotassium

65. 66.

Cyproterone acetate Danazol

67.

Dapsone

68.

Dasatinib

69. 70.

Deferiprone Desloratadine

71. 72.

Dexchlorpheniramin e maleate Dexketoprofen trometamol

73.

Diacerein

LIST OF COMPARATOR PRODUCTS FOR BIOEQUIVALENCE STUDIES (JUNE 2013) TEST PRODUCTS (Pharmaceutical name) Diclofenac potassium Comparator Products Trade Mark/Registration No./ Manufacturer Reference No. VOLTAREN DOLO 12.5 MG FILMNOVARTIS COATED TABLETS FARMACEUTICA S.A., MAL06071043A SPAIN CATAFLAM 25MG TABLETS NOVARTIS FARMA S.P.A., MAL19960970A ITALY CATAFLAM TABLET 50MG NOVARTIS SAGLIK, MAL19960971A TURKEY VOLTAREN TABLET 25MG NOVARTIS SAGLIK, MAL19861069A TURKEY VOLTAREN TABLET 50MG MAL19861068A DOLOBID TABLET 250MG MERCK SHARP & DOHME MAL19861106AR INT, UNITED STATES DOLOBID TABLET 500MG MAL19890178AR SEGLOR CAPSULE 5MG SANOFI WINTHROP MAL19870274A INDUSTRIE, FRANCE DRAMAMINE TABLET 50MG PROQUALIX PTY LTD, MAL19870328A AUSTRALIA Product is available in Costa Rica, Dominican Republic, El Salvador, Guatemala, Honduras, Mexico, Nicarague, Panama, Colombia, Peru and Chile. (Information obtained via an email from Johnson & Johnson Malaysia dated 27th Sept 2012) CEPHADOL TABLET 25MG NIPPON SHINYAKU CO MAL19861237A LTD, JAPAN PERSANTIN TABLET 75MG BOEHRINGER INGELHEIM MAL19870161A INTERNATIONAL GMBH, GERMANY MOTILIUM TABLET 10MG JANSSEN CILAG, FRANCE MAL19872254AR ARICEPT F.C. 5MG EISAI TAIWAN INC, MAL20013565A TAIWAN ARICEPT TABLET 10MG MAL05020190AC CARDURA TABLET 2MG PFIZER AUSTRALIA PTY. MAL19990562AS LTD., AUSTRALIA MULTAQ 400MG FILM-COATED SANOFI WINTHROP TABLETS INDUSTRIE, FRANCE MAL20102016A NO-SPA TABLETS 40MG CHINOIN MAL19900596A PHARMACEUTICAL &

Bil. 74.

75.

Diclofenac sodium

76.

Diflunisal

77. 78.

Dihydroergotamine mesylate Dimenhydrinate

79. 80.

Diphenidol hydrochloride Dipyridamole

81. 82.

Domperidone Donepezil

83. 84.

Doxazosin Dronedarone Hydrochloride Drotaverine

85.

LIST OF COMPARATOR PRODUCTS FOR BIOEQUIVALENCE STUDIES (JUNE 2013) TEST PRODUCTS (Pharmaceutical name) Comparator Products Trade Mark/Registration No./ Reference No. NO-SPA FORTE TABLET MAL20001801A Manufacturer

Bil.

86.

Dutasteride

87.

Eletriptan hydrobromide

88. 89.

Entacapone Entecavir

90. 91.

Eperisone hydrochloride Esomeprazole magnesium

92.

Estradiol

93. 94.

Estramustine sodium phosphate Etoricoxib

95.

Exemestane

CHEMICAL WORKS PRIVATE CO LTD, HUNGARY Product is available in Mexico, Vietnam, China & Pakistan (Information obtained via an email from Sanofi Malaysia dated 8th March 2013) AVODART SOFT GELATIN RP SCHERER SA, FRANCE CAPSULES MAL20040194AR RELPAX 20MG TABLET PFIZER AUSTRALIA PTY. MAL20021359A LTD., AUSTRALIA RELPAX 40MG TABLET MAL20021360A RELPAX 80MG TABLET MAL20021361A COMTAN TABLET 200MG ORION CORP, FINLAND MAL19992996A BARACLUDE TABLET 0.5 MG BRISTOL-MYERS SQUIBB MAL20061502AR COMPANY, UNITED STATES MYONAL TABLET 50MG MISATO PLANT OF EISAI MAL19940448A CO, JAPAN NEXIUM 20MG TABLET ASTRAZENECA AB, MAL20020238AR SWEDEN NEXIUM 40MG TABLET MAL20020239AR PROGYNOVA 1MG TABLET DELPHARM LILLE S.A.S., MAL09020971AC FRANCE PROGYNOVA TABLET 2MG MAL09020972AC ESTRACYT CAPSULE 140MG PFIZER ITALIA S.R.L., MAL19990993A ITALY ARCOXIA 60MG TABLET MERCK & CO INC, MAL20034170AR UNITED STATES ARCOXIA 90MG TABLET MAL20034179AR ARCOXIA 120MG TABLET MAL20034182AR AROMASIN TABLET 25MG PFIZER ITALIA S.R.L., MAL08111847A ITALY AROMASIN 25MG TABLETS MAL20013341A

LIST OF COMPARATOR PRODUCTS FOR BIOEQUIVALENCE STUDIES (JUNE 2013) TEST PRODUCTS (Pharmaceutical name) Ezetimibe Comparator Products Trade Mark/Registration No./ Reference No. EZETROL 10MG MAL20034627AR FAMVIR TILTAB TABLET 250MG MAL19950237A PEPCIDINE 20MG TABLET MAL19900506A Manufacturer SCHERING PLOUGH PRODUCTS, UNITED STATES NOVARTIS FARMACEUTICA S.A., SPAIN MERCK SHARP & DOHME (AUSTRALIA) PTY LTD, AUSTRALIA RECIPHARM FONTAINE, FRANCE

Bil. 96.

97.

Famciclovir

98.

Famotidine

99.

Fenofibrate

100. Fexofenadine hydrochloride

101. Finasteride

102. Flavoxate

103. Flecainide

LIPANTHYL SUPRA 160MGFILMCOATED TABLET MAL20020488A LIPANTHYL PENTA 145 FILM COATED TABLET MAL10053648A LIPANTHYL MICRO CAPSULE LABS FOURNIER SA, MAL19983968A FRANCE LIPANTHYL MICRO 267 CAPSULE MAL20014486A Product is available in Indonesia, Philippines, Singapore, Switzerland, Thailand & Vietnam (Information obtained via an email from Abbott Malaysia dated 12 April 2013) TELFAST 30MG TABLET AVENTIS PHARMA INC, MAL20031923A UNITED STATES TELFAST 60MG TABLET MAL20051395AR TELFAST 120MG HOECHST MARION MAL20000714A ROUSSEL INC, UNITED STATES TELFAST 180MG TABLET SANOFI-AVENTIS U.S. MAL20000715A LLC, UNITED STATES PROPECIA TABLET MERCK SHARP & DOHME MAL19992040AR QUIMICA DE PUERTO PROSCAR 5MG TABLET RICO LTD, UNITED MAL19985910AR STATES URISPAS 200 TABLET RECORDATI INDUSTRIA MAL20033669A CHIMICA E FARMACEUTICA S.P.A., ITALY TAMBOCOR TABLET 100MG 3M HEALTHCARE LTD, MAL19871528AR UNITED KINGDOM

LIST OF COMPARATOR PRODUCTS FOR BIOEQUIVALENCE STUDIES (JUNE 2013) TEST PRODUCTS (Pharmaceutical name) Comparator Products Trade Mark/Registration No./ Reference No. STAPHLEX 250 CAPSULE MAL19940106A STAPHLEX 500 CAPSULE MAL19940107A FLUDARA 10MG FILM COATED TABLETS MAL05051075AC FLORINEF 0.1MG TABLET MAL19990027A SIBELIUM CAPSULE 5MG MAL19880179AR SIBELIUM TABLET 5 MG MAL09100238A HALOTESTIN TABLETS 5MG (BELGIUM) MAL19920022A FLUANXOL TABLET 0.5MG MAL19890543A FLUANXOL TABLETS 3MG MAL19980544A FLUANXOL TABLETS 1MG MAL19900451A DALMADORM 15MG CAPSULES MAL07050892AC FROBEN TABLET 50MG MAL19861117A MONOPRIL TABLET 10MG MAL19992695AS MONOPRIL TABLET 10MG MAL19950242A MONOPRIL TABLET 20MG MAL19950243A NEURONTIN 100MG CAPSULE MAL06071076A NEURONTIN 300MG CAPSULE MAL19984786AS NEURONTIN 400MG CAPSULE MAL19984785AS NEURONTIN 300MG CAPSULE MAL19962169A NEURONTIN 400MG CAPSULE Manufacturer PACIFIC PHARM LTD, NEW ZEALAND PACIFIC PHARM LTD, NEW ZEALAND BAYER SCHERING PHARMA AG, GERMANY BRISTOL-MYERS SQUIBB PTY LTD, AUSTRALIA JANSSEN-CILAG S.P.A., ITALY

Bil.

104. Flucloxacillin

105. Fludarabine

106. Fludrocortisone acetate 107. Flunarizine hydrochloride

108. Fluoxymesterone

PHARMACIA & UPJOHN S.A., BELGIUM H.LUNDBECK A/S, DENMARK

109. Flupentixol dihydrochloride

110. Flurazepam Monohydrochloride 111. Flurbiprofen 112. Fosinopril sodium

LABIANA PHARMACEUTICALS SL, SPAIN THE BOOTS COMPANY PLC, UNITED KINGDOM PT BRISTOL-MYERS SQUIBB INDONESIA TBK BRISTOL-MYERS SQUIBB PTY LTD, AUSTRALIA

113. Gabapentin

PFIZER MANUFACTURING DEUTSCHLAND GMBH, GERMANY

PFIZER PHARMACEUTICALS LLC, UNITED STATES

LIST OF COMPARATOR PRODUCTS FOR BIOEQUIVALENCE STUDIES (JUNE 2013) TEST PRODUCTS (Pharmaceutical name) Comparator Products Trade Mark/Registration No./ Manufacturer Reference No. MAL19962170A NEURONTIN TABLET 600MG MAL20031747A NEURONTIN TABLET 800MG MAL20031748A REMINYL TABLET 4MG JANSSEN CILAG SPA, MAL20020123A ITALY REMINYL TABLET 8MG MAL20020124A REMINYL TABLET 12MG MAL20020125A CYMEVENE CAPSULE 250MG ROCHE PRODUCTS LTD, MAL19993019AR UNITED KINGDOM CYMEVENE HARD-GELATIN SYNTEX PUERTO RICO CAPSULE 250MG INC, UNITED STATES MAL19970079A LOPID CAPSULE 300MG PARKE DAVIS PTY LTD, MAL19990998A AUSTRALIA LOPID 600MG TABLET MAL19900442AR LOPID 600MG TABLET MAL19984784AS LOPID 450MG TABLET GOEDECKE A.G, WEST MAL19921617ARS GERMANY Products are available in Argentina, Australia, Austria, Brazil, Switzerland, Chile, Germany, Denmark, Spain, France, United Kingdom, Greece, Hong Kong, Indonesia, India, Ireland, Italy, Mexico, Netherlands, Norway, Peru, Portugal, Philippines, Sweden, Thailand, Turkey, Taiwan, United States DIMETRIOSE CAPSULE MAL19940494A MINIDIAB 5MG TABLET MAL19913361A KYTRIL TABLET 1MG MAL19940574A BUSCOPAN TABLET 10MG MAL09051577A HYDREA CAPSULE 500MG, MAL19962497A HYDREA CAPSULE 500MG, MAL19993027A ROUSSEL LABS LTD, UNITED KINGDOM PFIZER ITALIA S.R.L., ITALY F.HOFFMANN-LA ROCHE LTD, SWITZERLAND DELPHARM REIMS, FRANCE BRISTOL MYERS SQUIBB US BRISTOL MYERS SQUIBB S.R.L, ITALY

Bil.

114. Galantamine hydrobromide

115. Ganciclovir

116. Gemfibrozil

117. Gestrinone 118. Glipizide 119. Granisetron hydrochloride 120. Hyoscine butylbromide 121. Hydroxycarbamide

LIST OF COMPARATOR PRODUCTS FOR BIOEQUIVALENCE STUDIES (JUNE 2013) TEST PRODUCTS (Pharmaceutical name) Comparator Products Trade Mark/Registration No./ Reference No. HYDREA CAPSULE 500MG, MAL19962497A HYDREA CAPSULE 500MG, MAL19993027A DICHLOTRIDE TABLET 25MG, MAL19870271AR DICHLOTRIDE TABLET 50MG, MAL19870201AR DICHLOTRIDE 25MG TABLET, MAL19940018AS DICHLOTRIDE 50MG TABLET, MAL19940019AS CORTEF TABLET 10MG Manufacturer BRISTOL MYERS SQUIBB US BRISTOL MYERS SQUIBB S.R.L, ITALY MERCK SHARP & DOHME UNITED KINGDOM

Bil.

122. Hydroxyurea/ Hydroxycarbamide

123. Hydrochlorothiazide

124. Hydrocortisone

125. Ibandronic acid

126. Imatinib mesylate

127. Imidapril hydrochloride

128. Indapamide

MERCK SHARP & DOHME (AUSTRALIA) PTY LTD, AUSTRALIA CATALENT PHILADELPHIA Product is available in Bosnia, Canada, Georgia, Croatia, Hungary, Poland, Russia, Saudi Arabia, Thailand, Tunisia, United States. (Information obtained from Pfizer via a letter dated 25/1/2013) BONDRONAT FILM-COATED F.HOFFMANN-LA ROCHE TABLET 50 MG LTD, SWITZERLAND MAL20071698A BONVIVA FILM-COATED TABLETS 150 MG MAL20071629A GLIVEC 50MG CAPSULES NOVARTIS PHARMA MAL20020355A STEIN AG, SWITZERLAND GLIVEC 100MG CAPSULES MAL20020356A GLIVEC TABLET 100MG MAL06011679A GLIVEC TABLET 400MG MAL06011681A TANATRIL 2.5MG TABLET PT TANABE INDONESIA, MAL20034616A INDONESIA TANATRIL 5MG TABLET MAL20034617A TANATRIL 10MG TABLET MAL20034618A NATRILIX TABLET LES LABS SERVIER MAL19972491A INDUSTRIE, FRANCE NATRILIX TABLET 0.0025G MAL19870270AR Product is available in Australia, Bangladesh, China, India, Pakistan, France and United Kingdom (Information obtained from Servier (M) Sdn. Bhd on 4th April 2013)

LIST OF COMPARATOR PRODUCTS FOR BIOEQUIVALENCE STUDIES (JUNE 2013) TEST PRODUCTS (Pharmaceutical name) Comparator Products Trade Mark/Registration No./ Manufacturer Reference No. INDOCID CAPSULE 25MG MERCK SHARP & DOHME MAL19930412AS (AUSTRALIA) PTY LTD INDOCID CAPSULE 25MG MERCK SHARP & DOHME MAL19861080A INT, UNITED STATES As agreed upon in Mesyuarat Jawatankuasa Kerja Bioekuivalens Kebangsaan 1/2013 13 March 2013, the above products can be obtained from Aspen Pharmacare Australia and manufactured by Aspen Pharmacare South Africa. ISORDIL ORAL TABLET 10MG MAL19871489A ISORDIL SUBLINGUAL TABLET 5MG PBKD871488A ROACCUTANE ROCHE CAPSULE 20MG PBKD861795A ROACCUTANE ROCHE CAPSULE 10MG PBKD861794A ROACCUTANE CAPSULE 20MG MAL19991721AC ROACCUTANE CAPSULE 10MG MAL19991720A TORADOL 10 MG FILM-COATED TABLET MAL19973601A ZADITEN 1MG TABLET MAL20000272A TRANDATE TABLET 100MG, MAL19870059A WYETH CANADA WYETH CANADA

Bil.

129. Indomethacin

130. Isosorbide Dinitrate

131. Isotretinoin

F. HOFFMAN-LA ROCHE, SWITZERLAND F. HOFFMAN-LA ROCHE, SWITZERLAND R. P. SCHERER GMBH, GERMANY

132. Ketorolac Tromethamine 133. Ketotifen fumarate 134. Labetalol

ROCHE FARMA S.A, SPAIN

135. Lansoprazole

NOVARTIS PHARM UK LTD, UNITED KINGDOM GLAXOSMITHKLINE AUSTRALIA PTY LTD, AUSTRALIA PREVACID 30MG CAPSULE TAKEDA MAL19961284AR PHARMACEUTICAL COMPANY LIMITED, JAPAN This product is available in Anguilla, Aruba, Austria, Bahamas, Bahrain, Barbados, Belgium, Benin, Bermuda Botswana, Burkina Faso, Cambodia, Cameroon, Canada ,Cayman Islands, Chad,China, Colombia, Congo, Costa Rica, Cote D'ivoire, Curacao, Dominican Republic Ecuador, Egypt, El Salvador, France, Gabon, Germany, Greece, Grenada, Guatemala, Guinea, Haiti, Honduras, Hungary, Iraq,

LIST OF COMPARATOR PRODUCTS FOR BIOEQUIVALENCE STUDIES (JUNE 2013) TEST PRODUCTS (Pharmaceutical name) Comparator Products Trade Mark/Registration No./ Manufacturer Reference No. Italy, Ivory Coast, Jamaica Japan, Jordan, Jordan, Korea, Republic Of [Kr] [South Korea], Kuwait, Lebanon Libyan Arab Jamahiriya, Luxembour, Madagascar, Mali, Mauritania, Mexico, Morocco, Myanmar, Namibia, Netherland, Nicaragua, Niger, Oman, Pakistan , Panama, Peru, Philippines, Portugal, Qatar, Saint Lucia, Saudi Arabia, Senegal Singapore, South Africa, Spain, Switzerland, Syrian Arab Republic, Taiwan, Province Of China, Thailand, Togo,Trinidad And Tobago, Tunisia, Turkey, United Arab Emirates, United Kingdom, United States, Venezuela, Yemen (information obtained from Invida dated 25th February 2013) ARAVA 10MG TABLET SANOFI WINTHROP MAL20001528A INDUSTRIE, FRANCE ARAVA 20MG TABLET MAL20001527A ARAVA TABLET 100MG MAL20001529A ERGAMISOL TABLET 50MG JANSSEN MAL19990537A PHARMACEUTICA N.V., BELGIUM KEPPRA 250MG FILM COATED UCB S.A. SECTOR TABLET PHARMA, BELGIUM MAL20031725A KEPPRA 500MG FILM COATED TABLET MAL20031726A KEPPRA 1000MG FILM COATED TABLET MAL20031727A XYZAL 5MG FILM COATED UCB FARCHIM S.A., TABLET SWITZERLAND MAL20051323AR POSTINOR-2 TABLET 0.75MG GEDEON RICHTER PLC, MAL19872263AR HUNGARY OROXINE 100MCG TABLET ASPEN BAD OLDESLOE MAL06071058A GMBH, GERMANY OROXINE 50MCG TABLET MAL06071059A ZYVOX 400MG TABLETS PFIZER MAL20020873AR PHARMACEUTICALS LLC, ZYVOX 600MG TABLETS PUERTO RICO MAL20020874AR

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136. Leflunomide

137. Levamisole hydrochloride 138. Levetiracetam

139. Levocetirizine dihydrochloride 140. Levonorgestrel 141. Levothyroxine sodium

142. Linezolid

LIST OF COMPARATOR PRODUCTS FOR BIOEQUIVALENCE STUDIES (JUNE 2013) TEST PRODUCTS (Pharmaceutical name) Comparator Products Trade Mark/Registration No./ Manufacturer Reference No. MAXAQUIN 400MG TABLET SEARLE DE MEXICO, MAL19940539A MEXICO MAXAQUIN 400MG TABLET MONSANTO FRANCE SA, MAL19940540AS FRANCE CEENU CAPSULE 40MG BRISTOL-MYERS SQUIBB MAL19991719A S.R.L., ITALY IMODIUM CAPSULE 2MG JANSSEN CILAG, FRANCE MAL19871473AR DUSPATALIN TABLET 100MG ABBOTT BIOLOGICALS MAL19920644A B.V., NETHERLAND DUSPATALIN TABLET 135MG ABBOTT HEALTHCARE MAL19940428A SAS, FRANCE As agreed upon in Mesyuarat Jawatankuasa Kerja Bioekuivalens Kebangsaan 2/2012 26 Disember 2012, the following requirement to be submitted in place of bioequivalence report :i) ii) Validation process report for 3 consecutive batches Comparative dissolution profile for 3 consecutive batches (time points : 0, 5, 15, 30 & 45 minutes ) PFIZER ITALIA S.R.L., ITALY

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143. Lomefloxacin hydrochloride

144. Lomustine 145. Loperamide 146. Mebeverine

147. Meclozine

148. Medroxyprogesteron e acetate

FARLUTAL TABLET 100MG MAL19991379A FARLUTAL TABLET 500MG MAL19991380A PROVERA TABLET 5MG MAL19872113A

PHARMACIA & UPJOHN CO, UNITED STATES

149. Mefenamic acid

150. Mefloquine hydrochloride 151. Megestrol acetate

PROVERA 10MG TABLET PFIZER MAL20000997A PHARMACEUTICAL LLC, PROVERA 5MG TABLET PUERTO RICO MAL06051306A PONSTAN TABLET 500MG PT PFIZER (INDONESIA) MAL19990598AS PONSTAN CAPSULES PFIZER PHARM LTD, MAL19985093A CHINA This product can be obtained from Hong Kong and New Zealand (Information obtained via an email dated 7th September 2012 from Pfizer, Malaysia) LARIAM TABLET 250MG F.HOFFMAN-LA ROCHE, MAL19921123A SWITZERLAND MEGACE TABLET 160MG BRISTOL-MYERS SQUIBB MAL19962089A AUSTRALIA PTY LTD, AUSTRALIA

LIST OF COMPARATOR PRODUCTS FOR BIOEQUIVALENCE STUDIES (JUNE 2013) TEST PRODUCTS (Pharmaceutical name) Comparator Products Trade Mark/Registration No./ Reference No. MEGACE TABLET 40MG MAL19962090A ALKERAN TABLETS 2MG MAL07101257AC EBIXA FILM-COATEDTABLET 10MG MAL20061488ACR EBIXA FILM-COATED TABLET 20 MG MAL10120014ACR PRIMALAN TABLET 5MG MAL19871736A PURI-NETHOL TABLET 50MG MAL19861668A PROVIRONUM TABLET 25MG MAL09122025AC Manufacturer HAUPT PHARMA REGENSBURG GMBH, GERMANY EXCELLA GMBH, GERMANY ROTTENDORF PHARMA GMBH, GERMANY

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152. Melphalan 153. Memantine hydrochloride

154. Mequitazine 155. Mercaptopurine

156. Mesterolone

157. Methimazole 158. Methoxsalen

159. Methyldopa

TAPAZOLE (T-1765) TABLET 5MG 1986042151A OXSORALEN-ULTRA CAPSULES 10MG MAL19920052A MELADININE TABLET 10MG LABOBORATOIRES MAL05090015AC MACORS, FRANCE ALDOMET-M 125MG TABLET MERCK SHARP & DOHME MAL19920191A (AUSTRALIA) PTY LTD, ALDOMET 250MG TABLET AUSTRALIA (AUSTRALIA) MAL19920190A As agreed upon in Mesyuarat Jawatankuasa Kerja Bioekuivalens Kebangsaan 1/2013 13 March 2013, the above products can be obtained from Aspen Pharmacare Australia and manufactured by Aspen Pharmacare South Africa. RITALIN TABLET 10MG MAL19910002A MEDROL TABLET 4MG MAL19990558A NOVARTIS FARMACEUTICA S.A., SPAIN PHARMACIA & UPJOHN CO, UNITED STATES

MAY & BAKER LTD, UNITED KINGDOM THE WELLCOME FOUNDATION LTD, UNITED KINGDOM SCHERING DA BRASIL QUIMICAE FARMACEUTICA LTDA., BRAZIL ELI LILLY &C0 (TAIWAN) INC, TAIWAN ICN PHARM INC, UNITED STATES

160. Methylphenidate hydrochloride 161. Methylprednisolone

LIST OF COMPARATOR PRODUCTS FOR BIOEQUIVALENCE STUDIES (JUNE 2013) TEST PRODUCTS (Pharmaceutical name) Comparator Products Trade Mark/Registration No./ Manufacturer Reference No. MEDROL TABLET 16MG MAL19990559A MAXOLON TABLET 10MG BEECHAM PHARM, MAL19921400A UNITED KINGDOM This product can be obtained from South Africa and Pakistan. (Information obtained via email dated 26th Sept 2012 from GSK, Malaysia) TOLVON TABLET 10MG N.V. ORGANON, MAL19900637A NETHERLANDS TOLVON TABLET 30MG MAL19900638A TOLVON TABLET 60MG MAL19900639A DORMICUM ROCHE TABLET 7.5 PRODUCTOS ROCHE MG MEXICO MAL19890299A DORMICUM FILM-COATED F.HOFFMAN-LA ROCHE, TABLET 15MG SWITZERLAND MAL19920037A DIASTABOL 50MG BAYER AG, GERMANY MAL19990973A DIASTABOL 100MG MAL19990974A IXEL 25MG HARD CAPSULES PIERRE FABRE MAL20061611A MEDICAMENT IXEL 50MG HARD CAPSULES PRODUCTION, FRANCE MAL20061612A LONITEN 5MG TABLETS GLOBAL PHARM LTD, MAL20014500AR CANADA LONITEN 10MG TABLETS MAL20014501AR LONITEN TABLET 5MG UPJOHN LTD, UNITED MAL19861624A KINGDOM LONITEN TABLET 10MG MAL19861623A This product can be obtained from Australia, Brazil, Canada, France, Germany, Ireland, Italy, Netherlands, New Zealand, South Africa, Spain, Switzerland, Taiwan & United Kingdom (Information obtained via email dated 3rd May 2013 from Zeullig Pharma Sdn. Bhd., Malaysia) CYTOTEC TABLET 200MCG PIRAMAL HEALTHCARE MAL19890225AR UK LIMITED, UNITED

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162. Metoclopramide hydrochloride

163. Mianserin hydrochloride

164. Midazolam

165. Miglitol

166. Milnacipran hydrochloride

167. Minoxidil

168. Misoprostol

LIST OF COMPARATOR PRODUCTS FOR BIOEQUIVALENCE STUDIES (JUNE 2013) TEST PRODUCTS (Pharmaceutical name) Comparator Products Trade Mark/Registration No./ Reference No. MIZOLLEN TABLET 10MG MAL20001215A AURORIX FILM-COATED TABLET 150MG MAL19910811A AURORIX FILM-COATED TABLET 300MG MAL19987972A SINGULAIR TABLET 10MG MAL19990957AR KAPANOL CAPSULES 20MG MAL19984000AR KAPANOL CAPSULES 50MG MAL19984001AR KAPANOL CAPSULES 100MG MAL19984002AR AVELOX TABLET MAL20012664A PHYSIOTENS 0.2MG TABLET MAL20033335AR PHYSIOTENS 0.3MG TABLET MAL20033336AR PHYSIOTENS 0.4MG TABLET MAL20033337AR REVIA TABLET 50MG MAL20013367A Manufacturer KINGDOM SANOFI WINTHROP INDUSTRIE, FRANCE F.HOFFMANN-LA ROCHE LTD, SWITZERLAND

Bil.

169. Mizolastin 170. Moclobemide

171. Montelukast sodium 172. Morphine sulphate

MERCK SHARP & DOHME LTD, UNITED KINGDOM F.H. FAULDING & CO LTD, AUSTRALIA

173. Moxifloxacin hydrochloride 174. Moxonidine

BAYER SCHERING PHARMA AG, LEVERKUSEN, GERMANY ABBOTT HEALTHCARE SAS, FRANCE

175. Naltrexone hydrochloride 176. Nateglinide

STARLIX 60MG TABLET MAL20014476A STARLIX 120MG TABLET MAL20014477A 177. Nebivolol NEBILET TABLET MAL20041163A 178. Neostigmine bromide PROSTIGMIN ROCHE TABLET 15MG MAL19871818A 179. Nimodipine NIMOTOP TABLET 30MG MAL19940001A

DUPONT PHARM COMPANY, UNITED STATES NOVARTIS FARMA S.P.A., ITALY

BERLIN-CHEMIE AG, GERMANY ROCHE PRODUCTS LTD, UNITED KINGDOM BAYER SCHERING PHARMA AG, LEVERKUSEN, GERMANY

LIST OF COMPARATOR PRODUCTS FOR BIOEQUIVALENCE STUDIES (JUNE 2013) TEST PRODUCTS (Pharmaceutical name) Comparator Products Trade Mark/Registration No./ Manufacturer Reference No. SYSCOR CC 10MG TABLET BAYER AG, WEST MAL20000264AC GERMANY SYSCOR CC TABLET 20MG MAL20000265AC SYSCOR CC TABLET 30MG MAL20000266AC SYSCOR CC TABLET 40MG MAL20000267AC PU 3144 AXID CAPSULE 150MG LILLY S.A., SPAIN MAL19950508AC PRIMOLUT-N TABLET 5MG ZUELLIG PHARMA SDN MAL19900564A BHD POSTINOR-2 TABLET 0.75MG, GEDEON RICHTER PLC, MAL19872263AR HUNGARY MYCOSTATIN ORAL TABLET BRISTOL-MYERS SQUIBB 500000 IU PTY LTD, AUSTRALIA MAL19921327A This product can be obtained from Mexico. (Information obtained via email dated 13th December 2012 from Bristol Myers Squibb, Asia Pacific) As agreed upon JKKBE 1/2013 Meeting dated 13th Mac 2013, bioequivalence study can be waived. However, in-vitro comparative dissolution profile study between the test and reference product need to be performed and proved similarity. 185. Ondansetron hydrochloride dihydrate ZOFRAN TABLET 4MG MAL19950007ACR ZOFRAN TABLET 8MG MAL19950013ACR 186. Orlistat XENICAL CAPSULE 120MG MAL19992994A XENICAL CAPSULE 120 MG MAL05032548A 187. Orphenadrine citrate NORFLEX TABLET 100MG MAL19861502A ASPEN BAD OLDESLOE GMBH, GERMANY

Bil.

180. Nisoldipine

181. Nizatidine 182. Norethisterone 183. Norgestrel 184. Nystatin

F.HOFFMANN,LA ROCHE LTD, SWITZERLAND ROCHE S.P.A., ITALY

188. Oxcarbazepine

INOVA PHARMACEUTICALS (AUSTRALIA) PTY LTD, AUSTRALIA TRILEPTAL 600MG TABLETS NOVARTIS PHARMA MAL20021156A STEIN AG, SWITZERLAND TRILEPTAL 600 MG FILM-COATED NOVARTIS FARMA S.P.A., TABLET ITALY

LIST OF COMPARATOR PRODUCTS FOR BIOEQUIVALENCE STUDIES (JUNE 2013) TEST PRODUCTS (Pharmaceutical name) Comparator Products Trade Mark/Registration No./ Reference No. MAL07050038AS DRIPTANE TABLET 5MG MAL19991351AR OXYNORM 5MG CAPSULES MAL10070560AC OXYNORM 10MG CAPSULES MAL10070561AC OXYNORM 20MG CAPSULES MAL10070562AC ANAPOLON 50 TABLET MAL19870679A ANAPOLON 50 TABLET MAL19870678A CONTROLOC 20MG TABLET MAL20032151A CONTROLOC 40MG TABLET MAL19972093AR ZEMPLAR CAPSULES 1 MCG MAL20071708AC ZEMPLAR CAPSULES 2 MCG MAL20071709AC ZEMPLAR CAPSULES 4 MCG MAL20071710AC ARTAMIN CAPSULE 250MG MAL20021153AC TRENTAL 400 TABLET MAL19990996A GARDENAL TABLET 30MG MAL19871467A DUROMINE CAPSULE 15MG MAL19871769AR Manufacturer LABS FOURNIER SA, FRANCE BARD PHARMACEUTICALS LIMITED, UNITED KINGDOM

Bil.

189. Oxybutynin hydrochloride 190. Oxycodone hydrochloride

191. Oxymetholone

192. Pantoprazole

SYNTEX INCORPORATED, CANADA SYNTEX PHARM LTD, UNITED KINGDOM NYCOMED GMBH, GERMANY

193. Paricalcitol

CATALENT PHARMA SOLUTIONS, LLC, UNITED STATES

194. Penicillamine 195. Pentoxifylline 196. Phenobarbitone 197. Phentermine

DUROMINE CAPSULE 30MG MAL19871774AR

HAUPT PHARMA BERLIN GMBH, GERMANY SANOFI-AVENTIS DE MEXICO SA DE CV MAY & BAKER (INDIA) LTD, INDIA INOVA PHARMACEUTICALS (AUSTRALIA) PTY LTD, AUSTRALIA INOVA PHARMACEUTICALS (AUSTRALIA) PTY LTD, AUSTRALIA

As agreed upon in Mesyuarat Jawatankuasa Kerja Bioekuivalens Kebangsaan 1/2013- 13 March 2013 :

LIST OF COMPARATOR PRODUCTS FOR BIOEQUIVALENCE STUDIES (JUNE 2013) TEST PRODUCTS (Pharmaceutical name) Comparator Products Trade Mark/Registration No./ Reference No. i) Phentermine remain in BE list requirement. Manufacturer

Bil.

ii) For Generic immediate release, oral solid dosage form product which follows USP specification and bioequivalence study is not conducted, the label need to state Not Interchangeable with Duromine and other brand of product Containing Phentermine Resin. iii) For Generic immediate release, oral solid dosage form product which does not follow USP specification and bioequivalence study is also not conducted, the label need to include statement no. (ii). iv) For Generic immediate release, oral solid dosage form product which performed BE study and found bioequivalent with Innovator product (Duromine), there is no requirement to include the statement no. (ii). 198. Phthalylsulphathiazo le 199. Pindolol THALAZOLE TABLET 500MG VISKEN TABLET 5MG PBKD870587A VISKEN TABLET 10MG PBKD870074A ACTOS 15MG TABLET MAL20051432AR ACTOS 30MG TABLET MAL20051431AR ACTOS 15MG TABLETS MAL11100026ACR 201. Pipemidic acid URIXIN FILMTAB TABLET MAL19910050A URIXIN FILMTAB 400MG MAL19871869A NOOTROPIL TABLET 800 MG MAL07021408A NOOTROPIL TABLET 1200 MG MAL07021409A SANDOMIGRAN TABLET 0.5MG MAL19860378A PRAVACHOL TABLET 10MG MAY & BAKER LTD, UNITED KINGDOM NOVARTIS PHARMA AG, SWITZERLAND

200. Pioglitazone

TAKEDA PHARMACEUTICAL LTD., JAPAN TAKEDA PHARMACEUTICAL LTD., JAPAN DAITO PHARMACEUTICAL TOYOMA, JAPAN ABBOTT LABS, PHILIPPINES

202. Piracetam

UCB S.A. - SECTEUR PHARMA, BELGIUM

203. Pizotifen malate 204. Pravastatin sodium

NOVARTIS FARMA S.P.A., ITALY BRISTOL-MYERS SQUIBB

LIST OF COMPARATOR PRODUCTS FOR BIOEQUIVALENCE STUDIES (JUNE 2013) TEST PRODUCTS (Pharmaceutical name) Comparator Products Trade Mark/Registration No./ Reference No. MAL20032161A PRAVACHOL TABLET 40MG MAL19991374A Manufacturer PTY LTD, AUSTRALIA

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This products can be obtained from Canada, France, Germany, Ireland and United Kingdom (Information obtained from Bristol Myers Squibb Asia Pacific via an email dated 27th March 2013) 205. Prazosin MINIPRESS TABLET 1MG MAL19870096A MINIPRESS TABLET 2MG MAL19870098A MINIPRESS TABLET 5MG MAL19870100A MINIPRESS TABLET 1MG MAL19930148AC MINIPRESS TABLET 2MG MAL19930149AC MINIPRESS TABLET 5MG MAL19930150AC PRIMAQUINE TABLET MAL19911192X PFIZER AUSTRALIA PTY. LTD.

PHARMANIAGA MANUFACTURING BERHAD

206. Primaquine phosphate 207. Primidone 208. Probenecid 209. Procaterol hydrochloride 210. Prochlorperazine maleate

211. Progesterone

212. Proguanil hydrochloride

ASTRAZENECA UK LIMITED, UNITED KINGDOM MYSOLINE 250MG TABLETS UNITED KINGDOM BENEMID TABLET 0.5G MERCK SHARP & DOHME MAL19870994A INT, UNITED STATES MEPTIN TABLET 0.05MG OTSUKA MAL19890453AC PHARMACEUTICAL CO., LTD, JAPAN STEMETIL TABLET 5MG MAY & BAKER LTD, MAL19861398A UNITED KINGDOM This product can be obtained from Bangladesh, Denmark, Hong Kong, Jamaica, Malta, Mauritius, Namibia, Pakistan, Thailand, Ireland, South Africa and United Kingdom. (Information obtained via an email dated 21st Sept 2012 from Sanofi Aventis Malaysia) UTROGESTAN CAPSULE 100MG BESINS MAL19971796A MANUFACTURING BELGIUM, BELGIUM PALUDRINE TABLETS 100MG ASTRAZENECA UK PBKD911193A LIMITED, UNITED KINGDOM

LIST OF COMPARATOR PRODUCTS FOR BIOEQUIVALENCE STUDIES (JUNE 2013) TEST PRODUCTS (Pharmaceutical name) Comparator Products Trade Mark/Registration No./ Reference No. PHENERGAN TABLET 10MG PHENERGAN TABLET 25MG RYTMONORM TABLET 150MG MAL19880156A PRO-BANTHINE TABLET 15MG PBKD861516A PRO-BANTHINE TABLET 15MG PBKD861515A MICTONORM TABLET MAL20061584A Manufacturer

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213. Promethazine 214. Propafenone 215. Propantheline

216. Propiverine

217. Propylthiouracil 218. Pseudoephedrine

SANOFI AVENTIS, UNITED KINGDOM ABBOT GMBH & CO. KG, GERMANY SEARLE LABS, AUSTRALIA. G.D. SEARLE & CO, UNITED KINGDOM APOGEPHA ARZNEIMITTEL GMBH, GERMANY PROPYLTHIOURACIL TABLET EVANS MEDICAL LTD, B.P. 50MG UNITED KINGDOM SUDAFED TABLET 60MG, WELLCOME AUSTRALIA MAL19870799A LTD, AUSTRALIA As agreed upon in Mesyuarat Jawatankuasa Kerja Bioekuivalens Kebangsaan 1/2013 13 March 2013: Sudafed Tablet 60mg from different manufacturer (registered in other country) can also be used as a comparator. MESTINON TABLET 10MG MAL05090001ACR MESTINON DRAGEES 60MG MAL04112698ACR NOVONORM TABLET 0.5MG MAL20001007AC NOVONORM TABLET 1.0MG MAL20001008AC NOVONORM TABLET 2.0MG MAL20001009AC SERPASIL TABLET 0.10MG 1986044940A SERPASIL TABLET 0.25MG 1986044921A REBETOL CAPSULES 200MG MAL20001524A COPEGUS FILM-COATED TABLET 200MG MAL05012334A COPEGUS FILM COATED TABLET 200MG LABIANA PHARMACEUTICALS, SL, SPAIN BOEHRINGER INGELHEIM PHARMA KG, WEST GERMANY BOEHRINGER INGELHEIM PHARMA GMBH & CO.KG, WEST GERMANY NOVARTIS PHARMA STEIN AG, SWITZERLAND

219. Pyridostigmine bromide

220. Repaglinide

221. Reserpine

222. Ribavirin

SCHERING-PLOUGH LABO N.V., BELGIUM HOFFMANN-LA ROCHE INC, UNITED STATES PATHEON INC, CANADA

LIST OF COMPARATOR PRODUCTS FOR BIOEQUIVALENCE STUDIES (JUNE 2013) TEST PRODUCTS (Pharmaceutical name) Comparator Products Trade Mark/Registration No./ Reference No. MAL08051760ACS MYCOBUTIN 150MG CAPSULES MAL19960957A RILUTEK TABLETS 50MG MAL20051294A ACTONEL FILM-COATED TABLET 5MG MAL20012657AR ACTONEL 30MG TABLET MAL20012656AR ACTONEL 35MG TABLET MAL20034605AR Manufacturer

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223. Rifabutin 224. Riluzole 225. Risedronate sodium

PFIZER ITALIA S.R.L. SANOFI WINTHROP INDUSTRIE, FRANCE OSG NORWICH PHARM INC, UNITED STATES

226. Rivastigmine hydrogen tartrate

227.

228.

229.

230.

EXELON 1.5MG CAPSULES MAL19990976A EXELON 3MG CAPSULES MAL19990977A EXELON 4.5MG CAPSULES MAL19990978A EXELON 6MG CAPSULES MAL19990979A Rizatriptan benzoate MAXALT TABLET 5MG MAL20000249AR MAXALT TABLET 10MG MAL20000250AR REQUIP TABLET 0.25MG Ropinirole MAL19990966A hydrochloride REQUIP TABLET 1MG MAL19990967A REQUIP TABLET 2MG MAL19990968A REQUIP TABLET 5MG MAL19990969A AVANDIA TABLET 2MG Rosiglitazone MAL20000007A AVANDIA TABLET 4MG MAL20000008A AVANDIA TABLET 8MG MAL20000009A Rosuvastatin calcium CRESTOR 10MG TABLET MAL20041089AR

NORWICH PHARMACEUTICALS INC., UNITED STATES NOVARTIS FARMACEUTICA S.A., SPAIN

MERCK SHARP & DOHME LTD, UNITED KINGDOM

SMITHKLINE BEECHAM PHARM, UNITED KINGDOM

GLAXO WELLCOME S.A., SPAIN

IPR PHARMACEUTICALS INC, PUERTO RICO

LIST OF COMPARATOR PRODUCTS FOR BIOEQUIVALENCE STUDIES (JUNE 2013) TEST PRODUCTS (Pharmaceutical name) Comparator Products Trade Mark/Registration No./ Reference No. CRESTOR 20MG TABLET MAL20051357AR JUMEX TABLET 5MG MAL19950723A Manufacturer

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231. Selegiline

232. Sevelamer Carbonate

233. Sildenafil citrate

234. Sodium Iodide

235. Sodium fusidate

236. Sodium rabeprazole

237. Sorafenib tosylate

238. Sotalol hydrochloride

RENVELA (SEVELAMER CARBONATE) TABLETS MAL20102007A As agreed upon Mesyuarat Dasar Regulatori 1/2013 dated 20th Mac 2013, bioequivalence study is not required. However, the following are the studies that need to perform in order to support interchangeability between the test and comparator product:1. In-Vitro Equilibrium Binding Study 2. In-Vitro Kinetic Binding Study VIAGRA 25MG TABLET PFIZER INC, UNITED MAL19990542A STATES VIAGRA 50MG TABLET MAL19990543A VIAGRA 100MG TABLET MAL19990544A VIAGRA 25MG TABLET PFIZER AUSTRALIA PTY. MAL20012709AS LTD., AUSTRALIA VIAGRA 50MG TABLET MAL20012710AS VIAGRA 100MG TABLET MAL20012711AS SODIUM IODIDE (1311) THERAPY GE HEALTHCARE CAPSU* LIMITED, UNITED MAL19930360A KINGDOM FUCIDIN TABLET 250MG (FILM LEO PHARM PRODUCTS, COATED) DENMARK MAL19910821A PARIET TABLET 10MG EISAI CO LTD, JAPAN MAL19992540A PARIET TABLET 20MG MAL19992541A NEXAVAR FILM-COATED BAYER SCHERING TABLETS 200 MG PHARMA AG, MAL20071668A LEVERKUSEN, GERMANY SOTACOR TABLET 80MG BRISTOL-MYERS CO LTD, MAL19930231A UNITED KINGDOM

CHINOIN PHARMACEUTICAL AND CHEMICAL WORKS PVT. CO. LTD., HUNGARY GENZYME IRELAND LIMITED, IRELAND

LIST OF COMPARATOR PRODUCTS FOR BIOEQUIVALENCE STUDIES (JUNE 2013) TEST PRODUCTS (Pharmaceutical name) Comparator Products Trade Mark/Registration No./ Manufacturer Reference No. SOTACOR TABLET 160MG MAL19930232A SOTACOR TABLET 80MG BRISTOL-MYERS SQUIBB MAL19940601AS PTY LTD, AUSTRALIA SOTACOR TABLET 160MG MAL19940602AS ROVAMYCINE TABLET 1.5 FAMAR LYON, FRANCE MILLION IU MAL19890558A ROVAMYCINE 3 M.I.U. TABLETS MAL19962132A ALDACTONE TABLET 100MG SEARLE LABS, MAL19870236A AUSTRALIA This product is available in Argentina, Aruba, Australia, Bahamas, Bahrain, Barbados, Belgium, Belize, Bermuda, Brazil, Cambodia, Canada, Colombia, France, Ghana, Greece, Hong Kong, Iceland, Ireland, Israel, Jamaica, Japan, Kenya, Kuwait, Lebanon, , Korea, Mexico, Myanmar, Nigeria, Norway, Oman, Phillipines, Qatar, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Thailand, UK, UAE, Vietnam. (Information obtained from Pfizer Malaysia dated 10th June 2013 via an email) CLINORIL 200MG TABLET MERCK SHARP & DOHME MAL19950546A (AUSTRALIA) PTY LTD, AUSTRALIA VESSEL DUE F 250 LSU CAPSULE ALFA WASSERMANN MAL19992679A S.P.A., ITALY SALAZOPYRIN EN TABLET 500MG KEMWELL AB, SWEDEN MAL19950470A UNASYN TABLET PFIZER JAPAN INC MAL19910104A UNASYN ORAL TABLET 375MG PHARMANIAGA MAL20020026ACS MANUFACTURING BERHAD IMIGRAN TABLET 50MG GLAXOSMITHKLINE MAL19973576AR PHARMACEUTICALS SA, POLAND IMIGRAN TABLET 100MG GLAXO WELLCOME MAL19950008A OPERATIONS UK LTD, UNITED KINGDOM FUTRAFUL CAPSULE 200MG TAIHO PHARM CO LTD, MAL19861648A JAPAN

Bil.

239. Spiramycin

240. Spironolactone

241. Sulindac

242. Sulodexide 243. Sulphasalazine 244. Sultamicillin tosylate

245. Sumatriptan succinate

246. Tegafur

LIST OF COMPARATOR PRODUCTS FOR BIOEQUIVALENCE STUDIES (JUNE 2013) TEST PRODUCTS (Pharmaceutical name) Comparator Products Trade Mark/Registration No./ Reference No. MICARDIS TABLET 20MG MAL20014487A MICARDIS TABLET 40MG MAL19992673A MICARDIS TABLET 80MG MAL19992674A TEMODAL CAPSULES 5MG MAL07082878ACR TEMODAL CAPSULES 5 MG MAL06071048ACRS TEMODAL CAPSULES 20MG MAL07082880ACR TEMODAL CAPSULES 20 MG MAL06071049ACRS TEMODAL CAPSULES 100MG MAL07082881ACR TEMODAL CAPSULES 250 MG MAL06071051ACRS TEMODAL CAPSULES 20MG MAL20032408AR TEMODAL CAPSULES 100MG MAL20032409AR TEMODAL CAPSULES 250MG MAL20032410AR TILCOTIL`ROCHE`LACQ-COATED TAB 20MG MAL19890224A HYTRIN 1MG TABLET MAL20014488AC HYTRIN 2MG TABLET MAL20014489AC HYTRIN 5MG TABLET MAL20014490AC ANDRIOL TESTOCAPS CAPSULES 40MG MAL05032535AC ANDRIOL CAPSULE 40MG MAL19870663A LANVIS TABLETS 40MG MAL05032537ACR ELTROXIN TABLET 0.05 MG Manufacturer BOEHRINGER INGELHEIM PHARMA GMBH & CO.KG, WEST GERMANY

Bil.

247. Telmisartan

248. Temozolomide

ORION CORPORATION, ORION PHARMA, FINLAND

INTEGRATED THERAPEUTICS GROUP INC, UNITED STATES

249. Tenoxicam

F.HOFFMAN-LA ROCHE, SWITZERLAND AESICA QUEENBOROUGH LIMITED, UNITED KINGDOM

250. Terazosin hydrochloride

251. Testosterone Undecanoate

CATALENT FRANCE BEINHEIM SA, FRANCE R.P SCHERER GMBH & CO KG, GERMANY DSM PHARMACEUTICALS INC, UNITED STATES GLAXO WELLCOME

252. Thioguanine 253. Thyroxine sodium

LIST OF COMPARATOR PRODUCTS FOR BIOEQUIVALENCE STUDIES (JUNE 2013) TEST PRODUCTS (Pharmaceutical name) Comparator Products Trade Mark/Registration No./ Reference No. MAL19890455A ELTROXIN TABLET 0.1MG MAL19890456A LIVIAL TABLET 2.5MG MAL19913394A RASTINON TABLET 500MG MAL19870403A Manufacturer OPERATIONS UK LTD

Bil.

254. Tibolone 255. Tolbutamide

256. Tolterodine l-tartrate 257. Topotecan hydrochloride

258. Tranexamic Acid

259. Tramadol hydrochloride

260. Triazolam 261. Triflusal 262. Trimebutine maleate 263. Trimetazine hydrochloride

N.V. ORGANON, NETHERLANDS AVENTIS PHARMA DEUTSCHLAND GMBH, WEST GERMANY This product can be obtained from Japan, Australia, Hong Kong and Mexico (Information obtained via an email dated 2nd Oct 2012 from Sanofi Aventis, Malaysia) DETRUSITOL TABLET 2MG PFIZER ITALIA S.R.L., MAL19991686A ITALY HYCAMTIN 0.25MG HARD GLAXOSMITHKLINE CAPSULES MANUFACTURING S.P.A, MAL20091960A ITALY HYCAMTIN 1 MG HARD CAPSULES MAL20091961A TRANSAMIN CAPSULE 250MG CMIC CMO CO. LTD, MAL19890202AC JAPAN TRANSAMIN CAPSULE 250MG DAIICHI PHARMACEUTICAL LTS, JAPAN TRAMAL CAPSULE GRUNENTHAL GMBH, MAL19921516A WEST GERMANY Product is available in Australia, Austria, Bahrain, Belgium, China, Croatia, Denmark, Finland, France, Germany, Greece, Ireland, Israel, Italy, Jordan, Kenya, Kuwait, Lebanon, New Zealand, Netherlands, Nigeria, Norway, Oman, Portugal, Poland, Qatar, Saudia Arabia, Sweden, Taiwan, Thailand, Switzerland, UAE, UK, Yemen (Information obtained via an email from Grunenthal Gmbh, Germany dated 28th March 2013) SOMESE TABLET 0.25 MG SANICO N.V., BELGIUM MAL07050020ACR GRENDIS 300MG CAPSULE J. URIACH & CIA,S.A., MAL20051420A SPAIN DEBRIDAT TABLET JOUVEINAL LABS, 1990040029A FRANCE VASTAREL COATED TABLET LES LABS SERVIER 20MG INDUSTRIE, FRANCE

LIST OF COMPARATOR PRODUCTS FOR BIOEQUIVALENCE STUDIES (JUNE 2013) TEST PRODUCTS (Pharmaceutical name) Comparator Products Trade Mark/Registration No./ Reference No. MAL19870169A URSOFALK CAPSULE 250MG MAL19990011ACS SABRIL 500MG TABLET MAL19961357A NAVELBINE 20MG SOFT CAPSULE MAL20071635A NAVELBINE 30MG SOFT CAPSULE MAL20071636A VFEND 50MG TABLET MAL20040542A VFEND 200MG TABLET MAL20040543A ZELDOX CAPSULE 20MG MAL20032622A ZELDOX CAPSULE 40MG MAL20032623A ZELDOX CAPSULE 60MG MAL20032624A ZELDOX CAPSULE 80MG MAL20032625A BIFRIL 30 MAL20061470A Manufacturer LOSAN PHARMA GMBH, GERMANY PATHEON FRANCE S.A., FRANCE PIERRE FABRE MEDICAMENT PRODUCTION, FRANCE PFIZER MANUFACTURING DEUTSHLAND GMBH, GERMANY PFIZER AUSTRALIA PTY. LTD., AUSTRALIA

Bil.

264. Ursodeoxycholic acid

265. Vigabatrin 266. Vinorelbine tartrate

267. Voriconazole

268. Ziprasidone hydrochloride

269. Zofenopril calcium

270. Zuclopenthixol 271. Cycloserine

CLOPIXOL TABLET 10MG MAL19890537A CYCLOSERINE CAPSULE BP 250MG MAL19900001A

A. MENARINI MANUFACTURING LOGISTICS AND SERVICES S.R.L., ITALY H.LUNDBECK A/S, DENMARK ELI LILLY AND COMPANY LIMITED, UNITED KINGDOM

Note: If you need further clarification, kindly email to mazuwin@bpfk.gov.my and adilah@bpfk.gov.my

Updated on 11/06/2013