Professional Documents
Culture Documents
ON
AMLOPRES AT
(AMLODIPIN + ATENOLOL COMBINATION),
A PRODUCT OF CIPLA Ltd.
PEPARED BY
VIRAL B PATHAK
SUBMITTED TO
DEPARTMENT OF BUSINESS ADMINISTRATION
BHAVNAGAR UNIVERSUTY
BHAVNAGAR
COMPREHENSIVE REPORT ON AMLOPRES AT
INDEX
Page No.
The Indian pharmaceutical industry. 3
Background. 8
History. 8
Board of directors. 12
Milestones. 13
Business. 18
Quality control. 27
Exports. 28
Distribution. 31
Cardiac division. 33
Major competitors. 35
Cardiac therapy. 36
Competitors brand. 45
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Financial analysis. 49
Bibliography. 56
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BACKGROUND
Cipla was incorporated as a public limited company in 1935,
in the name of Chemical Industrial and Pharmaceutical
Laboratories Ltd. The name was changed to the acronym ‘Cipla’
in 1984. Over the last 6 decades Cipla has set up plants at 5
locations, mainly concentrated in Maharashtra. Currently it has
around 2200 employees. Its in house R&D was established in
1952. Cipla is managed by the Hamied brothers, sons of the
founder, late Dr K A Hamied. Dr Y K Hamied, with a doctorate in
Organic Chemistry from Cambridge, is the Chairman and
Managing Director. He heads the research division that has a
strength 200 people. His brother, M K Hamied, looks after
marketing and Amar Lulla heads the finance division. Cipla has
incorporated a unique, flat organization structure.
HISTORY
Khwaja Abdul Hamied, the founder of Cipla, was born on October
31, 1898. The fire of nationalism was kindled in him when he was 15 as
he witnessed a wanton act of colonial highhandedness. The fire was to
blaze within him right through his life.
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CIPLA IS BORN
In 1935, he set up The Chemical, Industrial & Pharmaceutical
Laboratories, which came to be popularly known as Cipla. He gave the
company all his patent and proprietary formulas for several drugs and
medicines, without charging any royalty. On August 17, 1935, Cipla
was registered as a public limited company with an authorised capital
of Rs 6 lakhs.
Cipla was officially opened on September 22, 1937 when the first
products were ready for the market. The Sunday Standard wrote: "The
birth of Cipla which was launched into the world by Dr K A Hamied will
be a red letter day in the annals of Bombay Industries. The first city in
India can now boast of a concern, which will supersede all existing
firms in the magnitude of its operations. India has lagged behind in the
march of science but she is now awakening from her lethargy. The new
company has mapped out an ambitious programme and with
intelligent direction and skillful production bids fair to establish a great
reputation in the East. "
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BOARD OF DIRECTORS
Board of Directors As on 26th July-2001
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M K Hamied
Amar Lulla
D R Narang
Dr H R Manchanda
S A A Pinto
Ramesh Shroff
V C Kotwal
B K Khare
Secretary
n/a
MILESTONES:
1935:
Dr K A Hamied sets up "The Chemical, Industrial and Pharmaceutical
Laboratories Ltd." in a rented bungalow, at Bombay Central.
1941
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As the Second World War cuts off drug supplies, the company starts
producing fine chemicals, dedicating all its facilities for the war effort.
1952
Sets up first research division for attaining self-sufficiency in
technological development.
1960
Starts operations at second plant at Vikhroli, Mumbai, producing fine
chemicals with special emphasis on natural products.
1968
Cipla manufactures ampicillin for the first time in the country.
1972
Starts Agricultural Research Division at Bangalore, for scientific
cultivation of medicinal plants.
1976
Cipla launches medicinal aerosols for asthma.
1980
Wins Chemexcil Award for Excellence for exports.
1982
Fourth factory begins operations at Patalganga, Maharashtra.
1984
Develops anti-cancer drugs, vinblastine and vincristine in collaboration
with the National Chemical Laboratory, Pune. Wins Sir P C Ray Award
for developing inhouse technology for indigenous manufacture of a
number of basic drugs.
1985
US FDA approves Cipla’s bulk drug manufacturing facilities.
1988
Cipla wins National Award for Successful Commercialisation of Publicly
Funded R&D.
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1991
Lauches etoposide, a breakthrough in cancer chemotherapy, in
association with Indian Institute of Chemical Technology.
1994
Cipla's fifth factory begins commercial production at Kurkumbh,
Maharashtra
1997
Launches transparent Rotahaler, the world's first such dry powder
inhaler device now patented by Cipla in India and abroad. The
palliative cancer care centre set up by the Cipla Foundation, begins
offering free services at Warje, near Pune.
1998
Launches lamivudine, becoming one of the few companies in the world
to offer all three component drugs of retroviral combination therapy
(zidovudine and stavudine already launched).
1999
Launches Nevirapine, antirltroviral drug, used to prevent the
transmission of AIDS from mother to child.
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Clofibrate Ondansetron
For hyperlipidaemias For cancer-induced
resistant to diet emesis
Propranolol Salmeterol
For hypertension For bronchial asthma
Lorazepam Deferiprone
For anxiety World ’s first oral iron
chelator for use in
Salbutamol sulphate thalassaemia
For bronchial asthma
Finasteride
Vincristine sulphate For benign prostatic
For acute leukaemia hyperplasia
Piroxicam Alendronate
For rheumatoid arthritis For osteoporosis
Gugulipid Stavudine
For cholesterol reduction
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BUSINESS
Cipla’s FY2002 sales consist of formulations (65%), sold in the
domestic and export market, and bulk drugs (35%), mostly exported
PRODUCTS
PRODUCTION:
MANUFACTURING FACILITIES
Vikhroli, Mumbai
Formulations
Bangalore
Bulk drugs, formulations, natural products
Patalganga
Bulk drugs, formulations
Kurkumbh
Bulk drugs, formulations
Goa : Formulations
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Bangalore
Intermed Pharma Pvt. Ltd.
Intermed Labs Pvt. Ltd.
Daman
Golden Cross Pharma Pvt. Ltd.
Healing Cross Pharma Pvt. Ltd.
Jupiter Remedies Pvt. Ltd.
Advanced Remedies Pvt. Ltd.
Goa
Medispray Laboratories Pvt. Ltd.
Meditab Specialities Pvt. Ltd.
Okasa Pvt. Ltd.
Kurkumbh
Orion Remedies Pvt. Ltd.
Satara
Okasa Pharma Ltd.
Mediorals Laboratories Pvt. Ltd.
Solapur
Aditi Pharmaceuticals Pvt. Ltd
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Dosage Forms
Cipla manufactures:
Tablets
Conventional
Sustained Release
Enteric Coated
Effervescent
Chewable
Mouth Dissolve
Dispersible
Bilayered
Capsules
Hard Gelatin
Sprinkles
Sustained Release
Immediate Release
Filled with liquid
Powder Plus Tablet
Enteric coated pellets
Soft Gelatin
Conventional
Microemulsion
Liquids
Suspensions
Syrups
Drops
Injections
Ampoules
Vials
Dry Powder
Lyophilized
Depot
Ophthalmic Preparations
Suspensions
Solutions
Ointments
Topical Preparations
Lotions
Creams
Ointments
Transdermal Patches
Transdermal Sprays
Gels
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Powders
Nasal Preparations
Suspensions
Solutions
Metered Sprays
Inhalers
Metered Dose
Dry Powder
Nebulizing Solutions
Rectal Preparations
Suppositories
Enema
Foams
Powders
Effervescent
Conventional
Dispersible
Buccal Preparations
Metered Sprays
Devices
For use with
Metered Dose Inhalers
Intramammary Preparations
For Veterinary Use
Toiletries
PRODUCTS
Cipla produces around 50 types of bulk drugs. Most of these
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CARDIAC CARE:
INFECTION CARE:
Forcan Ciplox TZ
ASTHAMA THEORAPY:
Fiohale
Optipres –S Ciplox
Optipres Norflox
ANTI-CANCER RANGE
Kelfer Cytoblustin
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Cytocristine Etosid
AIDS:
Duovir Nevimune
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a) Budesonide -corticosteroid
c) Docetaxel -anticancer
d) Ebastine- antihistamine
e) Gabapentin- antiepileptic
i) Olanzapine –antipsychotic
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QUALITY CONTROL:
Cipla’s highly qualified professionals help upgrade quality
standards by making consistent contributions to national and
international pharmacopoeia and to analytical science.
Expertise in method development and validation for new
molecules with special emphasis on impurity profiling, particle
size analysis, stability and integrity assay methods, and in-vitro
dissolution profiling.
Custom-made methods to evaluate sophisticated dosage forms
like metered dose inhalers, intra nasal preparations, ophthalmic
preparations, transdermal systems, dermatological products and
implants.
Cipla laboratories are equipped with the following sophisticated
equipment viz. HPLCs, HPTLCs, XRDs, GC-MS, FTIR Microscopy,
LC-MS, Thermal Analytical Systems, Laser Particle Size Analysers
and Illumination Chambers in order to test for conformity with
USP, BP, EP, IP as well as inhouse specifications surpassing
various pharmacopoeial standards.
Microbiological analysis including bacterial, endotoxin and
sterility testing.
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EXPORTS
Cipla was amongst the first few Indian pharma companies
to receive US FDA approval for its works in 1985. In FY2001,
exports grew 84% yoy, contributing 25% of net sales. A major
portion of Cipla’s exports is to the developed countries of
Americas (39%), and Europe (19%) which have highly stringent
quality norms. Other major markets are Africa (16%), Middle East
(15%), Asia (8%) and Australia (3%). Cipla has stopped exports to
Russia and CIS countries due to ongoing crisis.
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DISTRIBUTION:
For distribution of the product, mainly pull strategy is practiced.
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CARDIAC DIVISION:
The cardiac group forms a very important segment to Cipla as a
company. The cardiac market is very dynamic and growing one. Infact,
cardiac group as a whole industry is worth of 1419 crore and it is
growing 20.5%/annum. Cipla has a 93 crore share in this group and is
growing at a rate of 19.9%.
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MAJOR COMPETITORS:
1) Pfizer.
2) U.S.V.
3) Intas.
4) Sun Pharma
5) Ranbaxy Lab
6) Dr. Reddy’s Lab.
7) GSK Pharma.
8) Wockhardt.
9) Nicholas Piramal India.
10) Aventis Pharma.
11)Novrartis India.
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COMPREHENSIVE REPORT ON AMLOPRES AT
CARDIAC THERAPY
Indications
Anti-hypertensives :
ACE Inhibitors :
Beta Blockers :
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COMPREHENSIVE REPORT ON AMLOPRES AT
Diuretics :
Anti-anginals :
Anti-arrhythmics :
These help stabilise the heart rate and rhythm. But none of the
presently available drugs seem to have optimal effect. Main drugs are
Disopyramide, Quinidine, Propafenone, Amiodarone and Digoxin.
Peripheral Vasodilators :
These selectively dilate blood vessels in the limbs and increase blood
flow to the desired part of the body, without affecting overall blood
pressure. Major drugs are Pentoxyfilline, Isoxsuprine.
DRUG PROPERTIES
Atenolol Beta Blocker
Amlodipine Calcium Channel Blockers
Captopril ACE Inhibitor
Cinnarizine Peripheral Vasodilator
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COMPREHENSIVE REPORT ON AMLOPRES AT
INTRODUCTION TO PRODUCT
PRODUCT FEATURES
Introduction: Amlopres AT is the combination of two effective
medicines : Amlodipine & Atenolol, which was first introduced by
Cipla in the Indian Market.
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BRAND POSITIONING :
DESCRIPTION
Amlopres-AT and Amlopres-AT 25 are fixed-dose combinations of
amlodipine and atenolol. Amlodipine is a dihydropyridine calcium
antagonist that inhibits the transmembrane influx of calcium ions into
vascular smooth muscle and cardiac muscle; it has a greater effect on
vascular smooth muscle cells than on cardiac muscle cells. Amlodipine
is a peripheral vasodilator that acts directly on vascular smooth muscle
to cause a reduction in peripheral vascular resistance and reduction in
blood pressure. Amlodipine reduces tone, decreases coronary
vasoreactivity and lowers cardiac demand by reducing afterload.
INDICATIONS
The combination is indicated for the treatment of hypertension and
chronic stable angina.
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CONTRAINDICATIONS
Hypersensitivity to either component, sinus bradycardia, second and
higher degrees of heart block, cardiogenic shock, hypotension,
congestive heart failure, poor left ventricular function.
DRUG INTERACTIONS:
Disopyramide: Atenolol reduces the clearance of disopyramide by 20%.
Additive negative inotropic effects on the heart may be produced.
HYPOTENSION:
Excessive fall of blood pressure can occur in some patients especially
the elderly.
AGGRAVATION OF ANGINA:
Rarely patients, particularly those with severe obstructive coronary
artery disease, have developed increased frequency, duration and/or
severity of angina or acute myocardial infarction on starting calcium
channel blocker therapy.
DRUG WITHDRAWAL:
Since coronary heart disease may exist without being recognised,
patients should be warned against stopping the drug suddenly. Any
discontinuation should be gradual and under observation.
BRONCHOSPASM:
The combination should be used with caution in patients with airway
obstruction.
RENAL IMPAIRMENT:
The combination can be used in patients with renal impairment.
However, caution may be necessary if the creatinine clearance is less
than 30 ml/min because of possible reduction in the excretion of
unchanged atenolol.
HEPATIC IMPAIRMENT:
Caution may be necessary in the use of the combination in patients
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PREGNANCY:
The combination should be used during pregnancy only if the expected
benefit outweighs the potential foetal risk.
LACTATION:
The combination should not be used by nursing mothers. If its use is
considered necessary, breast feeding should be stopped.
SIDE EFFECTS
The combination of amlodipine and atenolol is well tolerated.
Side effects include headache, palpitations, flushing, edema,
depression, dizziness, dyspepsia, dyspnoea, muscle cramps, fatigue,
cold extremities and bradycardia.
OVERDOSAGE
Though not documented, hypotension and less frequently congestive
cardiac failure may occur in cases of overdosage.
Unabsorbed drugs may be removed by gastric lavage or administration
of activated charcoal. Symptomatic treatment is suggested.
PRESENTATION
Amlopres-AT Blister pack of 10 tablets
Amlopres-AT 25 Blister pack of 10 tablets
DOCTORS ON FOCUS :
Cardiologists
Physicians
General Practitioners
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COMPETITOR BRANDS :
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CORE COMPETENCE:
Amlopres AT was the first drug of Amlopres + Atenolol
combination in the Indian market, introduced by Cipla Ltd.
DISTRIBUTION:
For distribution of the product, mainly pull strategy is practiced.
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COMPREHENSIVE REPORT ON AMLOPRES AT
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FINANCIAL ANALYSIS
Net Sales have grown at a CAGR of 26% in the last three
years which is commendable considering the industry has
grown at only 11-12% in the same period. The growth has
been driven by new product launches in the domestic
market and new initiatives in the export market.
However, operating margins have declined over the period
from 24.7% in FY98 to 22.3% in FY2001. The main decline
has come over the last two years as the company moved
into the generic generic segment in the domestic market.
This segment has much lower margins than formulations
and has impacted overall profitability. Also, selling expenses
have increased from 2.5% of sales in FY98 to 4.4% in
FY2001, again due to higher trade push strategy in the
domestic market.
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COMPREHENSIVE REPORT ON AMLOPRES AT
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APPLICATION OF FUNDS
Gross block 1,787.5 2,138.6 2,423.8 2,838.0
Accumulated depreciation (612.7) (715.9) (843.3) (997.5)
Capital work in progress 50.1 26.3 37.0 31.3
Total fixed assets 1,224.9 1,448.9 1,617.5 1,871.8
Investments 728.2 1,404.0 1,950.0 2,229.3
Inventories 1,479.0 1,584.2 2,122.0 2,753.6
Sundry debtors 535.0 592.3 808.5 1,495.2
Cash & bank balance 30.2 35.4 42.7 58.0
Total loans & advances 1,484.7 1,685.5 1,763.0 2,032.9
Sundry creditors/
(359.0) (398.2) (797.1) (1,090.1)
Acceptances
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COMPREHENSIVE REPORT ON AMLOPRES AT
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RATIOS
As % of net sales
Gross sales 106.5 108.3 109.7 108.4
Excise duty (6.5) (8.3) (9.7) (8.4)
Net sales 100.0 100.0 100.0 100.0
Other income 5.5 4.9 4.6 4.0
Total income 105.5 104.9 104.6 104.0
Cost of material 49.9 48.9 50.1 50.3
Employee costs 4.7 5.1 5.0 5.2
Selling expense 2.0 2.5 3.4 4.4
Other expenses 17.2 16.8 17.4 16.5
Cost of sales 75.3 74.9 77.5 77.7
Profitability ratios (%)
PBIDT excl. other income 24.7 25.1 22.5 22.3
PBIDT 30.3 30.0 27.0 26.3
PBDT 29.7 29.5 26.9 26.2
Profit before tax 28.0 27.1 24.9 24.6
Profit after tax 21.1 20.2 19.2 18.5
Growth ratios (% yoy)
Net sales 13.8 18.1 21.5 39.6
PBIDT 17.2 16.9 9.6 35.7
PBT 31.4 14.4 11.8 37.6
PAT 44.1 12.7 15.8 34.6
Payout ratios (%)
Tax (% of PBT) 24.4 25.6 22.9 24.6
Dividend (% of PAT) 11.9 14.5 14.8 16.6
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COMPREHENSIVE REPORT ON AMLOPRES AT
Notes:
1. Provision for tax includes deferred taxation.
2. The Company is exclusively in the pharmaceutical business
segment.
3. The above results were taken on record at the meeting of
the Board of Directors held on April 29, 2002.
BIBILIOGRAPHY:
1. www.cipla.com
2. www.cipladoc.com
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COMPREHENSIVE REPORT ON AMLOPRES AT
3. www.indiainfoline.com
4. www.google.com
5. Business Today November-2002 issue
6. Cipla Company literature
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