The Indian Pharmaceutical Industry: New Strategies in a Changing World
The days when the Indian pharmaceutical industry was synonymous with cheap generic drug production are passing. While generics continue to play a major part in the industry’s success, many companies have started down the long road of drug discovery, novel product development and pharma services.
With high-quality research, low-cost manufacturing facilities and educated personnel, the Indian pharmaceutical industry presents both a competitive threat and partnering opportunities.
A significant international industry
India is the world’s fourth largest producer of pharmaceuticals by volume, accounting for around 8% of global production. In value terms, production accounts for around 1.5% of the world total. The Indian pharmaceutical industry directly employs around 500,000 people and is highly fragmented. While there are around 270 large R&D based pharmaceutical companies in India, including multinationals, government-owned and private companies, there are also around 5,600 smaller licensed generics manufacturers, although in reality only around 3,000 companies are involved in pharmaceutical production. Most small firms do not have their own production facilities, but operate using the spare capacity of other drug manufacturers.
A new approach
The advent of pharmaceutical product patent recognition in January 2005 changed the ground rules for Indian companies. In the run up to the new post-patent era and since, the Indian industry has been evolving. R&D departments are moving away from reverse-engineering in favour of developing novel drug delivery systems and discovery research. It is anticipated that the experience of selling generics in the international market will hold Indian companies in good stead for selling their own branded products to these markets in the future.
Focus on...current and future markets
The dynamics of the domestic Indian market have always encouraged Indian industry to pursue overseas lines of business. Expansion comes at a cost and some companies have had to restructure. In June 2009, Wockhardt divested its German business, esparma and more recently, in March 2010, Orchid sold its generic injectable formulations business to Hospira but came out of the deal with a long term supply agreement for its APIs.
INDIA
India remains an important market for the vast majority of Indian companies. The indigenous industry supplies around 70% of the country’s pharmaceuticals. The proportion of revenue derived from India depends largely on the strategy of the individual company and its penetration into overseas markets. For example, while Zydus Cadila aims to grow rapidly overseas, India remains its most important market, accounting for 55.8% of revenue in fiscal 2008/09. India is also Cipla’s key market, generating almost half of the company’s revenue in 2008/09, although this percentage has been declining in recent years as the company has increasingly targeted overseas markets. Other companies, such as Dr. Reddy’s, are less reliant on the Indian market; in 2008/09, India contributed just 17% of the company’s global revenue.
INTERNATIONAL DEVELOPMENT
The attractive opportunities offered by the loss of patent protection on several major products in the coming period, and resolution of the biosimilar regulatory issue in the US, has to be offset against price reduction pressures driven by the ongoing economic downturn and aggressive competition for the business that is on offer.
USA: The largest generic market and the most sought after target for Indian companies involved in the generic business, is the US. As more companies gained the expertise to file for FDA approval, the number of ANDAs approved increased dramatically. In 2005, the number increased to 52 and subsequently increased year-on-year, to reach 132 in 2008. In 2009, the total number of ANDA approvals was 125. In the first quarter of 2010, a further 20 were approved.
UK: Over 80% of prescriptions in the mature UK market are written generically. The UK has always been a focus for Indian companies with 9 companies running 11 manufacturing sites. Between January 2009 and January 2010, Indian companies had more than 260 marketing authorisations approved by the UK’s Medicines and Healthcare Regulatory Agency (MHRA) for a wide range of products. During this period, Ranbaxy received 55 approvals; Dr. Reddy’s received 54; Aurobindo received 39; and, Lupin received 25.
Europe: Beyond the UK and Germany, significant European markets have been slow to adopt a vigorous generics drugs policy. However, pressure on governments to cut costs in the face of burgeoning drugs bills and economic recession, are seeing countries such as France, Italy and Spain exploring the increased use of generics. A number of Indian companies are either monitoring them from the sidelines or have already identified growth potential; Ranbaxy, for example is established in France, Germany, Italy and Spain.
Brazil: Brazil is perhaps the most notable emerging generic market in recent years. According to the Brazilian generic industry association, Pró-Genéricos, prices of generic medicines have to be at least 35% cheaper than prices of original medicines but, in practice, they are up to 50% cheaper. In 2009, generic medicines represented 19.4% of the pharmacy sector by volume, increasing 19.0% over the previous year to 330.0 million units. In value terms, pharmacy sales of generic medicines increased by 24.0% to R$4.5 billion (US$2.2 billion). Indian companies have been present in the Brazilian market for several years. In 2008, Indian pharmaceutical exports to Brazil were valued at around US$166 million per year and made up a significant part of all trade between India and Latin America.
Australia: Due to low prices of branded products, Australia is not yet a major market for generics. A number of leading drugs are due to lose patent protection, but price competition tends to be muted for off-patent drugs. The government is, however, currently looking at ways to boost generic consumption in an effort to rein in the overall drugs bill. The market is beginning to attract Indian companies, a number of which have gained approval from the Therapeutic Goods Administration for their manufacturing facilities and a range of products.
Indian pharmaceutical companies are no strangers to competition. The Indian market is highly competitive with more than 300 organised players and branded promotional costs associated with every product, yet the industry is able to offer low-priced products and remain profitable in India. However, whether the Indian industry will be able to maintain the pace of expansion across the world is questionable in the current economic climate.
The Indian Pharma Industry - looking beyond generics
The Indian pharmaceutical industry has a long history of reverse-engineering and its ability to produce and distribute globally generic copies of pharmaceutical products is well proven. Post TRIPs, the R&D focus of Indian companies has shifted towards novel drug delivery systems or discovery research. But the global launch of innovative new products is still some way off, so what are the options for companies going forward?
In-licensing and custom manufacturing are alternative strategies to generics
Building upon its strengths in chemical synthesis and process engineering, the availability of highly-skilled labour and a low-cost manufacturing base, some companies have elected to pursue alternative business strategies.
Piramal Healthcare has always partnered global innovator companies and, in addition to an extensive Indian generic business, is a global player in custom manufacturing and has a number of early stage development candidates. In May 2010, it was announced that Abbott had agreed to pay a total of US$3.7 billion for the domestic drug business, leaving Piramal to concentrate on its research, formulation and customer manufacturing businesses.
Another company with a diverse portfolio of services is Jubilant Organosys. The company’s main focus is its Pharmaceuticals and Life Sciences Products and Services business, which has grown significantly over the last few years. Jubilant is active in APIs, proprietary products, contract manufacturing of liquid and lyophilized sterile injectables, ointments, creams and liquids, radiopharmaceuticals, drug discovery services, medicinal chemistry services, clinical research services, generic dosage forms and healthcare.
Biosimilars
The resolution of the regulatory issues surrounding biosimilars in the USA has removed at least one obstacle to the development of these products. As one of the leading producers of generic drugs, it is logical that Indian companies would see biosimilars as a natural follow-on business. Recent milestones in the development of biosimilars include:
With high-quality research, low-cost manufacturing facilities and educated personnel, the Indian pharmaceutical industry presents both a competitive threat and partnering opportunities.
A significant international industry
India is the world’s fourth largest producer of pharmaceuticals by volume, accounting for around 8% of global production. In value terms, production accounts for around 1.5% of the world total. The Indian pharmaceutical industry directly employs around 500,000 people and is highly fragmented. While there are around 270 large R&D based pharmaceutical companies in India, including multinationals, government-owned and private companies, there are also around 5,600 smaller licensed generics manufacturers, although in reality only around 3,000 companies are involved in pharmaceutical production. Most small firms do not have their own production facilities, but operate using the spare capacity of other drug manufacturers.
A new approach
The advent of pharmaceutical product patent recognition in January 2005 changed the ground rules for Indian companies. In the run up to the new post-patent era and since, the Indian industry has been evolving. R&D departments are moving away from reverse-engineering in favour of developing novel drug delivery systems and discovery research. It is anticipated that the experience of selling generics in the international market will hold Indian companies in good stead for selling their own branded products to these markets in the future.
Focus on...current and future markets
The dynamics of the domestic Indian market have always encouraged Indian industry to pursue overseas lines of business. Expansion comes at a cost and some companies have had to restructure. In June 2009, Wockhardt divested its German business, esparma and more recently, in March 2010, Orchid sold its generic injectable formulations business to Hospira but came out of the deal with a long term supply agreement for its APIs.
INDIA
India remains an important market for the vast majority of Indian companies. The indigenous industry supplies around 70% of the country’s pharmaceuticals. The proportion of revenue derived from India depends largely on the strategy of the individual company and its penetration into overseas markets. For example, while Zydus Cadila aims to grow rapidly overseas, India remains its most important market, accounting for 55.8% of revenue in fiscal 2008/09. India is also Cipla’s key market, generating almost half of the company’s revenue in 2008/09, although this percentage has been declining in recent years as the company has increasingly targeted overseas markets. Other companies, such as Dr. Reddy’s, are less reliant on the Indian market; in 2008/09, India contributed just 17% of the company’s global revenue.
INTERNATIONAL DEVELOPMENT
The attractive opportunities offered by the loss of patent protection on several major products in the coming period, and resolution of the biosimilar regulatory issue in the US, has to be offset against price reduction pressures driven by the ongoing economic downturn and aggressive competition for the business that is on offer.
USA: The largest generic market and the most sought after target for Indian companies involved in the generic business, is the US. As more companies gained the expertise to file for FDA approval, the number of ANDAs approved increased dramatically. In 2005, the number increased to 52 and subsequently increased year-on-year, to reach 132 in 2008. In 2009, the total number of ANDA approvals was 125. In the first quarter of 2010, a further 20 were approved.
UK: Over 80% of prescriptions in the mature UK market are written generically. The UK has always been a focus for Indian companies with 9 companies running 11 manufacturing sites. Between January 2009 and January 2010, Indian companies had more than 260 marketing authorisations approved by the UK’s Medicines and Healthcare Regulatory Agency (MHRA) for a wide range of products. During this period, Ranbaxy received 55 approvals; Dr. Reddy’s received 54; Aurobindo received 39; and, Lupin received 25.
Europe: Beyond the UK and Germany, significant European markets have been slow to adopt a vigorous generics drugs policy. However, pressure on governments to cut costs in the face of burgeoning drugs bills and economic recession, are seeing countries such as France, Italy and Spain exploring the increased use of generics. A number of Indian companies are either monitoring them from the sidelines or have already identified growth potential; Ranbaxy, for example is established in France, Germany, Italy and Spain.
Brazil: Brazil is perhaps the most notable emerging generic market in recent years. According to the Brazilian generic industry association, Pró-Genéricos, prices of generic medicines have to be at least 35% cheaper than prices of original medicines but, in practice, they are up to 50% cheaper. In 2009, generic medicines represented 19.4% of the pharmacy sector by volume, increasing 19.0% over the previous year to 330.0 million units. In value terms, pharmacy sales of generic medicines increased by 24.0% to R$4.5 billion (US$2.2 billion). Indian companies have been present in the Brazilian market for several years. In 2008, Indian pharmaceutical exports to Brazil were valued at around US$166 million per year and made up a significant part of all trade between India and Latin America.
Australia: Due to low prices of branded products, Australia is not yet a major market for generics. A number of leading drugs are due to lose patent protection, but price competition tends to be muted for off-patent drugs. The government is, however, currently looking at ways to boost generic consumption in an effort to rein in the overall drugs bill. The market is beginning to attract Indian companies, a number of which have gained approval from the Therapeutic Goods Administration for their manufacturing facilities and a range of products.
Indian pharmaceutical companies are no strangers to competition. The Indian market is highly competitive with more than 300 organised players and branded promotional costs associated with every product, yet the industry is able to offer low-priced products and remain profitable in India. However, whether the Indian industry will be able to maintain the pace of expansion across the world is questionable in the current economic climate.
The Indian Pharma Industry - looking beyond generics
The Indian pharmaceutical industry has a long history of reverse-engineering and its ability to produce and distribute globally generic copies of pharmaceutical products is well proven. Post TRIPs, the R&D focus of Indian companies has shifted towards novel drug delivery systems or discovery research. But the global launch of innovative new products is still some way off, so what are the options for companies going forward?
In-licensing and custom manufacturing are alternative strategies to generics
Building upon its strengths in chemical synthesis and process engineering, the availability of highly-skilled labour and a low-cost manufacturing base, some companies have elected to pursue alternative business strategies.
Piramal Healthcare has always partnered global innovator companies and, in addition to an extensive Indian generic business, is a global player in custom manufacturing and has a number of early stage development candidates. In May 2010, it was announced that Abbott had agreed to pay a total of US$3.7 billion for the domestic drug business, leaving Piramal to concentrate on its research, formulation and customer manufacturing businesses.
Another company with a diverse portfolio of services is Jubilant Organosys. The company’s main focus is its Pharmaceuticals and Life Sciences Products and Services business, which has grown significantly over the last few years. Jubilant is active in APIs, proprietary products, contract manufacturing of liquid and lyophilized sterile injectables, ointments, creams and liquids, radiopharmaceuticals, drug discovery services, medicinal chemistry services, clinical research services, generic dosage forms and healthcare.
Biosimilars
The resolution of the regulatory issues surrounding biosimilars in the USA has removed at least one obstacle to the development of these products. As one of the leading producers of generic drugs, it is logical that Indian companies would see biosimilars as a natural follow-on business. Recent milestones in the development of biosimilars include:
- Biocon signed a collaborative agreement with Mylan in June 2009 on the development, manufacturing, supply and commercialisation of multiple, high-value generic biologic compounds for the global marketplace. The collaboration combines Biocon’s scientific and biologics manufacturing with Mylan's global commercial footprint.
- In March 2010, Ranbaxy and the San Diego, California-based Pfenex announced that they had entered into an agreement under which Ranbaxy will develop an undisclosed biosimilar therapeutic produced in the Pfenex Expression Technology platform, a pseudomonas-based recombinant protein technology.
- In February 2009, Wockhardt announced that it had launched Glaritus, a recombinant long-acting human insulin analogue, in India. The company commented that it was the first company in the world, after the innovator, to launch this particular type of insulin, which works slowly for over 24 hours.
Contents
FOREWORDTHE INDIAN PHARMACEUTICAL INDUSTRY
Introduction
Indian bases
Sales revenue
The advent of the product patent regime in India
Background
The Patents (Amendments) Bill, 2005
Mashelkar Committee Report, December 2006
What effect has the product patent regime had on the pharmaceutical industry?
Looking beyond reverse-engineering
In-licensing and custom manufacturing
Key markets now and in the future
Established and emerging generic markets
The United States
Authorised generics – threat or opportunity?
Europe
South Africa
Brazil
Australia
Biosimilars
Biosimilars and Indian Companies
India’s competitive advantage
Foreign acquisitions
Exports
COMPANY PROFILES
ALEMBIC
Company Strategy
Manufacturing
R&D
Key Markets
Major Developments
Dabur Pharma Acquisition
Products
Domestic Formulations
APIs
International Formulations
Generics
Financials
AUROBINDO PHARMA
Company Strategy
Manufacturing
R&D
Key Markets
Major Developments
Trident Life Sciences acquisition
Licensing and supply agreements with Pfizer
TAD Italy acquisition
Pharmacin acquisition
Acquisition of US facility
Milpharm: Aurobindo’s first acquisition in Europe
Products
APIs
Domestic Formulations
International Generics
US and Canada
CNS
Antibacterials
Antiretrovirals
Cardiovascular
European Union
South Africa
Australia
Financials
BIOCON
Company Strategy
Manufacturing
R&D
Major Developments
Acquisitions
Biocon buys majority stake in German marketing company
Acquisition of asset of Nobex Corporation
Agreements
Biocon to acquire CIMAB’s stake in BBPL
Syngene collaborates with Endo
Amylin and Biocon to develop/commercialise novel phybrid for diabetes
Mylan/Biocon form collaboration for generic biologics
Abraxis and Biocon announce G-CSF partnership
Invitrogen/Biocon sign agreement to market insulin to cell culture market
Biocon/Vaccinex partner to discover and develop therapeutic Abs
Products
APIs
Domestic Formulations
International Formulations
Insugen
Financials
CIPLA
Company Strategy
Manufacturing
R&D
Key Markets
Major Developments
Strategic Alliances & Agreements
Akorn
Malaria agreement with DNDi
Divestiture of Cipla Medpro
Products
APIs
Domestic Formulations
International Generics
US
Europe
Financials
CLARIS LIFESCIENCES
Company Strategy
Manufacturing
R&D
Key Markets
Major Developments
Marketing agreement with Pfizer
Products
Domestic Formulations
International Generics
DR. REDDY’S
Company Strategy
Manufacturing
USP’s Pharmaceutical Ingredient Verification Programme
R&D
Perlecan
Cancer
Diabetes
Key Markets
Major Developments
Mergers & Acquisitions
BASF contract manufacturing operations
Dowpharma’s UK Small Molecules business
Jet Generici
betapharm
Roche’s Mexico API facility
Joint Ventures
China - Kunshan Rotam Reddy Pharmaceutical Co., Ltd.
South Africa - Dr. Reddy’s Laboratories (Proprietary) Ltd.
Agreements
Dr Reddy's enters strategic alliance with Aegis Therapeutics
Dr. Reddy’s files fondaparinux ANDA under Alchemia agreement
Dr Reddy’s makes dermatology product advances
TMH/Dr Reddy's sign agreement to create self-injectable product
Aquapharm signs new agreement and extends R&D licence with Dr Reddy's
7TM/Dr. Reddy’s enter drug-discovery collaboration
Dr. Reddy’s and Torrent sign Russian lisinopril agreement
Dr. Reddy's and ClinTec Co-Development Agreement
Dr. Reddy’s and Argenta announce R&D collaboration
Dr. Reddy’s and Rheoscience R&D collaboration
Dr. Reddy's/Pharmascience sign multi-product agreement
Litigation
Clarinex-D settlement with Schering-Plough and Sepracor
AstraZeneca sues Dr Reddy’s over generic zafirlukast
US court affirms that Eisai's Aciphex patent is valid and enforceable
Products
APIs
Domestic Formulations
International Generics
US
Europe
Financials
GLENMARK
Company Strategy
Manufacturing
R&D
Key Markets
Major Developments
Mergers & Acquisitions
Glenmark begins Polish venture
Glenmark purchases rights to CHR-1103 and CHR-1201 from Chromos
Medicamenta, Czech Republic
Bouwer Bartlett, South Africa
Agreements
Lilly/Glenmark form TRPV1 partnership
R&D agreement with Dyax for therapeutic antibodies
Merck KGaA
Royalty deal with Paul Capital Partners
Lehigh Valley Technologies
Aspen USA
Generics agreement with InvaGen for US market
Litigation
Glenmark launches fluticasone patent challenge; Nycomed files lawsuit
Abbott’s trandolapril/verapamil product
Products
APIs
Domestic Formulations
International Generics
US
Europe
Brazil
Financials
JUBILANT ORGANOSYS
Company Strategy
Manufacturing
R&D
Acquisitions
Draxis Health
Speciality Molecules Pvt. Ltd.
Hollister-Stier Laboratories
Trinity Laboratories/Trigen Laboratories
Joint Ventures
Jubilant/UAB/SRI form drug-discovery JV
Collaboration and JV with Eli Lilly
Agreements
Jubilant and Endo expand oncology drug discovery partnership
Duke and Jubilant announce intent for global research/drug-development partnership
Jubilant to provide preclinical drug candidates for AstraZeneca's pipeline
Distribution agreement with Guerbet
Jubilant and BioLeap enter drug-discovery alliance
Jubilant in Drug Discovery partnership with Amgen
Neoprobe signs non-binding LoI with Draximage for Lymphoseek distribution
Products
APIs
International Generics
US
Canada
Europe
Financials
LUPIN
Company Strategy
Manufacturing
R&D
Key Markets
Major Developments
Acquisitions
Multicare Pharmaceuticals Philippines
Pharma Dynamics
Generic Health
Hormosan Pharma GmbH
Kyowa Pharmaceutical Industry
Rubamin Laboratories
Agreements
Lupin/Salix to develop ER rifaximin using bioadhesive technology
Lupin/Forest agree US marketing pact for AeroChamber Plus
GSK Philippines
Litigation
Depomed files lawsuit against Lupin
Warner Chilcott files oral contraceptive litigation against Lupin
Lupin settles venlafaxine litigation with Wyeth
Lupin/Schering-Plough settle desloratadine litigation
Products
APIs
Domestic Formulations
International Formulations
US
Europe
Financials
MATRIX LABORATORIES
Company Strategy
Manufacturing
R&D
Key Markets
Major Developments
Mergers, Acquisitions & Divestitures
Aspen and Matrix end joint venture
Acquisition of residual holding in MChem
Mylan acquires Matrix
Matrix gains 43% stake in Explora
Matrix acquires Docpharma
Matrix purchases finished dosage facility
Agreements
Clinton HIV/AIDS Initiative
Litigation
Mylan/Matrix enter settlement deal with Pfizer for Vfend Tablets
Daiichi Sankyo sues Matrix for Azor patent infringement
Products
APIs
International Generics
Financials
ORCHID CHEMICALS & PHARMACEUTICALS
Company Strategy
Manufacturing
R&D
Key Markets
Major Developments
Sale of generic injectable formulations business to Hospira
Agreements
Ranbaxy
Actavis
Alpharma (now Actavis)
Acquisitions & Joint Ventures
Bexel Pharmaceuticals Inc.
Biotechnological Chemical Development Ltd.
NCPC Orchid Pharmaceuticals Ltd.
Litigation
Products
APIs
Domestic Formulations
International Generics
US
Europe
Financials
PIRAMAL HEALTHCARE
Company Strategy
Abbott to acquire Piramal's Healthcare Solutions Business
Manufacturing
R&D
Key Markets
Major Developments
Mergers & Acquisitions
Bharat Serums and Vaccines’ anaesthetic products business
Minrad International
RxElite’s inhalation anaesthetic gas distribution business
Haemaccel Brands Group of PlasmaSelect AG, Germany
Pharmaceuticals business of Healthline Private Limited, Bangalore
Boots Piramal Healthcare
Pfizer’s Morpeth facility
Agreements & Joint Ventures
Eli Lilly
Napo Pharmaceuticals
BioSyntech
AstraZeneca
Products
APIs
Domestic Formulations
International Formulations
Financials
RANBAXY
Company Strategy
Manufacturing
R&D
Key Markets
Major Developments
Daiichi Sankyo to commercialise products in Mexico through Ranbaxy subsidiary
Daiichi Sankyo acquires Ranbaxy
Industry comment
FDA takes regulatory action against Ranbaxy
Congressional Committee expands Ranbaxy probe to include PEPFAR programme
Mergers & Acquisitions
Ranbaxy acquires product rights and facility from Biovel
Ranbaxy acquires dermatology brands from Bristol-Myers Squibb
Ranbaxy acquires Be-Tabs for US$71 million
Ranbaxy acquires GSK's Mundogen generic business in Spain
Ranbaxy acquires Terapia
Ranbaxy acquires generic product portfolio from Efarmes
Divestitures
Ranbaxy (Guangzhou China) Limited (RGCL)
Agreements
Ranbaxy to market Gliadel for gliomas in India
Cipher/Ranbaxy enter agreement for CIP-Isoptretinoin acne treatment
Ranbaxy/Merck enter anti-infective drug-discovery and -development collaboration
Ranbaxy and Orchid enter long-term strategic alliance
Ranbaxy/DBT collaborate to develop TB therapeutics
Ranbaxy signs first biosimilars agreement
R&D Agreement with GlaxoSmithKline
Ipca and Ranbaxy sign deal for US market
Ranbaxy signs Canadian licensing and supply agreements with Janssen-Ortho
Ranbaxy to market Lupin’s TB brands in Africa
Litigation
Ranbaxy and Takeda settle Actos litigation
Pfizer and Ranbaxy settle majority of worldwide atorvastatin litigations
AstraZeneca settles esomeprazole patent litigation with Ranbaxy; enters further agreements
Forest and Merz file second suit against memantine challengers
Ranbaxy settles possible litigation with GSK over sumatriptan
Ranbaxy, Astellas and Boehringer resolve tamsulosin US patent litigation
Novartis sues Ranbaxy over valsartan
Ranbaxy and Goldshield win SFO cases
UK Department of Health legal action settled
Products
APIs
Domestic Formulations
International Formulations
Ranbaxy/Daiichi Sankyo global partnership
US
Canada
Europe
Australia
Japan
Brazil
Financials
STRIDES ARCOLAB
Company Strategy
Manufacturing
R&D
Key Markets
Major Developments
Acquisitions, Agreements & Joint Ventures
Strides to acquire injectable facility in Brazil from Aspen
Strides & Aspen restructure oncology partnership
Pfizer and Strides collaborate on generics
Ascent Pharmahealth
GlaxoSmithKline
Sagent
Grandix
Joint venture relationship for Spain and Portugal
Akorn-Strides
Products
Domestic Formulations
International Generics
US
Financials
SUN PHARMA
Company Strategy
Manufacturing
R&D
Key Markets
Major Developments
Mergers & Acquisitions
Taro Pharmaceutical Industries
Chattem Chemicals
Able Laboratories
Valeant
Litigation
Orion sues Sun Pharma to enforce patent covering Comtan
Products
APIs
Domestic Formulations
International Generics
US
Europe
Financials
TORRENT PHARMACEUTICALS
Company Strategy
Manufacturing
R&D
Key Markets
Major Developments
Mergers & Acquisitions
Heumann Pharma Generics
Agreements
Torrent signs licence and supply agreement with AstraZeneca
Dr Reddy’s and Torrent sign Russian lisinopril agreement
Torrent Pharma licenses AGE compound to Novartis
Products
Domestic Formulations
International Generics
US
Brazil
Financials
WOCKHARDT
Company Strategy
Manufacturing
R&D
Key Markets
Major Developments
Divestitures
Wockhardt sells its German business
Acquisitions
Morton Grove
Negma Laboratories
Pinewood Laboratories
Agreements & Joint Ventures
Wockhardt and Sinclair Pharma reach in-licensing and collaborative agreements
IDC and Wockhardt co-develop insulin pens for Indian market
Li-Taka Pharmaceuticals
Wockhardt Mexico
Wockhardt South Africa
Litigation
Orion and Wockhardt settle entacapone-based products litigation
Products
APIs
Domestic Formulations
International Generics
US
Europe
Financials
ZYDUS CADILA
Company Strategy
Manufacturing
R&D
Key Markets
Major Developments
Mergers & Acquisitions
Simayla Pharmaceuticals
Etna Biotech
Laboratorios Combix
Quimica e Farmaceutica Nikkho do Brasil
Nippon Universal Pharmaceutical
Liva Healthcare
Agreements & Joint Ventures
Zydus and Lilly collaborate on CV drug discovery/development
Zydus collaborates with WHO to develop MAb cocktail for rabies
Nycomed chemical production moved to Zydus Nycomed
Karo Bio/Zydus Cadila sign research agreement for novel GR modulators
Evolupharn and Aerocid
Bharat Serums and Vaccines
Venus Remedies
Mallinckrodt
Litigation
Three Rivers sues Zydus Cadila for ribavirin patent infringement
Products
APIs
Domestic Formulations
International Generics
US
Europe
Japan
Brazil
Financials
SOURCES
Espicom Sources
Others
LIST OF TABLES
Indian Company Sales, 2009
FDA ANDA Approvals, 2002-2010 (Number)
Indian Pharmaceutical Companies’ US Subsidiaries
FDA ANDA Approvals, January 2008 – March 2010
Indian Pharmaceutical Companies’ EU Subsidiaries
UK Marketing Authorisations, 2008-2010
Indian Company Registrations of Generic Medicines in Brazil, November 2009
Indian Companies’ Foreign Acquisitions
Export Summary, 2004-2008 (US$000)
Retail Medicament Exports, 1998-2008 (US$000)
Alembic’s Manufacturing Facilities
Alembic: Top 8 Brands
Alembic: FDA ANDA Approvals, 2009
Alembic: Financial Results 2006-2010
Aurobindo Pharma: Manufacturing Facilities
Aurobindo Pharma: Key Subsidiaries
Aurobindo Pharma: ANDA Approvals, 2004-2010
Cephazone Pharma: FDA ANDA Approval, 2007
Aurobindo UK MHRA Authorisations, 2006-2009
Milpharm UK MHRA Authorisations, 2006-2009
Aurobindo Pharma: Financial Results, 2005-2009
Biocon: Financial Results, 2006-2010
Cipla: Manufacturing Facilities
Cipla: FDA ANDA Approvals
Cipla: Tentative FDA ANDA Approvals
Cipla: Tentative FDA NDA Approvals
Cipla: Financial Results, 2006-2010
Claris Lifesciences: Key Subsidiaries
Claris Lifesciences: FDA ANDA Approvals, 2008
Dr. Reddy’s: Manufacturing Facilities
Dr. Reddy’s: Regional Headquarters and Key Subsidiaries
Dr. Reddy’s: Top 10 Brands in India, 2005-2009
Dr. Reddy’s: FDA ANDA Approvals, 2002-2010
Dr. Reddy’s: UK MHRA Marketing Authorisations, 2006-2010
Dr. Reddy’s: Financial Summary, 2006-2010
Glenmark Pharmaceuticals: Manufacturing Facilities
Glenmark Generics: Manufacturing Facilities
Glenmark: Key Subsidiaries
Glenmark: FDA ANDA Approvals, 2006-2010
Glenmark: UK MHRA Authorisations, 2008-2009
Glenmark: ANVISA Registered Generics, 2009
Glenmark: Financial Results, 2006-2010
Jubilant Organosys: Manufacturing Facilities
Cadista (Jubilant): FDA ANDA Approvals, 2004-2010
Pharmaceutical Services Incorporated (PSI): MHRA Authorisations, 2007
Jubilant Pharmaceuticals NV: MHRA Authorisations, 2009-2010
Jubilant Organosys: Financial Results, 2006-2010
Lupin: Manufacturing Facilities
Lupin: Leading Brands in India, 2008
Lupin: FDA ANDA Approvals, 2003-2010
Lupin: Tentative FDA Approvals
Lupin: UK MHRA Authorisations, 2007-2010
Lupin: Financial Results, 2006-2010
Matrix: Manufacturing Facilities
Matrix: FDA ANDA Approvals, 2008-2010
Matrix: Tentative ANDA Approvals
Matrix: Financial Results, 2005-2009
Orchid: Manufacturing Facilities
Orchid: Key Subsidiaries and Joint Ventures
Orchid: Top Ten Brands
Orchid: FDA ANDA Approvals, 2005-2010
Orchid: UK MHRA Authorisations, 2008-2010
Orchid: Financial Results, 2006-2010
Piramal Healthcare: Manufacturing Facilities
Piramal Healthcare: Financial Results, 2006-2010
Piramal Healthcare: Formulations Sales by Therapeutic Area, 2007-2009 (Rs. Million)
Ranbaxy: Manufacturing Facilities
Ranbaxy: Regional Headquarters & Key Subsidiaries
Ranbaxy Laboratories: FDA ANDA Approvals, 2002-2009
Ohm Laboratories: FDA ANDA Approvals, 2006-2009
UK MHRA Marketing Authorisations, 2006-2010
Ranbaxy: ANVISA Registered Generics, 2009
Ranbaxy: Financial Results, 2005-2009
Ranbaxy: Sales by Region, 2009
Strides Arcolab: Manufacturing Facilities
Strides Arcolab: Key Subsidiaries
Akorn Strides: FDA ANDA Approvals, 2007-2009
Sagent Strides: FDA ANDA Approvals
Strides Arcolab FDA ANDA Approvals
Strides: Financial Results, 2005-2009
Sun Pharma: Manufacturing Facilities
Sun Pharma: Key Subsidiaries
Sun Pharma: FDA ANDA Approvals, 2006-2009
Caraco Pharmaceutical: ANDA Approvals, 2002-2008
Sun Pharma Tentative ANDA Approvals
Sun Pharma UK Marketing Authorisations, 2008-2010
Sun Pharma: Financial Results, 2006-2010
Torrent Pharma: Manufacturing Facilities
Torrent Pharma: Key Subsidiaries
Torrent Pharma: FDA ANDA Approvals, 2007-2010
Torrent Pharma: Financial Results, 2006-2010
International Sales by Region, 2009
Wockhardt Manufacturing Facilities
Wockhardt: Key Subsidiaries
Wockhardt: FDA ANDA Approvals, 2003-2009
Wockhardt UK Marketing Authorisations, 2006-2009
Pinewood Laboratories UK Marketing Authorisations, 2006-2009
Wockhardt: Financial Results, 2005-2009
Wockhardt Sales by Region, 2008
Zydus Cadila: Manufacturing Facilities
Zydus Cadila: Key Subsidiaries
Zydus: ANDA Approvals, 2005-2009
Zydus: Tentative FDA ANDA Approvals
Zydus ANVISA Registered Generics, 2009
Zydus Cadila: Financial Results, 2006-2010
LIST OF FIGURES
Map: Indian Pharmaceutical Company Headquarters
Map: Manufacturing Locations in India
Map: Indian Companies in the US
Map: Indian Companies in the UK and Ireland
Map: Indian Companies in Continental Europe
Map: Indian Companies in Brazil
Map: Indian Companies in China
Exports of Raw Materials & Retail Medicaments, 1998-2008 (US$000)
Pharmaceutical Exports by Category, 1998 & 2008 (%)
Pharmaceutical Export Growth, 1999-2008 (%)
Cipla: Exports by Region, 2009 (%)
Dr. Reddy’s: Generic Sales by Region, 2010 (%)
Glenmark: Formulations Sales by Region, 2010 (%)
Matrix: Sales by Region, 2009 (%)
Piramal Formulations Revenue by Therapeutic Area, 2009 (%)
Ranbaxy: Sales by Region, 2009 (%)
Strides: Revenue by Region, 2008
Torrent Pharma: International Sales by Region, 2009 (%)
Wockhardt: Sales by Region, 2008 (%)
Zydus Cadila: Formulation Sales by Region, 2009 (%)
Zydus Cadila: Domestic Formulations Sales by Therapy Area, 2009 (%) Skip to top