Reportlinker Adds The Indian Pharmaceutical Industry: New Strategies in a Changing World
NEW YORK, July 19 /PRNewswire/ -- Reportlinker.com announces that a new market research report is available in its catalogue:
The Indian Pharmaceutical Industry: New Strategies in a Changing World
http://www.reportlinker.com/p0239938/The-Indian-Pharmaceutical-Industry-New-Strategies-in-a-Changing-World .html
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, Pro-Genericos, 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.
Table of Contents
FOREWORD ..... 1
THE INDIAN PHARMACEUTICAL INDUSTRY ........... 3
INTRODUCTION ... 3
Indian bases ... 5
Sales revenue 6
The advent of the product patent regime in India ........... 7
Background ... 7
The Patents (Amendments) Bill, 2005 .........8
Mashelkar Committee Report, December 2006 .........8
What effect has the product patent regime had on the pharmaceutical industry?................ 9
Looking beyond reverse-engineering ........9
In-licensing and custom manufacturing ....9
Key markets now and in the future .................. 10
Established and emerging generic markets .............. 10
The United States ........ 11
Authorised generics – threat or opportunity? .......... 22
Europe........... 23
South Africa 30
Brazil .............. 31
Australia ....... 36
Biosimilars ... 37
Biosimilars and Indian Companies ............ 39
India's competitive advantage . 40
Foreign acquisitions... 41
Exports .......... 46
COMPANY PROFILES ........ 49
ALEMBIC .............. 49
Company Strategy ...... 49
Manufacturing .............. 49
R&D................. 50
Key Markets 50
Major Developments . 51
Dabur Pharma Acquisition ......... 51
Products ....... 51
Domestic Formulations ............... 51
APIs ................. 51
International Formulations ........ 52
Generics........ 52
Financials ..... 53
AUROBINDO PHARMA ...... 54
Company Strategy ...... 54
Manufacturing .............. 55
R&D................. 56
Key Markets 57
Major Developments . 58
Trident Life Sciences acquisition ................ 58
Licensing and supply agreements with Pfizer .......... 58
TAD Italy acquisition .. 58
Pharmacin acquisition ................. 59
Acquisition of US facility ............. 59
Milpharm: Aurobindo's first acquisition in Europe . 59
Products ....... 59
APIs ................. 60
Domestic Formulations ............... 60
International Generics.................. 60
US and Canada ..... 60
CNS ......... 61
Antibacterials ......... 61
Antiretrovirals ........ 62
Cardiovascular ...... 62
European Union .... 65
South Africa ............ 66
Australia 67
Financials ..... 68
BIOCON ................ 69
Company Strategy ...... 69
Manufacturing .............. 69
R&D................. 70
Major Developments . 71
Acquisitions 71
Biocon buys majority stake in German marketing company ................ 71
Acquisition of asset of Nobex Corporation ............ 71
Agreements 71
Biocon to acquire CIMAB's stake in BBPL ............... 71
Syngene collaborates with Endo ........... 71
Amylin and Biocon to develop/commercialise novel phybrid for diabetes ......... 72
Mylan/Biocon form collaboration for generic biologics ...... 72
Abraxis and Biocon announce G-CSF partnership ................. 72
Invitrogen/Biocon sign agreement to market insulin to cell culture market ...... 72
Biocon/Vaccinex partner to discover and develop therapeutic Abs ... 73
Products ....... 73
APIs ................. 73
Domestic Formulations ............... 73
International Formulations ........ 74
Insugen .. 74
Financials ..... 75
CIPLA.. 76
Company Strategy ...... 76
Manufacturing .............. 76
R&D................. 77
Key Markets 78
Major Developments . 78
Strategic Alliances & Agreements .............. 78
Akorn...... 78
Malaria agreement with DNDi ............... 78
Divestiture of Cipla Medpro ...... 79
Products ....... 80
APIs ................. 80
Domestic Formulations ............... 80
International Generics.................. 82
US ............ 82
Europe ... 84
Financials ..... 84
CLARIS LIFESCIENCES ....... 86
Company Strategy ...... 86
Manufacturing .............. 86
R&D................. 86
Key Markets 87
Major Developments . 87
Marketing agreement with Pfizer .............. 87
Products ....... 88
Domestic Formulations ............... 88
International Generics.................. 88
DR. REDDY'S ....... 89
Company Strategy ...... 89
Manufacturing .............. 90
USP's Pharmaceutical Ingredient Verification Programme 91
R&D................. 92
Perlecan 92
Cancer.... 92
Diabetes 92
Key Markets 93
Major Developments . 94
Mergers & Acquisitions ................ 94
BASF contract manufacturing operations ............. 94
Dowpharma's UK Small Molecules business ......... 94
Jet Generici .............. 94
betapharm .............. 95
Roche's Mexico API facility.... 95
Joint Ventures ............... 95
China - Kunshan Rotam Reddy Pharmaceutical Co., Ltd. .... 95
South Africa - Dr. Reddy's Laboratories (Proprietary) Ltd. ... 95
Agreements 96
Dr Reddy's enters strategic alliance with Aegis Therapeutics ................ 96
Dr. Reddy's files fondaparinux ANDA under Alchemia agreement ..... 96
Dr Reddy's makes dermatology product advances ............... 96
TMH/Dr Reddy's sign agreement to create self-injectable product ..... 97
Aquapharm signs new agreement and extends R&D licence with Dr Reddy's ... 97
7TM/Dr. Reddy's enter drug-discovery collaboration ........... 97
Dr. Reddy's and Torrent sign Russian lisinopril agreement . 98
Dr. Reddy's and ClinTec Co-Development Agreement .......... 98
Dr. Reddy's and Argenta announce R&D collaboration ....... 98
Dr. Reddy's and Rheoscience R&D collaboration 98
Dr. Reddy's/Pharmascience sign multi-product agreement .................. 99
Litigation ...... 99
Clarinex-D settlement with Schering-Plough and Sepracor .................. 99
AstraZeneca sues Dr Reddy's over generic zafirlukast .......... 99
US court affirms that Eisai's Aciphex patent is valid and enforceable 99
Products .....100
APIs .............. 100
Domestic Formulations ............ 100
International Generics............... 101
US .......... 101
Europe . 104
Financials ...106
GLENMARK ....... 108
Company Strategy .... 108
Manufacturing ........... 109
R&D.............. 110
Key Markets ................ 112
Major Developments .................. 113
Mergers & Acquisitions ............. 113
Glenmark begins Polish venture .......... 113
Glenmark purchases rights to CHR-1103 and CHR-1201 from Chromos ........... 113
Medicamenta, Czech Republic ............. 113
Bouwer Bartlett, South Africa ............... 114
Agreements ................ 114
Lilly/Glenmark form TRPV1 partnership .............. 114
R&D agreement with Dyax for therapeutic antibodies ...... 114
Merck KGaA .......... 115
Royalty deal with Paul Capital Partners .............. 115
Lehigh Valley Technologies 115
Aspen USA ............. 116
Generics agreement with InvaGen for US market ................ 116
Litigation ... 116
Glenmark launches fluticasone patent challenge; Nycomed files lawsuit ........ 116
Abbott's trandolapril/verapamil product ............ 117
Products ..... 117
APIs .............. 117
Domestic Formulations ............ 117
International Generics............... 118
US .......... 118
Europe . 120
Brazil .... 120
Financials ... 121
JUBILANT ORGANOSYS .. 123
Company Strategy .... 123
Manufacturing ........... 124
R&D.............. 124
Acquisitions ................ 124
Draxis Health........ 124
Speciality Molecules Pvt. Ltd. ................ 125
Hollister-Stier Laboratories 125
Trinity Laboratories/Trigen Laboratories ............. 125
Joint Ventures ............ 126
Jubilant/UAB/SRI form drug-discovery JV ............ 126
Collaboration and JV with Eli Lilly ...... 126
Agreements ................ 127
Jubilant and Endo expand oncology drug discovery partnership ..... 127
Duke and Jubilant announce intent for global research/drug-development partnership ................ 127
Jubilant to provide preclinical drug candidates for AstraZeneca's pipeline ..... 127
Distribution agreement with Guerbet .................. 128
Jubilant and BioLeap enter drug-discovery alliance ........... 128
Jubilant in Drug Discovery partnership with Amgen .......... 128
Neoprobe signs non-binding LoI with Draximage for Lymphoseek distribution ............... 128
Products .....129
APIs .............. 129
International Generics............... 129
US .......... 129
Canada 129
Europe . 130
Financials .. 131
LUPIN ..................132
Company Strategy ....132
Manufacturing ........... 133
R&D.............. 134
Key Markets ................ 134
Major Developments ..................134
Acquisitions ................ 134
Multicare Pharmaceuticals Philippines ............... 134
Pharma Dynamics ................. 135
Generic Health ..... 135
Hormosan Pharma GmbH .. 135
Kyowa Pharmaceutical Industry ......... 135
Rubamin Laboratories ......... 135
Agreements ................ 136
Lupin/Salix to develop ER rifaximin using bioadhesive technology . 136
Lupin/Forest agree US marketing pact for AeroChamber Plus ........... 136
GSK Philippines .... 136
Litigation ... 136
Depomed files lawsuit against Lupin. 136
Warner Chilcott files oral contraceptive litigation against Lupin ...... 137
Lupin settles venlafaxine litigation with Wyeth . 137
Lupin/Schering-Plough settle desloratadine litigation ...... 137
Products .....138
APIs .............. 138
Domestic Formulations ............ 138
International Formulations ..... 139
US .......... 139
Europe . 141
Financials ... 142
MATRIX LABORATORIES 143
Company Strategy .... 143
Manufacturing ........... 143
R&D.............. 144
Key Markets ................ 144
Major Developments .................. 144
Mergers, Acquisitions & Divestitures ..... 144
Aspen and Matrix end joint venture ... 144
Acquisition of residual holding in MChem ........... 145
Mylan acquires Matrix ......... 145
Matrix gains 43% stake in Explora ...... 145
Matrix acquires Docpharma ................. 146
Matrix purchases finished dosage facility ............ 146
Agreements ................ 146
Clinton HIV/AIDS Initiative . 146
Litigation ... 147
Mylan/Matrix enter settlement deal with Pfizer for Vfend Tablets .... 147
Daiichi Sankyo sues Matrix for Azor patent infringement . 147
Products ..... 147
APIs .............. 147
International Generics............... 148
Financials ... 149
ORCHID CHEMICALS & PHARMACEUTICALS .................. 151
Company Strategy .... 151
Manufacturing ........... 152
R&D.............. 152
Key Markets ................ 153
Major Developments .................. 154
Sale of generic injectable formulations business to Hospira ................ 154
Agreements ................ 154
Ranbaxy ................. 154
Actavis . 154
Alpharma (now Actavis)...... 155
Acquisitions & Joint Ventures 155
Bexel Pharmaceuticals Inc. . 155
Biotechnological Chemical Development Ltd. ... 155
NCPC Orchid Pharmaceuticals Ltd. .... 155
Litigation ... 156
Products .....156
APIs .............. 156
Domestic Formulations ............ 156
International Generics............... 157
US .......... 157
Europe . 158
Financials ...160
PIRAMAL HEALTHCARE ..161
Company Strategy ....161
Abbott to acquire Piramal's Healthcare Solutions Business ................ 161
Manufacturing ........... 162
R&D.............. 163
Key Markets ................ 163
Major Developments ..................163
Mergers & Acquisitions ............. 163
Bharat Serums and Vaccines' anaesthetic products business ............ 163
Minrad International ............ 164
RxElite's inhalation anaesthetic gas distribution business .................. 164
Haemaccel Brands Group of PlasmaSelect AG, Germany . 164
Pharmaceuticals business of Healthline Private Limited, Bangalore .................. 165
Boots Piramal Healthcare ... 165
Pfizer's Morpeth facility ....... 165
Agreements & Joint Ventures 165
Eli Lilly .. 165
Napo Pharmaceuticals ........ 165
BioSyntech ............ 165
AstraZeneca.......... 166
Products .....166
APIs .............. 166
Domestic Formulations ............ 166
International Formulations ..... 166
Financials ...166
RANBAXY...........169
Company Strategy ....169
Manufacturing ........... 170
R&D.............. 171
Key Markets ................ 172
Major Developments .................. 172
Daiichi Sankyo to commercialise products in Mexico through Ranbaxy subsidiary ........ 172
Daiichi Sankyo acquires Ranbaxy ............ 173
Industry comment ................. 173
FDA takes regulatory action against Ranbaxy ....... 173
Congressional Committee expands Ranbaxy probe to include PEPFAR programme ..... 175
Mergers & Acquisitions ............. 176
Ranbaxy acquires product rights and facility from Biovel . 176
Ranbaxy acquires dermatology brands from Bristol-Myers Squibb . 176
Ranbaxy acquires Be-Tabs for US$71 million ..... 177
Ranbaxy acquires GSK's Mundogen generic business in Spain .......... 177
Ranbaxy acquires Terapia .. 177
Ranbaxy acquires generic product portfolio from Efarmes ................. 177
Divestitures ................. 177
Ranbaxy (Guangzhou China) Limited (RGCL) .... 177
Agreements ................ 178
Ranbaxy to market Gliadel for gliomas in India 178
Cipher/Ranbaxy enter agreement for CIP-Isoptretinoin acne treatment ........... 178
Ranbaxy/Merck enter anti-infective drug-discovery and -development collaboration .. 178
Ranbaxy and Orchid enter long-term strategic alliance .... 179
Ranbaxy/DBT collaborate to develop TB therapeutics ....... 179
Ranbaxy signs first biosimilars agreement .......... 179
R&D Agreement with GlaxoSmithKline ................ 179
Ipca and Ranbaxy sign deal for US market .......... 180
Ranbaxy signs Canadian licensing and supply agreements with Janssen-Ortho ............. 180
Ranbaxy to market Lupin's TB brands in Africa.. 180
Litigation ... 180
Ranbaxy and Takeda settle Actos litigation ........ 180
Pfizer and Ranbaxy settle majority of worldwide atorvastatin litigations ........ 181
AstraZeneca settles esomeprazole patent litigation with Ranbaxy; enters further agreements ..... 181
Forest and Merz file second suit against memantine challengers ..... 182
Ranbaxy settles possible litigation with GSK over sumatriptan ......... 182
Ranbaxy, Astellas and Boehringer resolve tamsulosin US patent litigation ..... 182
Novartis sues Ranbaxy over valsartan ................. 183
Ranbaxy and Goldshield win SFO cases .............. 183
UK Department of Health legal action settled .... 183
Products ..... 184
APIs .............. 184
Domestic Formulations ............ 184
International Formulations ..... 184
Ranbaxy/Daiichi Sankyo global partnership ...... 184
US .......... 185
Canada 189
Europe . 189
Australia................. 191
Japan ... 191
Brazil .... 191
Financials ...194
STRIDES ARCOLAB............196
Company Strategy ....196
Manufacturing ........... 196
R&D.............. 197
Key Markets ................ 197
Major Developments ..................198
Acquisitions, Agreements & Joint Ventures ........... 198
Strides to acquire injectable facility in Brazil from Aspen .. 198
Strides & Aspen restructure oncology partnership ............... 198
Pfizer and Strides collaborate on generics ........... 198
Ascent Pharmahealth .......... 198
GlaxoSmithKline . 199
Sagent . 199
Grandix 199
Joint venture relationship for Spain and Portugal ............... 199
Akorn-Strides ........ 199
Products .....200
Domestic Formulations ............ 200
International Generics............... 200
US .......... 200
Financials .. 202
SUN PHARMA ..203
Company Strategy ....203
Manufacturing ........... 204
R&D.............. 205
Key Markets ................ 206
Major Developments ..................206
Mergers & Acquisitions ............. 206
Taro Pharmaceutical Industries........... 206
Chattem Chemicals............... 208
Able Laboratories .................. 208
Valeant 208
Litigation ... 208
Orion sues Sun Pharma to enforce patent covering Comtan.............. 208
Products ..... 209
APIs .............. 209
Domestic Formulations ............ 209
International Generics............... 209
US .......... 209
Europe . 214
Financials ... 215
TORRENT PHARMACEUTICALS ...... 216
Company Strategy .... 216
Manufacturing ........... 216
R&D.............. 217
Key Markets ................ 217
Major Developments .................. 218
Mergers & Acquisitions ............. 218
Heumann Pharma Generics .................. 218
Agreements ................ 218
Torrent signs licence and supply agreement with AstraZeneca ......... 218
Dr Reddy's and Torrent sign Russian lisinopril agreement 219
Torrent Pharma licenses AGE compound to Novartis ......... 219
Products ..... 219
Domestic Formulations ............ 219
International Generics............... 220
US .......... 220
Brazil .... 220
Financials ... 221
WOCKHARDT ... 223
Company Strategy .... 223
Manufacturing ........... 224
R&D.............. 224
Key Markets ................ 225
Major Developments .................. 225
Divestitures ................. 225
Wockhardt sells its German business . 225
Acquisitions ................ 225
Morton Grove ....... 225
Negma Laboratories ............. 226
Pinewood Laboratories ....... 226
Agreements & Joint Ventures 226
Wockhardt and Sinclair Pharma reach in-licensing and collaborative agreements ........ 226
IDC and Wockhardt co-develop insulin pens for Indian market ........ 226
Li-Taka Pharmaceuticals .... 227
Wockhardt Mexico ................ 227
Wockhardt South Africa ...... 227
Litigation ... 227
Orion and Wockhardt settle entacapone-based products litigation 227
Products .....227
APIs .............. 228
Domestic Formulations ............ 228
International Generics............... 229
US .......... 229
Europe . 231
Financials ...232
ZYDUS CADILA ..................234
Company Strategy ....234
Manufacturing ........... 234
R&D.............. 235
Key Markets ................ 236
Major Developments ..................236
Mergers & Acquisitions ............. 236
Simayla Pharmaceuticals ... 236
Etna Biotech ......... 236
Laboratorios Combix............ 237
Quimica e Farmaceutica Nikkho do Brasil ........... 237
Nippon Universal Pharmaceutical...... 237
Liva Healthcare ... 237
Agreements & Joint Ventures 238
Zydus and Lilly collaborate on CV drug discovery/development ....... 238
Zydus collaborates with WHO to develop MAb cocktail for rabies.... 238
Nycomed chemical production moved to Zydus Nycomed ................. 238
Karo Bio/Zydus Cadila sign research agreement for novel GR modulators ...... 238
Evolupharn and Aerocid ..... 239
Bharat Serums and Vaccines ................ 239
Venus Remedies .. 239
Mallinckrodt ......... 239
Litigation ... 239
Three Rivers sues Zydus Cadila for ribavirin patent infringement ..... 239
Products .....240
APIs .............. 240
Domestic Formulations ............ 240
International Generics............... 241
US .......... 241
Europe . 243
Japan ... 243
Brazil .... 243
Financials ... 244
SOURCES .....247
Espicom Sources ............... 247
Others ................. 247
List of Tables
Indian Company Sales, 2009 ............... 7
FDA ANDA Approvals, 2002-2010 (Number) . 11
Indian Pharmaceutical Companies' US Subsidiaries ..... 12
FDA ANDA Approvals, January 2008 – March 2010 ...... 13
Indian Pharmaceutical Companies' EU Subsidiaries ..... 24
UK Marketing Authorisations, 2008-2010 ....... 26
Indian Company Registrations of Generic Medicines in Brazil, November 2009 ....... 33
Indian Companies' Foreign Acquisitions ........ 44
Export Summary, 2004-2008 (US$000) ............ 46
Retail Medicament Exports, 1998-2008 (US$000) .......... 48
Alembic's Manufacturing Facilities 50
Alembic: Top 8 Brands ..... 51
Alembic: FDA ANDA Approvals, 2009 ............. 52
Alembic: Financial Results 2006-2010 ............. 53
Aurobindo Pharma: Manufacturing Facilities .................. 56
Aurobindo Pharma: Key Subsidiaries .............. 57
Aurobindo Pharma: ANDA Approvals, 2004-2010 ......... 63
Cephazone Pharma: FDA ANDA Approval, 2007 ............ 65
Aurobindo UK MHRA Authorisations, 2006-2009 .......... 66
Milpharm UK MHRA Authorisations, 2006-2009 ............. 66
Aurobindo Pharma: Financial Results, 2005-2009 ......... 68
Biocon: Financial Results, 2006-2010 ............... 75
Cipla: Manufacturing Facilities ........ 77
Cipla: FDA ANDA Approvals ............. 83
Cipla: Tentative FDA ANDA Approvals ............. 83
Cipla: Tentative FDA NDA Approvals ............... 84
Cipla: Financial Results, 2006-2010 85
Claris Lifesciences: Key Subsidiaries ................. 87
Claris Lifesciences: FDA ANDA Approvals, 2008 ............. 88
Dr. Reddy's: Manufacturing Facilities ............... 91
Dr. Reddy's: Regional Headquarters and Key Subsidiaries ............ 94
Dr. Reddy's: Top 10 Brands in India, 2005-2009 ............101
Dr. Reddy's: FDA ANDA Approvals, 2002-2010 ..............103
Dr. Reddy's: UK MHRA Marketing Authorisations, 2006-2010 ...105
Dr. Reddy's: Financial Summary, 2006-2010 106
Glenmark Pharmaceuticals: Manufacturing Facilities 109
Glenmark Generics: Manufacturing Facilities .................110
Glenmark: Key Subsidiaries .............112
Glenmark: FDA ANDA Approvals, 2006-2010 .................119
Glenmark: UK MHRA Authorisations, 2008-2009 ..........120
Glenmark: ANVISA Registered Generics, 2009 ...............121
Glenmark: Financial Results, 2006-2010 ........122
Jubilant Organosys: Manufacturing Facilities ................124
Cadista (Jubilant): FDA ANDA Approvals, 2004-2010 .129
Pharmaceutical Services Incorporated (PSI): MHRA Authorisations, 2007 .................130
Jubilant Pharmaceuticals NV: MHRA Authorisations, 2009-2010 ................130
Jubilant Organosys: Financial Results, 2006-2010........131
Lupin: Manufacturing Facilities .....134
Lupin: Leading Brands in India, 2008 .............138
Lupin: FDA ANDA Approvals, 2003-2010 ......140
Lupin: Tentative FDA Approvals ...140
Lupin: UK MHRA Authorisations, 2007-2010 ..................141
Lupin: Financial Results, 2006-2010 ...............142
Matrix: Manufacturing Facilities ....144
Matrix: FDA ANDA Approvals, 2008-2010 .....149
Matrix: Tentative ANDA Approvals .................149
Matrix: Financial Results, 2005-2009 ..............150
Orchid: Manufacturing Facilities ...152
Orchid: Key Subsidiaries and Joint Ventures ..................153
Orchid: Top Ten Brands .156
Orchid: FDA ANDA Approvals, 2005-2010 ....158
Orchid: UK MHRA Authorisations, 2008-2010 ................159
Orchid: Financial Results, 2006-2010 ............. 160
Piramal Healthcare: Manufacturing Facilities................. 162
Piramal Healthcare: Financial Results, 2006-2010 ........ 167
Piramal Healthcare: Formulations Sales by Therapeutic Area, 2007-2009 (Rs. Million) ........... 167
Ranbaxy: Manufacturing Facilities .................. 171
Ranbaxy: Regional Headquarters & Key Subsidiaries . 172
Ranbaxy Laboratories: FDA ANDA Approvals, 2002-2009 ........... 187
Ohm Laboratories: FDA ANDA Approvals, 2006-2009 .................. 189
UK MHRA Marketing Authorisations, 2006-2010 .......... 190
Ranbaxy: ANVISA Registered Generics, 2009 ................. 192
Ranbaxy: Financial Results, 2005-2009 .......... 194
Ranbaxy: Sales by Region, 2009 .... 195
Strides Arcolab: Manufacturing Facilities ..... 197
Strides Arcolab: Key Subsidiaries .. 197
Akorn Strides: FDA ANDA Approvals, 2007-2009 ......... 201
Sagent Strides: FDA ANDA Approvals ............ 201
Strides Arcolab FDA ANDA Approvals ........... 201
Strides: Financial Results, 2005-2009 ............. 202
Sun Pharma: Manufacturing Facilities ............ 205
Sun Pharma: Key Subsidiaries ........ 206
Sun Pharma: FDA ANDA Approvals, 2006-2009 ............ 211
Caraco Pharmaceutical: ANDA Approvals, 2002-2008 .................. 213
Sun Pharma Tentative ANDA Approvals ....... 214
Sun Pharma UK Marketing Authorisations, 2008-2010................. 214
Sun Pharma: Financial Results, 2006-2010 ... 215
Torrent Pharma: Manufacturing Facilities .... 217
Torrent Pharma: Key Subsidiaries. 218
Torrent Pharma: FDA ANDA Approvals, 2007-2010 .... 220
Torrent Pharma: Financial Results, 2006-2010............... 221
International Sales by Region, 2009 ............... 221
Wockhardt Manufacturing Facilities .............. 224
Wockhardt: Key Subsidiaries .......... 225
Wockhardt: FDA ANDA Approvals, 2003-2009 .............. 230
Wockhardt UK Marketing Authorisations, 2006-2009 232
Pinewood Laboratories UK Marketing Authorisations, 2006-2009 ............ 232
Wockhardt: Financial Results, 2005-2009 ..... 233
Wockhardt Sales by Region, 2008 233
Zydus Cadila: Manufacturing Facilities .......... 235
Zydus Cadila: Key Subsidiaries .......236
Zydus: ANDA Approvals, 2005-2009 ..............242
Zydus: Tentative FDA ANDA Approvals .........243
Zydus ANVISA Registered Generics, 2009.....244
Zydus Cadila: Financial Results, 2006-2010 ..245
List of Figures
Map: Indian Pharmaceutical Company Headquarters .... 5
Map: Manufacturing Locations in India ............. 6
Map: Indian Companies in the US .. 12
Map: Indian Companies in the UK and Ireland ................ 25
Map: Indian Companies in Continental Europe .............. 30
Map: Indian Companies in Brazil..... 31
Map: Indian Companies in China .... 41
Exports of Raw Materials & Retail Medicaments, 1998-2008 (US$000) ....... 46
Pharmaceutical Exports by Category, 1998 & 2008 (%) .................. 47
Pharmaceutical Export Growth, 1999-2008 (%) .............. 48
Cipla: Exports by Region, 2009 (%). 85
Dr. Reddy's: Generic Sales by Region, 2010 (%) .............107
Glenmark: Formulations Sales by Region, 2010 (%) ....122
Matrix: Sales by Region, 2009 (%) .150
Piramal Formulations Revenue by Therapeutic Area, 2009 (%) 168
Ranbaxy: Sales by Region, 2009 (%) ...............195
Strides: Revenue by Region, 2008 202
Torrent Pharma: International Sales by Region, 2009 (%)............222
Wockhardt: Sales by Region, 2008 (%) ...........233
Zydus Cadila: Formulation Sales by Region, 2009 (%) 245
Zydus Cadila: Domestic Formulations Sales by Therapy Area, 2009 (%) ..246
To order this report:
Pharmaceutical Industry: The Indian Pharmaceutical Industry: New Strategies in a Changing World
Check our Company Profile, SWOT and Revenue Analysis!
Nicolas Bombourg |
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