Top Indian pharmaceutical companies are shifting a major part of their manufacturing bases to major pharmaceutical markets of the world as the export is becoming the key to higher profits. At least a dozen manufacturing facilities of Indian companies are already operating in the US, Europe and Latin America catering to these markets. Many more medium scale companies are planning to do the same in the coming months. Exploding generics market in the US and Europe as a result of the patent expiry of a number of blockbuster molecules was the starting point for Indian companies to march towards the developed world for establishing manufacturing facilities.
The new Patent regime and the consequent pressure to find huge resources for spending on new molecular research also forced Indian companies to look overseas markets for support. Indian companies are currently focusing on mergers and acquisitions, filing of DMFs and ANDAs in the regulated markets, partnering with global giants, undertaking contract research and setting up own manufacturing facilities. PHARMABIZ has taken a close look at these activities of Indian pharma companies in recent times and presented there efforts towards globalization drive.
Ranbaxy Laboratories, a leading Indian Pharma company, has already geared its resources towards globalization with more focus on entry in to new markets, filing of DMFs, ANDAs and patents, collaborative R&D efforts with multinationals, marketing tie ups, investments in wholly owned subsidiaries and building up of strong human resources.
The company expanded its New Drug Discovery Research facility and its total number of patent filed reached at 338 as at the end of 2004. It also launched its 'New Age Herbals' range with a basket of 3 new herbal products. The company filed 29 ANDA with US FDA and received 16 approvals. It has cumulatively filed about 150 ANDAs. Over 1100 personals are working in its R&D centers. The company is implementing expansion programme at Dewas Paonta Sahib, Mohali and Doansa in India.
Ranbaxy's international business contribute nearly 80 per cent of its total revenues. Of this US and Europe accounts for more than 50 per cent. It has presence in 21 European countries. The company introduced 41 new products and line extensions during 2004 of which 26 were developed in-house and 15 were outsourced.
Ranbaxy expanded its USA manufacturing facility at New Brunswick during 2004.The company is setting up a new plant at Sao Gonzalo near Rio de Janeiro in Brazil. It commissioned a state-of-the-art, high-speed infusion line at the Guangzhou facility in China. The company also commissioned its facility at Malaysia for manufacturing tablets and capsules. It commenced packaging lines at Cashel, Ireland, which will improve supply chain. Ranbaxy is implementing up-gradation work at its Nigerian facility.
Dr Reddy's Laboratories is increasing its presence in US and Europe by employing more and more people. It entered US through product partnerships but now established products under its own label. It is also strengthening its marketing team in other countries. It has setup a front-end commercial infrastructure in the US, Europe, Russia and China. The large investments in R&D has enabled it to emerge as a discovery-led global pharmaceutical company in short span. It is launching its own NCEs globally in niche therapeutic spaces with the objective to generate stable and attractive returns.
DRL is also focusing on biologics business for the emerging as well as developed markets. Biologics presents significant growth opportunities for innovator as well as generics companies. The company has set up research labs in India and Atlanta, USA with over 300 dedicated scientists. The company is managing the clinical development of two of its own NCEs outside India and one with in the country. DRL entered into dermatological segment by acquiring Trigenesis Therapeutics, Inc in US. As at the end of March 2005, it was awaiting approval from US FDA for 65 DMFs and 45 ANDAs.
DRL entered partnership with ICICI Venture to strengthen its development of generic pipeline. It also entered into an alliance with Pliva, a Europe-based pharma company, for the development and marketing of oncology products in Europe. It also entered a multi-product agreement for the development and marketing of generic products in Canada with Pharmascience Group. It has set up four plants outside India with two plants in UK, one in China and one in US.
Sun Pharmaceutical Industries Ltd has acquired stake in a Hungary based pharmaceutical company ICN Company Hungary Ltd from Valeant Pharmaceuticls International USA during August 2005.
It has strengthened its R&D activities by installing hi-tech R&D center at Mumbai for undertaking projects in new chemicals entity and novel drug delivery systems, bulk actives and formulations. The company launched 40 new product to market and awaiting approval for 22 new products. It has filed 399 patent up to March 2005. Sun is marketing its products in 26 markets across South East Asia, Russia, China, the Middle East and Africa. It has established its wholly owned subsidiary Caraco which posted turnover of US$ 60 million in the year 2004. The company commissioned its new plants at Dadra and Jammu during 2004-05 and doubled the capacity of its Panoli plant. The company added a new injectable at its Halol plant.
As a part of globalization Sun has strengthened its Caraco plant and invested over $4 million during last two years. The company has set up a joint venture unit in Dhaka, Bangladesh.
Aurobindo Pharma Ltd, a Hyderabad based pharma entity with 65 APIs in the non-antibiotics and over 55 APIs in the antibiotics segment, has established manufacturing facilities in the USA, Brazil and China. The company's 10 plants are located in Hyderabad and one each in Cuddalore, Vizag and Bhiwadi in Rajasthan. So far, it has invested Rs 495 crore in India on plants. The company has emerged as the largest producer of semi-synthetic penicillins in the continent, and is the fourth largest in the world.
The company filed 64 DMFs (24 with USFDA and 11 in Europe) and 25 ANDAs ( 15 with US FDA and 4 in Europe) during 2004-05. It filed 139 patents of which 24 have been granted. The company is one of the few proeucers of anti-retrovirals in the world withproduct and facility approvals from WHO and US FDA and others.
The company has setup 9 subsidiaries in various countries like USA, Canada, Netherlands, China Brazil, Thailand and Hong Kong. Further it has set up two manufacturing joint ventures in USA. The company has two plants in China and one in Brazil.
Nicholas Piramal India Ltd, a Rs 1200-crore Mumbai based pharma giant has completed its first international acquisition by acquiring Inhalation anaesthetics business of Rhodia Organique Fine Ltd for a consideration of Rs 58 crore. With this acquisition, NPIL is became a dominant global player in Halothane and gained a significant entry in the Isoflurane market. NPIL has set up a joint venture with Allergan India Ltd and Boots Piramal Healthcre Pvt Ltd.
The company entered in-licensing alliances with Laboratories Pierre Fabre, France, Genzyme Corporation ,USA and Ethypharm, France. The company is not focusing more on generics business but increasing its custom manufacturing business by entering new agreements.
Lupin Ltd is expanding its international operations by introducing new products into regulated market. Currently it is operating in more than 50 countries. It has identified CIS countries as a major growth area. Further, it has constituted a separate division 'AAMLA' to strengthen its foray into new markets like Japan, Australia, Latin America and others.
Lupin's subsidiary has set up Erythromycin plant in Thailand, which is facing stiff competition from China as well as India. The company filed 14 ANDAs and 15 DMFs in regulated market and entered into a development and licensing agreement with Cornerstone BioPharma Inc. Us for collaborating in the clinical development of a NDDS for an anti-infective product. The company set to launch injectible Ceftriaxone with the help of Baxter.
Wockhardt Ltd is focusing on biotechnology and setup global-scale biotech park at Auranabad during 2004 and launched Wosulin Pen, India's first automatic insulin deliverydevice, with recombinant insulin cartridge. The company's international business increased to Rs 700 crore with 50 per cent of the overall revenue coming from Europe and USA.
Wockhard achieved inorganic growth by implementing mergers and acquisitions. The company consolidated its UK business by merging CP Pharmaceuticals and Wallis Laboratories, which crossed annual sales of the Euro 50 million mark. The company has shifted large volume of products from UK plant to India as a cost saving measure.
Further Wockhardt has invested funds in its manufacturing facilities at Wrexham in UK during 2004. The company acquired sales and marketing infrastructure of esparma, Germany during May 2004
The company has formed joint ventures in Mexico and South Africa to stepped up its biopharmaceutical business.
Cadila Healthcare is expanding its global operations by entering into new collaborations with MNCs. The company entered into agreement with Zambon of Italy for manufacturing lyophilized vials. Further, it signed agreement with Mayne Pharma of Australia to set up integrated facilities for oncology injectables under a 50:50 joint venture. The company emerged as a Partner of Choice for research-driven pharma majors like Altana Pharma, Schering AG, and Boehringer Ingelheim.
The company acquired Alpharma France during 2003 and changed the name to Zydus France SAS. Its sales touched to Euro 7.2 million during 15 months period ended March 2005 from Euro 4.9 million in the last year.
Strides Arcolab Ltd has established strong presence in over 50 countries including main focus on US and Europe. The company has set up plants in New Jersey, USA, Mexico and Brazil with the help of its subsidiaries. The company received numbers of outlicensing and supply agreements with companies in US, UK, Australia Japan, South Africa and Europe. Its income from outlicensing activity increased to Rs 12 crore during 2003-04 from Rs 0.36 crore in the previous year.
Strides Arcolab has hive off its CRAM business into what is now called Strides Research and Specialty Chemicals Ltd during 2003-04. Further it has restructured its Latin American operations of the group and transferred its investments in subsidiaries/associate viz. Infabra, Solara SA de CV and Cellofarm Ltda to Strides Latina.
Cipla, the second largest pharma company in India, is managing its entire manufacturing business from India and exporting more than 45 per cent of its total income to various countries. It received approvals from major regulatory bodies like USFDA, MHRA, PIC Germany, MCC, TGA, the WHO, ANVISA, SIDC Slovak Republic and Department of health Canada. The company expanded its Goa capacity and set up new export oriented units in Kurkumbha and Bangalore. It is spending around 4 per cent of its total income on R&D activities.
Glenmark Pharmaceuticals is investing large amount in R&D activities and its NCE research made substantial progress with the company's lead molecule for asthma/ COPD. It has successfully completed the Phase-I clinical trials and also being out-licensed for the North American and Japanese market. For this the company collaborated with Forest Labs for North America and Teijin Pharma Ltd for Japan. Glenmark has established presence in 70 countries across the globe.
Glenmark acquired Laboratorios Klinger for a consideration of USD 6.25 million in Brazil. Klinger is a leading privately owned Brazilian company having ANVISA approved manufacturing facility in Greater Sao Paulo. Further, Glenmark has purchased a leading hormonal brand, Uno-Ciclo from Instituto Biochimico Industria Farmaceutica Ltd with exclusive manufacturing and marketing rights globally.
Torrent Pharmaceuticals has upgraded its manufacturing facilities to tap global opportunities. It is mainly focusing on five thrust areas - Brazil & Latin America, Russia & CIS countries, Europe, North America and Rest of the World. It has entered into a License Agreement with Novartis granting global rights for further development and commercialization of its patented Advanced Glycosylation Endproducts Breaker Compound to Novartis.The company also entered a research collaboration agreement with AstraZeneca to discovering a novel drug candidate for the treatment of hypertension. The company received approval for 32 products from USA, Japan, Europe, Czech Republic, Australia, Hong Kong, Russia and India. The company introduced 5 new products in Brazilian market during 2004-05.
Shasun Chemicals and Drugs Ltd has emerged as an integrated solutions provider and offering contract research and custom synthesis services to international customers like Aventis, Boots, Eli Lilly, GSK, Teva and others. It is undertaking contract manufacturing of both APIs and formulations. The company's manufacturing facilities successfully inspected by USFDA, MHRA, TGA and other regulatory bodies. It has set up a new R&D center to enhance capability and product development skills. Shasun filed 16 products in more than 22 countries for approvals.
Matrix Laboratories emerged as a major global player within short span and now expanding its boundaries by entering into new collaborations and tie-ups. As a backward integration to manufacture anti-retro viral intermediates, the company is setting up unit in China. International bodies are holding 48 per cent in equity capital, which will enable the company to access international resources and opportunities.
The company signed multi-year joint drug development collaboration agreement with a Rigen Inc, Japan during 2004-05. It also entered joint venture agreement with H Fischer & Co International GmbH and CES Beteiligungs GmbH Germany to develop and file finished dosage form dossiers for about 10 products. Matrix filed 31 DMFs with USFDA and introduced 18 new products during 2004-05.
Jubilant Organosys has adopted the growth strategy by acquiring units in foreign countries. The company acquired Trinity Laboratories, Inc along with its wholly owned subsidiary, Trigen Laboratories, Inc, a US based generic pharmaceuticals company. The cost of the acquisition worked out to $ 12.25 million during 2004-05. Trigen is in the business of generic dosage forms and has a USFDA approved cGMP compliant manufacturing facility in Maryland, US. The company also acquired pharmaceutical companies in Belgium which strengthen its presence in Europe.
Thus considering these activities like mergers and acquisitions, investment in R&D, expansion of capacities, setting up of subsidiaries and joint ventures, and raising funds by placement of FCCBs, GDRs and ADS, the Indian pharm giants will easily establish brand image in the world pharma market.