India is fast emerging as a power house of API production. According to industry reports, pharmaceutical companies from India submitted 119 DMF with the US Food and Drug Administration in 2003.
It amounts to a third of all the Drug Master Files for active pharma ingredients received in the US, followed by Italy (31) China and Israel (20-odd piece). Ranbaxy and Dr Reddys accounted for the largest number of DMFs filed.
DMFs are generic dossiers filed with the FDA in order to allow the API to appear in marketed drugs. Using this approach, an API manufacturer files just one application for a product, which can then be used to support approval of any generic based on that API.
Several major Indian pharma companies are stepping up there investments to capture more market share in the post Patent regime. Dr Reddy's Laboratories, Ranbaxy, Nicholas Piramal, Wockhardt, Lupin focusing on APIs as growth area.
Dr Reddy's Laboratories Ltd, with the largest API pipelines in the Indian Pharma industry, has filed 16 DMFs with the USFDA. This took the total number of DMFs on file with the USFDA to 56 as at the end of March 2004. The company is planning to file 20 DMFs in the current year. It launched ramipril API successfully in Europe and now set to launch new products. The company filed 6 PMFs in Canada and 10 EDMFs in Europe making total filings of 18 PMFs and 23 EDMFs respectively.
Dr Reddy's API revenue, based on US GAAP, increased to Rs 762.90 crore during 2003-04 from Rs 634.10 crore in 2002-03. Its exports of API went up to Rs 551.30 crore from Rs 459.2 crore. The share of Europe in the API sales increased from 7 per cent to 21 per cent in 2003-04 mainly due to launch of ramipril.
Ranbaxy Laboratories, a leading pharmaceutical company of India, continued with its focus on developing innovative, environment friendly and cost-effective technologies for high-value APIs. It filed total 148 patent applications in various countries during the year ended December 2003. Out of this, it filed 17 applications in US and received approval for 6 products.
Nicholas Piramal India, a relatively small player in APIs, achieved sales of Rs 73.49 crore during the year ended March 2004 as compared to Rs 18.29 crore in the previous year. Its exports of APIs went up to Rs 62.15 crore from 14.20 crore. Exports to regulated markets formed about 70 per cent of the API export sales. The current API portfolio consists of diltiazem, ketoconazole and verapamil hydrochloride. It has filed DMFs for diltiazem, varapamil hydrochloride, ketaconazole and itraconazole during 2003-04.
Lupin Ltd is manufacturing APIs at its globally accredited facilities in Mandideep (Madhya Pradesh), Ankleshwar (Gujarat) and Tarapur (Maharashtra). The API business constituted 50 per cent of the net revenues of Rs 1180 crore during the year ended March 2004. It continues to be a leader in the anti-TB and cephalosporin segments and now moved its API business strategically towards the cardiovascular segments. The company commenced exports of cefuroxime axetil to the lucrative US market. It also entered an agreement for the supply of cefotaxime for inclusion in a novel delivery system developed by its partner.
Lupin is taking steps to enhanced fermentation and process chemistry competencies to create products for the developed markets. It is creating powerful position in value-added cephaloshporins, statins and prils. It has developed a range of patent non-infringing processes, leading to the development of APIs that are sold to global customers. The company is investing large funds on R&D to generate higher revenues. It invested Rs 10 crore for API statins facility during the year ended March 2004 and Rs 22 crore for new API prils facility in the previous year. The company emerged a global player in cephalosporin APIs with approval from USFDA. Further, it is the only company in India and one of the few companies in the world to have its injectables facilities both, API as well as finished dosage, approved by the USFDA.
Lupin has filed a DMF for benazepril as well as for lovastatin and more products are in the pipeline. Lupin's sales of APIs and finished products from advanced market increased to Rs 229 crore during 2003-04 from Rs 109 crore in the previous year.
Wockhardt Ltd filed 30 DMFs in the US and eight European Certificates of Suitability in Europe during the year ended December 2003. It has been one of the leading suppliers of captopril active pharmaceutical ingredient to the US market. The company is planning to launch captopril tablets directly in the US wholesale market in the current year.
J B Chemicals and Pharmaceutical's API division generated revenues of Rs 22 crore during the year ended March 2004. The company is exporting APIs to more than 25 countries across America and Europe with a value of 43 per cent and 46 per cent respectively. Most of its API molecules have the DMF numbers while its manufacturing facility for diclofenec potassium and metronidoazole received the USFDA approval.
Similarly, a number of South-based players including Shasun Chemicals, Orchid Pharma, Aurobindo,Divi's etc are also position themselves as leading players in API business.