The Indian Active Pharmaceutical Ingredients (API) segment has established strong presence in world market and moving ahead with investments in R&D, expansion and new approvals from US and European authorities for their Drug Master Files (DMFs). Both listed and unlisted Indian pharma companies filed 90 DMFs during the first quarter of 2011 as compared to 75 and 91 DMFs respectively during first quarter of 2010 and 2009. The Indian pharma companies filed total 271 DMFs with US FDA during 2009 and 311 DMFs in 2010.

With investments in R&D and focus on quality as well as cost, Indian companies have been able to maintain their position in the international market. These API players are well ahead of other countries in filing of DMFs in US and Certificates of Suitability (CoS) in Europe. India ranks third in the world with producing about 500 different APIs and largest number of US FDA approved plants outside US.

The cost-cutting measures adopted by US and highly regulated countries in healthcare segment pushed the demands for low cost generics. Further, several blockbuster brands loss exclusivity during last couple of years and more are loosing in coming years. This assisted the overall growth in API operations and Indian players have grabbed this opportunity successfully.  The multinational pharma players adopted cost cutting measures to maintain profit margins. Sourcing bulk drugs from cost competitive destinations is one such strategic shift during last few years. Such a shift has provided India with immense opportunity for growth leveraging its existing capabilities.

Indian major players like Dr Reddy's Laboratories, Aurobindo Pharma,  Glenmark Pharmaceutical, Cipla, Lupin, Jubilant Life Sciences, Orchid Chemicals, Divi's Laboratories, Ranbaxy Laboratories, Ind-Swift Labs, etc., and several other manufacturers received higher approvals for DMFs in US as well as CoS in Europe. Indian players have been able to meet the domestic demand and exporting huge quantity to several emerging pharma markets as well as regulated markets. With number of international standard facilities, talent pool, CRAMS opportunities and backup of R&D activities, India has emerged as major hub for API sourcing.


DMFs filed in First Quarter of 2011