Indian pharmaceutical companies filed 417 Drug Master Files (DMFs) with the US FDA during the year 2012 as against 404 DMFs in the previous year. The DMF filings during the year 2010 and 2009 were at 311 and 271 respectively. This shows that the API segment is spreading its presence in market with higher filings. Hetero Drugs Ltd filed 24 DMFs followed by Emcure Pharmaceuticals Ltd 16, Hetero Laboratories Ltd 15, Aurobindo Pharma and Dr Reddy's Laboratories filed 13 each, Lupin filed 12 and Cadila Healthcare 11 during 2012. Macleods Pharmaceuticals and Sun Pharmaceutical Industries filed nine DMFs each.

The same trend is likely to continue in the current year also as Indian companies filed 79 DMFs during the first quarter ended March 2013. Jubilant Life Sciences filed 6 DMFs followed by Lupin and Sun Pharmaceutical five each.

India's API manufacturers have maintained momentum in filing DMFs in US with higher investments in cGMP facilities, research and development and talent pool during last couple of years. The major factors like better infrastructure, cost-effectiveness, contract research and manufacturing services and tie-ups with international players assisted well these API players. India remains one of most favored API destinations globally. Despite several odds like stiff competition, slowdown in world economy, cost-cutting measures in highly regulated markets and adverse foreign exchange rates, Indian API players dominated market share after China. Indian producers are well set to grab future opportunities coming from expiration of patents in next few years.

The major Indian companies like Dr Reddy's Laboratories, Lupin, Aurobindo Pharma, Divi's Laboratories, Ipca Laboratories, Alembic Pharmaceuticals, Glenmark Pharmaceuticals, Jubilant Life Sciences, Shasun Pharmaceuticals, Dishman Pharmaceuticals etc., have established strong presence in the markets and set to capture future opportunities. The financial performance of these companies remained mixed during the year 2012-13 due to competition, exchange rates and limited outcome from R&D activities.

India has been recognized as one of the leading global players with filing of large number of DMFs  and dossier registrations for Active Pharmaceutical Ingredients (APIs) with manufacturing facilities approved by regulatory authorities of the developed countries. Indian companies have emerged as a preferred pharmaceuticals manufacturing partners on account of R&D investments,  international quality standards and easy availability of talent pool. Indian API players are set to grab upcoming opportunities as several drugs are going off patent in the next couple of years. R&D based pharma companies are all ready in a position to grab the API contracts through technology tie-ups, expansions, cost optimization and development of new products.

However, the Indian API industry is facing stiff competition from China in the international market. Currency fluctuations, inflation, price erosion in the key international markets and increase in input costs put pressure on overall working during the last few years. The increased captive consumption of APIs due to substantial growth in the international formulations business restricted the sales volume of the APIs. The overcapacity for bulk products is adversely impacting the margins of API players. Several players reduced focus on APIs and shifted to other profitable segments like formulations.

DMF Filed during 2012 and 2013