Indian pharma firms top in drug master file pleas

Indian drug makers have made the maximum number of drug master file (DMF) applications globally, underscoring its competitiveness at the global level.

The DMF list of the US Food and Drug Administration (FDA) for the second quarter of 2004 (April-June), reveals that Indian pharmaceutical firms have made 43 filings, or 27 per cent of all global filings.

A DMF is a submission to the US FDA that may be used to provide confidential detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of one or more human drugs. The information contained in the DMF may be used to support an investigational new drug application (IND), a new drug application (NDA), an abbreviated new drug application (ANDA), another DMF, an export application, or amendments and supplements to any of these.

For the first six months of 2004, Indian firms have filed 74 DMFs representing 30 per cent of all global filings.

This essentially indicates that the competition among the Indian companies to supply active pharmaceutical ingredients (API) to the US generic companies and in the abbreviated new drug application is increasing. The 43 DMFs are distributed among 25 Indian companies.

Dilip Shanghvi, chairman and managing director of Sun Pharmaceutical Industries told Business Standard, "The increasing number of DMF filings is a natural progression of the domestic market. Competing on very large-sized filings may affect the pricing of generics. However, it is difficult to say how universal this would be and how specifically the dynamics would evolve."

According to Kamal Sharma, managing director of Lupin, the growing trend of more and more Indian pharmaceutical companies going for DMF filings is a result of investments made by them to set up USFDA-approvable facilities necessary for entry into the lucrative US market.

"The investment in infrastructure has been adequately supported by increasing investment in research, for the development of a product portfolio for these markets of interest. The blend of products for short-term, mid-term and long-term shows the seriousness of Indian players towards US markets," he added.

An analyst said Indian pharma companies together have committed $1 billion to capacity expansion over 2003-05 which increases their fixed assets by two-thirds.

"In several products which go off patent in a year from now, there are more than three Indian product filings apart from the usual US generic companies," he added.

Teva has the largest generic pipeline of about 109 ANDAs and among Indian players Ranbaxy is understood to have the biggest pipeline. Though Ranbaxy, Dr Reddy's, Wockhardt, Cipla and Sun Pharma account for a majority of all DMFs by Indian companies, the growth is not restricted to the front-runners.

Lupin , Aurobindo Pharma, IPCA Laboratories, Matrix Laboratories, Orchid Chemicals and Pharmaceuticals are among the fast track players.