India accounts for 35% of U.S. drug master filings
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India accounts for 35% of U.S. drug master filings

By agencies   |   Wednesday, 20 July 2005, 07:00 Hrs
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MUMBAI: Matrix Laboratories, the Indian pharma company has filed the highest number of drug master files (DMF) with the U.S. Food & Drug Administration (U.S. FDA) in the second quarter of calendar year 2005.

Matrix has filed 12 DMFs out of the total 74 filings made by Indian companies during the period.

Dr Reddy’s follows at the second slot with eight DMFs, another Hyderabad-based company Aurobindo Pharma filed six DMFs during the quarter.

Drug master files (DMFs) are confidential, proprietary assets that present to U.S. Food and Drug A the formulae, processes, test methodology, and other data relevant to the manufacture of products used in the composition, packaging, processing of pharmaceuticals or biologics.

With 74 out of 213 DMFs filed with the U.S. FDA, Indian companies accounted for 35 percent new DMF filings during the period.

China, the emerging giant in the bulk drug business in Asia, has only 10 percent of the filings, states the DMF list released by the FDA this week.

Industry analysts pointed out that the trend of more players filing for the same molecule has continued with nine molecules now seeing greater competition as against 12 in the first quarter of 2005. Five additional molecules now have more than five Indian players in competition.

“This trend has really caused concern within the industry as the pricing pressure will be intense in the U.S. generics market, where Indian companies have bigger stake as the domestic market is shrinking in the post-patents period,” said an industry analyst.

A recent DMF update by J P Morgan shows that 70 percent ($27 billion out of $39 billion) of the molecules coming off patent in the next three years will see intense competition, as bulk is freely available.

This is in line with our expectation that 80 percent of the products will see intense competition.

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