Indian pharma dominates drug master filings in US

Rupali Mukherjee - New Delhi

Indian pharma companies dominated the drug master files (DMF) space with 74 filings, accounting for 37 per cent share of the total 198 filings received by the US Food and Drug Administration (FDA).

According to the latest DMF list for quarter ended March 2005, the filings have been of primarily of Type I and II.

The total 74 filings were divided among 25 companies from India. Another significant feature has been multiple filings by companies indicating an increasing competition in the generics market. Zydus Cadila (with seven DMFs) and Aurobindo, Glenmark, Divi’s (with six DMFs each) lead the pack for March 2005. A drug master filing is a submission to the US Food and Drug Administration (FDA) that may be used to provide confidential information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of one or more human drugs.

The submission of a DMF is not required by law or FDA regulation, and depends on the sole discretion of the holder. Interestingly, Chinese companies have turned out as aggressive filers with 25 filings this quarter (up from 9 filings last quarter ended December ’04).

According to analysts, among the Indian companies, Cadila has filed the maximum number with seven DMFs, taking their total tally to 25.

The company’s product portfolio for the US market has been pretty decent with an equal number of abbreviated new drug application (ANDAs) also in place. Other major companies which have filed DMFs include Cipla, Dr Reddy’s,Ranbaxy, Wockhardt, Lupin, Cadila and Aurobindo.

The domination of domestic companies in the DMF list gives a good indication of the expected competition in the generic space in times to come, analysts added.

Companies need to aggressively add to their pipeline continuously and seek tie-ups (with US companies, distributors, wholesalers, retailers, pharmacy chains) to expand their market share and sustain generic revenues. Indian companies with their cost-effective manufacturing and research advantage, are poised to double their market shares in the US from the existing below five per cent level.

— The Financial Express