Indian drug companies maintained their lead in the number of drug master filings to the U.S. Food and Drug Administration during fourth quarter 2004, accounting for 37 percent of global filings, according to the Indian business journal Business Standard

Drug Store News,  Feb 14, 2005  

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Indian drug companies maintained their lead in the number of drug master filings to the U.S. Food and Drug Administration during fourth quarter 2004, accounting for 37 percent of global filings, according to the Indian business journal Business Standard. From October through December, Cipla, Matrix Laboratories, Aurobindo Pharma, Sun Pharmaceuticals, Lupin, Dr. Reddy's and Glenmark Pharmaceuticals filed 59 DMFs, up from 36 in the third quarter. DMFs usually are followed by abbreviated new drug applications.

India recently has been a leading filer of DMFs. In 2003, Indian pharmaceutical companies filed 119 DMFs with the FDA, accounting for one, third of total global filings. According to Business Standard, "The trend highlights the aggressive strategy of domestic pharma firms wanting to strengthen their product pipeline for the lucrative U.S. market."

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