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New Delhi, May 16 : India continues to lead in the number of drug master files (DMF) filed with the US Food and Drug Administration (FDA).
Out of the total 246 DMFs filed in the first quarter of 2006, Indian companies like Ranbaxy, Aurobindo Pharma and Cipla accounted for 78 or 31.7%. This is a continuation of the trend witnessed in the past couple of years according to which Indian companies account for a third of the DMFs filed with the USFDA.
In 2005, domestic corporates filed 313 out of a total 946 DMFs. In the quarter ended March 2006, Aurobindo Pharma filed the highest number of DMFs at 10, followed by Ranbaxy Labs (9) and Sun Pharma (5).
With competition on the rise, more than one player files DMFs for most molecules.
For blockbuster molecules like Atorvastatin Calcium (brand name Lipitor with sales of $12 billion a year) and Simvastatin (brand name Zocor with 2005 sales of $4.38 billion), more than 5 companies have filed their DMFs.
| Tight fight | |||||||
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