INDIAN DRUGMAKERS' US FDA FILINGS REPORTED SURGING

According to local reports, Indian drugmakers submitted drug master files (DMFs) for 59 active pharmaceuticals ingredients with the US FDA in the third quarter of 2004, accounting for some 37% of overall submissions. The country's 38% share of global initial data submissions to the US FDA in the second quarter, which totalled 36 filings, confirms that Indian drugmakers have maintained their recent performance as a leading source of drug applications over the last few quarters. Indian companies filed some 119 DMFs in 2003 alone.

Much of the trend can be attributed to Indian drugmakers' aggressive expansion strategy for the lucrative US market. In December, filings were led by Cipla, Matrix and Aurobindo, with six filings each, while Sun Pharma filed five DMFs in the month. However, leading drugmaker Ranbaxy filed only one application, apparently due to its increasing move from generics production toward research and development activity.

A significant share of Indian companies' drug filings in December were for the cephalosporin segment. Lupin targeted Cefdinir, on which the branded equivalent has annual US sales of some US$380mn, and Cefprozil, which has annual US sales of about US$250mn. Orchid Chemical also filed a DMF for Ceftraixone, on which branded product sales in the US market total some US$700mn per year. Observers point out that the filings, which do not necessarily result in final US FDA approval, can nevertheless be used to support additional filings for generics using similar active ingredients.