With 62 filings, domestic pharma companies have filed the maximum number of drug master filings with the US Food and Drug Administration in the July-September 2006 quarter.
The total number of DMFs with the US FDA in the last quarter was 223, with Indian companies accounting for 27.8 per cent. In the last quarter, the Chinese were second in terms of DMFs, with 23 filings.
DMFs are confidential, proprietary assets that present to the US FDA the formulae, processes, test methodology, and other data relevant to the manufacture of products used in the composition, packaging and processing of pharmaceuticals or biologics.
In the April-June 2006 quarter also, the Indian firms, with 104 out of the 251 DMFs had filed the maximum number of DMFs. Once again Aurobindo Pharma filed the maximum number of DMFs amongst Indian players, with 9 filings.
Other Indian players such as Wockhardt filed five DMFs, while Glenmark and Orchid filed four each in the last quarter. Aurobindo Pharma filed 21 DMFs in the June 2006 quarter.