Indian pharma companies have filed the largest number of drug master filings with the US Food and Drug Administration in the April-June 2006 quarter.
According to data available, Indian pharma companies filed 104 out of the 251 new DMFs made in the US in April-June 2006, compared with 74 out of 213 DMFs made a year ago.
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.
Indian players accounted for 41.4 per cent of total DMFs with the US FDA in the last quarter. Also, among Indian players, mid-cap players emerged as one of the larger players with DMFs.
For instance, Aurobindo Pharma filed for 21 DMFs in the June 2006 quarter, which was the largest number filed by an Indian pharma company.
Lupin filed nine DMFs in the last quarter, while Matrix filed eight. In the June 2005 quarter, Matrix filed the maximum number of DMFs among Indian players, accounting for 12 out of the total 74 filings.
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