Indian drug firms top filings with USFDA
Indian pharma companies have filed the maximum number of drug master filings (DMFs) to the US Food and Drug Administration (US FDA) in October-December 2007 quarter.
The total number of DMFs filed to the US FDA in the last quarter was 187, Indian companies alone filing for 89 DMFs, according to data gathered from analysts and industry sources. Indian DMFs filing accounting for 47.6 per cent of the total DMFs filed in the last quarter.
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. DMFs filings from the Chinese pharma players to the US FDA amounted to less than 20.
Amongst the Indian pharma players, Ranbaxy has filed 13 DMFs to the US FDA in the last quarter, while both Dr Reddy’s and Aurobindo Pharma filed 10 DMFs, add analysts.
Ranbaxy is understood to have filed a DMF for cilastatin to the US FDA in the last quarter. Analysts say Cilastatin is not a drug in itself, it is administered along with the antibiotic imipenem, to prevent the latter from being inactivated by the enzyme dehydropeptidase.
May 14, 2009