India Holds More Than 2K Type II Active DMF Filed With
US.FDA. - Pharmexcil

Pharmexcil analysis on U.S. FDA database reveals that, India holds the largest share (29%) of the total 7,183 Type-II active Drug Master Files (DMF) filed with US F.D.A. DMF is the dossier filed for Active Pharmaceutical Ingredients (APIs) and is reviewed by the FDA once a Pharmaceutical product (formulation) incorporating the said API is filed for approval and marketing authorization. The total type II active DMFs held by companies from India stood at 2,101 as on 30th Sep 2009. India is distinctly ahead of its closest counterpart USA which has 15.6% of the share. As per the Pharmexcil research more than 450 different API are filed by Indian companies with a vendor base of 3.75 companies per molecule. There are more than 10 DMFs form India for several high value molecules like Metformin, Amlodipine, Simvastatin, Omeprazole, etc. Among Indian companies highest number of DMFs was filed by Dr. Reddy's laboratories followed by Aurobindo pharma and Cipla Ltd. Pharmexcil has previously published updates on DMFs and Certificate of Suitability (CEP), which represent API registration in European Union.

Global DMF (Type II active) {updated to Sep.2009}
Rank	Country	No. of DMFs	%    share	Cumulative %
1	India	2,101	29.25%	29.25%
2	USA	1,122	15.62%	44.87%
3	Italy	732	10.19%	55.06%
4	China	663	9.23%	64.29%
5	Japan	328	4.57%	68.86%
6	Germany	300	4.18%	73.03%
7	Spain	264	3.68%	76.71%
8	France	203	2.83%	79.54%
9	Israel	174	2.42%	81.96%
10	Switzerland	158	2.20%	84.16%
	Others	1138	15.84%	100.00%
	Total	7,183
Source: Pharmexcil research on CDER US.FDA data base.