Desi Companies Dominate U.S. Generic Space

Bangalore: India pharmaceutical companies filed 51 percent of the overall global applications called ‘drug master filings’ in the U.S. market during 2011. The DMFs are the approvals to supply complex raw materials to all generic manufacturers in the U.S. market beneficial of all global markets. These companies have put aside over half the certified profiles for active pharmaceutical ingredients (API).

Of the global DMF filings in U.S., India estimated for 45 percent in 2009 which increased to 49 percent in 2010 and 51 percent in 2011, so for the last three years there has been a constant increase in the trend of such application from India.  In comparison to China which is the leading API supplier and they cornered 18 percent of the total DMFs filed in 2011.

Companies like Hetero, USV, Nectar Life Sciences, Shilpa Medicare and Gland Pharma are now filing for approvals from U.S. Food and Drug Administration. Hyderabad based Hetero has maximum eight new filings during the fourth quarter of 2011. Other companies like Alembic, Emcure and Gland have filed four each.