Indian Pharma Firms Grab 144 ANDA Approvals from FDA in 2011

The US FDA has approved total 2,244 ANDAs during last five years from 2007 to 2011, of which Indian companies received final approval for 694 ANDAs.

Research based Indian pharma companies are set to capture a major share of the US domestic market with increasing number of filing of Abbreviated New Drugs Applications (ANDAs).

During 2011, 28 Indian companies and their subsidiaries or joint ventures have grabbed 144 ANDA approvals from US FDA and 49 tentative approvals.

The US FDA approved a total 431 ANDAs and 117 tentative approvals during 2011. Thus Indian companies obtained over 33 per cent of US FDA approvals in 2011.

The US FDA has approved total 2,244 ANDAs during last five years from 2007 to 2011, of which Indian companies received final approval for 694 ANDAs.