Date: 25-Jul-2019

Indian pharma companies get 207 ANDA approvals from US FDA during first half of 2019, tentative approvals at 55 ANDAs

The Indian research-based pharmaceutical companies have improved their presence in international market during the last couple of years with investments in research and development (R&D) activities. This can be seen from rising Abbreviated New Drug Application (ANDA) approvals from US FDA. Indian pharma companies and their subsidiaries grabbed a total of 207 final ANDA approvals out of the total 476 ANDA approvals during the first half ended June 2019 by US FDA or over 43 per cent of total approvals. Similarly, US FDA offered 102 tentative approvals of which Indian companies received 55 tentative approvals.