Indian Pharmaceutical companies and their subsidiaries have received 125 final ANDA approvals from US FDA during the first half ended June 2018 out of total 323 Abbreviated New Drug Applications (ANDA) approvals.
This worked out to around 39 per cent of total approvals basically due to higher investments in R&D activities. Similarly, these companies received 22 tentative approvals out of total 71 tentative approvals by the US FDA. The approval rate is slightly lower compared to first half of 2017 in which US FDA approved total 387 ANDAs and 85 tentative products, and out of this Indian companies secured 137 ANDA approvals and 32 tentative approvals.
Aurobindo Pharma remained star performer and grabbed the highest level of final approval of 22 ANDA approvals followed by Zydus Pharma (16 ANDAs), Strides Shashun (12) and Cipla (11). Similarly, Lupin got 8 ANDA approvals and Sun Pharma Global and Taro Pharma also received 8 approvals. This was followed by Dr Reddy’s Laboratories and Glenmark Pharma 7 ANDA approval each during the first half ended June 2018. Further, Aurobindo received highest number of tentative approvals during the first half.
For the full year ended December 2017, Indian companies received final approval for 304 ANDAs out of 846 ANDA approvals and 61 tentative approvals among 171 total tentative approvals from US FDA. The investments in R&D has started yielding positive results for Indian players. The company’s focus on providing complex and speciality products, customer-centricity, regulatory compliance, quality improvement and operational efficiency will play important role in coming years. Indian companies are not only focusing on highly regulated markets, but are also moving in emerging markets in a big way.