Generic drug approvals on the rise in US; 101 applications get nod in Oct

Since April, top Indian firms have secured approvals for 203 drugs: Edelweiss Securities report

The US Food and Drug Administration (FDA) approved 101 generic drug applications in October — highest in a single month, the agency’s commissioner Scott Gottlieb tweeted on Wednesday. These included 14 tentative approvals. 

Records show Indian companies and their foreign subsidiaries secured approvals for 35 applications in that month.

The rise in approvals is helping Indian drugmakers to expand the product offerings but on the flip side has resulted in increased competition and has hit margins. 

“We are seeing around 10 per cent price erosion in the US market and the pressure is likely to continue for 15-18 months. While most of the