Source: Business Standard, Oct 13, 2018
Mumbai: The US Food and Drug Administration (USFDA) has granted the highest number of drug approvals in its history this year. The regulator has bettered last year’s numbers with 971 approval actions this year. This includes 781 final nods and 190 tentative go-aheads.
Indian firms account for 35-40 per cent of the global nods. Analysts feel that rising rate of approvals would on one hand increase competition in the US generic market, and on the other allow new players to enter.
However, analysts expect the growth in approvals to flatten as the number of filings has seen a dip in FY18. This is not expected to rise substantially in the coming years. Read the rest of this entry »