Tide turns for pharma as US FDA concerns get addressed

On Monday, Divi’s Laboratories became the fourth company that claimed redressal of the US Food and Drug Administration (FDA) concerns this year. This indicates turn-of-the-tide of regulatory concerns raised by the US FDA in the last three years.

The Hyderabad-based company said the US FDA would lift import alert 99-32 issued in March on unit-II of its Visakhapatnam plant, though the import alert 66-40 on the unit stays. The regulator issued the alerts following an audit between November 29 and December 6, 2016. Alert 99-32 is issued when a firm refuses an FDA inspection of its facility, while alert 66-40 is