US FDA issues warning letter for Divi's Laboratories' Visakhapatnam unit

The Hyderabad-based active pharmaceutical ingredients (APIs) maker Divi's Laboratories has received a warning letter from the US Food & Drug Administration (FDA) for the company's Unit-II at Visakhapatnam. 

Earlier, the US FDA had issued an import alert on March 20, 2017 on the products manufactured at the company's Unit-II at Visakhapatnam, Andhra Pradesh. However, the US drug regulator had exempted products such as levetiracetam, gabapentin, lamotrigine, capecitabine, naproxen sodium, raltegravir potassium, atovaquone, chloropurine, BOC core succinate and 2,4-wing active ester from the import alert.

“In the Import Alert issued, US-FDA has exempted several products manufactured at the company's Unit-II at Visakhapatnam, Andhra Pradesh. We will continue to supply these active ingredients to meet its obligations to our customers,” said the company in a BSE filing on Saturday.