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.
Divi's Labs added that the company, along with external consultants and subject matter experts, was working to address the concerns of the US FDA and was making all efforts to fully meet the compliance requirements. “We will respond to this warning letter with a detailed plan within the stipulated time,” it said.
