Divis Labs gets USFDA warning letter for Vishakhapatnam unit; shares down

By: |
April 24, 2017 9:45 AM

Pharma company Divis Laboratories on Saturday informed the bourses that is Vishakhapatnam facility has received a warning letter from United States Food and Drug Administration (USFDA). The company said that the USFDA has issued warning letter for its Unit-II at Vishakhapatnam.

Divi’s Lab further added that it along with external consultants and subject matter experts, are working to address the concerns of the US-FDA and is making all efforts to fully meet the compliance requirements. (Reuters image for representation only)

Pharma company Divis Laboratories on Saturday informed the bourses that is Vishakhapatnam facility has received a warning letter from the United States Food and Drug Administration (USFDA). The company said that the USFDA has issued warning letter for its Unit-II at Vishakhapatnam.

Reacting to the news, shares of Divis Laboratories were trading 1.72 per cent down at Rs 620.30 at 9.20 am. BSE Sensex was trading 101.87 points up at 29,467.17 during the same time.

“Divi’s Laboratories responded to the US-FDA inspection observations with an appropriate remediation process to overcome the deficiencies observed. As part of our commitments, we have also provided periodic updates to the USFDA,” the company said in a BSE filing.

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

In the import alert issued, US-FDA has exempted several products manufactured at the company’s Unit-II at Visakhapatnam, Andhra Pradesh. Divi’s Labs said it will continue to supply these active ingredients to meet its obligations to its customers.

Earlier in a BSE filing on March 22, the company updated the bourses that the import alert by US-FDA for the products manufactured at the company’s Unit-II at Visakhapatnam was issued under two clauses 66-40 and 99-32 of the FDA regulations. The agency has exempted Levetiracetam, Gabapentin, Lamotrigine, Capecitabine, Naproxen sodium, Raltegravir potassium, Atovaquone, Chloropurine, BOC core succinate and 2,4-wing active ester.

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