Divis Labs gets USFDA warning letter

Drug firm, Divis Laboratories on Saturday, informed bourses that its 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.

The company along with its experts and external consultants is working to address the concern of USFDA, and is making all effort to fully meet the compliance requirements.

The company yet has not provided the details of the warning letter.

Divi's was earlier served with an import alert for the facility. Usually, an import alert precedes a warning letter. The USFDA had issued the import alert on the products manufactured at its Unit II in Visakhapatnam.

Such an alert generally means that a company cannot export products to the US from a particular facility.

The regulator had earlier exempted 10 products, including Levetiracetam, Gabapentin, Lamotrigine, Capecitabine, Naproxen sodium and BOC core succinate, from the import alert. 

The company will respond to this warning letter with a detailed plan within the stipulated time, Divi's Laboratories said. 

The stock on Monday has opened at Rs 607 per share, which is also its low of the day; and touched a high of Rs 638.40;  and on 12.42 pm its quoting at Rs 630.30 per share.