Divi’s Laboratories hit 52-week low of Rs 607, down 4% on BSE in early morning trade after the company on Saturday said that the US drug regulator has issued a warning letter for its unit-II at Visakhapatnam, Andhra Pradesh.
“The US Food and Drug Administration (USFDA) have issued a Warning Letter for the company's Unit-II at Visakhapatnam,” Divis Laboratories said in a BSE filing.
The company responded to the US-FDA inspection observations with an appropriate remediation process to overcome the deficiencies observed, it added.
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. It will continue to supply these active ingredients to meet its obligations to the customers.
“Divi's Labs, 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,” it added.
The US FDA had earlier had issued form 483 with five observations after inspecting the Visakhapatnam unit between November 29, 2016 and December 6, 2016.
In past six months, the stock has underperformed the market by falling 52% as compared to 4% rise in the S&P BSE Sensex.
At 9:21 am; the stock was down 1.7% at Rs 620 on BSE as compared to 0.34% rise in the benchmark index. A combined 734,175 equity shares changed hands on the counter on BSE and NSE so far.
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