ALSO READDivi's Labs tanks over 30% in two trading days; hits 28-month low Divi's Vizag unit gets form 483, five observations from USFDA Divi's Lab hits 52-week low; stock tanks 17% intra-day Divi's Laboratories falls as Vizag unit gets five observations from USFDA Vivimed Labs surges on successful USFDA inspection of Alathur facility
“The United States Food and Drug Administration (USFDA) have issued an Import Alert 66-40 on 20th March 2017 on the products manufactured at the company's Unit-II at Visakhapatnam, Andhra Pradesh,” Divis Laboratories said in a statement.
“The agency has exempted the 10 active pharmaceutical ingredients (APIs) namely Levetiracetam, Gabapentin, Lamotrigine , Capecitabine, Naproxen Sodium, Raltegravir potassium, Atovaquone, Chloropurine , BOC core succinate and 2,4-wing active ester from the import alert,” it added.
Divis Labs said the company, along with third party consultants, is currently working to address the concerns of the US-FDA and is making all efforts to fully meet the compliance requirements.
At 09:35 am; the stock was down 18% at Rs 646 on BSE as compared to 0.15% rise in the S&P BSE Sensex. The trading volumes on the counter jumped more than five-fold with a combined 6.78 million shares changed hands on the BSE and NSE so far.