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The US health regulator has issued an import alert on Divis Laboratories Visakhapatnam unit-II.
Divis Laboratories has said in a statement that “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.”
It further said that “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.”
Divis Labs has said that it, 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.
