The company has announced that it is working with third party consultants to address concerns of USFDA
US FDA has issued an Import Alert 66-40 to Divis Laboratories for its Unit-II at Visakhapatnam, Andhra Pradesh. However, the US agency has exempted 10 products manufactured in the plant from the alert list.
The exempted products are Levetiracetam, Gabapentin, Lamotrigine, Capecitabine, Naproxen sodium, Raltegravir potassium, Atovaquone, Chloropurine, BOC core succinate and 2,4-wing active ester.
The company has announced that it is working with third party consultants to address the concerns of the USFDA and meet the compliance requirements.