Divis Laboratories provides update on import alert issued by USFDA

Initiates measures to meet compliance requirements

Divis Laboratories further updated that the Import Alert by US-FDA for the products manufactured at the company's Unit-II at Visakhapatnam was issued under two clauses 66-40 & 99-32 of the FDA regulations. As mentioned earlier, the Agency has exempted the following products from the Import Alert: 1. Levetiracetam 2. Gabapentin 3. Lamotrigine 4. Capecitabine 5. Naproxen sodium 6. Raltegravir potassium 7. Atovaquone 8. Chloropurine 9. BOC core succinate 10. 2,4-wing active ester .The company has already initiated necessary measures to address the concerns raised by the US-FDA and is making all efforts to fully meet the compliance requirements.

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