1. Manufacturing norms, inspection issues led to USFDA alert on Divis Laboratories

Manufacturing norms, inspection issues led to USFDA alert on Divis Laboratories

Divis Laboratories today said the US health regulator issued import alert for products made at one of its units at Visakhapatnam citing violation of manufacturing norms and refusal of inspection.

By: | Published: March 22, 2017 8:43 PM
USFDA, Divis Laboratories, Visakhapatnam, BSE filing, GMP The company said it has already initiated measures to address the concerns raised by the USFDA.(Reuters)

Divis Laboratories today said the US health regulator issued import alert for products made at one of its units at Visakhapatnam citing violation of manufacturing norms and refusal of inspection. The company said it has already initiated measures to address the concerns raised by the USFDA. “We wish to update that the import alert by USFDA 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,” Divis Laboratories said in a BSE filing.

As per US Food and Drug Administration (USFDA), a import alert under 66-40 entails “detention without physical examination” of drugs from firms which have not met drug GMPs, while alert under 99-32 is issued to “firms refusing FDA foreign establishment inspection”.

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Divis said: “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.”

The regulator had exempted ten products, including Levetiracetam, Gabapentin, Lamotrigine, Capecitabine, Naproxen sodium and BOC core succinate, from the import alert.

Divis stock closed 1.19 per cent down at Rs 626.80 on BSE.

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