USFDA exempts more products from import alert: Divis

Drug firm Divis Laboratories today said the US health regulator has exempted some more products manufactured at the company's Visakhapatnam facility from an import alert issued earlier.
"The United States Food and Drug Administration (USFDA) has exempted some more products manufactured at the company's Unit-II at Visakhapatnam from the import alert issued under clauses 66-40 and 99-32 of the FDA regulations," Divis Laboratories said in a filing to BSE.
The regulator had earlier exempted 10 products, including Levetiracetam, Gabapentin, Lamotrigine, Capecitabine, Naproxen sodium and BOC core succinate, from the import alert.
Earlier on March 22, Divis Laboratories had said that the regulator had issued import alert for products made at one of its units at Visakhapatnam citing violation of manufacturing norms and refusal of inspection.

As per the USFDA, an import alert under clauses 66-40 entails "detention without physical examination" of drugs from firms which have not met drug good manufacturing practices (GMPs), while alert under 99-32 is issued to "firms refusing FDA foreign establishment inspection".