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This Article is From Apr 09, 2017

U.S. Drug Regulator Has Exempted More Products From Ban: Divi’s

U.S. drug regulator had issued an import alert for Unit-II of Divi’s Visakhapatnam facility.

U.S. Drug Regulator Has Exempted More Products From Ban: Divi’s
Tablets of multiple vitamin and minerals supplement are arranged for a photograph (Photographer: Kiyoshi Ota/Bloomberg)

Drugmaker Divi's Laboratories Ltd. on Saturday said the U.S. health regulator has exempted some more products from the ban on sale of drugs manufactured at its Visakhapatnam facility.

The regulator had earlier exempted 10 products. Divi's Laboratories had said on March 22 that the U.S. Food and Drug Administration had issued an import alert for products made at Unit-II in Visakhapatnam, citing violation of manufacturing norms and refusal of inspection.

As per the U.S. FDA, an import alert under clauses 66-40 entails “detention without physical examination” of drugs from firms which have not met good manufacturing practices, while alert under 99-32 is issued to firms refusing inspection.

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