USFDA banned import from Emcure Pharma’s Pune plant over GMP issues
In a series of regulatory action against Indian drug firms over violation of good manufacturing practices norms, the US health regulator (Food and Drug Administration) has issued an import alert against Emcure Pharmaceuticals for products made at its plant in Hinjwadi, Pune.
FDA revealed during inspection that the company was not following manufacturing quality standards.
As per the import alert posted on US FDA website named as ‘Detention Without Physical Examination of Drugs From Firms Which Have Not Met Drug GMPs’ (DWPE) is issued “when an FDA inspection has revealed that a firm is not operating in conformity with current good manufacturing practices (GMP’s).
Detention without physical examination of such firms remains in effect until FDA is satisfied that the appearance of a violation has been removed, either by re-inspection or submission of appropriate documentation to the responsible FDA Center.
Emcure Pharmaceuticals has nine manufacturing facilities, including eight in India and one in the US, and manufactures pharmaceutical products as well as active pharmaceutical ingredients at its plants.