Continuing regulatory action against Indian drug firms violating good manufacturing norms, the US health regulator has issued an import alert against Pune-based Emcure Pharmaceuticals for products made at its plant in Hinjwadi, Pune.
The import alert named 'Detention Without Physical Examination of Drugs From Firms Which Have Not Met Drug GMPs' is issued "when an FDA inspection has revealed that a firm is not operating in conformity with current good manufacturing practices (GMP's)," United States Food and Drug Administration (USFDA) said on its website.
Detention without physical examination of such firms remains in effect until such time as 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, it added.
However, query sent to Emcure Pharma did not elicit any immediate response.
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.
The company claims to be the 14th largest pharma firm in India in terms of market share, based on domestic sales of the pharmaceutical products.
