The FDA has banned the import of drugs manufactured by Mumbai-based Polydrug Laboratories for alleged lapses in good manufacturing practices, making it the latest Indian firm facing action by the American regulator.
In its latest list of entities put under 'import alert', the US Food and Drug Administration (FDA) has named Mumbai-based Polydrug Laboratories' manufacturing plant in Ambernath Industrial Area.
The FDA has put this manufacturing plant under the import alert of 'Detention Without Physical Examination of drugs from firms which have not met drug good manufacturing practices'. Such a categorisation generally happens when the regulator's inspection has revealed that a firm is not operating in conformity with current good manufacturing practices.
Polydrug is into manufacturing drugs for various ailments including hypertension.
In recent times, many Indian drug makers have come under the scanner of the FDA with regard to various quality issues.
