US FDA bans import from Megafine Pharma’s Maharashtra facility

The US health regulator, US FDA, has banned imports of human and animal drugs manufactured by Mumbai-based Megafine Pharma at its Lakhamapur plant in Maharashtra over non-compliance of manufacturing norms.

The import alert by US FDA on the drugs made at the facility entails ‘detention without physical examination of drugs from firms which have not met drug Good Manufacturing Practices (GMPs).’

Under the import alert 66-40, the authorities ‘may detain, without physical sampling and analysis, the indicated drug products from the foreign processors noted in the Red List of this import alert,’ as per the US FDA notice on its site.

Megafine manufactures APIs and advanced intermediates for itself but also contract manufactures for global drug discovery and generic companies.

The company has presence in more than 40 countries, as per the information on its site.

EP News Bureau – Mumbai