Intas Pharmaceuticals Limited has informed that its manufacturing facility SEZ (Pharmez) near Ahmedabad has been listed under ‘Import Alert’ by the US Food and Drug Administration (USFDA).

The USFDA’s issuance of Import Alert #66-40 published on June 1, 2023, calls for “detention without physical examination (DWPE), which may be appropriate when an FDA inspection has revealed that a firm is not operating in conformity with current good manufacturing practices (GMP).”

Commenting on businessline’s query, Intas confirmed receiving a “communication from USFDA stating that their manufacturing facility SEZ (Pharmez) has been listed under Import alert.”

“This import alert is limited to this specific manufacturing site of Intas. The USFDA has allowed Intas to continue to supply from that site 24 critical products in short supply in the US after completion of necessary testing and verification.”

The critical care drugs excluded from DWPE include injectable products belonging to therapeutic areas such as vitamins, oncology, bacterial infections, cardiology and for sedation and tablet products in the areas of neuro therapy, kidney stone diseases, cancer care, hormonal complications and heart issues, the USFDA list showed.

Intas makes solid oral products, injectables and liquid oral products at the Pharmez unit - inspected by the USFDA.