The US Food and Drug Administration inspected the facility in June 2022 and subsequently placed it under “Official Action Indicated” status.
The OAI classification implied that the USFDA may withhold approval of any pending product applications or supplements filed from such facility till the outstanding observations related to non-compliance with manufacturing norms laid down by the regulator.
“We now wish to inform you that the US FDA has placed the Baddi (India) facility under import alert 66-40,” Glenmark Pharmaceuticals said in a regulatory filing.
As per the USFDA, import alert 66-40 implies detention without physical examination of drugs from firms which have not met drug GMPs.
“The US revenues from products supplied from this facility contributed to 1-2 per cent of FY22 total revenues for the company,” Glenmark said.
In FY22, the company posted revenue of Rs 8,141.58 crore, as per BSE records.
Glenmark said it will engage with the agency to resolve the import alert at the earliest.