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Drugmaker Glenmark Pharmaceuticals has said that its Baddi plant (Himachal Pradesh) has received an import alert from the United States Food and Drug Administration (USFDA).
“The US revenues from products supplied from this facility contributed to 1-2 per cent of FY22 total revenues,” said the company in a stock exchange filing, without detailing the products. Glenmark Pharma shares were down on the development but ended Thursday only marginally down at ₹398 on the BSE.
The plant had been under an OAI (official action indicated) status, following the USFDA’s inspection in June. Referring to a communication in September, informing about the continuation of the OAI status on its Baddi manufacturing facility by US FDA, Glenmark said, it would engage with the agency to resolve the import alert at the earliest.
An import alert informs FDA’s field staff and public that the agency “has enough evidence to allow for Detention Without Physical Examination (DWPE) of products that appear to be in violation of the FDA’s laws and regulations”. These violations could be related to the product, manufacturer, shipper and/or other information, said the USFDA.
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