USFDA inspection: Sun Pharma Halol facility listed under import alert

Mumbai: Pharma major, Sun Pharma, has recently announced that the US Food and Drug Administration (USFDA) has listed its Halol facility in Gujarat under an Import Alert.

The Import Alert implies interalia, that all future shipments of products manufactured at this facility are subject to refusal of admission to the US market until the facility becomes compliant with cGMP standards. The USFDA has excluded 14 products from this Import Alert subject to certain conditions.

The USFDA had inspected the Company's Halol facility from April 26 to May 9, 2022.

For the year ended 31 March 2022, supplies to the US market from the Halol facility accounted for approximately 3% of the Company's consolidated revenues, including the 14 excluded products.

"The Company continues to cooperate with the USFDA and will undertake all necessary steps to resolve these issues and to ensure that the regulator is completely satisfied with the Company's remedial action. Sun Pharma remains committed to being cGMP compliant and in supplying high-quality products to its customers and patients globally," the company stated in a BSE filing.

Read also: Sun Pharma Halol facility gets OAI from USFDA

Sun Pharma is an Indian multinational pharmaceutical company headquartered in Mumbai, Maharashtra. The company manufactures and markets a large basket of pharmaceutical formulations covering a broad spectrum of chronic and acute therapies. It includes generics, branded generics, specialty, complex or difficult-to-make technology-intensive products, over-the-counter (OTC), antiretrovirals (ARVs), Active Pharmaceutical Ingredients (APIs), and Intermediates.

Read also: Madras HC relief to Sun Pharma, stays NGT order of Rs 10 crore compensation