USFDA issues warning letter to Sun Pharma Dadra facility

Mumbai: Sun Pharmaceutical Industries Limited has received a Warning Letter from the US Food and Drug Administration (USFDA) for its Dadra facility.

"The Warning Letter summarizes violations with respect to Current Good Manufacturing Practice (cGMP) regulations. The contents of the Warning Letter shall be made public by the USFDA in due course," the Company informed in a BSE filing.

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USFDA had inspected the facility from December 4, 2023 to December 15, 2023 and determined the inspection classification status of the Company's Dadra facility as Official Action Indicated (OAI). OAI means regulatory and/or administrative actions are recommended.

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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.