USFDA lists Sun Pharma's Halol facility under import alert

08 Dec 2022 Evaluate

The United States Food and Drug Administration (USFDA) has placed Sun Pharmaceutical Industries' Halol facility under '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.

For the year ended March 31, 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 as mentioned above. 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.

Sun Pharmaceutical Industries is the world's fourth largest specialty generic pharmaceutical company and India's top pharmaceutical company.

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