Sun Pharma gets import alert for Halol facility

9 Dec 2022 , 09:18 AM

Sun Pharmaceutical Industries Limited had earlier announced regarding the USFDA inspection at the Company’s Halol (Gujarat) facility from April 26 to May 9, 2022.

The Company has received a communication from the USFDA stating that the facility has been listed under Import Alert. The Import Alert implies, 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.

At around 9:18 AM, Sun Pharmaceuticals Industries Ltd is currently trading at Rs985 per share up by Rs4.05 or 0.41% from its previous closing of Rs980.95 per share on the BSE.

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