Sun Pharma down 4 percent as USFDA issues import alert on Halol facility

Published On: Thursday, December 8, 2022 | By:

Sun Pharma down 4 percent as USFDA issues import alert on Halol facility

Shares of Sun Pharmaceutical Industries slipped 4 percent to Rs 975 on the BSE in Thursday’s intra-day after the company said that the US health regulator had put its manufacturing facility at Halol under import alert. “This is with respect to our communication dated May 10, 2022, and August 13, 2022, regarding the USFDA inspection at the Company’s Halol (Gujarat) facility from April 26 to May 9, 2022. We now wish to inform you that the Company has received a communication from the USFDA stating that the facility has been listed under Import Alert," Sun Pharma said in a regulatory filing.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 (Current Good Manufacturing Practice) standards. The USFDA has excluded 14 products from the restriction, the company said.

It added that for the year ended 31 March 2022, supplies to the US market from the Halol facility accounted for approximately 3 percent of the company's consolidated revenues, including the 14 excluded products.Sun Pharma said it "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.”

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