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Sun Pharma says Halol unit listed under US FDA import alert, shares slip nearly 3%

US FDA had listed Sun Pharmaceutical Industries Ltd's Halol facility in Gujarat under an import alertPremium
US FDA had listed Sun Pharmaceutical Industries Ltd's Halol facility in Gujarat under an import alert

  • The import alert means all future shipments of products made at the Halol plant can be refused admission to the US market until the facility becomes compliant with the FDA's Current Good Manufacturing Practice standards, Sun Pharma said in a statement

The US Food and Drug Administration (FDA) had listed Sun Pharmaceutical Industries Ltd's Halol facility in Gujarat under an import alert, the company said today. Shares of Sun Pharmaceutical Industries slipped nearly 3  per cent to 987.15 on the BSE at 11.30 am today.

“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 means all future shipments of products made at the Halol plant can be refused admission to the US market until the facility becomes compliant with the FDA's Current Good Manufacturing Practice standards, Sun Pharma said in a statement.

"The company continues to cooperate with the U.S. FDA 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 said.

The FDA has excluded 14 products from the import alert, subject to certain conditions.

 

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