Sun Pharmaceutical Industries Ltd. on Thursday said its Halol facility in Gujarat had been listed under import alert by the U.S. FDA with products manufactured at the unit now are subject to refusal of admission in the U.S. market.
The development follows an inspection of the facility by the U.S. Food and Drug Administration from April 26 to May 9, 2022.
“We now wish to inform you that the company has received a communication from the U.S. FDA stating that the facility has been listed under import alert,” Sun Pharma said in a regulatory filing.
Import alert implies that all future shipments of products manufactured at this facility are subject to refusal of admission to the U.S. market until the facility becomes compliant with cGMP (current good manufacturing practice) standards, it added.
The company further said, “The U.S. FDA has excluded 14 products from this import alert subject to certain conditions.” For the year ended March 31, 2022, supplies to the U.S. market from the Halol facility accounted for approximately 3% of the company’s consolidated revenues, including the 14 excluded products, it added.
As per information available on BSE, Sun Pharma had clocked revenue of ₹15,585.98 crore in 2021-22.
Sun Pharma said it “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.”
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