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Sun Pharmaceutical Industries Ltd on Thursday said its Halol facility in Gujarat has been listed under import alert by the USFDA with products manufactured at the unit now are subject to refusal of admission in the US market.
The development follows an inspection of the facility by the US Food and Drug Administration (USFDA) 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.
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, it added.
The company further said, "The USFDA has excluded 14 products from this import alert subject to certain conditions."
For the year ended 31-March-2022, supplies to the US market from the Halol facility accounted for approximately 3 per cent 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 Rs 15,585.98 crore in 2021-22.
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".