US FDA lists Sun Pharma’s Halol unit under ‘import alert’, Health News, ET HealthWorld

US FDA lists Sun Pharma's Halol unit under 'import alert'

Mumbai: The United States Food and Drug Administration (US FDA) has placed Sun Pharmaceuticals’ Halol unit under ‘import alert‘. This 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 US FDA inspected Sun Pharma’s Halol unit from April 26 to May 9, 2022. The US FDA has excluded 14 products from this import alert subject to certain conditions.

The company said that supplies to the US market from the Halol facility accounted for roughly 3 per cent of its consolidated revenue for the year ended March 31, 2022, including the 14 excluded products 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,” the company said in a statement to the exchanges.

Sun Pharma’s stock dipped following the disclosure. As of 10:20 am, the scrip was trading with a loss of 2.37 per cent while the broader index was trading up 0.24 per cent.

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