USFDA lists Sun Pharma’s Halol unit under ‘Import Alert’

The USFDA inspected Sun Pharma's Halol unit from April 26 to May 9, 2022, and has excluded 14 products from this import alert, subject to certain conditions.

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USFDA
Picture: Pixabay

Last Updated on December 10, 2022 by The Health Master

Mumbai: The United States Food and Drug Administration (USFDA) has placed Sun Pharmaceuticals‘ Halol unit under “import alert.

This means that all future shipments of products manufactured at this facility will be denied entry into the US market until the facility meets cGMP standards.

The USFDA inspected Sun Pharma’s Halol unit from April 26 to May 9, 2022. The USFDA 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 percent 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 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 percent, while the broader index was trading up 0.24 percent.

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