Sun Pharmaceuticals on Sunday said that its Halol, Gujarat facility has been flagged by the United States Food and Drugs Administration (USFDA) after a December 2019 inspection.

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The Halol facility has been classified as “Official Action Indicated”, or OAI, meaning that pending product approvals from the facility could be withheld by the USFDA.

“The OAI classification implies interalia that the USFDA may withhold approval of any pending product applications or supplements filed from this facility till the outstanding observations are resolved,” Sun Pharma said in a BSE filing on Sunday.

It added: “The company continues to manufacture and distribute existing products for the US market, thereby not likely to have any adverse impact on current business from the facility.”

Last December, the USFDA had issued form 483 for its Halol facility with eight observations.

At Friday’s closing, the Sun Pharma stock closed at Rs 338.20, down 0.10 percent from Thursday.

First Published:Mar 29, 2020 11:41 AM IST