Sun Pharmaceutical Industries Ltd's drug shipments from its Gujarat plant could be refused entry in its key U.S. market after the drug regulator slapped an import alert on the facility, the drugmaker said on Thursday.
A guard walks inside the office of Sun Pharmaceutical Industries Ltd in Mumbai, India, November 13, 2018. REUTERS/Francis MascarenhasHalol supply to U.S. accounted for 3% of Sun revenue in FY22BENGALURU, Dec 8 - Sun Pharmaceutical Industries Ltd's
"The company 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," Sun Pharma said. It was not immediately clear what remedial action the FDA had asked the company to take. Sun Pharma did not immediately respond to Reuters' request for further comment. The company also said it was evaluating whether it would incur any additional costs for remediation.
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India's Sun Pharma says plant listed under U.S. FDA import alertThe U.S. Food and Drug Administration (FDA) had listed Indian drugmaker Sun Pharmaceutical Industries Ltd's facility in the western Indian state of Gujarat under an import alert, the company said on Thursday, sending its shares down 3.6%.
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India's Sun Pharma hit by U.S. FDA import alert on plant, shares dropSun Pharmaceutical Industries Ltd's drug shipments from its Gujarat plant could be refused entry in its key U.S. market after the drug regulator slapped an import alert on the facility, the drugmaker said on Thursday.
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