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 Mascarenhas/FilesHalol supply to U.S. accounted for 3% of Sun revenue in FY22
The Food and Drug Administration's import alert is effectively a ban, implying all future shipments of products made at the plant in Halol, Gujarat could be refused admission to the U.S. market until the facility becomes compliant with the regulator's Current Good Manufacturing Practice standards. "Import alerts are very tough to remove, and several companies are still not able to get their facilities back in compliance after 7-10 years," said Shrikant Akolkar of Asian Markets Securities, after it cut Sun Pharma's revenue and earnings outlook, and lowered target price by 4.5% to 1,156 rupees.
The Halol plant had received the same inspection classification in August after the FDA made 10 observations.
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