Shipments of the drug from Sun Pharmaceutical Industries Ltd’s Gujarat plant may be denied entry into its key US market after the drug regulator issued an import alert at the facility, the drugmaker said on Thursday.
The Food and Drug Administration’s (FDA) import alert means that all future shipments of products made at the plant in Halol, Gujarat, may be denied entry to the US market until the facility meets the regulator’s current good manufacturing standards. Practice does not conform to standards.
Sun Pharma said, “The company will continue to cooperate with the US FDA and take all necessary steps to resolve these issues and ensure that the regulator is fully satisfied with the remedial action taken by the company.”
Sun Pharma shares fell 3.6% in their worst day since May 28, 2021, and were the biggest losers among blue-chips smelly 50 index.
The drugmaker is not revising its revenue forecast for this fiscal year because of the FDA action, it said in a separate filing after market close.
FDA has taken 14 products out of import alert subject to conditions, which Sun Pharma said were confidential.
It was not immediately clear what remedial action the FDA asked the company to take. Sun Pharma did not immediately respond to a Reuters request for further comment. The company also said that it is evaluating whether any additional cost will have to be borne for the treatment.
“It is very difficult to remove the import alert, and many companies are still not able to bring their facilities back into compliance after 7-10 years,” said Srikant Akolkar of Asian Markets Securities. Reduce target price by 4.5% to Rs 1,156.
Akolkar said the focus would now be on Sun’s Mohali facility. Following an inspection in November the plant was classified as “Official Action Indicated,” which means the FDA will recommend regulatory or administrative action.
The Halol plant received the same inspection classification in August after the FDA made 10 observations.
Sun said that transferring products made in Halol to other sites would be a complex and time-consuming process, so product transfers would be assessed on a case-by-case basis.
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