The U.S. drug regulator placed Sun Pharmaceutical Industries Ltd.’s Halol facility in Gujarat under an import alert, halting all future shipments from the plant to the American market.
Sun Pharma received communication from the Food and Drug Administration of U.S. that the facility has been listed under import alert, according to the drugmaker’s exchange filing on Thursday.
Shipments of products manufactured at the facility shall be refused admission to the U.S. until the facility becomes compliant with current good manufacturing practice regulations standards, it said. The FDA, however, excluded 14 products from the import alert subject to certain conditions.
Centrum Broking said Halol contributes 3% of U.S. sales (including the excluded products) and it does not see any material impact on Sun Pharma’s earnings estimates from the import alert.
The facility was inspected between April 26 to May 9, and in August received Form 483 with 10 observations, classifying it under “official action initiated” or approvals will be withheld for any pending product applications till the outstanding issues are resolved.
“The company continues to cooperate with the USFDA 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 in the filing.
Sun Pharma shares were trading 2.61% lower at 11 a.m. compared with a 0.11% rise in Nifty 50.