US FDA Issues Import Alert on Baddi Manufacturing Plant of Glenmark Pharmaceuticals

Glenmark Pharmaceuticals has announced that the US Food and Drug Administration (FDA) has put its manufacturing plant located at Baddi, India, under import alert. The drugs manufactured at Glenmark Pharmaceuticals at Baddi plant can now be detained without any physical examination.

The US FDA inspected the facility in June 2022, and has subsequently placed it under the status of Official Action Indicated. The Official Action Indicated status implies that the US Food and Drug Administration (FDA) might withhold the approval of any pending applications filed by the facility due to non-compliance with the production norms laid down by the US FDA.

In a regulatory filing, Glenmark Pharmaceuticals said that, they now want to inform you that the US FDA has placed the Baddi plant under import alert 66-40. According to the US FDA, the import alert 66-40 implies the detention of the products manufactured in the facility without any physical examination of drugs.

According to Glenmark Pharmaceuticals, the United States of America generate revenues from the products that are supplied from the Baddi facility, and the facility has also contributed to 1 to 2 percent of FY22 total revenues for Glenmark Pharmaceuticals. The company announced that it will engage with the US FDA to resolve the import alert as early as possible.