USFDA issues warning letter to Glenmark’s Goa facility

"The Company is committed to working along with the USFDA to implement all the necessary corrective actions required to address the concerns at the earliest."

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Warning Letter Sign FDA USFDA
Warning Letter

Last Updated on October 15, 2024 by The Health Master

The drugmaker Glenmark said it does not believe that the warning letter will have an impact on the disruption of supplies or the existing revenues from the operations of this facility.

The US Food and Drug Administration (USFDA) inspected Glenmark’s Goa facility in May 2022 and issued an Official Action Indicated (OAI).

The drug regulator has now issued a warning letter to the Goa facility.

“The company is committed to working with the USFDA to implement all necessary corrective actions as soon as possible to address the concerns.”

“The company is committed to maintaining the highest quality and compliant manufacturing standards at all of its facilities across the globe,” Glenmark said in a statement.

Glenmark Pharmaceuticals is primarily engaged in the business of the development, manufacture, and marketing of pharmaceutical products.

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