US FDA issues warning letter to Glenmark Pharma Goa unit

US FDA issues warning letter to Glenmark Pharma Goa unit

United States Food & Drug Administration (USFDA) has issued a warning letter to Glenmark Pharma's manufacturing facility in Goa, the company said in a regulatory filing on November 23.

The facility was inspected in May 2022 and was placed under an Official Action Indicated (OAI) status in August. An OAI classification by the FDA indicates that objectionable manufacturing conditions were found at the facility and regulatory action is forthcoming.

Meanwhile, the company believes that the warning letter will not have an impact on 'disruption of supplies or the existing revenue from operations of this facility'.

The pharma company also said that it aims to work with UFSDA to implement all the necessary corrective actions required to address the concerns at the earliest, and maintain the highest quality and compliant manufacturing standards at all of its facilities.

In October 2022, the company's Baddi unit was placed under an import alert by the USFDA. It had been issued a warning letter by the drug regulator.

Separately, on November 22, Glenmark reached a settlement agreement with Pfizer for Axitinib Tablets (1 mg and 5 mg) and the generic version of their Inlyta1 Tablets, the pharma major informed indices.

Glenmark had previously announced it received tentative approval from the USFDA for their generic Axitinib Tablets on November 30, 2020.

Glenmark Pharmaceuticals Limited is a global research pharmaceutical company that has a generics, exclusive and otc business and has operations in more than 50 countries. 

Glenmark has 10 world-class manufacturing facilities across 4 continents and has operations in more than 80 countries.


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