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US FDA issues warning letter to Glenmark's Goa facility

US FDA issues warning letter to Glenmark's Goa facility

The United States Food & Drug Administration (USFDA) has issued a warning letter for Glenmark Pharma's manufacturing facility in Goa. The US drug regulator inspected Glenmark's Goa facility in May 2022 and issued an Official Action Indicated (OAI).

Pursuant to Regulation 30 of SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015 and in furtherance to intimation dated August 26, 2022 for the United States Food and Drug Administration (USFDA) inspection of our Goa manufacturing facility, we wish to inform you that the Company has received a communication from the USFDA that the classification of Company's said facility continues to be as Official Action Indicated ('OAI'). USFDA may continue to withhold product approvals from this facility till the outstanding observations are resolved. The Company has an ongoing de-risking plan in place for new product approvals," Glenmark said in a statement.

The pharma company also said that it aims to work closely with the US FDA and is committed to addressing these within the stipulated time.

 

More news about: quality / gmp | Published by Sudeep Soparkar | November - 25 - 2022 | 252

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