USFDA issues warning letter to Glenmark Pharma’s Monroe facility; stock tumbles ~3%

22 Jun 2023 , 12:34 PM

Glenmark Pharmaceuticals Limited informed that the USFDA has issued a warning letter to the Monroe facility of the company. 

Earlier on August 23, 2022, USFDA has issued “Official Action Indicated” OAI status to the company’s Monroe, North Carolina (USA) manufacturing facility, on which inspection was conducted between April 04 to May 19, 2022.

The company voluntarily recalled all of its products from this site in August 2021 and has not commercialized any products from this site since. As a result, the warning letter will have no effect on current revenues, said the company in its filing with the bourses.

Glenmark continues to work with the USFDA and strives to take all necessary steps to address their concerns as soon as possible. The company is dedicated to maintaining the highest quality and compliance manufacturing standards at all of its global facilities.

Following this development, Glenmark Pharma was trading 2.85% lower at Rs 624.70, against the previous close of Rs 643.05 on NSE. The counter plunged to an intraday low of Rs 622.90, so far.

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