Shares of Glenmark Pharmaceuticals are trading with losses on Thursday after the company's manufacturing facility in Monroe, North Carolina, United States, received a warning letter from the US drug regulator.
The USFDA warning letter will not impact any existing revenue from the said plant as the company has not been commercialising any product from the site since August 2021.
“The company had done a voluntary recall of all its products from this site in August 2021 and since then has not been commercializing any product from this site. Hence, the warning letter will have no impact on the existing revenues,” Glenmark said.
The company's manufacturing unit located in Monroe, North Carolina, was investigated by the USFDA from April 4 to May 19, 2022 and after that it was placed under "Official Action Indicated" (OAI) in August last year.
Going by the USFDA definition, Official Action Indicated (OAI) generally means objectionable conditions were found and regulatory administrative sanctions are indicated during inspections.
Glenmark said that it continues to cooperate with the USFDA and is committed to undertaking all necessary measures required to address its observations at the earliest.
Further, the pharma major said that it is committed to maintaining the highest quality and compliant manufacturing standards at all of its facilities across the world.
In December 2022, the USFDA issued a warning letter to Glenmark Pharma's Goa unit for violations of current good manufacturing practices.
The warning letter stated that there the company failed to establish and follow the required laboratory control mechanisms.
Shares of Glenmark Pharma are trading 1.6 percent lower at Rs 633.
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