The U.S. FDA has issued Form 483 with 17 observations after an inspection at Glenmark Pharmaceuticals Limited's formulation manufacturing facility based out of Monroe, North Carolina, between April 04, 2022 and May 19, 2022.
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.
The Company will continue to work with the U.S. FDA and is committed to undertake all necessary steps required to address their observations at the earliest. The Company is committed to maintaining the highest quality and compliant manufacturing standards at all of its facilities across the globe.
Shares of Glenmark Pharmaceuticals Limited was last trading in BSE at Rs. 407.40 as compared to the previous close of Rs. 392.50. The total number of shares traded during the day was 33932 in over 1279 trades.
The stock hit an intraday high of Rs. 408.80 and intraday low of 397.05. The net turnover during the day was Rs. 13688287.00.