Glenmark Pharmaceuticals Ltd update on Monroe, North Carolina, USA Facility

Glenmark Pharmaceuticals Limited has received a communication from the US FDA indicating the inspection classification as "Official Action Indicated" (OAI). The OAI classification implies that the US FDA may withhold approval of any pending product applications or supplements filed from this facility till the outstanding observations are resolved.

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.

Glenmark continues to cooperate with the US 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. 376.15 as compared to the previous close of Rs. 369.95. The total number of shares traded during the day was 76299 in over 2239 trades.

The stock hit an intraday high of Rs. 377.55 and intraday low of 366.00. The net turnover during the day was Rs. 28486426.00.

Source : Equity Bulls

Keywords

GlenmarkPharmaceuticals INE935A01035 OAI USFDA Monroe NorthCarolina