USFDA marks Glenmark Pharma North Carolina Facility's inspection as ‘Official Action Indicated'

24 Aug 2022 , 02:28 PM

Glenmark Pharmaceuticals Limited informed that the Company has received a communication from the US FDA indicating the inspection classification as “Official Action Indicated” (OAI).

According to the OAI classification, the USFDA may suspend approval of any pending product applications or supplements filed from this facility until the outstanding observations are rectified.

The company added that this further announcement is in continuation of its announcement dated May 20, 2022, regarding USFDA inspection at Glenmark’s Monroe, North Carolina (USA) facility from April 4 to May 19, 2022, and issuance of Form‐483 with 17 observations.

The Company voluntarily recalled all of its items from this site in August 2021 and has not commercialized any products from this site since then.

Glenmark continues to work with the US FDA and is dedicated to taking all necessary efforts to resolve their concerns as soon as possible, stated the company in its filing.

At around 2.30 PM, Glenmark Pharmaceuticals was trading at Rs379.85 up by 0.98% from its previous closing of Rs376.15 on the BSE. The scrip touched intraday high and low of Rs381.90 and Rs368 respectively.