Glenmark receives OAI communication from US FDA

The company continues to cooperate with the US FDA and is committed to undertake all necessary steps required to address their observations at the earliest

Glenmark Pharmaceuticals Limited has received an "Official Action Indicated" (OAI) communication from the US FDA which implies inter‐alia that the US FDA may withhold approval of any pending product applications or supplements filed from this facility till the outstanding observations are resolved.

This communication is with respect to the communication dated May 20, 2022 regarding the US FDA inspection at Glenmark’s Monroe, North Carolina (USA) facility from April 04 to May 19, 2022 and issuance of Form‐483 by US FDA with 17 observations.

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.