Glenmark Pharmaceuticals Limited had earlier announced regarding the US FDA inspection at Glenmark's Goa (India) facility from May 12 to May 20, 2022 and issuance of Form-483 by US FDA with five observations.

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

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.