Glenmark Pharmaceuticals Ltd announced that it has received the Establishment Inspection Report (EIR) from the U.S. Food and Drug Administration for its formulations manufacturing facility in Monroe, North Carolina. The inspection, which took place between 9 June and 17 June 2025, has been classified as Voluntary Action Indicated (VAI)—a positive outcome that confirms the facility meets the agency’s compliance expectations with only minor issues, none requiring further regulatory action.
The company described the development as an important step toward strengthening its U.S. operations. With the EIR and VAI status now in hand, Glenmark will begin restarting commercial manufacturing activities at the Monroe site. This is expected to support its product supply in the U.S. market and enhance its overall operational momentum.
Glenmark added that the clearance reflects its ongoing commitment to high-quality, research-driven pharmaceutical manufacturing.
