Glenmark receives Establishment Inspection Report from U.S. FDA for its Monroe facility

New Delhi: Glenmark Pharmaceuticals, a research-led, global pharmaceutical company has announced that it has received the Establishment Inspection Report (EIR) from the U.S. Food and Drug Administration (U.S. FDA) for its formulations manufacturing facility in Monroe, North Carolina (USA) with a Voluntary Action Indicated (VAI) status.

The inspection was conducted at the Company’s manufacturing facility from 09 June to 17 June 2025.

With this positive development, the Company will restart commercial manufacturing at the Monroe site.