Glenmark Pharmaceuticals announced on Thursday that it has received the Establishment Inspection Report (EIR) from the US Food and Drug Administration (USFDA) for its formulations manufacturing facility in Monroe, North Carolina. The facility has been classified as “Voluntary Action Indicated” (VAI), indicating that the regulator’s observations do not require any further mandatory action.
The inspection was carried out between June 9 and June 17, 2025. Following this positive outcome, Glenmark said it will resume commercial manufacturing operations at the Monroe site.