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Glenmark Pharmaceuticals gets EIR with VAI status for USA manufacturing facility

The commercial manufacturing at the Monroe site will now restart

Glenmark Pharmaceuticals has received Establishment Inspection Report (EIR) with a Voluntary Action Indicated (VAI) status from the United States Food & Drug Administration (USFDA) for its formulations manufacturing facility situated in Monroe, North Carolina, USA. This is following an inspection conducted by the Agency from June 09 to June 17 2025. The commercial manufacturing at the Monroe site will now restart.

Glenmark Pharmaceuticals is a global research-led pharmaceutical company with presence across Generics, Specialty and OTC business with operations in over 50 countries.