Glenmark's Monroe facility receives VAI status from US FDA

Glenmark Pharmaceuticals Ltd. has received an Establishment Inspection Report (EIR) with a Voluntary Action Indicated (VAI) status from the U.S. Food & Drug Administration (FDA) for its formulations manufacturing facility in Monroe, North Carolina. This follows an inspection conducted by the FDA from June 9 to June 17, 2025, enabling the restart of commercial manufacturing at the Monroe site.

The company had previously informed the stock exchange on June 18, 2025, about a Form-483 with five observations from the June 2025 inspection. This VAI status marks a notable improvement, as the Monroe site had been under a Warning Letter since June 2023.

Glenmark Pharmaceuticals operates 11 manufacturing facilities across four continents and has a presence in over 80 countries. The company focuses on branded, generics, and OTC segments, with therapeutic areas including respiratory, dermatology, and oncology.