Glenmark Pharmaceuticals has received an Establishment Inspection Report (EIR) from the U.S. Food and Drug Administration (FDA) for its manufacturing facility in Monroe, North Carolina, with a Voluntary Action Indicated (VAI) status. The inspection, conducted in June 2025, has resulted in the company restarting commercial manufacturing at the Monroe site. This follows a previous Form-483 issued in June 2025 and a Warning Letter from June 2023.
FDA Approval Received
Glenmark Pharmaceuticals Ltd. has announced the receipt of the Establishment Inspection Report (EIR) from the United States Food & Drug Administration (FDA) for its formulations manufacturing facility located in Monroe, North Carolina (USA). The FDA has assigned a Voluntary Action Indicated (VAI) status to the facility. This development follows an inspection conducted from June 9 to June 17, 2025.
Restarting Production
With the receipt of the EIR, Glenmark is set to restart commercial manufacturing operations at the Monroe facility. The company had previously informed the stock exchange on June 18, 2025, about the Form-483, which contained five observations following the inspection. The site had been operating under a Warning Letter since June 2023.
Company Overview
Glenmark Pharmaceuticals Ltd. is a global pharmaceutical company involved in the Branded, Generics, and OTC segments, with a focus on respiratory, dermatology, and oncology. The company has 11 manufacturing facilities across 4 continents and operations in over 80 countries. Glenmark’s Green House Gas (GHG) emission reduction targets have been approved by the Science Based Target initiative (SBTi) in 2023. The company has impacted over 3 million lives over the last decade through CSR interventions.
Source: BSE
