Glenmark Pharmaceuticals' Monroe Facility Cleared for Production Restart

Glenmark Pharmaceuticals Ltd received a positive establishment inspection report from the US FDA for its North Carolina manufacturing facility, classified as Voluntary Action Indicated. Following the inspection conducted in June 2025, the company plans to resume commercial production at the Monroe site.

Drugmaker Glenmark Pharmaceuticals Ltd announced on Thursday that it has received an establishment inspection report from the US health regulator, USFDA, for its formulations manufacturing facility located in Monroe, North Carolina. The facility has been classified under 'Voluntary Action Indicated', signifying a positive development for the company.

The inspection took place from June 9 to June 17, 2025. Despite finding objectionable conditions, the USFDA has decided not to recommend regulatory action. This means Glenmark Pharmaceuticals can proceed with resuming commercial manufacturing at the Monroe site.

This clearance marks a significant step forward for Glenmark, allowing it to continue operations at the facility and maintain its supply chain in the US market.

(With inputs from agencies.)