Glenmark Pharma plant completes U.S. FDA inspection sans observation

Drugmaker Glenmark Pharmaceuticals’ formulations manufacturing facility in Chhatrapati Sambhajinagar, Maharashtra, has completed an inspection by the U.S. Food and Drug Administration.

A pre-approval inspection, of the facility, it was carried out from November 24-28 and concluded with zero Form 483 observations, the company said in a filing on Monday.

The development comes on the heels of the company’s formulations manufacturing facility in North Carolina, USA, received establishment inspection report with a voluntary action indicated status from the U.S. FDA.

The commercial manufacturing at the Monroe site, in the U.S. will now restart, the company said in a filing on November 27, announcing the EIR with VAI status.

The U.S. FDA had inspected the facility from June 9-17 June and on conclusion had issued issued Form-483 with five observations. The facility was under warning letter since June 2023.