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.
Published – December 01, 2025 11:53 pm IST
Source: https://www.thehindu.com/business/glenmark-pharma-plant-completes-us-fda-inspection-sans-observation/article70346182.ece
