Glenmark Pharmaceuticals has received a major regulatory boost as the US Food and Drug Administration (US FDA) has successfully completed a Pre-Approval Inspection (PAI) at the company’s formulations manufacturing facility located in Chhatrapati Sambhajinagar (Aurangabad).
According to the company’s filing, the inspection was conducted from November 24 to November 28, 2025, and concluded with zero Form 483 observations, indicating full compliance with US FDA standards. This clean report reflects strong manufacturing practices and enhances the company’s readiness for product approvals intended for the US market.
The update was submitted under Regulation 30 of SEBI’s Listing Obligations and Disclosure Requirements (LODR), marking it as a material event for investors and regulatory bodies.
Glenmark’s compliance track record at this site has now received a significant endorsement, strengthening confidence in its US supply chain and regulatory preparedness.
