The U.S. Food and Drug Administration (FDA) has completed its Pre-Approval Inspection of Glenmark Pharmaceuticals’ formulations manufacturing facility in Chhatrapati Sambhajinagar (Aurangabad). The inspection, which took place from November 24 to November 28, 2025, concluded with zero observations. This positive outcome signifies the facility’s compliance with U.S. FDA standards and supports Glenmark’s commitment to quality manufacturing practices.
Inspection Completion
Glenmark Pharmaceuticals has announced the successful completion of a Pre-Approval Inspection by the U.S. Food and Drug Administration (FDA) at its formulations manufacturing facility located in Chhatrapati Sambhajinagar (Aurangabad).
Inspection Details and Outcome
The U.S. FDA conducted the inspection from November 24 to November 28, 2025. The inspection concluded with zero observations, indicating a successful outcome. This result reflects the facility’s adherence to quality standards.
Source: BSE