Glenmark facility clears FDA inspection with no observations

Glenmark Pharmaceuticals Limited has reported that its formulations manufacturing facility in Chhatrapati Sambhajinagar (Aurangabad) successfully completed a Pre-Approval Inspection by the U.S. Food and Drug Administration (U.S. FDA) with zero Form 483 observations. The inspection, conducted from November 24 to November 28, 2025, represents a positive outcome for the company's regulatory compliance and manufacturing quality standards.

This regulatory success is crucial for Glenmark as it pertains to its ability to manufacture and supply pharmaceutical products to the U.S. market, underscoring the facility's adherence to stringent international quality and operational guidelines.

This announcement was communicated on December 1, 2025, by Harish Kuber, company secretary and compliance officer. The outcome of this inspection is expected to bolster confidence in Glenmark's manufacturing capabilities.