Glenmark Pharmaceuticals Clears US FDA Inspection at Aurangabad Facility with Zero 483 Observations

Glenmark Pharmaceuticals Limited has announced the successful conclusion of the US Food and Drug Administration (FDA) inspection at its Aurangabad-based formulation manufacturing plant. The routine inspection, conducted over 12 days from September 9 to September 20, 2024, resulted in a clean Form 483 report with zero observations—signifying no deviations or compliance issues.

A Form 483 is issued by the FDA to note any concerns or observations about manufacturing practices; obtaining one with zero observations signals flawless adherence to current good manufacturing practices (cGMP). This achievement bolsters Glenmark’s position as a trusted supplier in regulated markets, especially the critical US pharmaceutical market.

The Aurangabad facility plays a key role in Glenmark’s global supply chain, producing pharmaceutical formulations for the US and other markets. The positive inspection outcome is likely to enhance operational continuity, reduce regulatory risks, and contribute positively to investor confidence.

This inspection success contrasts with a separate June 2025 FDA inspection at Glenmark’s Monroe, USA facility, which received a warning letter but is under remediation.

Key Highlights:

US FDA inspection at Aurangabad site completed with zero Form 483 observations

Inspection spanned September 9-20, 2024, focusing on cGMP compliance

Aurangabad facility is pivotal in Glenmark’s global pharmaceutical supply chain

Zero observations reflect high-quality standards and regulatory adherence

Outcome strengthens Glenmark’s credibility in regulated international markets

Contrasts with challenges faced at Monroe, USA facility inspected in June 2025

Source: CNBC TV18, India Infoline, Glenmark Pharmaceuticals Ltd official filings