Pharma major Glenmark Pharmaceuticals Ltd on Tuesday (June 30) said the US Food and Drug Administration (US FDA) has issued six observations following a Good Manufacturing Practices (GMP) inspection of its manufacturing facility in Goa.

The inspection was conducted between June 22 and June 30, 2026. At the conclusion of the inspection, the company received a Form 483 carrying six observations.

Glenmark said none of the observations relates to data integrity, adding that none are repeat observations. The company described the observations as procedural in nature. The drugmaker said it does not anticipate any impact on the supply of its commercial products.

Glenmark added that it will work closely with the US FDA to address the observations and submit its response to the regulator within the stipulated timeline.

What is a Form 483

A Form 483 is a list of observations made during the inspection and is issued by the USFDA inspectors post the completion of the inspection. The inspector will communicate and explain these observations to the supplier during the closing conference. But a Form 483 does not represent a final FDA determination regarding the facility’s GMP compliance.

Post Form 483 is issued, the company is given 15 days to submit its response to the USFDA explaining what steps the company will take to resolve the observations made by the USFDA.

This month, Glenmark Pharmaceuticals said it has projected FY27 revenue of ₹17,000-18,000 crore, with EBITDA margins expected to remain in the 21-22% range.

Anurag Mantri, Executive Director & Global Chief Financial Officer, Glenmark Pharmaceuticals, highlighted continued momentum in India, expansion in the US respiratory and injectable segments, and new product launches across Europe and emerging markets as key contributors to future growth.

Mantri also discussed Glenmark's long-term ambition of becoming a global innovation-led pharmaceutical company. With branded products currently contributing about 60% of revenue, the company is targeting a 70% share by 2030 through a combination of in-licensed therapies, specialty products and global brand expansion.

Shares of Glenmark Pharmaceuticals Ltd ended at ₹2,204.90, down by ₹18.70, or 0.86%, on the BSE.