Glenmark Pharma's USA facility gets five observations from USFDA

According to a regulatory filing by the company, the USFDA conducted a good manufacturing practices (GMP) inspection at the Monroe site from 9 June to 17 June 2025. Following the conclusion of the inspection, the USFDA has issued a Form 483 with five observations. Glenmark clarified that all the observations are procedural in nature and none pertain to data integrity.

The company stated that it will work closely with the USFDA to address the observations and will submit its response within the stipulated timeline.

Glenmark Pharmaceuticals is a research-led, global pharmaceutical company, having a presence across Branded, Generics, and OTC segments; with a focus on therapeutic areas of respiratory, dermatology and oncology.

On a consolidated basis, Glenmark Pharmaceuticals reported net profit of Rs 4.65 crore in Q4 March 2025 as against net loss of Rs 1,218.28 crore in Q4 March 2024. Net sales rose 6.77% year-on-year to Rs 3220.13 crore in Q4 March 2025.

The counter shed 0.30% to Rs 1,648.80 on the BSE.

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