Glenmark Pharmaceuticals Receives USFDA Observations

Glenmark Pharmaceuticals announced that the US FDA issued a Form 483 with five procedural observations following an inspection at its Monroe, North Carolina manufacturing plant. The company will collaborate with the agency to address these observations and respond within the required timeframe. Share prices saw a slight rise.

Glenmark Pharmaceuticals disclosed that the US Food and Drug Administration (FDA) has issued a Form 483 with five observations after an inspection at its Monroe, North Carolina, manufacturing facility.

The inspection, which took place from June 9 to June 17, 2025, aimed to ensure compliance with Good Manufacturing Practices (GMP).

According to Glenmark, the observations are procedural, with no issues related to data integrity. The company plans to address the observations through close cooperation with the FDA and will submit a timely response. Despite the report, Glenmark's shares rose 0.22% to Rs 1,657.35 on the BSE.

(With inputs from agencies.)