Glenmark's Monroe facility receives five observations from USFDA

Glenmark Pharmaceuticals (BSE: 532296) disclosed that a GMP inspection by the United States Food & Drug Administration (USFDA) was conducted at its manufacturing facility in Monroe, North Carolina, from June 9, 2025, to June 17, 2025. The company received a Form 483 with five observations at the conclusion of the inspection, all of which are procedural in nature. Glenmark reported that no observation pertained to data integrity. The company stated that it will collaborate closely with the FDA to address the observations and will respond within the stipulated timeline. The company has notified the National Stock Exchange of India Ltd. and BSE Ltd. of this development.