Mumbai, March 24 -- According to an exchange filing, the inspection was conducted from 17 March to 21 March 2025 and concluded with one observation in Form 483. The observation was procedural in nature and does not relate to data integrity or product quality. The company will provide the necessary response to USFDA within the stipulated period.

The Hyderabad facility has a manufacturing capacity of 120 KL, specializing in niche small-volume and high-value molecules. It holds multiple regulatory approvals, including USFDA, EU GMP, KFDA, ANVISA, PMDA, and CDSCO.

P. Vamsi Krishna, executive director, stated, "The successful completion of the USFDA inspection underscores our commitment to quality, compliance, and global regulatory standards...