SMS Pharmaceuticals completes USFDA inspection at Hyderabad facility

SMS Pharmaceuticals Limited has announced the successful completion of a US Food and Drug Administration (USFDA) inspection at its Active Pharmaceutical Ingredient (API) manufacturing facility situated at Bachupally, Hyderabad, Telangana.

The inspection, conducted from March 17 to March 21, 2025, concluded with one observation in Form 483. The observation is 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 120 KL manufacturing capacity for niche small-volume and high-value molecules. It has multiple regulatory approvals, including USFDA, EU GMP, KFDA, ANVISA, PMDA, and CDSCO.

Commenting on this achievement, P. Vamsi Krishna, Executive Director said, “The successful completion of the USFDA inspection underscores our commitment to quality, compliance and global regulatory standards. This is the 6th USFDA inspection for this facility, reflecting our team’s dedication to maintaining the highest manufacturing practices. This milestone further strengthens our reputation as a trusted partner in the pharmaceutical industry, ensuring an uninterrupted supply of high-quality APIs to key international markets.”