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

The inspection, conducted from December 08 to December 12, 2025, concluded with one minor observation in Form 483. The observation is procedural in nature and does not relate to data integrity.

The company will provide the necessary response to USFDA within the stipulated time period.

The Vizag facility is a 3,000 KL flagship, multipurpose API manufacturing facility, specialising in niche, large-volume molecules. It is backed by multiple global regulatory approvals, including USFDA, WHOGMP, EU-GMP, KFDA, CDSCO, and PMDA.

Commenting on this achievement, P. Vamsi Krishna, Executive Director, stated: "The successful completion of the USFDA inspection reaffirms our commitment to stringent quality, compliance, and global regulatory standards. This marks the 4th inspection for this facility and the 12th across our manufacturing sites, including two audits of our Central Laboratory Analytical Services (CLAS). This milestone further reinforces our position as a reliable partner to global pharmaceutical companies and ensures continued, high-quality API supply to key international markets."