SMS Pharmaceuticals passes Vizag USFDA inspection with minor observation

SMS Pharmaceuticals Limited successfully completed a US Food and Drug Administration (USFDA) inspection at its Active Pharmaceutical Ingredient (API) manufacturing facility in Visakhapatnam, Andhra Pradesh. The inspection, conducted from December 8 to December 12, 2025, resulted in one minor observation on Form 483, which was procedural and unrelated to data integrity. The company plans to address this observation within the stipulated timeframe.

The Vizag facility is a 3,000 KL multipurpose API manufacturing site with multiple global regulatory approvals, including USFDA, WHO-GMP, EU-GMP, KFDA, CDSCO, and PMDA. This marks the fourth inspection for this facility and the twelfth across the company's manufacturing sites.

Mr. P. Vamsi Krishna, executive director, highlighted that this milestone reinforces the company's position as a reliable partner for global pharmaceutical companies, ensuring high-quality API supply to international markets. Established in 1990, SMS Pharmaceuticals operates two manufacturing facilities in Hyderabad and Vizag, with capacities of 120 KL and 3,000 KL respectively.