SMS Pharmaceuticals Successfully Completes USFDA Inspection at Vizag Facility with One Minor Observation

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 in Visakhapatnam, Andhra Pradesh. The inspection, conducted from December 08 to December 12, 2025, resulted in one minor observation in Form 483, which is procedural and does not concern data integrity. The Vizag facility is a 3,000 KL flagship, multipurpose API manufacturing facility with multiple global regulatory approvals. This is the 4th inspection for this facility and the 12th across the company's manufacturing sites. The successful completion of the USFDA inspection reinforces SMS Pharmaceuticals' position as a reliable partner to global pharmaceutical companies and ensures continued, high-quality API supply to key international markets.