SMS Pharmaceuticals Reaffirms Global Standards with Successful USFDA Inspection at Vizag

Inspection Dates: December 8&ndash;12, 2025&nbsp;&nbsp;
Outcome: One minor procedural Form 483 observation; no data integrity concerns&nbsp;&nbsp;
Facility Details: 3,000 KL flagship API unit in Vizag with global regulatory accreditations&nbsp;&nbsp;
Regulatory Track Record: Fourth inspection at the Vizag unit, twelfth overall within the group&nbsp;&nbsp;
Leadership Quote: Reaffirms focus on regulatory compliance and consistent API supply to global markets&nbsp;&nbsp;
Operational Footprint: Two manufacturing facilities&mdash;Hyderabad (120 KL) and Visakhapatnam (3,000 KL)&mdash;serving clients in over 75 countries&nbsp;&nbsp;

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SMS Pharmaceuticals’ Vizag API facility has successfully completed a USFDA inspection with only one minor procedural observation. This fourth inspection underscores the company’s strong compliance culture and global manufacturing standards, highlighting its continued reliability as an API supplier to international markets across multiple therapeutic categories.