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.
SMS Pharmaceuticals Limited announced the successful completion of a United States Food and Drug Administration (USFDA) inspection at its Visakhapatnam-based Active Pharmaceutical Ingredient (API) manufacturing facility. The inspection, conducted between December 8 and 12, 2025, concluded with a single minor procedural observation on Form 483 — a non–data integrity issue, reflecting the company's robust manufacturing and compliance framework.
The company confirmed that it will respond to the USFDA within the stipulated timeline. The Vizag facility, with a 3,000 KL capacity, serves as SMS Pharma’s flagship multipurpose unit catering to niche, large-volume molecules. It already holds several global regulatory approvals, including from USFDA, WHO-GMP, EU-GMP, KFDA, CDSCO, and PMDA.
Executive Director P. Vamsi Krishna described this as a reaffirmation of SMS Pharma’s commitment to quality, compliance, and global regulatory excellence. This marks the fourth USFDA inspection at the Vizag facility and the twelfth across the company's manufacturing sites, including two audits of its Central Laboratory Analytical Services.
Notable Updates:
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Inspection Dates: December 8–12, 2025
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Outcome: One minor procedural Form 483 observation; no data integrity concerns
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Facility Details: 3,000 KL flagship API unit in Vizag with global regulatory accreditations
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Regulatory Track Record: Fourth inspection at the Vizag unit, twelfth overall within the group
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Leadership Quote: Reaffirms focus on regulatory compliance and consistent API supply to global markets
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Operational Footprint: Two manufacturing facilities—Hyderabad (120 KL) and Visakhapatnam (3,000 KL)—serving clients in over 75 countries
Sources: BSE Corporate Announcement, SMS Pharmaceuticals Limited Announcement