SMS Pharmaceuticals clears USFDA inspection at Vizag API plant with one minor observation

SMS Pharmaceuticals Ltd 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 exchange filing said the inspection was carried out between December 8 and December 12, 2025, and concluded with a single minor Form 483 observation. The company said the observation is procedural in nature and does not pertain to data integrity.

SMS Pharma added that it will submit its response to the USFDA within the prescribed timeframe.

The Vizag unit is the company’s flagship 3,000 KL multipurpose API facility, focused on niche and large-volume molecules.

P. Vamsi Krishna, Executive Director, said the inspection outcome underscores the company’s commitment to stringent quality and regulatory compliance.

“This marks the fourth inspection for this facility and the twelfth across our manufacturing sites, including two audits of our Central Laboratory Analytical Services (CLAS). This milestone further strengthens our position as a reliable partner to global pharmaceutical companies and supports the continued supply of high-quality APIs to key international markets,” he stated.

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Shares of SMS Pharmaceuticals Ltd ended lower on Friday, December 12, by 0.23% at ₹320.15 on the NSE.