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USFDA completes inspection at SMS Pharmaceuticals’ API manufacturing facility at Visakhapatnam
Dec-13-2025

US Food and Drug Administration (USFDA) has successfully completed inspection at SMS Pharmaceuticals’ Active Pharmaceutical Ingredient (API) manufacturing facility situated at Visakhapatnam, Andhra Pradesh. The inspection, conducted from December 08, 2025 to December 12, 2025, concluded with one minor observation in Form 483. The observation is procedural in nature and does not relate to data integrity.

The company will provide the necessary response to USFDA within the stipulated time period. The Vizag facility is a 3,000 KL flagship, multipurpose API manufacturing facility, specialising in niche, large-volume molecules. It is backed by multiple global regulatory approvals, including USFDA, WHOGMP, EU-GMP, KFDA, CDSCO, and PMDA. 

SMS Pharmaceuticals is a diversified and integrated pharmaceutical company specialising in API and intermediates for global customers.


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