SMS Pharmaceuticals Clears USFDA Inspection at Vizag API Facility With One Observation

15 Dec 2025 , 12:54 PM

SMS Pharmaceuticals said it has successfully completed a US Food and Drug Administration inspection at its active pharmaceutical ingredient manufacturing facility in Visakhapatnam, Andhra Pradesh. The inspection was carried out between December 8 and December 12, 2025.

In its exchange filing, the company said the inspection concluded with one Form 483 observation. It clarified that the observation was minor and procedural in nature, and did not involve any data integrity concerns. SMS Pharma added that it will submit its formal response to the USFDA within the stipulated timeline, in line with standard regulatory practice.

The Visakhapatnam plant is the company’s flagship multipurpose API facility with a capacity of 3,000 kilolitres. The unit manufactures both niche products and large-volume molecules for global markets.

Commenting on the development, Executive Director P Vamsi Krishna said the outcome of the inspection reflects the company’s continued focus on quality systems and regulatory compliance.

He noted that this was the fourth USFDA inspection at the Vizag facility and the twelfth across all of the company’s manufacturing locations. This also includes two audits of its Central Laboratory Analytical Services.

According to the management, the inspection outcome further strengthens SMS Pharmaceuticals’ position as a dependable supplier to global pharmaceutical companies and supports uninterrupted supply of high-quality APIs to international customers.

For feedback and suggestions, write to us at [e-mail]