SMS Pharmaceuticals Limited (NSE: SMSPHARMA; BSE: 532815) today announced the successful completion of a US Food and Drug Administration (USFDA) inspection at its Active Pharmaceutical Ingredient (API) manufacturing facility located in Visakhapatnam, Andhra Pradesh.
The inspection, carried out from December 08 to December 12, 2025, concluded with one minor Form 483 observation, which the Company confirmed is procedural in nature and not related to data integrity. SMS Pharmaceuticals will submit its response to the USFDA within the stipulated timeframe.
The Vizag facility, a 3,000 KL flagship multipurpose API plant, is designed for the production of niche, large-volume molecules and is supported by multiple international regulatory approvals, including USFDA, WHO-GMP, EU-GMP, KFDA, CDSCO, and PMDA.
Commenting on the development, Mr. P. Vamsi Krishna, Executive Director, stated: “The successful completion of this USFDA inspection underscores our strong focus on quality, compliance, and global regulatory excellence. This marks the fourth inspection for this facility and the twelfth across our manufacturing network, including two audits of our Central Laboratory Analytical Services (CLAS). This achievement further strengthens our position as a reliable API partner to global pharmaceutical companies.”
