SMS Pharma gets one USFDA observation for Bachupally facility
SMS Pharmaceuticals Limited has announced the US Food and Drug Administration (USFDA) has concluded its inspection with one observation at the Company's Active Pharmaceutical Ingredient (API) manufacturing facility situated at Bachupally, Hyderabad, Telangana.
The inspection, conducted from March 17 to March 21, 2025, concluded with one observation in Form 483.
An FDA Form 483 is issued to firm management at the conclusion of an inspection when an investigator(s) has observed any conditions that in their judgment may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts.
The observation is procedural in nature and does not relate to data integrity or product quality. The Company will provide the necessary response to USFDA within the stipulated period.
The Hyderabad facility has a 120 KL manufacturing capacity for niche small-volume and high-value molecules. It has multiple regulatory approvals, including USFDA, EU GMP, KFDA, ANVISA, PMDA and CDSCO.
Commenting on this achievement, Mr. P. Vamsi Krishna, Executive Director, stated, "The successful completion of the USFDA inspection underscores our commitment to quality, compliance and global regulatory standards. This is the 6th USFDA inspection for this facility, reflecting our team's dedication to maintaining the highest manufacturing practices. This milestone further strengthens our reputation as a trusted partner in the pharmaceutical industry, ensuring an uninterrupted supply of high-quality APIs to key international markets."
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Established in 1990, SMS Pharmaceuticals Limited is a diversified and integrated pharmaceutical company specialising in API and intermediates for global customers. The Company operates two state of-the-art manufacturing facilities in Hyderabad and Vizag, with capacities of 120 KL and 3,000 KL, respectively.
