SMS Pharmaceuticals (SMS Pharma) has successfully completed a US Food and Drug Administration (USFDA) inspection at its Active Pharmaceutical Ingredient (API) manufacturing facility situated at Bachupally, Hyderabad, Telangana.
The inspection, conducted from March 17, 2025 to March 21, 2025, concluded with one observation in Form 483. 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.
SMS Pharmaceuticals is a diversified and integrated pharmaceutical company specialising in API and intermediates for global customers.
