SMS Pharmaceuticals Limited — Updates, 21-03-2025: Press Release

The US Food and Drug Administration (USFDA) has successfully completed an inspection of SMS Pharmaceuticals' Active Pharmaceutical Ingredient (API) manufacturing facility in Bachupally, Hyderabad. The inspection, which took place over several days, resulted in one procedural observation noted on Form 483, which does not concern data integrity or product quality. The company plans to respond to the USFDA within the required timeframe. This facility, with a manufacturing capacity of 120 KL, holds multiple regulatory approvals, reinforcing SMS Pharma's commitment to quality and compliance. The Executive Director highlighted that this marks the sixth USFDA inspection for the facility, which enhances the company's reputation and ensures a steady supply of high-quality APIs to international markets.