According to an exchange filing, the inspection was conducted from 17 March to 21 March 2025 and concluded with one observation in Form 483. The observation was 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 manufacturing capacity of 120 KL, specializing in niche small-volume and high-value molecules. It holds multiple regulatory approvals, including USFDA, EU GMP, KFDA, ANVISA, PMDA, and CDSCO.
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."
The official announcement was made on Friday, 21 March 2025, after market hours.
SMS Pharmaceuticals is a diversified and integrated pharmaceutical company specializing in APIs 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. The company has a proven track record of delivering quality products across a diversified portfolio of therapeutic segments, serving as a trusted partner to a global customer base in over 70 countries.
The company’s consolidated net profit surged 58.9% to Rs 18.24 crore in Q3 FY25 as against Rs 11.48 crore recorded in Q3 FY24. Revenue from operations rose 7.4% to Rs 173.35 in the quarter ended 31 December 2024.