SMS Lifesciences Completes USFDA Inspection with One Observation

SMS Lifesciences India Ltd has successfully completed a US Food and Drug Administration inspection at its Active Pharmaceutical Ingredient manufacturing facility in Bachupally, Hyderabad. The inspection, conducted from March 17 to March 21, 2025, concluded with a single observation in Form 483, which was procedural in nature and did not relate to data integrity or product quality.  

Inspection Highlights:  
- The facility specializes in niche small-volume and high-value molecules, holding multiple regulatory approvals, including USFDA, EU GMP, KFDA, ANVISA, PMDA, and CDSCO.  
- The company will provide the necessary response to the USFDA within the stipulated period to address the observation.  
- This marks the sixth successful USFDA inspection for the facility, reinforcing its commitment to quality and global regulatory standards.  
Industry Impact:  
- The completion of the inspection strengthens SMS Lifesciences’ reputation as a trusted pharmaceutical partner in international markets.  
- The company continues to focus on maintaining high manufacturing practices to ensure uninterrupted supply of high-quality APIs.  
- Investors responded positively to the announcement, with SMS Lifesciences’ stock seeing a slight uptick following the news.  

Sources:  
Business Standard, Medicare Pharma Business.