OneSource Secures approval from Brazil for its flagship facility

Continues to maintain its exemplary track record in regulatory compliance and manufacturing quality.

Bangalore, India, April 10, 2025: OneSource Specialty Pharma Limited today announced that its flagship Unit 2 facility in Bengaluru has been granted Good Manufacturing Practices (GMP) certification by ANVISA, the Brazilian Health Regulatory Agency, following a successful regulatory inspection held in Nov 2024.

This approval marks a significant milestone in OneSource’s ongoing commitment to quality and regulatory compliance. Unit 2 is OneSource’s flagship site dedicated to manufacturing high quality Biologics drug substance and finished products including Drug Device Combinations (DDC) and other injectable products.

Neeraj Sharma, CEO & Managing Director of OneSource, commented: “We are proud to add ANVISA to the growing list of global regulatory agencies that have approved our flagship facility Unit 2 for its quality, compliance, and technical excellence. This approval now enables OneSource to supply pharmaceutical products specially DDCs, including GLP-1s manufactured at this site to the Brazilian market upon our customers getting their product approvals. It is a critical milestone for our company as Brazil is one of the biggest markets opening for generic Semaglutide in 2026.”