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OneSource’s Unit 2 Facility in Bengaluru Gets Brazilian Health Regulatory

11 Apr 2025
Admin
News Article

OneSource’s Unit 2 Facility in Bengaluru Gets Brazilian Health Regulatory

"OneSource Specialty Pharma Limited 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.”

OneSource Specialty Pharma Limited (formerly known as Stelis Biopharma Limited), is India’s first specialty pharma pure-play CDMO business. OneSource Specialty Pharma operates five state-of-the-art facilities in India, all approved by major regulatory bodies, including the US FDA and EU authorities."