Unit 2 is OneSource’s flagship site dedicated to manufacturing high-quality biologics drug substances and finished products

OneSource Specialty Pharma 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 November 2024.

The 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 substances and finished products including Drug Device Combinations (DDC) and other injectable products.

Neeraj Sharma, CEO and MD, 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, especially 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.”