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OneSource receives Brazilian regulatory approval for its flagship Unit 2

10-Apr-2025, 12:49

OneSource Specialty Pharma 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.