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(10 Apr 2025, 12:49)

OneSource receives Brazilian regulatory approval for its flagship Unit 2


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.


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