USFDA10 Apr 2025, 05:30 pm
OneSource Secures ANVISA Approval for its Flagship Facility in Brazil
AI Summary
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. 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. This approval now enables OneSource to supply pharmaceutical products specially DDCs, including GLP-1s manufactured at this site to the Brazilian market upon their customers getting their product approvals.
Key Highlights
- OneSource's flagship Unit 2 facility in Bengaluru receives GMP certification from ANVISA, the Brazilian Health Regulatory Agency.
- 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.
- This approval enables OneSource to supply pharmaceutical products specially DDCs, including GLP-1s manufactured at this site to the Brazilian market upon their customers getting their product approvals.
- OneSource continues to maintain its exemplary track record in regulatory compliance and manufacturing quality.