Regulatory17 Apr 2026, 07:41 pm
Onesource Pharma gets EU-GMP renewal for Bengaluru Unit II
AI Summary
Onesource Specialty Pharma Limited has successfully secured the renewal of its European Union Good Manufacturing Practices (EU-GMP) certification for its flagship Unit II manufacturing facility in Bengaluru. This renewal follows a thorough inspection conducted by a European regulatory authority. The Unit II facility is a key integrated site, specializing in biologics drug-substance and drug-product manufacturing, and also possesses capabilities for drug-device combinations and sterile injectable products. This certification ensures the company's continued compliance with stringent European quality standards, enabling it to maintain and expand its presence in the EU market for these specialized pharmaceutical products.
Key Highlights
- Onesource Pharma's Bengaluru Unit II facility received EU-GMP renewal.
- Certification ensures continued access to European markets.
- Unit II specializes in biologics, drug-device, and sterile injectables.
- Renewal confirms compliance with high European quality standards.