OneSource Specialty Pharma Wins EU GMP Nod for Bangalore Sterile Facility

OneSource Specialty Pharma Limited ( (IN:ONESOURCE) ) has issued an update.

OneSource Specialty Pharma Limited’s Sterile Product Division facility in Bangalore has received an EU Good Manufacturing Practice (GMP) Certificate of Compliance for sterile products from the German state authority of Schleswig-Holstein, following an inspection conducted in October 2025 and certification dated April 27, 2026. The certificate confirms EU GMP compliance for aseptically prepared small-volume sterile liquids, secondary packing and quality control testing, further strengthening the division’s regulatory credentials and supporting its positioning as a global provider of sterile contract manufacturing services.

This new EU GMP certification adds to the Sterile Product Division’s existing approvals from major regulators such as the US FDA, Health Canada, ANVISA and TGA, enhancing OneSource’s ability to serve international markets with a broad range of sterile presentations including vials, lyophilised vials, pre-filled syringes and autoinjectors. The expanded regulatory recognition is expected to reinforce customer confidence, potentially broaden market access in the European Union, and consolidate the company’s role in the global sterile pharmaceuticals supply chain.

More about OneSource Specialty Pharma Limited

OneSource Specialty Pharma Limited, formerly Stelis Biopharma Limited, operates in the pharmaceutical contract development and manufacturing (CDMO) sector with a focus on sterile products. Its Sterile Product Division in Bangalore offers capabilities across liquid vials, lyophilised vials, pre-filled syringes and autoinjectors, and the facility already holds approvals from regulators including the US FDA, Health Canada, ANVISA and Australia’s TGA.

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