OneSource Specialty Pharma Limited has announced that its Sterile Product Division (SPD) facility in Bangalore has received a prestigious EU GMP Certificate of Compliance. Issued by the German authority following an inspection on October 14, 2025, this certification validates the facility’s adherence to international quality standards for sterile production. The approval covers a range of processes, including aseptically prepared small volume liquids, secondary packaging, and rigorous quality control testing.
Facility Certification Milestone
The EU GMP Certificate, dated April 27, 2026, marks a significant regulatory achievement for OneSource Specialty Pharma. The certification was granted by the State Office for Occupational Safety, Social Affairs and Health of Schleswig-Holstein, Germany, following a comprehensive facility assessment. This milestone confirms that the Bangalore-based Sterile Product Division meets the stringent manufacturing requirements set for sterile products within the European Union.
Capabilities and Global Reach
Beyond its recent European certification, the Sterile Product Division operates a highly capable facility designed to handle complex drug delivery requirements. The site supports a wide portfolio, including liquid vials, lyophilised vials, pre-filled syringes, and autoinjectors. With this latest development, the company further solidifies its international standing, complementing its existing approvals from major global regulatory bodies, including the US-FDA, Health Canada, ANVISA, and TGA.
Source: BSE
