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OneSource Specialty Pharma secures EU GMP certificate for SPD facility

The certificate covers sterile products, including aseptically prepared small volume liquids, secondary packing and quality control testing

OneSource Specialty Pharma has received an EU GMP Certificate of Compliance of a Manufacturer for its Sterile Product Division (SPD) facility from the competent German authority, the State Office for Occupational Safety, Social Affairs and Health of Schleswig-Holstein, Germany. The certificate, dated April 27, 2026, was issued following the latest inspection conducted on October 14, 2025, and confirms compliance with EU GMP requirements for sterile products. The certificate covers sterile products, including aseptically prepared small volume liquids, secondary packing and quality control testing.

Separately, the Sterile Product Division has capabilities across liquid vials, lyophilised vials, pre-filled syringes and autoinjectors, and holds approvals from US-FDA, Health Canada, ANVISA and TGA.

OneSource Specialty Pharma is a multimodal specialty pharma CDMO with end-to-end capabilities across technology platforms and therapeutic modalities.