OneSource Specialty Pharma receives EU GMP certification for sterile product division

OneSource Specialty Pharma Ltd on Tuesday (April 28) said its sterile product division (SPD) facility in Bengaluru has received an EU GMP Certificate of Compliance of a Manufacturer from the competent German authority, the State Office for Occupational Safety, Social Affairs and Health of Schleswig-Holstein.The certificate is dated April 27, 2026 and follows an inspection conducted on October 14, 2025. It confirms compliance with EU GMP requirements for sterile products. The certification covers sterile products, including aseptically prepared small volume liquids, secondary packing and quality control testing.

The company also stated that its Sterile Product Division has capabilities across liquid vials, lyophilised vials, pre-filled syringes and autoinjectors. It added that the facility holds approvals from the US-FDA, Health Canada, ANVISA and TGA.
Also Read: Explained: Why Onesource Specialty Pharma and Shaily Engineering stocks were in focus todayIn April this year, OneSource Specialty Pharma Ltd said it had received the renewal of the European Union Good Manufacturing Practices (EU-GMP) certification for its flagship Unit II manufacturing facility in Bengaluru, following an inspection by a European regulatory authority.

The certification applies to the company’s integrated biologics manufacturing site, which handles both drug-substance and drug-product operations. The Unit II facility also has capabilities in drug–device combinations and sterile injectable products.

Shares of Onesource Specialty Pharma Ltd ended at ₹1,765.00, down by ₹63.20, or 3.46%, on the BSE.

Also Read: OneSource Specialty sees Canada leading semaglutide volumes; Brazil, Turkey next