OneSource Specialty Pharma Ltd announced on Tuesday (April 28) that 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. According to reports from CNBC TV18, the certificate is dated April 27, 2026 and follows an inspection conducted on October 14, 2025. The certification confirms compliance with EU GMP requirements for sterile products, covering sterile products, including aseptically prepared small volume liquids, secondary packing and quality control testing. This milestone validates the facility's adherence to international quality standards for sterile production within the European Union.
As reported by CNBC TV18, the company's Sterile Product Division has capabilities across liquid vials, lyophilised vials, pre-filled syringes and autoinjectors. The facility holds approvals from multiple international regulatory bodies, including the US-FDA, Health Canada, ANVISA and TGA. With this latest development, the company further solidifies its international standing, complementing its existing approvals from major global regulatory bodies. The facility operates a highly capable site designed to handle complex drug delivery requirements, supporting a wide portfolio including liquid vials, lyophilised vials, pre-filled syringes, and autoinjectors.
According to latest market data, shares of OneSource Specialty Pharma Ltd were trading at ₹1,762.50 on the BSE, compared to the previous close of ₹1,828.20. The stock experienced an intraday range between ₹1,750.00 and ₹1,835.00, with a total turnover of ₹11,760,942.00 during the trading session. The certification applies to the company's integrated biologics manufacturing site, which handles both drug-substance and drug-product operations, and also has capabilities in drug–device combinations and sterile injectable products.
