Onesource Specialty Pharma Receives EU GMP Certificate for Sterile Product Division
Onesource Specialty Pharma Limited has confirmed that its Sterile Product Division (SPD) facility in Bangalore has obtained an EU GMP Certificate of Compliance of a Manufacturer. The certificate was issued by the competent German authority, the State Office for Occupational Safety, Social Affairs and Health of Schleswig-Holstein, Germany.The certificate, dated April 27, 2026, confirms that the facility complies with strict EU GMP requirements for sterile products. This certification followed a recent inspection conducted on October 14, 2025.
The scope of the EU GMP compliance covers critical aspects of sterile product manufacturing, including aseptically prepared small volume liquids, secondary packing, and quality control testing.
Beyond its EU GMP certification, the SPD facility holds diverse capabilities in sterile product handling and manufacturing. These capabilities span across liquid vials, lyophilised vials, pre-filled syringes, and autoinjectors.
The company also reports holding approvals from major global regulatory bodies, ensuring international reach and compliance.
| Approvals/Capabilities | Scope |
|---|---|
| Global Approvals | US-FDA, Health Canada, ANVISA, and TGA |
| Products Covered | Liquid vials, lyophilised vials, pre-filled syringes, and autoinjectors |
ONESOURCE Stock Price Movement
Onesource Specialty Pharma Limited shares on Tuesday slipped by 3.66% to close at ₹1763, marking a significant dip from the previous day's close. The stock shed ₹67.00 during the session, amid a total trading volume of 275,867 shares.Disclaimer: Due care and diligence have been taken in compiling and presenting news and market-related content. However, errors or omissions may arise despite such efforts.
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