Whalesbook
Onesource Specialty Pharma Ltd. announced that its Unit II manufacturing facility in Bengaluru has successfully renewed its EU Good Manufacturing Practice (EU-GMP) certification. This renewal is vital for the site, which is a key hub for producing biologics, drug-device combinations, and sterile injectables for the European market.
The certification, renewed following an inspection by a European regulatory authority on April 17, 2026, ensures that products manufactured at Unit II continue to meet the European Union's stringent regulatory standards. This compliance is crucial for the uninterrupted supply of these specialized products to European clients and reinforces the company's reputation for quality and reliability.
Unit II is recognized for its integrated capabilities in manufacturing both biologics drug substance and drug product, alongside its specialized work in drug-device combinations and sterile injectables.
The company, formerly known as Stelis Biopharma Limited, is a leading Indian Contract Development and Manufacturing Organization (CDMO) with comprehensive services in biologics, injectables, and drug-device combinations across multiple advanced facilities in Bengaluru. This EU-GMP renewal for Unit II follows other significant regulatory achievements, including obtaining ANVISA GMP certification for the same facility in April 2025. Recent corporate milestones for Onesource Specialty Pharma include a complex multi-entity merger completed in late 2024 and the successful listing of its shares on the BSE and NSE in early 2025.
The renewal means Onesource Specialty Pharma can continue to export and sell products manufactured at Unit II to European countries. This strengthens client confidence in the site's quality and regulatory adherence, supports ongoing contracts, and aids future business development in Europe. It also solidifies the company's market position as a trusted CDMO partner for regulated markets.
The pharmaceutical industry sees many Indian companies pursuing global accreditations. For instance, Aarti Pharmalabs and Cipla Limited operate facilities accredited by both USFDA and EU GMP standards, reflecting a strong focus on international compliance. Taj Pharma India Ltd. holds WHO-GMP certification with an upcoming EU GMP approval, while Taxane Healthcare boasts facilities approved by EU-GMP, PIC/s, and WHO GMP, highlighting a competitive landscape for companies serving regulated markets.
Looking ahead, investors and industry observers will be tracking any new contract wins or expansions with European clients that leverage this renewed EU-GMP status, as well as future regulatory inspections and certifications for other facilities. The company's financial performance post-merger and its ability to capitalize on market opportunities, including expansion into new therapeutic areas, will also be of interest.