OneSource Specialty Pharma has received an Establishment Information Report (EIR) with a 'Voluntary Action Indicated' (VAI) status from the U.S. Food and Drug Administration (USFDA) for its BLD facility in Bangalore. The report follows an inspection of the facility, conducted from November 14 - 22, 2024.
OneSource operates five state-of-the-art cGMP facilities and has a strong track record, with 138 successful regulatory and customer audits to date by all major regulatory bodies.
OneSource Specialty Pharma formerly known as Stelis Biopharma, is India’s first specialty pharma pure-play CDMO business.