Onesource Specialty Pharma has received the Establishment Inspection Report (EIR) from the U.S. Food and Drug Administration (USFDA) for its Sterile Product Division (SPD) facility in Bengaluru, with a 'Voluntary Action Indicated' (VAI) classification. The report follows an inspection of the facility conducted from June 22 to June 30, 2026.
The development adds to the company’s regulatory track record as it continues to build a differentiated, globally competitive CDMO platform spanning four key modalities - drug-device combination, biologics, sterile injectables and soft gelatin capsules.
OneSource Specialty Pharma is a multimodal specialty pharma CDMO with end-to-end capabilities across technology platforms and therapeutic modalities.
