Onesource Specialty Pharma receives USFDA inspection report
Key Highlights
Onesource Specialty Pharma received an Establishment Inspection Report from the USFDA for its Bengaluru facility with a VAI classification.
Onesource Specialty Pharma received the Establishment Inspection Report from the U.S. Food and Drug Administration for its Bengaluru facility. The regulator issued a Voluntary Action Indicated classification following an inspection of the Sterile Product Division unit. This regulatory update covers the site visit conducted by the agency between June 22 and June 30, 2026.
The company operates this site as part of its contract development and manufacturing organization platform. The facility focuses on sterile injectables and other modalities including biologics, soft gelatin capsules, and drug-device combinations. Onesource Specialty Pharma maintains these capabilities to provide end-to-end services across various technology platforms and therapeutic areas.
This classification follows the completion of the formal review process by the U.S. Food and Drug Administration. The company stated that this development contributes to its regulatory track record as it continues to build its competitive platform. The firm remains focused on expanding its presence across its four key manufacturing modalities.
Based on company and agency reports. For information only; not investment advice.