The report follows a comprehensive inspection of the facility, conducted from November 14 to November 22, 2024

OneSource Specialty Pharma has received an Establishment Information Report (EIR) with a 'Voluntary Action Indicated' (VAI) status from the US Food and Drug Administration (USFDA) for its BLD facility in Bengaluru. The report follows a comprehensive inspection of the facility, conducted from November 14 to November 22, 2024.

Neeraj Sharma, CEO, OneSource said, “We are pleased to receive the EIR with VAI classification from the USFDA for our BLD facility. This inspection outcome reflects our commitment to maintaining high-quality standards and regulatory compliance across all aspects of our operations. Our facility stands as one of the few FDA-approved penicillin sites globally, with a long-standing legacy of supplying to the US market. As a speciality pharma CDMO, we are dedicated to continually advancing quality standards, and solidifying our position as a trusted partner in the CDMO sector globally.”