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 Limited 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 Bangalore.

The report follows an inspection of the facility, conducted from November 14 - 22, 2024.

Commenting on the development 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 specialty pharma CDMO, we are dedicated to continually advancing quality standards, and solidifying our position as a trusted partner in the CDMO sector globally.”

OneSource operates five  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 Limited formerly known as Stelis Biopharma Limited, is India’s first specialty pharma pure-play CDMO business.