OneSource Specialty Pharma's Bengaluru Facility Receives USFDA EIR with VAI Classification
Bengaluru: OneSource Specialty Pharma Limited has received the Establishment Inspection Report (EIR) from the US Food and Drug Administration (USFDA) for its Sterile Product Division (SPD) facility in Bengaluru, with a Voluntary Action Indicated (VAI) classification.
The report follows a USFDA inspection of the facility conducted from June 22 to June 30, 2026.
Commenting on the development, Neeraj Sharma, Managing Director and CEO of OneSource Specialty Pharma, said, “We are pleased to receive the EIR with VAI classification from the USFDA for our SPD facility. This inspection outcome reflects our continued commitment to maintaining high standards of quality, regulatory compliance and operational excellence across our operations. Our SPD facility plays an integral role in our sterile manufacturing capabilities, enabling us to support the evolving needs of our global partners.”
The development adds to OneSource's regulatory track record as it continues to build a contract development and manufacturing organisation (CDMO) platform spanning four key modalities: drug-device combinations, biologics, sterile injectables and soft gelatin capsules.
OneSource Specialty Pharma Limited is a specialty pharmaceutical CDMO focused on the development and manufacturing of complex pharmaceutical products, including biologics, drug-device combinations, sterile injectables and oral technologies such as soft gelatin capsules.
The company operates five manufacturing facilities approved by global regulatory authorities and has a workforce of more than 1,600 professionals. Its development capabilities, manufacturing capacities and compliance track record support its partnerships with global pharmaceutical companies seeking end-to-end solutions.
