Bengaluru, October 30, 2026: OneSource Specialty Pharma Limited (BSE: 544292, NSE: ONESOURCE) has received an Establishment Inspection Report (EIR) from the U.S. Food and Drug Administration (USFDA) for its Sterile Product Division (SPD) facility in Bengaluru, the company announced. The EIR, which carries a ‘Voluntary Action Indicated’ (VAI) classification, follows an inspection conducted at the facility from June 22 to June 30, 2026.
The completion of the USFDA inspection process marks a regulatory milestone for OneSource Specialty Pharma as it continues to expand its global manufacturing capabilities.
USFDA inspection and classification
The USFDA’s VAI classification indicates that the agency found certain issues that do not warrant regulatory or administrative action, allowing the facility to continue its operations. The inspection and subsequent EIR are key steps for companies seeking to supply sterile pharmaceutical products to the US market.
Company leadership comments
Neeraj Sharma, Managing Director & CEO of OneSource Specialty Pharma, said the EIR with VAI classification reflects the company’s commitment to quality, regulatory compliance, and operational excellence. Sharma highlighted the SPD facility’s role in supporting the company’s sterile manufacturing capabilities and meeting the needs of global partners.
Expanding CDMO platform
OneSource Specialty Pharma’s regulatory progress supports its strategy to build a globally competitive contract development and manufacturing organisation (CDMO) platform. The company operates across four modalities: drug-device combination, biologics, sterile injectables, and soft gelatin capsules.
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