OneSource Specialty Pharma Limited announced that its Sterile Product Division (SPD) facility in Bengaluru has received the Establishment Inspection Report (EIR) from the U.S. Food and Drug Administration (USFDA). The facility was classified as ‘Voluntary Action Indicated’ (VAI) following an inspection conducted from June 22 to June 30, 2026. This outcome underscores the company’s commitment to quality and regulatory compliance.
USFDA Inspection Concludes with VAI Classification
OneSource Specialty Pharma Limited (BSE: 544292, NSE: ONESOURCE) has announced the successful conclusion of its inspection by the U.S. Food and Drug Administration (USFDA) for its Sterile Product Division (SPD) facility located in Bengaluru. The company received the Establishment Inspection Report (EIR) for the facility, which was classified as ‘Voluntary Action Indicated’ (VAI). This classification follows an inspection that took place between June 22 and June 30, 2026.
Commitment to Quality and Compliance
Neeraj Sharma, Managing Director & CEO of OneSource Specialty Pharma, expressed satisfaction with the outcome. “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,” Sharma stated. He further emphasized the integral role of the SPD facility in the company’s sterile manufacturing capabilities, enabling it to support global partners.
Strengthening CDMO Platform
This development further bolsters OneSource’s regulatory track record as it continues to enhance its position as a differentiated, globally competitive CDMO platform. The company specializes in drug-device combinations, biologics, sterile injectables, and soft gelatin capsules. OneSource operates five state-of-the-art manufacturing facilities, approved by global regulatory authorities, and employs over 1,600 professionals. Its comprehensive capabilities and strong compliance record have earned the trust of global pharmaceutical companies seeking end-to-end solutions.
Source: BSE
