Onesource Pharma Receives USFDA EIR with VAI Classification

OneSource Specialty Pharma Limited has established itself as India’s foremost pure-play Contract Development and Manufacturing Organisation (CDMO) in the speciality pharmaceutical sector. The company offers a diverse portfolio of comprehensive solutions across cutting-edge technological platforms and therapeutic modalities.

USFDA EIR Milestone Achieved

In a pivotal achievement for India’s burgeoning speciality pharma industry, OneSource Specialty Pharma Limited has secured an Establishment Inspection Report (EIR) with a ‘Voluntary Action Indicated’ (VAI) status from the US Food and Drug Administration (USFDA) for its state-of-the-art BLD facility in Bangalore.

The accolade follows a meticulous inspection conducted from 14 to 22 November 2024. The VAI status indicates that although some observations were noted, they are unlikely to prompt further regulatory action, reaffirming OneSource’s stellar reputation for compliance and operational excellence.

Statement from the OneSource

Neeraj Sharma, CEO of OneSource, remarked, “We are delighted to have received the EIR with VAI classification from the USFDA for our BLD facility. This milestone reflects our unwavering dedication to upholding world-class quality standards and stringent regulatory compliance across every facet of our operations.

“Our BLD facility is among the exclusive few FDA-approved penicillin manufacturing sites worldwide, with a distinguished legacy of supplying to the US market. As a globally trusted speciality pharma CDMO, we remain committed to pushing the boundaries of quality and innovation.”

Strategic Financial Infusion

In a noteworthy financial development, OneSource Specialty Pharma Limited recently secured equity funding totalling ₹8,010 million (£75 million), achieving a valuation of $1.65 billion (£1.35 billion). The substantial capital injection is earmarked for debt reduction and the expansion of manufacturing capacities, further bolstering the company’s competitive edge in the dynamic CDMO sector.

This remarkable achievement cements OneSource’s position as a frontrunner in speciality pharmaceuticals and underscores its relentless pursuit of global leadership in the CDMO arena.

Share Price Performance 

At 3:30 PM today, Onesource Specialty Pharma Ltd. shares traded at ₹1,570.00 per share on the NSE.

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