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OneSource Pharma Scores USFDA Nod, Eyes Global Expansion with Xbrane Investment!

Updated: June 10, 2025 09:12

Image Source: Xbrane Biopharma
OneSource Specialty Pharma Ltd. has achieved a major regulatory milestone and signaled global ambitions with two strategic developments. The company’s Bangalorebased BLD facility has received an Establishment Inspection Report (EIR) with a Voluntary Action Indicated (VAI) classification from the USFDA, following a detailed inspection in November 2024. At the same time, OneSource is proposing to subscribe to shares of Swedenbased Xbrane Biopharma AB, aiming to strengthen its biologics portfolio and widen its global footprint.
 
Key Highlights:
  • USFDA VAI Classification: The VAI status indicates that while minor observations were noted, no further regulatory action is required. This boosts OneSource’s credibility in the contract development and manufacturing (CDMO) space.
  • Bangalore Facility Spotlight: The BLD plant stands as one of the rare FDAapproved penicillin facilities globally, reinforcing OneSource’s compliance and manufacturing strength.
  • Global Investment Move: The proposed investment in Xbrane Biopharma AB, a Nasdaq Stockholmlisted firm, aligns with OneSource’s strategy to expand its presence in biosimilars and advanced biologics.
  • Strategic Capital Allocation: Following a recent ₹8,010 million equity infusion, OneSource is focusing on scaling operations, reducing debt, and exploring international collaborations.
Together, these developments signal OneSource’s transformation into a globally competitive CDMO player with a keen eye on innovation, regulation, and biotech opportunity.
 
Sources: OneSource Press Release, Angel One, Express Pharma.

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