cGMP Manufacturing
(Hwaseong Plant)
Built for scale: Delivering commercial scale manufacturing with consistency and reliability.
"Established in 2016 in response to growing customer demand, Yuhan’s Hwaseong Plant is mainly built for large-scale commercial manufacturing. The facility has successfully supported multiple commercial campaigns, demonstrating proven scalability and reliability.
We continue to expand this foundation by investing in advanced technologies and strengthening our continuous manufacturing capabilities."
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    Total Site Area
    36,526 m³
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    Total Reactor Capacity
    532,650 L
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    Established Year
    2016 Years
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    Containment Level
    OEB 4 (~1 ug/m³)
Plant Overview
  • 01 / Technology
    Built for Demanding Chemistry
    Hwaseong handles high-pressure hydrogenation and continuous flow chemistry, with both packed bed and plug flow reactors on site. Routes involving fast exotherms or unstable intermediates can go to commercial scale here without being redesigned first.
  • 02 / Supply
    A Reliable Supply Base
    Manufacturing in Korea means a stable regulatory environment and a supply route many of our partners are actively looking to add. As a newer site, Hwaseong also has the capacity to fit campaigns around your schedule.
  • 03 / Visibility
    Real-time Production Tracking
    We monitor critical process parameters continuously through the campaign, so trends and deviations show up while the batch is still running. That gives everyone time to act instead of react.
  • 04 / Data
    Data Interity
    Every result is recorded at source and traceable back through the full chain, from instrument to final report. When an inspector or a partner asks how a number came about, we can show them.
Regulatory Track Record
Inspected by the FDA, MFDS, PMDA and TGA across more than two decades of
commercial supply with no OAI to date.
record
record
Location