cGMP Manufacturing
(Ansan Plant)
Where the CDMO legacy began: Established in 1980, Yuhan’s Ansan Plant has supported the success of numerous blockbuster, life-saving drugs.Built on decades of GMP expertise, the facility offers flexible multipurpose API manufacturing with proven quality and regulatory compliance. Today, it continues to serve global partners with reliable supply and scalable capabilities across the drug lifecycle.
  • icon
    Total Site Area
    31,598 m³
  • icon
    Total Reactor Capacity
    462,700 L
  • icon
    Established Year
    1998 Years
  • icon
    Containment Level
    OEB 4 (~1 ug/m³)
Plant Overview
  • 01 / Scale-up
    Seamless scale-up from development
    Our development and manufacturing teams work under one organisation, so processes arrive at the plant already understood. What was learned in the lab carries directly into the first commercial campaign.
  • 02 / Supply
    Reliable supply, campaign after campaign
    Decades of commercial manufacturing have taught us that consistency is the product. Stable yields, disciplined scheduling and continuous process improvement keep your supply predictable over the life of a program.
  • 03 / Quality
    Quality built for global review
    The site operates under cGMP and is approved by major regulatory authorities including the FDA, MFDS and TGA. Client audits and agency inspections are part of how we work, not an exception to it.
  • 04 / Responsibility
    Safe and responsible operations
    Safety and environmental performance are managed with the same rigour as quality. Our commitments through PSCI, the UN Global Compact, Science Based Targets Initiative and Ecovadis hold the site to standards our partners can stand behind.
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