Milestone
For over four decades, Yuhan CDMO has grown into a trusted global API manufacturing partner.
We continue to advance through expanded capabilities, regulatory excellence, and long-term investment.
We continue to advance through expanded capabilities, regulatory excellence, and long-term investment.
46 Years of
Integrity and Service
Integrity and Service
For over four decades, Yuhan CDMO has grown into a trusted
global API manufacturing partner. We continue to advance
through expanded capabilities, regulatory excellence,
and long-term investment.
global API manufacturing partner. We continue to advance
through expanded capabilities, regulatory excellence,
and long-term investment.
1998
1999
2002
2004
2006
2013
2016
2017
2023
2024
2028
1998
Establishment of YuhanCDMO's Ansan Plant
Launched YuhanCDMO’s first manufacturing facility at Ansan,
establishing a foundation for global CDMO operations.
1999
Ansan Plant GMP-approved by the KFDA
Achieved Korean GMP certification, demonstrating compliance
with national pharmaceutical manufacturing standards.
2002
Ansan Plant cGMP-approved by the FDA
Received U.S. FDA cGMP approval, enabling the supply
of products to the U.S. market.
2004
Ansan Plant GMP-approved by the TGA
Secured Australian TGA GMP certification, validating
the plant’s quality systems for international markets.
2006
Ansan Plant GMP-approved by the PMDA and EDQM
Obtained GMP approvals from Japan’s PMDA and Europe’s EDQM,
strengthening global regulatory competitiveness.
2013
Construction of Building G - Ansan Plant Expansion
Expanded manufacturing capacity through the construction
of Building G to support growing customer demand.
2016
Establishment of YuhanCDMO's Hwaseong Plant
Established a state-of-the-art Hwaseong facility to enhance
production capabilities and future growth.
2017
Hwaseong Plant cGMP-approved by the FDA
Received U.S. FDA cGMP approval, confirming the Hwaseong Plant’s
compliance with global pharmaceutical manufacturing standards.
2023
Construction of Building HB - Hwaseong Plant Expansion
Expanded production capacity with the construction of Building HB
to support increasing project and commercial manufacturing needs.
2024
Ansan Plant Completed Inspection by FDA and ANVISA
Successfully completed regulatory inspections by the U.S. FDA
and Brazil’s ANVISA, demonstrating continued compliance with
international quality standards.
2028
Expected
Construction of Building HC - Hwaseong Plant Expansion
Further enhancing manufacturing capabilities and operational
flexibility through the construction of Building HC.
Our History, Our Direction
YuhanCDMO has operated as a pharmaceutical API manufacturer for over four decades.
What began as a single facility producing anti-tuberculosis compounds has grown into a two-site CDMO network with regulatory clearances spanning the U.S., Europe, Japan, and Latin America, and a service range that covers the full development-to-commercial manufacturing continuum.
Going forward, our priorities reflect where the industry is heading.
We are increasing our clinical-stage API manufacturing capacity to engage partners at the IND-filing stage. We are maintaining and expanding our multi-regulator inspection record across key global markets. And we are continuing to invest in the quality, environmental, and safety management systems that global pharmaceutical partners require of their suppliers.
We are increasing our clinical-stage API manufacturing capacity to engage partners at the IND-filing stage. We are maintaining and expanding our multi-regulator inspection record across key global markets. And we are continuing to invest in the quality, environmental, and safety management systems that global pharmaceutical partners require of their suppliers.