Factory Information

Manufacturing Facility (API)
Manufacturing Facility
Plant of DongKook Lifescience in Won-ju was established in 1995 and has been approved by ‘Ministry of Food & Drug Safety BGMP’ to equip the production system of contrast agent API. And we are exporting API to world-wide based on PMDA(Japan)DMF, EDQM (Europe) CEP.
With the goal of the world’s No.1 contrast agent API manufacturer, we have built a highly efficient manufacturing system through continuous investment and the research of productivity improvement. We are a leader of contrast agent API production through systematic management system based on compliance with quality standard.
2019.11 Passed PMDA audit (Gadoteridol, Iopamidol)
2019.04 DOTA DMF
2018.06 Cilastatin Na DMF
2017.08 Gadobutrol monohydratel(MRI contrast agent API) DMF
2017.08 Establishment of DongKook Lifescience
2017.02 Passed PMDA audit (Gadopentetate monomeglumine)
2015.12 Acquired Certificate of GMP Compliance of a Manufacturer (MFDS)
2013.12 Developed Gadoteridol (MRI contrast agent API)
2009.10 Developed DOTA(MRI contrast agent API)
2007.12 Registered Gadopentetate monomeglumine(API) to PMDA (219MF10351)
2007.04 Approved aseptic process of GMP (Cilastatin Na)
2006.06 Developed Gadodiamide(MRI contrast agent API)
2005.06 Developed Gadopentetate monomeglumine(MRI contrast agent API)
2002.07 Developed Iohexol(X-ray contrast agent API)
2001.07 Acquired BGMP certificate (KFDA)
2000.06 Acquired EU CEP certificate (Iopamidol)
1999.12 Developed Iopamidol(X-ray contrast agent API)
1995.09 Establishment of DongKook Fine-chemical
Product(API) Category
Iopamidol CT contrast agent
Gadobutrol monohydrate MRI contrast agent
Gadoteridol MRI contrast agent
DOTA MRI contrast agent
Cilastatin Na Antibiotic API