Factory Information
Introduction
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.
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 |