CDMO
We provide comprehensive integrated service from research to full-scale contract manufacturing for cytotoxic injection.
Main Products
-
Lyophilized Injection
-
Liquid Injection
CDMO Service Process
Develop
dosage form
Develop
standard and
test method
Conduct
safety test
Development
Commercial production
Quality management
and assurance
Production
Our Facilities
We built new plants to ensure that we have the newest facilities
and proprietary technology of the highest level.
| Facility Name |
Made in | Notes |
|---|---|---|
| RABS | Korea | Negative Pressure Room |
| Cooling Condition | ||
| Weighing System | Korea | Local Protection |
| Formulation System | Korea | Semi-Automatic |
| 10 ~ 200L | ||
| Vacuum Mixer | ||
| Teflon Coated Tank | ||
| Cooling Under -5°C | ||
| Filling System | Korea | Fully Automatic : Vial Washer ~ Capping Machine |
| Filling Speed : 60 Vial/min | ||
| Range Of Vial : 1 ~50mL | ||
| Freeze Dryer | Korea | Shelf Area : 4㎡, Ice Capacity : 50kg |
| Germany | Shelf Area : 4㎡, Ice Capacity : 100kg | |
| Exterior Washer | Korea | 100 Vial/Min |
| Visual Inspection | - | Manual |
| Packaging | Korea | Semi-Automatic |
| Part Washer | - | Manual |
GMP Certification
| First Certification |
Certification | Authorities |
|---|---|---|
| 2013 | JGMP (API(Chemical synthesis), Last recertification 2020) |
PMDA |
| 2011 | EU GMP (API (Chemical synthesis), Last recertification 2021) |
BJV |
| 2011 | BGMP (API(Chemical synthesis), Last recertification 2021) |
MFDS |
| 2010 | JGMP (FDF, Last recertification 2022) | PMDA |
| 2010 | JGMP (API (Fermentation), Last recertification 2020) |
PMDA |
| 2010 | EU GMP (FDF, Last recertification 2022) | BJV |
| 2010 | Iranian GMP (API and FDF) | MHME |
| 2007 | KGMP (FDF, Last recertification 2021) | MFDS |
| 2005 | EU GMP (API(Fermentation), Last recertification 2021) |
BJV |
| 2005 | Hungarian GMP (API) | OGYÉI |
| 2002 | BGMP (API (Fermentation), Last recertification 2021) |
MFDS |
