CDMO

We provide comprehensive integrated service from research to full-scale contract manufacturing for cytotoxic injection.

Main Products

  • Azalid® 150 milligrams

    Lyophilized Injection

  • Genexol® paclitaxel

    Liquid Injection

CDMO Service Process

01

Develop
dosage form

02

Develop
standard and
test method

03

Conduct
safety test

Development

04

Commercial production

05

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.

Facilities table
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

GMP Certification table
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
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Posted on March 28, 2023

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