PLANT

Our advanced GMP-approved plant produces high-quality cytotoxic
anti-cancer drugs.

Pharmaceuticals
Plant

Our biopharmaceuticals plant is the only EU-GMP and
JGMP-approved plant in Korea, which produces high-quality cytotoxic anti-cancer drugs with exceptional GMP technologies.

Our biopharmaceuticals plant was built in August 1997 and started the mass production of paclitaxel by cultivating plant cells. Currently we are focused on expanding our presence in the overseas market, such as Europe and Japan, through continuous investment in the production of various pharmaceutical products, including synthetic active pharmaceutical ingredients and injections.

Our biopharmaceutical plant is equipped with facilities that are in compliance with KGMP, cGMP and EU-GMP. Starting with the BGMP certification by the Food and Drug Administration (FDA), we received the GMP certifications for our active pharmaceutical ingredient production facility in Germany and Japan.

After completing the injection plant in 2007, we acquired the GMP certification from the FDA, Germany and Japan, and we are currently selling our pharmaceutical products overseas, making efforts to expand our presence, such as entering the U.S. market.

In addition, in response to the increasing amount of sales, we are building a new anti-cancer injection plant which also complies with cGMP, EU-GMP, JGMP and KGMP by investing approximately 30 billion KRW.

Certification

Certification table
Acquired
Year
Certification Description Institute
2013 JGMP
(API, Fermentation, Last recertification 2020)
Pharmaceutical and
Medical Device Agency(PMDA), Japan
2011 EU GMP
(API, Chemical Synthesis, Last recertification 2021)
Behörde für Justiz und
Verbraucherschutz (BJV), Germany
2011 BGMP
(API, Chemical synthesis, Last recertification 2021)
Korean Ministry of Food and
Drug Safety (MFDS), Korea
2010 JGMP
(finished dosage form, Last recertification 2022)
Pharmaceutical and
Medical Device Agency(PMDA), Japan
2010 JGMP
(API, Last recertification 2020)
Pharmaceutical and
Medical Device Agency(PMDA), Japan
2010 EU GMP
(finished dosage form, Last recertification 2022)
Behörde für Justiz und
Verbraucherschutz (BJV), Germany
2010 Iranian GMP
(API and finished dosage form)
Ministry of health and
Medical education(MHME), Iran
2007 KGMP
(finished dosage form, Last recertification 2021)
Korean Ministry of Food and
Drug Safety(MFDS), Korea
2005 EU GMP
(API, Fermentation, Last recertification 2021)
Behörde für Justiz und
Verbraucherschutz (BJV), Germany
2005 Hungarian GMP
(API)
National Institute of Pharmacy, Hungary
2002 BGMP
(API, Fermentation, Last recertification 2021)
Korean Ministry of Food and
Drug Safety(MFDS), Korea
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Posted on March 28, 2023

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