Company

Facilities Facilities

  • Pharmaceutical plants
  • MD plant

BioPharmaceutical plants BioPharmaceutical plants

BioPharmaceutical plants Image BioPharmaceutical plants Image
  • Address :
  • 79, Sinildong-ro, Daedeok-gu,
    Daejeon
  • TEL :
  • +82-42-930-9302
  • FAX :
  • +82-42-934-1403

Pharmaceutical plants was constructed in August 1997 and started off as mass production facility of paclitaxel by plant-cell-culture technology.
Currently, there are efforts being made to export synthesis and injection based medicine to overseas market, such as Europe and Japan.

Pharmaceutical plants has advanced facilities that are comply with KGMP, cGMP, EU-GMP and other products.
Beginning with the BGMP certification for the fermentation process from the Ministry of Food and Drug Safety in 2002, we have also obtained the GMP certification for the establishment of API pharmaceutical production facilities in Germany and Japan.
Since the completion of the injection plant in 2007, we have obtained GMP certification from the Ministry of Food and Drug Safety, in Germany and Japan.

To meet the growing demand, Samyang Biopharmaceuticals Division invested US $26 million in the construction of a new Pharmaceutical plants to manufacture oncology injections; it will be compliant with cGMP, EU-GMP, JP-GMP, and KGMP standards.

GMP Certifications

BioPharmaceutical plants Certification
Initial Year Content Authority
2011 BGMP (Chemical synthesis) MFDS
2010 BGMP (Chemical synthesis) MFDS
2010 JGMP (API FDF, Last recertification 2015) PMDA
2009 EU GMP (FDF, Last recertification 2019) BGV
2008 Iranian GMP (API and FDF) MHME
2007 EU GMP (API, Last recertification 2014) BGV
2006 KGMP (FDF, Last recertification 2015) MFDS
2005 EU GMP (API, Last recertification 2014) BGV
2005 Hungarian GMP (API) OGYĖI
2005 BGMP (Fermentation) MFDS

Recent Inspection History

BioPharmaceutical plants Certification
Date Country Country Authority
2019.05 Japan PMDA Drug Product
2019.04 Germany BGV Drug Product
2018.03 Korea MFDS Drug Substance, Drug Product
2017.07 Germany BGV Drug Product
2015.11 Japan PMDA Drug Substance, Drug Product
2015.09 Germany BGV Drug Product
2015.03 Korea MFDS Drug Substance, Drug Product
2014.06 Germany BGV Drug Substance
2013.06 Korea MFDS Drug Product
2013.05 Japan PMDA Drug Substance
• BGV : Behörde für Gesundheit und Verbraucherschutz (Agency for Health and Consumer Protection, Hamburg)
• PMDA : Pharmaceuticals and Medical Devices Agency (Japan)
• MFDS : Korean Ministry of Food and Drug Safety (Former name = KFDA, Korea)
• MHME : Ministry of Health and Medical Education
• OGYĖI : National Institute of Pharmacy and Nutrition

MD Plant MD Plant

MD Plant image BioPharmaceutical plants Image
  • Address :
  • 55, Munpyeongseo-ro 18 beon-gil,
    Daedeok-gu, Daejeon
  • TEL :
  • +82-42-930-3114
  • FAX :
  • +82-42-931-6439

Established in 1996, the MD plant was the first KGMP plant in Korea to specialize in producing synthetic absorbable sutures using biodegradable polymers and a transdermal patch, which is a product of DDS (drug delivery system) technology.

We are producing biodegradable surgical sutures that meet US (USP) and European (EP) standards. As we export to the global markets such as Europe, the U.S, the Middle East, China, Southeast Asia, etc., we now have the world’s best-selling synthetic absorbable suture materials.

Currently, the MD plant is focusing on the development of production line based on the polymer technology for biodegradable hemostat SurgiGuard® and anti-adhesive agent InterGuard® in order to expand our portfolio of surgical products.

Furthermore, with accumulated expertise in manufacturing DDS technology-based transdermal patches as well as in applying polymer technologies, the MD plant produces Nicostop® and Nicostop® gum (smoking cessation aids), Rheumastop® (an antiarthritic drug), Angiderm® (a treatment for angina pectoris), and Tubrol® patch (a treatment for bronchial asthma).

Certification Certification

MD Plant Certification
Category Acquisition year Description Scope
Medical
Devices
2003 ISO 13485 All medical devices
2002 CE Mark Finished medical devices
1999 KGMP Finished medical devices
Medical
Substances
2011 Australian GMP RheumaStop Plaster
1996 KGMP Completed drugs

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