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
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
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 |
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).
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 |