PLANT
We produce Medical Devices
using biodegradable materials.
Our MD Plant, completed in July 1996, is the first KGMP plant in Korea that specializes
in the production of absorbable sutures using biodegradable polymer.
Our MD Plant produces biodegradable Surgical Suture Materials that comply with the U.S. (USP) and European (EP) standards. Our sutures are exported to various regions and countries including Europe, U.S., Middle East, China, and Southeast Asia, recording the highest sales in the world.
We are also building a production base to create a portfolio of various surgical products, such as Surgi-Guard®, a biodegradable hemostatic agent, and Inter-Guard®, an anti-adhesion product, using our extensive knowledge in polymer technologies.
Certification
Acquired Year |
Certification Description |
Institute |
---|---|---|
2003 | ISO 13485 | 3EC |
2002 | CE certification |
3EC, UDEM |
1999 | KGMP (Medical Devices) |
Korean Ministry of Food and Drug Safety(MFDS), Korea |
Our Gongju Plant produces biodegradable polymer materials used on the human body.
Glycolide, lactide and p-dioxanone, which are main products of our Gongju Plant, are FDA-approved biodegradable polymer materials that can be used on the human body. They are used as the raw material for biodegradable surgical sutures, drug delivery agents, and orthopedic devices.
As these products are mainly used on the human body, they must pass strict quality standards of the client company (source of demand), which means the entry barrier to the market is very high, requiring years of testing and analysis. Only a few companies around the world are producing and supplying these products, and Samyang Holdings has an unrivaled position in the Korean market.
Our products boast world-class quality and the best prices. They are currently exported to various countries around the world, including the U.S., Germany, Japan, China, Taiwan and India, achieving import-substitution effects.
Certification
We strive to provide the best quality and build trust with our technological excellence.
Acquired Year |
Certification Description |
Institute |
---|---|---|
2010 | ISO 9001 (Quality Management System) |
ANAB |