Company

About Us

Samyang Biopharm is endeavoring to improve people’s health.

Samyang group has identified healthcare as its key strategic business focus for the 21st century.
The Samyang Biopharm is engaged in research and development of innovative technology platforms for drug delivery and
novel application of its expertise in biopolymers for developing biomedical devices.

Biomedicine Research Center

The Biomedical R&D Center aims to lead the DDS(Drug Delivery System) research
sector worldwide. Based on our accumulated experience in synthetic synthetic
resins and fine chemicals, we are continuing to closely cooperate with overseas
partners and developing innovative DDS.
Thanks to Samyang Discovery Center, which was established in Seongnam
Pangyo Techno Valley in April 2016, Samyang Biopharm will confirm its position
as a specialized pharmaceutical company with improved R&D capability and become
an R&D center that leads the sustainable growth and development of the company.

Samyang Biopharm set ‘Value Creative Pharma Company’ as its vision for 2020,
which illustrates its goal to become a company that provides ‘Life’s Ingredients.

Biopharmaceutical Plant

The Samyang Biopharm’s pharmaceutical plant was established in 1997 to
produce premium quality active pharmaceutical ingredients(APIs) using novel plant
cell culture and semisynthetic technologies. The plant was equipped in 2007 with
modern injection filling line which is dedicated to produce anti-cancer injectables.
The Biopharmaceutical plant is Korean GMP compliant and passed inspection of
German and Japanese health agencies.

Certificates

Biopharmaceutical Plant Certificates
Acquisition year description Agency
2015 EU GMP for finished dosage form (Extension) German authorities
Freie und Hansestadt Hamburg
Behörde für Gesundheit und Verbraucherschutz
2014 EU GMP for API (Extension) German authorities
Freie und Hansestadt Hamburg
Behörde für Gesundheit und Verbraucherschutz
2013 EU GMP for finished dosage form (Extension) German authorities
Freie und Hansestadt Hamburg
Behörde für Gesundheit und Verbraucherschutz
2012 EU GMP for API (Extension) German authorities
Freie und Hansestadt Hamburg
Behörde für Gesundheit und Verbraucherschutz
2011 BGMP (Extension) Korean FDA
2010 Japanese GMP
GMP for API and finished dosage form
Japanese authorities
PMDA, Japan
2010 EU GMP for API and finished dosage form German authorities
Freie und Hansestadt Hamburg
Behörde für Gesundheit und Verbraucherschutz
2010 Iranian GMP
Iran GMP for API and finished dosage form
Iranian authorities
Ministry of health and Medical Education, Iran
2007 KGMP (Extension) Korean FDA
2005 EU GMP for API German authorities
Freie und Hansestadt Hamburg
Behörde für Gesundheit und Verbraucherschutz
2005 Hungarian GMP
GMP for API
Hungarian authorities
National Institute of Pharmacy, Hungary
2002 BGMP KFDA
Korean FDA

MD Plant

The Samyang Biopharm’s first manufacturing plant was designed to produce
its pharmaceutical drug loaded transdermal patches and the wound closure
medical devices. This plant was completed and granted GMP-compliant status
in 1996. The plant also obtained its ISO9001 designation for medical devices
in August of 1999. This plant has been now dedicated exclusively to produce
innovative wound closure and medical devices.

Certificates

MD Plant
Category Acquisition year Description Agency Scope
Medical
device
2003 ISO 13485 snch All medical devices
2002 CE Mark ITC/3EC Finished medical devices
1999 KGMP Korea FDA Finished medical devices
Drug 2011 Austrailan GMP TGA Rheumastop Plaster
1996 KGMP Korea FDA Finished drugs

※ ITC : Institute for Testing and Certification, Inc.

※ TGA : Therapeutic Goods Administration