Samsung Biologics Receives both FDA & EMA Regulatory Approvals for GMP Production
- Certificate of GMP Compliance of a Manufacturer for Biologics Drug Substance and Drug Product issued by European Medicines Agency
- Licensed by US FDA for the manufacture of additional Biologics Drug Substances
[INCHEON, KOREA] September 7th, 2016 - Samsung Biologics announced today that on July 29, 2016 it received a Certificate of Good Manufacturing Practice (GMP) Compliance of a Manufacturer for Biologics Drug Substance and Drug Product from the European Medicines Agency (EMA). This certification is in addition to the initial US FDA license for the manufacture of Biologics Drug Substances received in November 2015 for Samsung Biologics’ facility based in Incheon, Korea.
- Certificate of GMP Compliance of a Manufacturer for Biologics Drug Substance and Drug Product issued by European Medicines Agency
- Licensed by US FDA for the manufacture of additional Biologics Drug Substances
[INCHEON, KOREA] September 7th, 2016 – Samsung Biologics announced today that on July 29, 2016 it received a Certificate of Good Manufacturing Practice (GMP) Compliance of a Manufacturer for Biologics Drug Substance and Drug Product from the European Medicines Agency (EMA). This certification is in addition to the initial US FDA license for the manufacture of Biologics Drug Substances received in November 2015 for Samsung Biologics’ facility based in Incheon, Korea.
The EMA certificate issued in July 2016 is for the production of 3 monoclonal antibody Drug Substances and a Drug Product.
Samsung Biologics has been licensed by the FDA for an additional 2 monoclonal antibody Drug Substances in August 2016 following the first license in November 2015.
With the certification and licenses from the EMA and FDA respectively, Samsung Biologics is manufacturing commercial Biologics Drug Substance and Drug Product in just five years since its launch in 2011.
“We are eager to maintain and further improve our biopharmaceutical quality systems and manufacturing process in a GMP-certified manufacturing facility to provide high-quality products to our clients,” said TH Kim, CEO of Samsung Biologics. “We can expect and are prepared to receive more inspections from various other regulatory agencies such as those in Japan, Russia, and so on this year.”
Samsung Biologics aims to strengthen its presence in the rapidly growing global biopharmaceutical market by utilizing its world-class plant design and operation technology that maximizes production efficiency and ensures highest quality product for the patient.
Samsung Biologics is investing USD 730 million in its third plant with a bioreactor capacity of 180,000 liters.
Once the third plant is operational in 2018, Samsung Biologics is expected to have the world’s largest capacity for a biologics contract manufacturing organization (CMO), with a total production capacity of 362,000 liters.
Currently, Samsung Biologics has the production capacity of 182,000 liters through its first plant with 30K liters of capacity, which started full commercial operation in November 2015, and second plant with 152K liters of capacity, which started operation in February 2016.
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