Samsung BioLogics said Thursday that its second factory received manufacturing approval from the European Medicines Agency (EMA).
The factory has a floor space of 81,945 square meters to become the world’s first biopharmaceutical factory to install 10 incubators, compared with the average of four to six incubators established, which are expected to improve production efficiency.
The EMA approval is the second one obtained by the company overseas, after it won approval from the U.S. Food and Drug Administration (FDA) on Oct. 12.
Samsung BioLogics was able to successfully obtain the approval by actively nurturing the quality management workforce and strengthening the ability to deal with the due diligence through constant rehearsal, the company said.
“Samsung BioLogics once again proved that it possesses world-class capabilities in quality control as well as production scale,” CEO Kim Tae-han said. “The company will do its best to produce the best quality biopharmaceuticals more quickly through continuous innovation and to provide customers and patients with a timely supply of pharmaceuticals.”
The pharmaceutical unit of the Samsung Group also plans to complete mechanical installation on its third factory by the end of this year. The facility will be larger than the previous two plants and enhance manufacturing flexibility for the production of biopharmaceuticals in medium and large volumes.
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