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Samsung BioLogics Licensed by Health Canada

To manufacture a monoclonal antibody drug substance at its first plant

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By: Kristin Brooks

Managing Editor, Contract Pharma

Samsung BioLogics has been licensed by Health Canada for manufacturing a monoclonal antibody drug substance at its first plant in Incheon, Korea.
 
This is milestone for Samsung BioLogics as it’s another global regulatory agency approval in addition to FDA, EMA, and PMDA. To date, Samsung BioLogics has received 14 global manufacturing approvals for 14 biologics products. The company expects the number of global approvals to reach 30 this year. 
 
Samsung BioLogics also received an approval for its Drug Product manufacturing from the EMA. This is the company’s second drug product and third global approval.  
 
TH Kim, chief executive officer and president of Samsung BioLogics, said, “Samsung BioLogics has grown rapidly during the last seven years with 14 global regulatory agency approvals and 362,000 liters biologics manufacturing capacity. We will change the paradigm of the bio industry with innovation and ultimately benefit the patients by providing the biologics drugs in a timely manner at lower cost.”

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