Press Releases
Samsung Biologics Receives Health Canada Approval
Samsung Biologics Receives Health Canada Approval
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- Additional global regulatory agencies’ approval following with FDA, EMA, and PMDA
- Also received DP EMA approval, One-Stop Service from DS to DP
'18. 06. 21st (Thurs)
[Incheon, Korea] June 21st, 2018 ? Samsung Biologics announced today that it has licensed by the Health Canada for manufacturing a monoclonal antibody Drug Substance at its first plant.
This is a great milestone for Samsung Biologics as it is another global regulatory agency’ approval in addition to FDA, EMA, and PMDA. With the additional two approvals, Samsung Biologics has received 14 global manufacturing approvals for 14 biologics products.
Samsung Biologics is continuously receiving approvals at an accelerated rate and the number of global approvals is expected to be reach 30 within this year.
Samsung Biologics also received an approval for its Drug Product manufacturing from EMA. This is the company’s second drug product and third global approval.
TH Kim, CEO 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” Then he added “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”
Samsung Biologics Receives Health Canada Approval
- Additional global regulatory agencies’ approval following with FDA, EMA, and PMDA
- Also received DP EMA approval, One-Stop Service from DS to DP
'18. 06. 21st (Thurs)
[Incheon, Korea] June 21st, 2018 – Samsung Biologics announced today that it has licensed by the Health Canada for manufacturing a monoclonal antibody Drug Substance at its first plant.
This is a great milestone for Samsung Biologics as it is another global regulatory agency’ approval in addition to FDA, EMA, and PMDA. With the additional two approvals, Samsung Biologics has received 14 global manufacturing approvals for 14 biologics products.
Samsung Biologics is continuously receiving approvals at an accelerated rate and the number of global approvals is expected to be reach 30 within this year.
Samsung Biologics also received an approval for its Drug Product manufacturing from EMA. This is the company’s second drug product and third global approval.
TH Kim, CEO 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” Then he added “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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