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Drug product approval from FDA follows previous approvals from European and Japanese authorities.
Samsung BioLogics announced on July 25, 2018 that it has been licensed by FDA to manufacture a monoclonal antibody drug product at its Songdo Plant 1. The company has 16 global approvals for manufacturing drug substance in Plant 1 and 2, and drug products in Plant 1 including two European Medicines Agency drug product approvals and one Pharmaceuticals and Medical Device Agency (Japan) drug product approval.
In a statement announcing the FDA approval, Samsung BioLogics reported the company expects additional global drug substance and drug product approvals for both Plant 1 and Plant 2 during the second half of 2018.
Source: Samsung Biologics