Tag: Samsung

Merck KGaA gets hold on $117 million contract for Samsung biosimilar

biosimilars
Merck KGaA, a global health care company, has won a $117 million contract to supply the biosimilar Renflexis, developed by Samsung Bioepis Co., to the U.S. Department of Veterans Affairs.

Samsung Biologics third plant commenced production

samsung biologics
Samsung BioLogics announced that its Plant 3, the world’s largest single bio manufacturing plant, has become cGMP ready and started production after its successful validation.

Samsung BioLogics gets FDA approval to manufacture a monoclonal antibody drug

samsung biologics
Samsung BioLogics announced that it has been licensed by the US FDA to manufacture a monoclonal antibody Drug Product (DP) at its first plant. The company did not disclose the name of the product.

Samsung Biologics biggest plant received FDA approval

samsung biologics
Samsung BioLogics announced that a third monoclonal antibody Drug Substance has been licensed by the US FDA (Food and Drug Administration) for its second plant, the world’s largest single plant.

Samsung BioLogics is concerned about the accusation of accounting fraud

samsung biologics
South Korea’s major biopharmaceutical firm Samsung BioLogics Co., which has been embroiled in an alleged violation of accounting rules, expressed concern over the local financial regulator’s disclosure of sensitive information.

Samsung BioLogics obtained ISO 22301 certificate

samsung biologics
Samsung BioLogics, one of the global biologics development and manufacturing companies, announced that it received ISO 22301 certificate, , as the first Korean pharmaceutical company from BSI, a global certification association.

Samsung Biologics signed the first contract for its newly built Plant 3

samsung biologics
Samsung BioLogics entered into the first manufacturing contract for its Plant 3 facility. The approximate value of the contract is $148 million if the product will be successful in the clinic.

Samsung Biologics obtained EMA approval for its plant

samsung biologics
Samsung BioLogics announced today that it has been licensed by the Europe’s EMA for the first monoclonal antibody Drug Substance

Merck and Samsung BioLogics signed Memorandum of Understanding

merck
Merck KGaA announced on October 30 the signing of a Memorandum of Understanding with Samsung BioLogics for a strategic alliance

Samsung Biologics achieved FDA approval for its largest plant

samsung biologics
Samsung BioLogics announced that it has been licensed by the US FDA for the first monoclonal antibody Drug Substance at its second plant, the world's largest single plant