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CBPO - China Biologic receives approval for commercial manufacturing of prothrombin
China Biologic announced that the company has received approval from the China Food and Drug Administration for commercial manufacturing of human prothrombin complex concentrate at its Shandong Taibang facility. The CFDA inspected Shandong Taibang's new coagulation factor production facility for Good Manufacturing Practices compliance in June 2013 and is expected to issue the GMP certificate before early December. The company expects to commence commercial production of PCC at its Shandong Taibang facility immediately upon the receipt of the GMP certificate. PCC is used for the prophylaxis and treatment of congenital and acquired clotting factor II, factor VII, factor IX or factor X deficiencies, including those caused by hemophilia and other liver diseases. Other indications for PCC include anticoagulant reversal and vitamin K deficiency. The company has already received CFDA approval to commercially manufacture PCC at its Guizhou Taibang facility and expects to commence commercial production in early 2015.