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China Biologic to manufacture PCC at Shandong Taibang facility

20 October 2014 | Regulatory | By BioSpectrum Bureau

China Biologic to manufacture PCC at Shandong Taibang facility

PCC is used for the prophylaxis and treatment of congenital and acquired clotting factor II, factor VII, factor IX or factor X deficiencies

PCC is used for the prophylaxis and treatment of congenital and acquired clotting factor II, factor VII, factor IX or factor X deficiencies

Singapore: China Biologic Products, China-based biopharmaceutical company, has received China Food and Drug Administration (CFDA) approval for commercial manufacturing of human prothrombin complex concentrate (PCC) at its Shandong Taibang facility.

CFDA inspected Shandong Taibang's new coagulation factor production facility for Good Manufacturing Practices (GMP) 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.

Mr David (Xiaoying) Gao, chairman and chief executive officer, China Biologic, commented, "We are delighted to receive approval from the CFDA to launch PCC production. With production underway at both our Shandong Taibang and Guizhou Taibang facilities, we are confident that we will be able to meet the growing market demand for PCC. We anticipate that the added production will contribute to our 2015 financial performance as we continue to reinforce our industry leadership."

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