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news.Shandong Taibang Biological Products, an indirectly owned subsidiary of China Biologic Products, has won the China State Food and Drug Administration (SFDA) manufacturing approval for human coagulation factor VIII (FVIII).
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The FVIII will primarily be used in the treatment of hemophilia A.
The only approval now remaining for Taibang’s commercial production of FVIII is the SFDA’s good manufacturing practice certification of the FVIII production line itself.
China Biologic Products Chairman and CEO David Gao said receiving SFDA manufacturing approval represents the culmination of more than five years of work and the first technological approval of a coagulation factor product developed by Taibang.
"With the addition of Factor VIII, we should soon be able to offer three major categories of blood products: albumin products, immunoglobulin products and coagulation factor products," Gao added.