The Korean pharmaceutical industry is watching with interest whether Green Cross’ new immunoglobulin product, IV-Globulin-S injection (IVIG-sn), will be able to win the approval of the U.S. Food and Drug Administration within this year.

Green Cross_녹십자 plans to submit supplementary data on its manufacturing process at its Ochang 1 Plant in the third quarter, as directed by the FDA last November.

If the U.S. agency gives its go-ahead, the Korean pharmaceutical company will begin to make the product at Ochang 1 Plant in North Chungcheong Province before relocating its manufacture to its facility in Canada. Green Cross started the operation of the Ochang 2 Plant last month, resuming the stable supply of its blood products.

Stock market analysts predict Green Cross will be able to win the approval by the end of this year, citing the FDA raised no problems with the safety or efficacy of the product after examining documents, and it usually takes three to six months for the reviewing process.

KB Securities expects Green Cross will register a double-digit growth rate in its sales of blood products this and next year.

Green Cross is also highly likely to expand its market share in the blood product market through diversifying its subcutaneous injections of immunoglobulin and blood inhibitors, according to the brokerage house.

Green Cross acquired the Korean government’s approval for IV-Globulin SN Inj. 10% earlier this month. Among diseases for which this medication is efficacious are hypogammaglobulinemia, agammaglobulinemia, an antibiotic combination for severe infections, idiopathic thrombocytopenic purpura, Guilin Barre syndrome (acute spleen neuritis), and Kawasaki disease (for the prevention of coronary artery complications).

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