GC Pharma (006280.KS) announced Wednesday that its US subsidiary ABO Plasma's plasma center in Laredo, Texas, has obtained approval from the US Food and Drug Administration (FDA). The approval came more than three months ahead of schedule, demonstrating ABO Plasma's operational capabilities and the Laredo center's ability to rapidly stabilize its processes.
In the United States, only plasma collected at FDA-approved plasma centers can be used for commercial sale or as pharmaceutical raw materials. With this approval, ABO Plasma has now secured FDA authorization for all seven of its plasma centers operating in the US, significantly strengthening its plasma supply base.
ABO Plasma plans to open an eighth plasma center in Eagle Pass, Texas, within this year. The company aims to raise the utilization rate of all centers to 100% by 2028, targeting self-procurement of 80% of the plasma materials needed to produce immunoglobulin product Alyglo. This strategy is seen as a move to proactively manage supply chain risks while strengthening value chain internalization.
Raw material internalization is expected to serve as a key driver for improving profitability going forward. By reducing dependence on external procurement, the company can secure cost competitiveness and thereby boost product operating margins.
"We will strengthen our competitiveness in the US plasma fractionation business based on a solid business structure," GC Pharma CEO Heo Eun-chul said.
Meanwhile, GC Pharma is developing a subcutaneous (SC) immunoglobulin to improve administration convenience over Alyglo, which is currently an intravenous (IV) formulation.