GC Green Cross Obtains FDA Approval for Laredo Plasma Center in the U.S.

GC Green Cross announced on April 9 that the Laredo Plasma Center in Texas, operated by its U.S. subsidiary ABO Plasma, has received approval from the U.S. Food and Drug Administration (FDA). This achievement comes more than three months ahead of schedule, demonstrating ABO Plasma's operational expertise and the Laredo center's rapid process stabilization capabilities.

Interior photo of the Laredo Plasma Center opened in Texas. GC Green Cross

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In the United States, only plasma collected from FDA-approved plasma centers can be used for commercial sale or as raw material for pharmaceuticals. With this latest approval, ABO Plasma has now obtained FDA approval for all seven of its plasma centers operating in the U.S., significantly strengthening its ability to secure raw plasma supplies.

ABO Plasma plans to open its eighth center in Eagle Pass, Texas, within this year. The company aims to raise the operating rate of all centers to 100% by 2028 and to self-supply 80% of the raw plasma needed for the production of 'Alyglo.' This strategy aligns with the global plasma fractionation company's approach of proactively managing supply chain risks and strengthening value chain internalization.

Internalizing raw material supply is also expected to become a key driver for improving the company’s future profit structure, as reducing dependence on external markets will enhance cost competitiveness and maximize product operating margins.

Heo Eun-cheol, CEO of GC Green Cross, stated, "We will continue to strengthen our competitiveness in the U.S. plasma fractionation business based on our robust business structure."

Meanwhile, GC Green Cross is developing a subcutaneous (SC) immunoglobulin formulation of Alyglo, which offers improved dosing convenience compared to the intravenous (IV) form.

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