Kamada Receives FDA Approval for Houston Plasma Collection Center, Expanding Specialty Plasma Operations
核心洞察
Kamada Ltd. received FDA approval for its Houston plasma collection center following a second quarter 2025 inspection, clearing the facility to commence commercial sales of normal source plasma.
The 12,000 square foot facility features 50 donor beds with an annual collection capacity of approximately 50,000 liters and projected revenue contribution of $8-10 million at full capacity.
The Houston center is anticipated to become one of the largest specialty plasma collection sites in the U.S., collecting both normal source plasma and specialty plasma including anti-rabies and anti-D products.
Kamada Ltd. announced that the U.S. Food and Drug Administration has approved the supplement to its existing Biologics License Application for the company's plasma collection center in Houston, Texas. The approval was obtained following an on-site FDA inspection conducted during the second quarter of 2025, clearing the facility to commence commercial sales of normal source plasma.
The state-of-the-art Houston facility spans 12,000 square feet and supports 50 donor beds, with a planned annual collection capacity of approximately 50,000 liters of plasma. The center is projected to generate annual revenues of $8 million to $10 million in normal source plasma sales at full capacity and is anticipated to be one of the largest collection centers for specialty plasma in the United States.
Expanding Texas Operations
The Houston approval represents a significant milestone in Kamada's plasma collection expansion strategy. "We are extremely pleased to announce the FDA approval of our state-of-the-art plasma collection center in Houston, and for the work of our dedicated team of plasma collection experts who achieved the approval of this facility," said Amir London, Chief Executive Officer of Kamada. "Our three Texas-based sites, in Houston, San Antonio and Beaumont, provide us with significant capacity of specialty and normal source plasma collection."
The Houston center joins Kamada's existing facilities in Beaumont, Texas, and San Antonio, Texas, which opened in March 2025. Each of the Houston and San Antonio centers are expected to generate similar annual revenues of $8 million to $10 million in normal source plasma sales at full capacity.
Specialty Plasma Collection Focus
The Houston facility is structured to collect both normal source plasma and specialty plasma products, including anti-rabies and anti-D plasma. This capability supports Kamada's portfolio of six FDA-approved specialty plasma-derived products: KEDRAB®, CYTOGAM®, GLASSIA®, WINRHO SDF®, VARIZIG®, and HEPAGAM B®, as well as KAMRAB®, KAMRHO (D)®, and two types of equine-based anti-snake venom products.
Regulatory Strategy and Future Plans
Following the FDA approval, Kamada intends to seek subsequent inspection and approval by the European Medicines Agency (搜索) for the Houston site, potentially expanding the facility's market reach beyond the United States.
The plasma collection expansion represents one of Kamada's four primary growth pillars, aimed at supporting revenue growth through normal source plasma sales to other plasma-derived manufacturers and meeting increasing demand for hyper-immune plasma. The company's strategy also focuses on organic growth from commercial activities, business development opportunities, and advancing its pipeline, including the lead product candidate Inhaled AAT, currently in the InnovAATe Phase 3 clinical trial for areas of significant unmet medical need.