Kamada Secures FDA Approval for San Antonio Plasma Collection Center, Expanding Specialty Plasma Production Capacity
核心洞察
Kamada Ltd. received FDA approval for its San Antonio plasma collection center following a February 2026 inspection, clearing the facility to commence commercial sales of normal source plasma.
The 11,100 square foot facility supports up to 50 donor beds with an annual collection capacity of approximately 50,000 liters and projected revenues of $8-10 million at full capacity.
The center is designed to collect both normal source plasma and specialty plasma including anti-rabies and anti-D products, positioning it as one of the largest specialty plasma collection centers in the United States.
Kamada Ltd., a global biopharmaceutical company specializing in plasma-derived therapies for rare and serious conditions, announced that the U.S. Food and Drug Administration has approved its plasma collection center in San Antonio, Texas. The approval follows an on-site FDA inspection conducted in February 2026, clearing the facility to begin commercial sales of normal source plasma.
Facility Specifications and Capacity
The state-of-the-art San Antonio facility spans 11,100 square feet and accommodates up to 50 donor beds. At full operational capacity, the center is designed to collect approximately 50,000 liters of plasma annually, with projected revenues ranging from $8 million to $10 million from normal source plasma sales.
The facility is structured to collect both normal source plasma and specialty plasma products, including anti-rabies and anti-D immunoglobulins. According to Kamada, the center is anticipated to become one of the largest collection centers for specialty plasma in the United States.
Strategic Expansion in Texas
"We are extremely pleased to announce the FDA approval of our state-of-the-art plasma collection center in San Antonio, 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 San Antonio approval represents the third FDA-approved plasma collection center for Kamada in Texas, joining existing facilities in Houston and Beaumont. This expansion significantly enhances the company's plasma collection operations, which support both revenue generation through normal source plasma sales to other manufacturers and the increasing demand for hyper-immune plasma used in Kamada's proprietary products.
Regulatory Pathway and Future Plans
Following the FDA approval, Kamada intends to seek subsequent inspection and approval from the European Medicines Agency (EMA) for the San Antonio site, potentially expanding its international market reach for plasma-derived products.
Company Portfolio and Growth Strategy
Kamada maintains a portfolio of six FDA-approved specialty plasma-derived products: KEDRAB®, GLASSIA®, CYTOGAM®, VARIZIG®, WINRHO SDF®, and HEPAGAM B®, along with KAMRAB® and two equine-based anti-snake venom products. The company's growth strategy encompasses four primary pillars: organic growth of its commercial portfolio, distribution partnerships in Israel and the MENA region, expansion of plasma collection operations, and pursuit of mergers, acquisitions, and licensing opportunities.
The plasma collection expansion directly supports Kamada's third growth pillar, enabling revenue generation through normal source plasma sales while ensuring adequate supply for its increasing hyper-immune plasma requirements. FIMI Opportunity Funds (搜索), Israel's leading private equity firm, serves as the company's controlling shareholder with approximately 38% ownership of outstanding ordinary shares.