Kamada’s In-House RFFIT Lab Gains FDA Approval, Expands $70M Rabies Testing
KMDA•Kamada’s new in-house RFFIT laboratory in Beit Kama, Israel received FDA approval, joining its Health Canada and Israeli Ministry of Health clearances and expanding potency testing for its KEDRAB® and KAMRAB® rabies therapies. The facility supports manufacturing tests and bolsters QC for products generating over $70 million in 2025 sales.
1. Lab Approval and Regulatory Clearances
Kamada’s Rapid Fluorescent Focus Inhibition Test laboratory in Beit Kama, Israel secured FDA approval, complementing existing clearances from Health Canada and the Israeli Ministry of Health. This facility is one of a limited global network capable of RFFIT testing for rabies-neutralizing antibody quantification.
2. Expanded Testing Capabilities
The in-house RFFIT lab enables Kamada to perform gold-standard potency testing across all manufacturing stages of its KEDRAB® and KAMRAB® products, from plasma sourcing through to final lot release, strengthening quality control and ensuring compliance with GMP standards.
3. Financial Impact
In 2025, sales of KEDRAB® and KAMRAB® surpassed $70 million, establishing them as Kamada’s leading specialty plasma-derived franchise. Bringing RFFIT testing internally is expected to accelerate product release cycles and reduce external testing expenses.
4. Strategic Integration
This expansion aligns with Kamada’s vertical integration strategy and commitment to advanced quality infrastructure, supporting long-term growth through operational efficiencies and scientific innovation within its specialty plasma-derived portfolio.
