Kamada wins FDA clearance for in-house rabies testing facility

Kamada (NASDAQ:KMDA) announced Monday that the U.S. Food and Drug Administration has approved its new in-house Rapid Fluorescent Focus Inhibition Test (RFFIT) rabies virus neutralization laboratory at its manufacturing plant in Beit Kama, Israel.

The regulatory milestone allows the global biopharmaceutical company to expand its advanced quality control network by internalizing highly specialized testing capabilities.

The newly cleared laboratory will directly support the processing and regulatory release of KEDRAB and KAMRAB, which together represent Kamada's core commercial product line.

The anti-rabies antibody franchise generated consolidated sales exceeding $70 million in 2025, anchoring its status as the leading revenue contributor within the company's broader specialty portfolio of plasma-derived products.

The RFFIT method is widely recognized across the global biomedical sector as the clinical gold standard for quantifying neutralizing antibodies against the rabies virus.

Because of the stringent technical, safety, and Good Manufacturing Practice (GMP) criteria required to execute the analysis, Kamada’s facility joins a highly restricted group of specialized laboratories globally capable of running these specific protocols.

Prior to securing the U.S. regulatory nod, the facility also achieved corresponding quality and compliance approvals from Health Canada and the Israeli Ministry of Health.