Fresenius Kabi, Phlow form alliance for US-based epinephrine supply chain

Fresenius Kabi, a global healthcare company based in Lake Zurich, Illinois, and Phlow Corp., a contract development and manufacturing organization (CDMO) headquartered in Richmond, Virginia, are collaborating to establish a fully domestic supply chain in the U.S. for Fresenius Kabi’s epinephrine injection, an essential medicine used in hospitals nationwide.

Under the agreement, Phlow will produce the active pharmaceutical ingredient (API), and Fresenius Kabi will handle formulation and production of finished doses for hospitals and clinics. The companies said the arrangement is designed to be scalable to other essential medicines.

Phlow recently completed a U.S.-based validation campaign for the epinephrine API and filed a Drug Master File with the Food and Drug Administration (FDA), positioning it as a domestic source for the ingredient, according to the announcement. While Fresenius Kabi has been producing epinephrine injection domestically, there is currently no domestic source for the API.

Pending FDA and other approvals, the companies said epinephrine injection produced under the agreement could be available to U.S. hospitals in 2027.

The collaboration follows recent manufacturing-focused developments by both companies. In January, Fresenius Kabi completed the first phase of a project with Cellular Origins to integrate a robotic cell processing system into an automated manufacturing platform designed to reduce manual intervention while maintaining biological workflows.

Separately, Phlow reported a pilot program with Enveda that generated nearly 20,000 chemical reactions in three months to train AI models for predicting reaction performance. The companies said the approach could reduce API process development timelines from years to months.

Fresenius Kabi said it produces more than 70% of the medicines it sells in the U.S. at domestic facilities, while Phlow operates domestic sites capable of producing APIs at kilogram and metric-ton scale using batch and continuous processes.