- Fresenius Kabi and Phlow Corp. have announced a collaboration to establish domestic manufacturing of Epinephrine Injection, USP, including both API and finished doses.
- Pending regulatory approvals, epinephrine produced under the agreement could be available to U.S. hospitals in 2027.
Fresenius Kabi and Phlow Corp. have announced a collaboration to onshore the manufacture of Epinephrine Injection, USP, a medicine designated as essential by the U.S. Food and Drug Administration and the World Health Organization. The agreement covers domestic production of both the active pharmaceutical ingredient and finished doses for hospitals and clinics in the United States.
Under the arrangement, Phlow will manufacture the epinephrine API, while Fresenius Kabi will be responsible for formulation and production of finished injectable doses. Phlow has completed a U.S.-based validation campaign for epinephrine API and has filed a Drug Master File with the FDA, positioning it as a domestic source for API manufacturing. Fresenius Kabi has been producing Epinephrine Injection, USP in the U.S., but there is currently no domestic source for the API.
The collaboration is intended to support a scalable model that could be extended to other essential medicines. Epinephrine Injection is used in hospitals for the emergency treatment of allergic reactions, including anaphylaxis, and to increase mean arterial blood pressure in adults with hypotension associated with septic shock.
“Fresenius is a committed partner in advancing America’s vision of a fully domestic, end-to-end, supply chain for essential medicines, closing a vital gap in national security.”
Joel Rosenstack, President U.S. Pharmaceuticals, Fresenius Kabi
Phlow operates as an advanced pharmaceutical CDMO, while Fresenius Kabi manufactures injectable medicines at multiple U.S. production sites. Pending FDA and other required approvals, Epinephrine Injection, USP produced through this contract manufacturing collaboration could be available to U.S. hospitals in 2027.
