Fresenius Kabi and Phlow announced a collaboration to onshore the manufacture of Epinephrine Injection, USP. The arrangement, which includes the domestic manufacture of active pharmaceutical ingredients (APIs) and finished doses, is designed to be scalable to other essential medicines.
Phlow will produce the API for Epinephrine Injection, USP, and Fresenius Kabi will perform the formulation and production of finished doses for hospitals and clinics. Phlow recently completed a successful U.S.-based validation campaign for epinephrine API and filed a Drug Master File (DMF) with FDA, positioning it as the emerging domestic source for onshoring API production.
Epinephrine injection is considered an essential medicine by the FDA and the World Health Organization. It's indicated for emergency treatment of allergic reactions, including anaphylaxis, in adults and pediatric patients. It is also indicated to increase mean arterial blood pressure in adult patients with hypotension associated with septic shock. While Fresenius Kabi has been producing Epinephrine Injection, USP in the U.S., there is no domestic source for epinephrine API today.
“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,” said Joel Rosenstack, President U.S. Pharmaceuticals, Fresenius Kabi.
“Phlow is pioneering bold solutions to restore pharmaceutical sovereignty and strengthen America’s national health security,” said Eric Edwards, M.D., Ph.D., CEO of Phlow. “For several years, we have worked alongside Fresenius Kabi to build resilient, end-to-end supply assurance for essential medicines. This expanded collaboration is focused on securing a reliable domestic supply of epinephrine, one of the most critical, life-saving drugs used across emergency and acute care settings in the United States.”
Pending FDA and other necessary approvals, Epinephrine Injection, USP produced under this agreement could be available to U.S. hospitals in 2027.
