Fresenius Kabi and Phlow Corp. have joined forces to onshore the manufacture of Epinephrine Injection, USP, an essential medicine long at risk of chronic shortage in the U.S. and widely used in hospitals nationwide.

Epinephrine injection is a lifesaving drug 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.

The arrangement, which includes the domestic manufacture of active pharmaceutical ingredients (APIs) and finished doses, is designed to be scalable to other essential medicines.

Under the collaboration, 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.

“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.

“For several years, we have worked alongside Fresenius Kabi to build resilient, end-to-end supply assurance for essential medicines,” said Eric Edwards, M.D., Ph.D., CEO of Phlow. “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.

API Manufacturing Insights

From new supply chain dynamics to emerging technologies and shifting regulatory standards— learn how CDMOs are adapting to the new API manufacturing playbook.