The collaboration covers the essential medicine's active pharmaceutical ingredients (APIs) and finished doses.
Fresenius Kabi and Phlow have agreed a deal that will see the firms conduct end-to-end production of Epinephrine Injection in the US for the first time.
The non-selective alpha and beta adrenergic agonist is an essential medicine used to treat allergic reactions, including anaphylaxis, in adults and children that has long been susceptible to shortages.
Although Fresenius Kabi has been producing Epinephrine Injection, USP in the US, its deal with the contract development and manufacturing organisation (CDMO) Phlow marks the inauguration of the first domestic source for epinephrine’s active pharmaceutical ingredient (API).
In doing so it fits with President Trump’s executive order last Summer directing the health department to draw up a list of drugs deemed essential and stockpile the active APIs they need.
Joel Rosenstack, President US Pharmaceuticals at Fresenius Kabi, said: “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.”
Under the terms of the companies’ new agreement, Phlow will produce the API for Epinephrine Injection, USP, and Fresenius Kabi will perform its formulation and the production of finished doses.
Phlow CEO Eric Edwards said: “Phlow is pioneering bold solutions to restore pharmaceutical sovereignty and strengthen America’s national health security.
“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.”
Subject to receiving the necessary approvals from the likes of the US Food and Drug Administration (FDA), Fresenius Kabi and Phlow’s Epinephrine Injection, USP could be made available to US hospitals in 2027.
The companies said their approach could offer “a scalable model for secure, resilient, US-based pharmaceutical manufacturing” of other essential medicines.
Meanwhile, domestic US production of APIs has been the focus for a number of big pharma investment decisions, featuring in Lilly’s manufacturing expansion, the enlargement of AbbVie’s Chicago site and AstraZeneca’s widened remit for its Virginia facility.
