Fresenius Kabi and Phlow Corp. Launch First End-to-End U.S. Manufacturing Partnership for Epinephrine Injection
核心洞察
Fresenius Kabi and Phlow Corp (搜索). announced a groundbreaking collaboration to establish the first fully domestic end-to-end manufacturing of epinephrine injection, addressing chronic shortages of this critical emergency medicine.
The partnership combines Phlow's API production capabilities in Virginia with Fresenius Kabi's finished dose manufacturing, creating the first U.S.-based source for epinephrine active pharmaceutical ingredients.
Pending FDA approval, the domestically manufactured epinephrine injection could be available to U.S. hospitals by 2027, potentially serving as a scalable model for other essential medicines.
Fresenius Kabi and Phlow Corp (搜索). have announced a first-of-its-kind collaboration to establish complete domestic manufacturing of epinephrine injection, USP, marking a significant milestone in addressing chronic shortages that have long impacted the availability of this life-saving medicine in the United States. The partnership represents the first end-to-end U.S. manufacturing initiative that encompasses both active pharmaceutical ingredient (API) production and finished dose manufacturing.
Addressing Critical Supply Chain Gaps
The collaboration utilizes a divided production model where Phlow Corp (搜索). will produce the epinephrine APIs at its advanced manufacturing campus in Virginia, while Fresenius Kabi will handle formulation and production of finished doses at its existing U.S. facilities. This integration addresses a critical vulnerability in the domestic supply chain, as while finished injection production has existed in the U.S., there has been no domestic source for the epinephrine API until now.
"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," stated Joel Rosenstack, president of U.S. pharmaceuticals at Fresenius Kabi.
A successful U.S.-based validation campaign for the API has been completed, and a Drug Master File has been filed with the FDA, marking important regulatory milestones toward domestic production.
Strategic Response to National Health Security
The initiative aligns with broader efforts to strengthen pharmaceutical sovereignty and reduce dependence on foreign manufacturing for critical medicines. Eric Edwards, MD, PhD, CEO of Phlow, emphasized the collaboration's significance: "Phlow is pioneering bold solutions to restore pharmaceutical sovereignty and strengthen America's national health security."
Edwards further noted, "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."
Scalable Framework for Essential Medicines
The collaboration is designed as a scalable model that can be applied to other essential medicines identified by the FDA and World Health Organization. The partnership leverages tech-enabled processes and advanced development techniques to create resilient supply assurance for critical medications.
Fresenius Kabi's commitment to domestic manufacturing is supported by more than $1 billion in investments to establish modern pharmaceutical manufacturing and logistics centers. As part of its local-for-local strategy, the company produces more than 70 percent of the medicines it sells in the U.S. at state-of-the-art production centers in Illinois, New York, and North Carolina.
Timeline and Regulatory Pathway
Pending FDA and other necessary regulatory approvals, the domestically manufactured epinephrine injection could be available to U.S. hospitals in 2027. This timeline reflects the comprehensive regulatory review process required for pharmaceutical manufacturing partnerships and the establishment of new domestic supply chains.
The epinephrine injection is indicated for emergency treatment of allergic reactions, including anaphylaxis (搜索), in adults and pediatric patients, as well as for increasing mean arterial blood pressure in adult patients with hypotension (搜索) associated with septic shock (搜索).
Expanding Manufacturing Innovation
Beyond traditional injectable medicines, Fresenius Kabi is also advancing manufacturing capabilities in emerging therapeutic areas. The company has entered a strategic development agreement with TQ Therapeutics (搜索) to enhance cell and gene therapy accessibility through integrated cell selection technology.
Saurabh Bhasin, head of Portfolio, Cell Therapies & contract manufacturing operations at Fresenius Kabi, explained: "By integrating TQ Therapeutics (搜索)' novel selection technology into our Cue system, our aim is to improve manufacturing success and scalability—key steps toward supporting the advancement of cell and gene therapies."
This broader manufacturing innovation strategy reflects the industry's movement toward more sophisticated production capabilities that can support next-generation therapies while maintaining the security and reliability of essential medicine supplies.