Fresenius Kabi and Phlow Corp have announced a major collaboration to onshore the complete manufacturing process of Epinephrine Injection, USP. The partnership aims to establish a fully domestic, end-to-end supply chain for a critical medicine that has faced ongoing supply chain challenges. By combining their expertise, the companies seek to improve the reliability of a life-saving drug used across emergency and acute care settings.
Today, much of the epinephrine supply chain relies on a global network of manufacturers, with key components—particularly the active pharmaceutical ingredient (API)—often produced overseas before being shipped to the United States for final formulation and packaging. This fragmented system has introduced vulnerabilities, including delays, variability in quality, and exposure to geopolitical or logistical disruptions. As a result, even widely used, off-patent drugs like epinephrine have faced periodic supply constraints, highlighting the challenges of maintaining a stable supply of essential medicines in a globally dependent manufacturing model.
While Fresenius Kabi has historically produced finished epinephrine doses domestically, the US has lacked a domestic source for the active pharmaceutical ingredient. Under the agreement, Phlow will produce the API at its Virginia-based facility, with Fresenius Kabi handling final formulation and manufacturing in the US.
The initiative is rooted in national health security and efforts to reduce reliance on overseas suppliers. Company leaders emphasized the importance of building a resilient domestic supply chain for essential medicines. Joel Rosenstack, President of US Pharmaceuticals at Fresenius Kabi, underscored the mission, noting the company’s commitment to advancing a fully domestic supply chain for critical drugs.
Phlow has already completed a US-based validation campaign for the epinephrine API and submitted a Drug Master File to the FDA, supporting regulatory alignment and quality standards.
Leaders from both organizations describe the collaboration as a scalable model that could be applied to other essential medicines identified by regulators. Eric Edwards, MD, PhD, CEO of Phlow, and co-developer of the Auvi-Q auto-injector, emphasized the importance of securing a reliable domestic supply of epinephrine, a drug widely used in emergency and acute care settings.
The effort aligns with Fresenius Kabi’s broader “local-for-local” strategy, supported by significant investment in US manufacturing and logistics infrastructure.
Pending regulatory approvals, the partners aim to bring the domestically produced supply to market in the coming years—offering a more resilient and reliable source of this essential medication for US healthcare providers.
