Fresenius Kabi and Phlow Corp. Announce First-Ever, End-to-End, U.S. Manufacturing Collaboration for Epinephrine Injection, USP

A Scalable Model for U.S. Pharmaceutical Security

LAKE ZURICH, Ill. & RICHMOND, Va.--(BUSINESS WIRE)--Fresenius Kabi and Phlow Corp. announced today a first-of-its-kind collaboration 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.

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 agreement, 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 U.S. Food and Drug Administration and the World Health Organization. It 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.

“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.”

Fresenius Kabi, an operating company of the Fresenius group, is a global leader in injectable medicines, biosimilars, clinical nutrition, and medical technologies. It is the nation’s leading manufacturer of generic injectable medicines and offers more than 70 percent of the medicines designated as essential by the FDA.

As part of its local-for-local strategy, Fresenius Kabi produces more than 70 percent of the medicines it sells in the U.S. in state-of-the-art production centers in Illinois, New York and North Carolina. The company has invested more than $1 billion to stand up modern domestic pharmaceutical manufacturing and logistics centers. To learn more about these initiatives, please visit www.moreinamerica.com.

Phlow is a leading American advanced pharmaceutical contract development and manufacturing organization with a state-of-the-art advanced manufacturing campus in Virginia, including facilities in Richmond and Petersburg, that produces APIs and other pharmaceutical products. Learn more at www.phlow-usa.com.

Pending FDA and other necessary approvals, Epinephrine Injection, USP produced under this agreement could be available to U.S. hospitals in 2027.

About Phlow Corp.

Phlow, a B Corporation™, helps brilliant minds bring medicines to life through advanced development and manufacturing in America. Focused on innovations in drug substance development, Phlow supports government and private industry customers to create innovative approaches with scientific expertise, world-class manufacturing, and tech-enabled processes that propel the industry forward to a new standard as we create the future of how medicines are made. As a modern contract development and manufacturing provider, we measure our impact by increasing speed to market, reducing waste, and offering an environmentally friendly approach to manufacturing medicines that lead to healthy, resilient communities. For more, visit phlow-usa.com.

About Fresenius Kabi

As a global healthcare company, Fresenius Kabi is Committed to Life. The company’s products, technologies, and services are used for the therapy and care of patients with critical and chronic conditions. With more than 41,000 employees and present in more than 100 countries, Fresenius Kabi’s expansive product portfolio focuses on providing access to essential medicines and technologies.

In Biopharma, Fresenius Kabi offers cutting-edge biosimilars for autoimmune diseases and oncology. With leading market positions in Clinical Nutrition, a broad portfolio of enteral and parenteral products makes a distinct difference in patients’ nutritional status. In MedTech, the company provides vital infusion pumps, cell and gene therapy devices, disposables, and more. Fresenius Kabi is a global leader in supplying blood collection bags and devices, supporting blood banks and health care facilities worldwide. The company’s I.V. Generics and Fluids for infusion therapy help save millions of lives every year, in emergency medicine, surgery, oncology, and intensive care.

Fresenius Kabi takes a holistic approach to health care and uniquely combines experience, expertise, innovation, and dedication – making a difference in the lives of 450 million patients annually. With the #FutureFresenius strategy, the company is developing, producing, and selling new products and technologies and aspires to expand its position as a leading global provider of therapies, improve patient care, generate sustainable value for stakeholders – shaping the future of healthcare.

Fresenius Kabi is part of the Fresenius Group, founded in 1912, along with Helios and Quirónsalud. As ONE team, the companies in the Fresenius Group are committed to providing lifesaving and life-changing healthcare solutions on a global scale.

For more information, please visit www.fresenius-kabi.com/us. To learn about U.S. career opportunities at Fresenius Kabi, visit us at www.fresenius-kabi.com/us/join-us and follow us on LinkedIn and Facebook.

Epinephrine Injection, USP Important Safety Information

WARNINGS AND PRECAUTIONS

• Do not inject into buttocks, digits, hands, or feet.
• Avoid extravasation into tissues, which can cause local necrosis.
• Monitor patient for acute severe hypertension.
• Potential for pulmonary edema, which may be fatal.
• May constrict renal blood vessels and decrease urine formation.
• May induce potentially serious cardiac arrhythmias or aggravate angina pectoris, particularly in patients with underlying heart disease.
• Presence of sulfite in this product should not deter use.

ADVERSE REACTIONS

Most common adverse reactions to systemically administered epinephrine are headache; anxiety; apprehensiveness; restlessness; tremor; weakness; dizziness; sweating; palpitations; pallor; peripheral coldness; nausea/vomiting; and/or respiratory difficulties. Arrhythmias, including fatal ventricular fibrillation, rapid rises in blood pressure producing cerebral hemorrhage, and angina have occurred.

To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC at 1-800-551-7176, option 5, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DRUG INTERACTIONS

• Drugs that counter the pressor effects of epinephrine include alpha blockers, vasodilators such as nitrates, diuretics, antihypertensives, ergot alkaloids, and phenothiazine antipsychotics.
• Drugs that potentiate the effects of epinephrine include sympathomimetics, beta blockers, tricyclic antidepressants, MAO inhibitors, COMT inhibitors, clonidine, doxapram, oxytocin.
• Drugs that increase the arrhythmogenic potential of epinephrine include beta blockers, cyclopropane and halogenated hydrocarbon anesthetics, quinidine, antihistamines, exogenous thyroid hormones, diuretics, and cardiac glycosides. Observe for development of cardiac arrhythmias.
• Potassium-depleting drugs, including corticosteroids, diuretics, and theophylline, potentiate the hypokalemic effects of epinephrine.

USE IN SPECIFIC POPULATIONS

Pregnancy: May cause fetal harm.

Elderly patients and pregnant women may be at greater risk of developing adverse reactions when epinephrine is administered parenterally.

INDICATIONS AND USAGE

Epinephrine is a non-selective alpha and beta adrenergic agonist indicated:

• For emergency treatment of allergic reactions (Type 1), including anaphylaxis, in adults and pediatric patients.
• To increase mean arterial blood pressure in adult patients with hypotension associated with septic shock.

This Important Safety Information does not include all the information needed to use Epinephrine Injection, USP safely and effectively. Please see full prescribing information for Epinephrine Injection, USP at www.fresenius-kabi.com/us.