Validation Completed for a Novel, Cost-Competitive Epinephrine Active Pharmaceutical Ingredient Process, Drug Master File Successfully Filed
Richmond, Virginia, March 17, 2025 (GLOBE NEWSWIRE) — Phlow Corp., a U.S.-based certified B Corporation on a mission to bring medicines to life through advanced development and manufacturing in America, today announced a major milestone, achieving a successful process validation campaign for Epinephrine active pharmaceutical ingredient (API) production. This achievement positions Phlow to continue advancing toward full domestic production capabilities in its state-of-the-art U.S. facilities for this life-saving medicine.
The company has filed a Drug Master File (DMF) with the U.S. Food and Drug Administration (FDA) — a critical regulatory step. This product is now ready to be converted into a finished drug product. The entirety of the Epinephrine API manufacturing campaign has been performed in the United States, further reinforcing Phlow’s commitment to reshoring modern medicine development and manufacturing and strengthening national health resilience.
Phlow developed a manufacturing method leveraging novel chemistry that streamlines production, reducing both waste and manufacturing costs, while making the production of Epinephrine on U.S. soil cost competitive. Epinephrine, a life-saving generic medication, is used along with emergency medical treatment to help treat cardiac arrest, life-threatening low blood pressure associated with septic shock, and life-threatening allergic reactions (Type 1), including anaphylaxis. This life-saving medication has been in chronic shortage for more than 13 years.1 To date, Phlow has filed a total of four DMFs — solidifying the company’s progress and demonstrating its readiness for full-scale domestic production.
“This milestone represents a meaningful step forward in our vision of creating the future of how medicines are made in America,” said Eric Edwards, M.D., Ph.D., CEO and co-founder of Phlow. “We’re proud to lead a movement that’s bringing pharmaceutical development and manufacturing back to the United States with purpose, precision, and impact. This latest achievement underscores Phlow’s commitment to providing secure, domestic sources for active pharmaceutical ingredients vital to patient care and national security — doing so with relentless innovation and a collaborative spirit.”
To complete end-to-end domestic production of epinephrine, a leading U.S.-based generic pharmaceutical company is producing the final sterile injectable product. This will then enable a 100% Made in America supply of this critical drug, which is relied upon daily by hospitals, emergency responders, and patients across the country.
Through advanced development and manufacturing methods in America, Phlow is reshoring critical APIs and reducing dependency on foreign supply chains. Phlow helps secure our nation’s essential medicine supply and medical countermeasures by bringing the development and manufacturing of these critical national pharmaceutical ingredient assets back home. By providing innovative and stable solutions for onshore API production, Phlow helps the U.S. government protect the health of Americans with domestically supplied, life-changing APIs needed for high-quality care.
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 development & 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 making medicines that lead to healthy, resilient communities. For more, visit phlow-usa.com.
1. U.S. Food and Drug Administration. (2024). Epinephrine injection syringes – Current and Resolved drug shortages. Retrieved March 12, 2025, from https://dps.fda.gov/drugshortages/resolved/epinephrine-injection-syringes
CONTACT: Leslie Strickler Phlow Corp. leslies@etrecommunications.com
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