- Phlow Corp. has been selected for the FDA Commissioner’s National Priority Voucher (CNPV) Pilot Program for its ketamine API project.
- The initiative aims to establish a fully domestic U.S. supply chain for ketamine, addressing chronic shortages and strengthening national health security.
Phlow Corp. has announced that its active pharmaceutical ingredient (API) for ketamine will be included in the first U.S. Food and Drug Administration (FDA) Commissioner’s National Priority Voucher (CNPV) Pilot Program. The programme is designed to accelerate regulatory review for projects addressing U.S. public health crises and reduce reliance on foreign pharmaceutical manufacturing.
The company’s ketamine project, in partnership with the U.S. Department of Health and Human Services’ Administration for Strategic Preparedness and Response (ASPR), seeks to create a fully domestic supply chain from raw materials to finished dosage form. Currently, there are no U.S.-based ketamine API suppliers, and chronic shortages have affected the market, with the most recent shortage lasting from February 2018 to August 2025.
“Phlow is pioneering bold solutions that restore pharmaceutical sovereignty to the United States. We are honored to have been selected to participate in the FDA Commissioner’s National Priority Voucher pilot program.”
Eric Edwards, M.D., Ph.D., CEO of Phlow
The designation allows Phlow to leverage the voucher to accelerate FDA review timelines, ensuring more timely and resilient availability of ketamine. The company’s capabilities include process research and development, kilo- to metric ton-scale API production, and strategic pharmaceutical ingredient reserves.
Through this initiative, Phlow Corp. aims to strengthen U.S. supply chain resilience and reduce dependence on overseas sources, ensuring reliable access to this critical medicine for both civilian and military healthcare settings.
