Phlow Corp., a leading American advanced pharmaceutical contract development and manufacturing organization (CDMO), today announced that the active pharmaceutical ingredient for ketamine will be included in the first-ever U.S. Food and Drug Administration (FDA) Commissioner’s National Priority Voucher (CNPV) Pilot Program. This designation recognizes Phlow’s leadership in advancing domestic manufacturing of essential and life-changing medicines in the United States.
The FDA’s CNPV Pilot Program is designed to accelerate the development and regulatory review of projects that address a U.S. public health crisis, strengthen the U.S. pharmaceutical supply chain, and reduce dependence on foreign manufacturing. Phlow proposed ketamine, a critical medicine widely used as a general anesthetic in both civilian and military medicine settings, for the CNPV Pilot Program earlier this year.
With no current domestic ketamine API suppliers, Phlow’s project, in partnership with the U.S. Department of Health and Human Services’ Administration for Strategic Preparedness and Response (ASPR), is intended to establish a fully domestic, end-to-end supply chain, from raw materials to finished dosage form, closing a vital gap in national health security. As part of the pilot, Phlow will leverage the voucher to accelerate FDA review timelines, ensuring the timely and resilient availability of this essential medicine through secure U.S.-based production.
“Phlow is pioneering bold solutions that restore pharmaceutical sovereignty to the United States. We are deeply committed to ensuring our Nation stands ready to develop, manufacture, and deliver life-changing medicines with speed, security, and confidence,” said Eric Edwards, M.D., Ph.D., CEO of Phlow. “We are honored to have been selected to participate in the FDA Commissioner’s National Priority Voucher pilot program. This critical initiative will accelerate our efforts to support domestic production of the active pharmaceutical ingredient for ketamine, further strengthening resilience in the U.S. supply chain.”
Our nation has suffered from multi-year ketamine shortages, with a notable shortage lasting from February 2018 to August 2025. By advancing U.S.-based API production, Phlow is helping to ensure a more secure, transparent, and reliable supply of this critical medicine while reducing the nation’s dependence on overseas sources.
Phlow’s capabilities span process research and development, kilo-scale and metric ton-scale API production, and strategic pharmaceutical ingredient reserves. Through this infrastructure, Phlow is reshaping how life-changing medicines are developed and manufactured in the U.S., ensuring high-quality, affordable, and sustainable access to patients and health systems.
“This is a significant initiative that validates the advanced manufacturing path that Phlow has been building from day one. It reinforces our belief that pharmaceutical sovereignty is critical to national preparedness and should send a strong signal to the market that there are real, tangible benefits to making medicines in America end-to-end,” Edwards concluded.
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