Phlow Corp. selected as FDA CNPV pilot program sponsor

We’re honored to announce that Phlow Corp. has been selected as the ketamine sponsor in the U.S. Food and Drug Administration (FDA) Commissioner’s first-ever National Priority Voucher (CNPV) pilot program. This designation recognizes Phlow’s leadership in advancing U.S.-based manufacturing of essential medicines.   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. Earlier this year, Phlow proposed ketamine, a critical medicine widely used as a general anesthetic in both civilian and military medicine settings, for inclusion in the CNPV Pilot Program.   With no current domestic ketamine API suppliers, Phlow’s project, in partnership with the U.S. Department of Health and Human Services (HHS) HHS 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.   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. Read the FDA press release: https://lnkd.in/e7QsK3Aj Read Phlow's press release: https://lnkd.in/eTM9J45j