Psyence BioMed Partners with DEA-Registered Benuvia Operations to Establish U.S. Manufacture of Pharmaceutical-Grade Ibogaine
Key Highlights
- ➤Benuvia partnership targets U.S. cGMP manufacture of pharmaceutical-grade ibogaine API
- ➤Benuvia operates an 83,000-square-foot DEA-registered controlled-substance facility in Texas
- ➤Benuvia reportedly holds approximately half of the U.S. aggregate ibogaine production quota
- ➤PsyLabs definitive agreement for exclusive U.S. supply targeted by November 30, 2026
Expert Statements
Jody Aufrichtig, Chief Executive Officer of Psyence BioMed and TIRC
“Benuvia brings a DEA-registered U.S. facility with the quota, systems and track record required to manufacture controlled substances to pharmaceutical standards. Combined with our planned licensed supply, we believe this has the potential to create an end-to-end pathway from pharmaceutical-grade source material through U.S.-based manufacturing.”
Terry Novak, Chief Executive Officer of Benuvia
“Benuvia brings more than 10 years of experience in the development and commercial manufacturing of DEA Schedule I–V controlled substances to rigorous pharmaceutical standards.”
Terry Novak, Chief Executive Officer of Benuvia
“Our Round Rock facility was purpose-built for controlled-substance manufacturing and provides the infrastructure, regulatory capabilities, and commercial-scale capacity required for complex programs like ibogaine.”
Terry Novak, Chief Executive Officer of Benuvia
“While ibogaine has been discussed for decades, pharmaceutical-grade manufacturing capacity in the United States has remained extremely limited.”
Terry Novak, Chief Executive Officer of Benuvia
“Through our partnership with TIRC and Psyence BioMed, we believe we have an opportunity to change that — manufacturing ibogaine in America, to exacting specifications and at the scale this program will require if and as DEA quota expands.”
Terry Novak, Chief Executive Officer of Benuvia
“We have the experience, the facility, and the team in place. We are ready to begin.”
Dr. John Thorne, Project Lead, TIRC
“For a regulated ibogaine development program, manufacturing is inseparable from the regulatory strategy.”
Dr. John Thorne, Project Lead, TIRC
“Establishing a U.S.-based manufacturing pathway is intended to strengthen chain-of-custody controls, batch consistency and the chemistry, manufacturing and controls work required to support future regulatory submissions.”
Dr. John Thorne, Project Lead, TIRC
“We believe Benuvia’s capabilities give us an experienced U.S. manufacturing platform on which to build that work.”
HIGHLIGHTS * Texas Ibogaine Research Corporation (“TIRC”), the wholly-owned Texas subsidiary of Psyence BioMed, enters manufacturing partnership with Benuvia Operations, LLC for the planned U.S. manufacture of pharmaceutical-grade ibogaine active pharmaceutical ingredient (“API”) * Benuvia operates an 83,000-square-foot, DEA-registered controlled-substance manufacturing facility in Round Rock, Texas, with capabilities spanning development through commercial-scale production * Partnership is intended to connect TIRC’s planned exclusive U.S. access to PsyLabs’ pharmaceutical-grade ibogaine under TIRC’s previously announced binding term sheet with PsyLabs, with U.S.-based controlled-substance manufacturing capabilities * The partnership represents another step in Psyence BioMed’s strategy to build an integrated U.S. supply, manufacturing and regulatory development platform for ibogaine through TIRC NEW YORK, Oct. 05, 2026 (GLOBE NEWSWIRE) -- Psyence Biomedical Ltd. (Nasdaq: PBM) (“Psyence BioMed” or the “Company”) today announced that its wholly-owned Texas subsidiary, Texas Ibogaine Research Corporation (“TIRC”), has entered into a manufacturing services agreement with Benuvia Operations, LLC (“Benuvia”) of Round Rock, Texas, establishing a manufacturing partnership for the planned U.S. manufacture of pharmaceutical-grade ibogaine active pharmaceutical ingredient (“API”) under current Good Manufacturing Practice (“cGMP”) standards.
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