Psyence BioMed's Texas unit signs manufacturing pact with Benuvia for ibogaine API
Texas Ibogaine Research Corporation will work with DEA-registered Benuvia Operations to pursue U.S. cGMP manufacture of pharmaceutical-grade ibogaine API.
Psyence Biomedical Ltd. (Nasdaq: PBM) announced on October 5, 2026 that its wholly-owned Texas subsidiary, Texas Ibogaine Research Corporation (TIRC), entered into a manufacturing services agreement with Benuvia Operations, LLC of Round Rock, Texas, establishing a manufacturing partnership for the planned U.S. manufacture of pharmaceutical-grade ibogaine active pharmaceutical ingredient under current Good Manufacturing Practice standards.1
The deal connects to an earlier arrangement: TIRC had previously signed a binding term sheet with Psyence Labs Ltd. (PsyLabs), described as a significant shareholder of Psyence BioMed in which Psyence BioMed holds an ownership interest, covering an exclusive U.S. license, supply and wholesale distribution arrangement for PsyLabs' pharmaceutical-grade ibogaine.1 That term sheet is expected to be replaced by a definitive agreement, which the parties have agreed to finalize on or before November 30, 2026.1
On the manufacturing side, Benuvia operates an approximately 83,000-square-foot pharmaceutical manufacturing facility in Round Rock, Texas, registered with the DEA, covering controlled-substance API development, manufacturing, analytical work, stability testing and regulatory support.1 Benuvia has stated it currently holds roughly half of the U.S. aggregate production quota for ibogaine.1 Benuvia is pursuing the import permit and procurement quota needed for the planned production with the DEA.1
The company said because Benuvia's manufacturing infrastructure already exists, the pace and scale of any U.S. ibogaine production will depend mainly on DEA quotas, import rules and other regulatory clearances.1
The release carries cautionary language noting that ibogaine and the company's other neuroplastogen compounds have not been approved for therapeutic use by the FDA, Health Canada or other regulators, and their safety and efficacy have not been established in authorized clinical research.1 It also notes information about Benuvia's facility, capabilities, DEA registration and quota allocations came from Benuvia and has not been independently verified by the company.1
Written by readthrough’s AI from the linked primary sources and fact-checked against them automatically before publishing. Not investment advice.