Benuvia Partners with TIRC to Manufacture Pharmaceutical-Grade Ibogaine API
Published on October 6, 2026
Establishing a Texas-Based cGMP Pathway for Pharmaceutical-Grade Ibogaine
ROUND ROCK, Texas, October 6, 2026 – Benuvia Operations, LLC, a leading contract development and manufacturing organization (CDMO) specializing in controlled substances, today announced a manufacturing services agreement with Texas Ibogaine Research Corporation (“TIRC”), the wholly-owned Texas subsidiary of Psyence Biomedical Ltd. (Nasdaq: PBM), for the planned U.S. manufacture of pharmaceutical-grade ibogaine active pharmaceutical ingredient (API) under current Good Manufacturing Practice (cGMP) standards. The partnership was announced by Psyence BioMed on October 5, 2026.
The partnership is intended to connect TIRC’s planned exclusive U.S. access to pharmaceutical-grade ibogaine from Psyence Labs Ltd. (“PsyLabs”), under TIRC’s previously announced binding term sheet with PsyLabs, with Benuvia’s U.S.-based controlled-substance manufacturing capabilities. Together, the parties aim to establish a domestic pathway from pharmaceutical-grade source material through cGMP API manufacture in Round Rock, Texas.
Benuvia is advancing the DEA import permit and procurement quota applications required for the planned production. Because Benuvia’s commercial-scale manufacturing infrastructure is already in place, the timing and scale of U.S. ibogaine production will be governed by applicable DEA quotas, controlled-substance import requirements, and other regulatory authorizations.
“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,” said 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. While ibogaine has been discussed for decades, pharmaceutical-grade manufacturing capacity in the United States has remained extremely limited. 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. We have the experience, the facility, and the team in place. We are ready to begin.”
Benuvia’s Round Rock facility combines controlled-substance API development and manufacturing with analytical development, stability programs, and regulatory support – capabilities that support the chain-of-custody, batch-consistency, and chemistry, manufacturing and controls (CMC) demands of a regulated ibogaine development program.
Benuvia welcomes interest from academic institutions, biotech and pharmaceutical companies, and other qualified investigators exploring ibogaine and other neuroplastogens for the treatment of serious conditions, including substance use disorders. Our team is available to discuss how our GMP API manufacturing, regulatory documentation, and development expertise can support your program.
About Benuvia
Benuvia Operations, LLC is a global contract development and manufacturing organization (CDMO) that helps pharmaceutical and biotech companies deliver life-changing therapies to patients in need. We provide end-to-end development and manufacturing services for active pharmaceutical ingredients (APIs) and finished dosage products and have deep expertise with cannabinoids, psychedelics, and other controlled substances.
Our 83,000-square-foot, state-of-the-art, cGMP facility in Round Rock, Texas is purpose-built to manufacture Schedule I–V compounds, offering comprehensive solutions throughout the entire drug development lifecycle-from early development, API synthesis, and clinical trial supply to commercial production. Benuvia is committed to quality, regulatory excellence, and scientific partnership to advance innovative therapies that can improve lives.
About Texas Ibogaine Research Corporation
Texas Ibogaine Research Corporation (TIRC) is the wholly-owned Texas subsidiary of Psyence Biomedical Ltd. (Nasdaq: PBM), a biopharmaceutical company specializing in nature-derived, neuroplastogen-based therapeutics and the manufacture of pharmaceutical-grade drug candidates. TIRC is advancing a planned U.S. development program for pharmaceutical-grade ibogaine. For more information, visit psyencebiomed.com.
Contact:
Eric Kizior, ekizior@benuvia.com
SOURCE Benuvia Operations, LLC