Psyence BioMed, Benuvia Partner to Manufacture Ibogaine in Texas

Psyence BioMed Corp. has entered into a partnership with Benuvia Operations, a Drug Enforcement Administration-registered manufacturer, to establish a Texas-based production pathway for pharmaceutical-grade ibogaine, the companies announced. The move is designed to support Psyence's subsidiary TIRC as it advances a planned U.S. drug development program centered on the controlled substance.

Ibogaine, derived from the West African iboga plant, has drawn growing scientific and regulatory interest for its potential to treat opioid use disorder and other addiction-related conditions. Securing a domestic, DEA-compliant manufacturing source is widely regarded as a critical prerequisite for any company seeking to conduct clinical trials or seek eventual U.S. regulatory approval for an ibogaine-based therapy.

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Benuvia's DEA Schedule I manufacturing registration positions the Texas facility as a legally authorized site to handle ibogaine, a substance that remains federally classified as a Schedule I controlled drug. Establishing such a supply chain domestically could reduce dependence on foreign sources and streamline regulatory compliance as the psychedelic medicine sector matures.

The partnership reflects a broader industry trend in which psychedelic drug developers are moving to lock in compliant supply agreements ahead of anticipated regulatory milestones. TIRC's planned U.S. development program would require consistent, traceable, pharmaceutical-grade material to satisfy Food and Drug Administration standards for investigational drug applications.

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