Psyence BioMed Partners With Benuvia to Build U.S. Ibogaine Manufacturing Pathway

Key Points

• Psyence BioMed’s Texas subsidiary, TIRC, signed a manufacturing agreement with Benuvia Operations for planned U.S. production of pharmaceutical-grade ibogaine API.
• Benuvia operates an approximately 83,000-square-foot DEA-registered controlled-substance manufacturing facility in Round Rock, Texas.
• The planned production remains subject to DEA quotas, import permits and other required regulatory authorizations.
• The arrangement builds on TIRC’s proposed exclusive U.S. ibogaine supply and distribution agreement with PsyLabs, which requires a definitive agreement by November 30, 2026.
• The announcement does not report current commercial production, clinical trial results, FDA approval or revenue.

Psyence BioMed (NASDAQ: PBM) has entered a manufacturing partnership with Benuvia Operations to support planned U.S. production of pharmaceutical-grade ibogaine active pharmaceutical ingredient, or API. The agreement gives Psyence’s wholly owned Texas subsidiary, Texas Ibogaine Research Corporation, or TIRC, a potential domestic manufacturing platform as it develops an ibogaine supply and regulatory strategy.

Benuvia Provides a DEA-Registered U.S. Manufacturing Platform

Benuvia operates an approximately 83,000-square-foot DEA-registered pharmaceutical manufacturing facility in Round Rock, Texas. Its capabilities include controlled-substance API development and production, analytical work, stability programs and regulatory support.

According to Benuvia, it holds approximately half of the aggregate U.S. ibogaine production quota. However, Benuvia still needs the required DEA import permit and procurement quota for the planned work. Psyence said the timing and scale of any U.S. manufacturing will depend on those authorizations and other regulatory requirements.

Partnership Complements Proposed PsyLabs Supply Agreement

The manufacturing agreement builds on TIRC’s previously announced binding term sheet with PsyLabs. That proposed agreement would provide TIRC with exclusive U.S. rights, supply and distribution arrangements for PsyLabs’ pharmaceutical-grade ibogaine.

The parties must complete a definitive agreement by November 30, 2026, or the term sheet will lapse. PsyLabs is a significant Psyence BioMed shareholder, while Psyence BioMed also owns an interest in PsyLabs.

Investor Takeaway: Supply Chain Progress, Not Commercial Production

For PBM investors, the Benuvia arrangement adds a potential U.S. manufacturing partner to Psyence BioMed’s ibogaine-development strategy. It could help establish a controlled domestic path from source material to cGMP manufacturing if required regulatory approvals are obtained.

The key risks and milestones remain the final PsyLabs agreement, DEA permits and quotas, production authorization, and TIRC’s future manufacturing, nonclinical and clinical development. This announcement does not establish a marketed product, FDA approval or near-term commercial revenue.