Pharmaceutical Manufacturing

Benuvia is a US-based contract development and manufacturing organization (CDMO) and API supplier specialising in psychedelic and controlled-substance therapeutics. Operating an 83,000 sq ft GMP facility in Round Rock, Texas, the company holds DEA authorisation to manufacture psilocybin, psilocin, DMT, MDMA, and 5-MeO-DMT. In March 2025, Benuvia was awarded a five-year NIH/NIDA contract for GMP psilocybin synthesis and received ANVISA GMP certification from Brazil. The company also holds the FDA-approved cannabinoid drug SYNDROS®.

Global CDMO supporting pharmaceutical development and manufacturing, including explicit psychedelic-related cGMP drug-product programs in sponsor disclosures.

Established supplier and CDMO platform (with Cayman Pharma) providing cGMP API manufacturing, including psychedelic compounds for clinical-trial pathways and analytical support.

Reference standards manufacturer supporting analytical, forensic, and clinical-lab workflows, with psychedelic standards in its certified catalog.

Australian psychedelic medicines supply and commercialization venture focused on GMP-grade MDMA and psilocybin pathways for clinical and authorized-prescriber use.

Biotech startup focused on biosynthetic psychedelic compounds and clinical-grade supply, with a product slate spanning psilocybin, DMT, 5-MeO-DMT, and bufotenine.

Clinical-stage natural psychedelic drug development company with publicly announced Nagoya Protocol-compliant iboga import activity from Gabon for R&D and potential therapeutic development.

Canadian GMP-certified manufacturer of pharmaceutical-grade psilocybin and MDMA, licensed by Health Canada. Optimi's facility in Princeton, British Columbia is one of the largest legal psilocybin production operations in North America. Supplies clinical trial material to researchers in Australia, Israel, and Canada.

PharmAla Biotech (CSE: MDMA) is a Canadian biotech specialising in MDXX-class molecule R&D and GMP MDMA manufacturing. Founded in January 2021 by CEO Nick Kadysh, the company operates two business lines: (1) LaNeo — clinical-grade GMP MDMA supplied to research institutions worldwide under a supply-for-data model, now with a US distribution hub and agreements spanning Mt. Sinai, Yale, UAB, University of Washington, and institutions in Norway and Netherlands; and (2) proprietary drug development led by ALA-002, a patented non-racemic MDMA (70–80% R-MDMA / 20–30% S-MDMA) targeting social anxiety in autism, plus APA-001, a novel non-scheduled MDXX molecule discovered via University of Windsor AI collaboration. ALA-002 holds US Patent No. 12,053,452 (composition of matter, issued 2024), MHRA written guidance that no further preclinical data is needed, and FDA NCE classification. Phase 2a clinical trial drug substance manufacture was contracted with a UK CDMO in December 2025 in preparation for an Australian Phase 2a with University of Sydney (Dr. Adam Guastella). Revenue grew 95% in FY2024 to C$1.04M from MDMA product sales. Note: master list originally classified as private, but is publicly listed on CSE.

Psilo Scientific Ltd is a Health Canada-licensed psilocybin producer and wholly-owned subsidiary of Filament Health Corp (NEO: FH), supplying purified botanical psilocybin (PEX010) to clinical trials including the PSYCHED-PAL palliative care microdosing study; it also licensed PEX010 to Cybin for Phase 2 trials in treatment-resistant depression and alcohol use disorder.

PsyLabs is a privately held psychedelic API developer and pharmaceutical manufacturer supplying naturally derived psilocybin, psilocin, ibogaine, mescaline, DMT, and related compounds for legal research, clinical trial, and drug-development markets. It operates a licensed Southern Africa production and extraction platform and has a strategic licensing/equity relationship with Psyence Biomedical (Nasdaq: PBM).

Psygen is a Canadian GMP-certified active pharmaceutical ingredient (API) manufacturer specialising in psychedelic compounds for clinical research. Founded in 2019 and based in Calgary, Alberta, the company produces pharmaceutical-grade psilocybin, LSD, MDMA, DMT, ibogaine, and 5-MeO-DMT under DEA- and Health Canada-compliant conditions, supplying clinical trial sponsors and research institutions. Psygen raised $5.5M to expand its GMP manufacturing capabilities.

US-based API CDMO with stated capabilities for Schedule I psychedelic compounds, supporting clinical trial supply and cGMP manufacturing workflows.

Large-scale pharma services and CDMO provider engaged by psychedelic developers for U.S.-based clinical supply and potential commercial manufacturing.

Usona Institute is a US-based 501(c)(3) non-profit medical research organisation headquartered in Madison, Wisconsin. Usona develops and supports clinical research on psilocybin and other consciousness-expanding medicines with a mission-driven access model. Its psilocybin programme received FDA Breakthrough Therapy Designation for major depressive disorder in 2019. After completing the Phase 2 PSIL201 study, Usona launched the Phase 3 uAspire trial in 2024, a 240-participant randomised, double-blind multicentre study of 25 mg psilocybin with psychosocial support for adults with MDD. In April 2026, industry reporting said Usona confirmed it had received an FDA Commissioner National Priority Voucher for psilocybin in MDD, potentially shortening review if an NDA is filed and accepted. Usona is also exploring 5-MeO-DMT in early-stage research.