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®.

Catalent is a global contract development and manufacturing organisation (CDMO) headquartered in Somerset, New Jersey, and established in 2007. It supports pharmaceutical development and drug-product manufacturing across the industry, including cGMP psychedelic drug-product programmes disclosed by clinical-stage sponsors. Catalent was acquired by Novo Holdings in 2024.

Cayman Chemical is a US biochemical supplier and manufacturer based in Ann Arbor, Michigan, founded in 1980. Through its own operations and its Cayman Pharma cGMP API platform it provides research biochemicals, reference materials and cGMP active pharmaceutical ingredients, including psychedelic compounds supplied for analytical work and clinical-trial pathways.

Cerilliant is a US manufacturer of certified reference materials and analytical standards, based in Round Rock, Texas, and founded in 1980. It pioneered DEA-exempt reference standards for controlled substances and offers a certified catalogue that includes psychedelic reference standards used in analytical, forensic and clinical-laboratory testing. Cerilliant was acquired by Sigma-Aldrich in 2011 and now operates under the MilliporeSigma brand (part of Merck KGaA).

Cortexa is a Melbourne-based psychedelic-medicines supplier, formed as a 50/50 joint venture between PharmAla Biotech and Vitura Health. It was the first company in the world to supply psilocybin under Australia's TGA Authorised Prescriber Scheme (2024) and is positioned as the only Australian company able to supply both GMP MDMA and psilocybin for clinical trials and prescriptions under the country's regulated prescribing pathways.

Eywa Biotech is a Uruguayan synthetic-biology company, founded in Montevideo in 2022 by Paola Rodríguez Camarot and Victoria Costa Paz, that uses metabolic engineering and fermentation to produce GMP-grade psychedelic active pharmaceutical ingredients, including psilocybin, DMT, 5-MeO-DMT and bufotenin. It aims to provide a sustainable, high-purity supply chain for psychedelic compounds used in research and therapeutics, and raised a US$2.5 million round led by Tim Draper.

Filament Health is a Canadian natural-psychedelics drug-development company and a leading supplier of pharmaceutical-grade botanical psilocybin. Its patented lead candidate, PEX010, is a standardised natural psilocybin drug candidate used across more than 80 academic and clinical studies worldwide, including Germany's compassionate-use programme and numerous depression, PTSD and cancer-distress trials. On 30 April 2026, Filament was acquired by and became a wholly-owned subsidiary of Red Light Holland (Cboe CA: TRIP), which now advances the PEX010 supply business and a patent portfolio of 76 issued patents across 15 families. In July 2026 Filament agreed to supply PEX010 for an ARQ National Psychotrauma Centre veterans-PTSD study in the Netherlands.

Natural MedTech Pty Ltd is an Australian manufacturer of active pharmaceutical ingredients, founded in 2021, that uses biosynthesis (precision fermentation) to produce psychedelic APIs. It is the only manufacturer of psilocybin and MDMA APIs in Australia, holding Schedule 8 and Schedule 9 cGMP manufacturing licences and complying with TGO 112 and TGO 113. Natural MedTech supplies both API and finished dose forms, has supported more than ten Phase 2 or later clinical trials in Australia and internationally, and runs a sustainable process that avoids petrochemicals, harsh solvents and plastic waste. Supply is via authorised professional and clinical-trial channels only.

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.

Purisys is a US active-pharmaceutical-ingredient CDMO based in Athens, Georgia, spun off from Noramco in 2019 (with controlled-substance manufacturing heritage dating to 1979). It provides custom synthesis of APIs, reference standards and controlled substances, and holds DEA licences for several psychedelic classes; it has produced GMP psilocybin and psilocin and filed an IND-enabling drug master file for psilocybin to support clinical-trial supply. Purisys is now part of the Siegfried Group.

Thermo Fisher Scientific is a global life-sciences and laboratory-services company headquartered in Waltham, Massachusetts, formed in 2006 through the merger of Thermo Electron and Fisher Scientific. Its contract development and manufacturing arm (including Patheon) is engaged by psychedelic drug developers for US-based clinical supply and potential commercial manufacturing, alongside its broad reagents, instruments and analytical-services portfolio.

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.