Lab Testing, Quality Control & Production Standards

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®.

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.

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.