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 (MRO) headquartered in Madison, Wisconsin. Co-founded in 2014 by Bill Linton (CEO of Promega Corporation) and Malynn Utzinger, M.D., Usona was established after Linton witnessed the profound impact of a Johns Hopkins psilocybin study on a terminally ill friend. Unlike commercial drug developers, Usona operates as a mission-driven MRO — conducting and supporting pre-clinical and clinical research on psilocybin and other consciousness-expanding medicines, with the goal of developing accessible, affordable treatments. Its research leadership includes Dr. Charles Raison (Director of Clinical and Translational Research, UW-Madison psychiatrist) and Dr. Alexander Sherwood (medicinal chemist). Usona's psilocybin programme received FDA Breakthrough Therapy Designation for major depressive disorder in 2019. After completing the Phase 2 PSIL201 study (the largest Phase 2 randomised controlled trial of psilocybin for MDD at the time), the Institute launched the Phase 3 uAspire trial in 2024 — a 240-participant, randomised, double-blind, multicentre study comparing 25 mg psilocybin vs placebo in adults with MDD. Usona is also exploring 5-MeO-DMT in early-stage research.