Benuvia Operations has been awarded a five-year contract by the National Institute on Drug Abuse (NIDA), part of the National Institutes of Health (NIH), to synthesize psilocybin and other bulk drug substances under Good Manufacturing Practice (GMP) conditions.
The contract will support the production of active pharmaceutical ingredients (APIs) for research into treatments for substance use disorders and mental health conditions.
The initial focus of the contract is the synthesis and scale-up of psilocybin, a Schedule I controlled substance that has received Breakthrough Therapy designation from the U.S. Food and Drug Administration (FDA) for major depressive disorder and treatment-resistant depression. Benuvia will manufacture GMP-grade psilocybin for use in NIDA’s preclinical toxicity studies and clinical trials.
Psilocybin, a psychedelic compound found in certain mushrooms, is being studied for its potential to treat depression, anxiety, and substance use disorders. Its classification as a Schedule I substance has historically limited access for research purposes. Under the NIH contract, Benuvia will supply psilocybin in compliance with FDA and Drug Enforcement Administration standards, enabling consistent and regulated access for scientific investigation.
The NIH-funded contract aims to expand research infrastructure for controlled substances. Benuvia, a global contract development and manufacturing organization, operates an 83,000-square-foot manufacturing facility in Round Rock, Texas, with the capacity to produce Schedule I–V compounds for pharmaceutical research and development.
“We are honored to support NIH’s efforts in advancing groundbreaking research into innovative therapies for substance use disorders and mental health conditions. Our state-of-the-art capabilities enable us to supply the highest-quality pharmaceutical compounds that meet the most rigorous regulatory standards,” Benuvia CEO Terry Novak said in a statement.