Benuvia Secures Five-Year NIH Contract for GMP Psilocybin Production

• Benuvia Operations, LLC has been awarded a five-year contract by the National Institute on Drug Abuse (NIDA) for the GMP synthesis of psilocybin and other bulk drug substances.

• The contract will support research into treatments for substance use disorders and mental health conditions.

Benuvia Operations, LLC has secured a five-year contract from the National Institute on Drug Abuse (NIDA), a division of the National Institutes of Health (NIH), to manufacture psilocybin and other bulk drug substances under Good Manufacturing Practice (GMP) conditions. The contract aims to support research into treatments for substance use disorders and mental health conditions.

Under the agreement, Benuvia will focus on the synthesis and scale-up of psilocybin, a Schedule I substance that has received Breakthrough Therapy designation from the U.S. Food and Drug Administration (FDA) for major depressive disorder and treatment-resistant depression. The company will supply GMP-grade psilocybin for NIDA’s preclinical toxicity studies and clinical trials.

“This contract highlights our leadership in the development and manufacturing of controlled substances under GMP conditions,” said Terry Novak, CEO of Benuvia. “We are honored to support NIH’s efforts in advancing groundbreaking research into innovative therapies for substance use disorders and mental health conditions.”

Psilocybin is a naturally occurring psychedelic compound derived from certain mushrooms. Its classification as a Schedule I controlled substance has historically restricted research access. The NIH contract enables Benuvia to manufacture pharmaceutical-grade psilocybin that meets FDA and Drug Enforcement Administration (DEA) regulations, ensuring a consistent supply for scientific studies.

The contract, funded under Contract No. 75N95025D00003, reinforces Benuvia’s role in providing high-purity substances for pharmaceutical research and development. The company will collaborate with the NIH to assess psilocybin’s potential therapeutic applications for patients with mental health and substance use disorders.