Benuvia Awarded NIH Contract for GMP Synthesis of Psilocybin, Other Drug Substances

The Texas-based contract development and manufacturing organization Benuvia Operations has been awarded a five-year contract by the National Institutes of Health (NIH)’s National Institute on Drug Abuse (NIDA) for good manufacturing practice (GMP) synthesis of the naturally occurring psychedelic compound psilocybin, which comes from certain types of mushrooms, as well as other bulk drug substances (1).

Benuvia said in a press release on March 25, 2025 that the contract supports R&D of high-quality APIs for substance use disorders and mental health conditions, initially focusing on synthesis and scale-up of psilocybin, which is a Schedule I substance under the Controlled Substances Act (1). Psilocybin was granted breakthrough therapy designation by FDA in 2018 for treatment-resistant depression, and 2019 for major depressive disorder.

“This contract highlights our leadership in the development and manufacturing of controlled substances under GMP conditions,” Terry Novak, Benuvia CEO, said in the press release (1). “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.”

The contract stipulates that Benuvia Operations will manufacture and deliver GMP-grade psilocybin for NIDA preclinical toxicity studies as well as clinical trials (1). Clinical studies are currently evaluating psilocybin as a potential treatment for depression, anxiety, and substance use disorders.

“Our mission at Benuvia is to provide high-purity, federally approved substances for scientific research and pharmaceutical development,” Novak said. “We look forward to working with the NIH to help evaluate psilocybin’s therapeutic potential for the millions of patients suffering from these conditions.”

Previously, on March 11, 2025, Benuvia Operations announced that it received a GMP certification (Certificado de Boas Práticas de Fabricação [CBPF]) from Brazil’s National Health Surveillance Agency (ANVISA), such certification being essential, according to the company, as a regulatory prerequisite for pharmaceutical companies to manufacture and distribute products in Brazil (2).

“Achieving ANVISA’s CBPF certification underscores Benuvia’s strategic commitment to providing high-quality, compliant pharmaceutical manufacturing specifically tailored to Brazil’s rapidly growing healthcare market,” Novak said at the time (2). “ANVISA CBPF certification allows us to be the preferred provider for companies seeking a partner with quicker market entry, reduced regulatory hurdles, and stronger credibility among regulatory bodies, healthcare providers, and pharmaceutical customers.”

In June 2023, FDA published a draft guidance, “Psychedelic Drugs: Considerations for Clinical Investigations,” concerning the use of such drugs—psilocybin among them—for treatment of various medical conditions, including psychiatric and substance use disorders (3).

“Psychedelic drugs show initial promise as potential treatments for mood, anxiety and substance use disorders. However, these are still investigational products,” Tiffany Farchione, director, Division of Psychiatry, Center for Drug Evaluation and Research, FDA, said in a press release announcing the draft guidance (3). “The goal is to help researchers design studies that will yield interpretable results that will be capable of supporting future drug applications.”

The other bulk drug substances beside psilocybin that will be future areas of focus for Benuvia under the contract with NIDA were not disclosed by name in the Benuvia press release (1).

References

1. Benuvia Operations. Benuvia Operations Awarded NIH Contract for GMP Synthesis of Psilocybin and Other Bulk Drug Substances. Press Release. March 25, 2025.
2. Benuvia Operations. Benuvia Operations Granted GMP Certification from Brazil National Health Surveillance Agency (ANVISA). Press Release. March 11, 2025.
3. FDA, Draft Guidance for Industry, Psychedelic Drugs: Considerations for Clinical Investigations (CDER, June 2023).