Benuvia Operations LLC
Benuvia is a US-based specialty CDMO and API supplier specializing in controlled substances, cannabinoids, psychedelics, and small molecules. The company is committed to innovation, excellence, and compliance, providing tailored solutions across discovery, development, manufacturing, and commercialization. With a focus on high standards and regulatory expertise, Benuvia supports clients in bringing groundbreaking therapies to market efficiently and safely.
Industries
Nr. of Employees
small (1-50)
Benuvia Operations LLC
Products
Dronabinol (Δ9-THC) API
Synthetic delta-9-tetrahydrocannabinol API produced under cGMP suitable for clinical trials; available as GLP material for preclinical studies or non-GMP research grade material.
Cannabidiol (CBD) API
Synthetic cannabidiol supplied as GMP material for clinical trials or GLP/non-GMP material for research and preclinical studies.
Psilocybin and psilocin APIs
Psychedelic APIs produced under GMP suitable for regulated clinical trials; available as GLP material for preclinical testing or research-grade material.
DMT (and 5‑MeO‑DMT) APIs
Synthetic DMT and 5-MeO-DMT APIs manufactured under GMP for clinical use and available as GLP or research-grade materials for preclinical work.
rac‑MDMA HCl API
Racemic MDMA hydrochloride produced in a GMP-compliant manner suitable for clinical trials and available as GLP or research-grade material for preclinical studies.
Other cannabinoid APIs (Delta‑8, CBDV, THCV, CBN)
A portfolio of synthetic cannabinoid APIs produced under GMP or GLP conditions appropriate for research, preclinical or clinical programs.
Dronabinol (Δ9-THC) API
Synthetic delta-9-tetrahydrocannabinol API produced under cGMP suitable for clinical trials; available as GLP material for preclinical studies or non-GMP research grade material.
Cannabidiol (CBD) API
Synthetic cannabidiol supplied as GMP material for clinical trials or GLP/non-GMP material for research and preclinical studies.
Psilocybin and psilocin APIs
Psychedelic APIs produced under GMP suitable for regulated clinical trials; available as GLP material for preclinical testing or research-grade material.
DMT (and 5‑MeO‑DMT) APIs
Synthetic DMT and 5-MeO-DMT APIs manufactured under GMP for clinical use and available as GLP or research-grade materials for preclinical work.
rac‑MDMA HCl API
Racemic MDMA hydrochloride produced in a GMP-compliant manner suitable for clinical trials and available as GLP or research-grade material for preclinical studies.
Other cannabinoid APIs (Delta‑8, CBDV, THCV, CBN)
A portfolio of synthetic cannabinoid APIs produced under GMP or GLP conditions appropriate for research, preclinical or clinical programs.
Services
Route scouting, process optimization, scale-up and documentation to support IND-enabling and commercial manufacture of small-molecule APIs.
Analytical method development, validation, transfer and routine QC testing to support release and stability programs.
Design and optimization of formulations from concept to clinical-ready batches with stability and performance optimization.
cGMP-compliant production of APIs and drug products with capacity for technology transfer and commercial supply.
Regulatory strategy, preparation of IND/IDE/DMF/NDA dossiers, and management of electronic CTD/eCTD submissions and global regulatory interactions.
Support for product launches including scale-up, packaging/labeling, warehousing, distribution and supply agreements.
Route scouting, process optimization, scale-up and documentation to support IND-enabling and commercial manufacture of small-molecule APIs.
Analytical method development, validation, transfer and routine QC testing to support release and stability programs.
Design and optimization of formulations from concept to clinical-ready batches with stability and performance optimization.
cGMP-compliant production of APIs and drug products with capacity for technology transfer and commercial supply.
Regulatory strategy, preparation of IND/IDE/DMF/NDA dossiers, and management of electronic CTD/eCTD submissions and global regulatory interactions.
Support for product launches including scale-up, packaging/labeling, warehousing, distribution and supply agreements.
Expertise Areas
- Controlled-substance API development
- API process development and scale-up
- Formulation development for clinical programs
- Analytical method development and QC
Key Technologies
- cGMP manufacturing
- GLP material production
- API synthesis and scale-up
- Formulation development for clinical use
News & Updates
If your company is developing ibogaine or ibogaine analogs for clinical use, there’s a rare public-private opportunity in Texas you should be aware of.
As global pharmaceutical supply chains adjust to international tariffs, many manufacturers are reevaluating their reliance on offshore solutions, increasing demand for U.S.-based CDMOs.
Benuvia Operations has signed a supply agreement with a top U.S. pharmaceutical company for Dronabinol API, expanding its commercial manufacturing capabilities.
Benuvia stands out as a pioneer in controlled substances, offering GMP-compliant manufacturing of cannabinoids, psychedelics, and Schedule I-V compounds, ensuring high-quality, regulatory-compliant products.
Benuvia’s operations have been granted GMP certification by Brazil’s National Health Surveillance Agency (ANVISA), demonstrating compliance with international standards.
If your company is developing ibogaine or ibogaine analogs for clinical use, there’s a rare public-private opportunity in Texas you should be aware of.
As global pharmaceutical supply chains adjust to international tariffs, many manufacturers are reevaluating their reliance on offshore solutions, increasing demand for U.S.-based CDMOs.
Benuvia Operations has signed a supply agreement with a top U.S. pharmaceutical company for Dronabinol API, expanding its commercial manufacturing capabilities.
Benuvia stands out as a pioneer in controlled substances, offering GMP-compliant manufacturing of cannabinoids, psychedelics, and Schedule I-V compounds, ensuring high-quality, regulatory-compliant products.
Benuvia’s operations have been granted GMP certification by Brazil’s National Health Surveillance Agency (ANVISA), demonstrating compliance with international standards.