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
Round Rock, Texas, United States, North America
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
API process development
Route scouting, process optimization, scale-up and documentation to support IND-enabling and commercial manufacture of small-molecule APIs.
Analytical development and QC services
Analytical method development, validation, transfer and routine QC testing to support release and stability programs.
Formulation development
Design and optimization of formulations from concept to clinical-ready batches with stability and performance optimization.
cGMP manufacturing services
cGMP-compliant production of APIs and drug products with capacity for technology transfer and commercial supply.
Regulatory services and submission support
Regulatory strategy, preparation of IND/IDE/DMF/NDA dossiers, and management of electronic CTD/eCTD submissions and global regulatory interactions.
Commercialization and supply services
Support for product launches including scale-up, packaging/labeling, warehousing, distribution and supply agreements.
API process development
Route scouting, process optimization, scale-up and documentation to support IND-enabling and commercial manufacture of small-molecule APIs.
Analytical development and QC services
Analytical method development, validation, transfer and routine QC testing to support release and stability programs.
Formulation development
Design and optimization of formulations from concept to clinical-ready batches with stability and performance optimization.
cGMP manufacturing services
cGMP-compliant production of APIs and drug products with capacity for technology transfer and commercial supply.
Regulatory services and submission support
Regulatory strategy, preparation of IND/IDE/DMF/NDA dossiers, and management of electronic CTD/eCTD submissions and global regulatory interactions.
Commercialization and supply services
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