Benuvia Manufacturing
CANNABINOID CAPABILITIES
CANNABIDIOL (CBD) SYNTHETIC
Benuvia Quality
- High purity, non detectable THC synthetic material. White, crystalline free flowing powder.
- US DMF 32552
- Not a US DEA controlled substance
- Biomimetic, “nature identical” to phyto derived Cannabidiol
- IP protected
- Proven large scale production
- Reference standards (including key degradation products and metabolites) available
- Currently supporting Phase II & III Clinical Studies in the US.
Suitable for human clinical trials
US Validation to be completed in Q2 2023
Dual-Sourced starting materials
US DMF filed and referenceable (US DMF #32552)
Comprehensive Technical Package available
CANNABIDIOL (CBD) PHYTO DRUG SUBSTANCE
Benuvia Quality
- High purity, non detect THC, botanical drug substance material
- White, crystalline free flowing powder
- Not a US DEA controlled substance
- Proven large scale production
- Reference standards (including key degradation
products and metabolites) available
Dual-Sourced starting materials - 100% USA Hemp sourced
US DMF to be filed in Q3 2022
US Validation completed Q2 2023
Comprehensive Technical Package available
DRONABINOL (D9 THC)
Benuvia Quality
- US DMF 19207
- High purity synthetic material. A viscous, resinous semi-solid
- Neat dronabinol meets USP and German DAC Quality Standards
- Robust and reliable supply chain
- IP Protected
- Excellent technical and regulatory support, deep knowledge of product handling requirements
- Comprehensive Technical Package available
Neat (pure) dronabinol process fully validated and ICH Q7-compliant.
Current DMF 19207
New DMF filing Q1 2023
API manufactured at Benuvia HQs in Round Rock, TX USA
Neat dronabinol meets USP and German DAC Quality Standards
Comprehensive Technical Package available
CANNABIDIVARIN (CBDV)
Benuvia Quality
- Capable of producing under cGMP for clinical applications
- High purity, non Detect THC
- Fully synthetic material
- White to off white to yellow solid
- No contamination from heavy metals, microbes or pesticides
- DEA non-controlled minor cannabinoid
- Robust and reliable supply chain
- Excellent technical and regulatory support, deep knowledge
of product handling requirements - Reference standards available
Currently manufactured as a non-GMP grade suitable for pre-clinical use at our HQs in Round Rock, TX USA
Leverages the commercial supply chain; Key starting material is commercial CBD
TETRAHYDROCANNABIVARIN (THCV)
Benuvia Quality
- High purity synthetic material. A viscous, resinous semi-solid
- Room temperature stable product with a projected commercial shelf life of > 24 months
- Robust and reliable supply chain
- Excellent technical and regulatory support, deep knowledge of product handling requirements
- Reference standards available at
Neat (pure) THCV, US validation to be completed in Q2 2023
DMF planned for Q3 2022
API manufactured at Benuvia HQs in Round Rock, TX USA
Comprehensive Technical Package available
IND-enabling DMF in progress
CANNABINOL (CBN)
Benuvia Quality
- Process suitable for scale up to support Phase I and
Phase II clinical trials - High purity
- Fully synthetic material
- White to slightly colored solid
- Streamlined, one step process
- DEA non-controlled minor cannabinoid
- Robust and reliable supply chain
- Excellent technical and regulatory support, deep knowledge of product handling requirements
- Reference standards available
Currently manufactured as a non-GMP grade suitable for pre-clinical use at our HQs in Round Rock, TX USA
Leverages the commercial supply chain; Key starting material is commercial CBD
All other reagents easily sourced
D8 THC
Benuvia Quality
- High purity synthetic material. A viscous, resinous semi-solid
- Room temperature stable product with a projected commercial shelf life of > 24 months
- Robust and reliable supply chain
- Excellent technical and regulatory support, deep knowledge of product handling requirements
- Reference standards available at