Benuvia Manufacturing
ENTHEOGEN CAPABILITIES
DMT
Benuvia Quality
- All DEA licenses in place to make, test, release and ship cGMP API
- Able to ship material globally
- Ability to help customers navigate Schedule 1 controlled substances API quota and material handling regulations
- Robust and reliable supply chain
- Excellent technical and regulatory support, deep knowledge of product handling requirements
Will be supported by a IND-enabling technical package
Will be supported by stability studies
IND enabling DMF can be filed pending customer needs
5MeO DMT
Benuvia Quality
- All DEA licenses in place to make, test, release and
ship cGMP API - Able to ship material globally
- Ability to help customers navigate CI API quota and material handling regulations
- Robust and reliable supply chain
- Excellent technical and regulatory support, deep knowledge of product handling requirements
Currently manufactured used existing, non-IP protected technology in the public domain
Non-GMP material available early Q4 2021
cGMP manufacturing to support Phase I Q4 2022 / Q1 2023
Will be supported by stability studies (starting Q1 2023)
IND enabling DMF can be filed pending customer needs
PSILOCYBIN
Benuvia Quality
- All DEA licenses in place to make, test, release and
ship cGMP API - Able to ship material globally
- Ability to help customers navigate CI API quota and material handling regulations
- Robust and reliable supply chain
- Excellent technical and regulatory support, deep knowledge of product handling requirements
Currently manufactured used existing, non-IP protected technology in the public domain
Non-GMP material available
cGMP manufacturing to support Phase I and Phase II trials in 2023
Will be supported by stability studies (starting Q3 2023)
IND enabling DMF can be filed pending customer needs
MDMA
Benuvia Quality
- All DEA licenses in place to make, test, release and ship cGMP API
- Able to ship material globally
- Ability to help customers navigate Schedule 1 controlled substances API quota and material handling regulations
- Robust and reliable supply chain
- Excellent technical and regulatory support, deep knowledge of product handling requirements
Currently manufactured used existing, non-IP protected technology in the public domain
Non-GMP material available early Q4 2022
cGMP manufacturing to support clinical and Commercial supply
Will be supported by stability studies (starting Q3 2023)
APPROVED DRUG MASTER FILES
CANNABINOIDS
DRONABINOL USP (D9 THC)
US DMF 19207
New DMF filing Q1 2023
CANNABIDIOL (synthetic)
US DMF 32552
CANNABIDIOL (phyto)
US DMF to be filed
in Q3 2022;
ENTHEOGENS
DMT
IND enabling development in process
MeO DMT
IND enabling development in process
PSILOCYBIN
IND enabling DMF can be
filed pending customer needs
MDMA
IND enabling development in process