BENUVIA IS A LEADING DRUG DEVELOPER AND MANUFACTURER OF PHARMACEUTICAL CANNABINOIDS AND PSYCHEDELICS
Owner of the FDA Approved Cannabinoid (dronabinol oral solution; THC) SYNDROS®. The Largest Synthetic Cannabinoid Manufacturing Facility in the US**
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SYNDROS® (Dronabinol Oral solution) is an FDA Approved
CII Tetrahydrocannabinol (THC) Oral Solution
SYNDROS® is an FDA approved Liquid Dronabinol (THC) with a consistent, synthetic formulation targeting the cannabinoid receptors
Patent No. US8222292, US9345771, US10265293, US11253472
SYNDROS® provides fast initial Absorption: THC detected in blood plasma levels in 15 minutes in 100% fasting adult patients on liquid dronabinol vs <25% on dronabinol capsules
SYNDROS® demonstrated lower interindividual absorption variability versus the capsule formulation. This has implications with regards to providing more consistent drug delivery for patients
SYNDROS® provides tailored, flexible dosing allowing titration without additional prescriptions (BSA Dosing for CINV)
SYNDROS® is an option for patients who are already taking multiple pills, prefer liquid medications, have difficulty swallowing pills and who need medications administered in feeding tubes
SYNDROS® needs refrigeration, and once opened, SYNDROS® does not require refrigeration for 42 days, and the unused portion should be discarded 42 days after first opening
Benuvia’s Drug Development Pipeline is Focused on the Following 3 Indicators:
Alzheimer’s Disease Agitation
Drug Candidate: BEN-166S
(In Development)
5.7 Million
Americans who Suffer
with Alzheimer’s Disease
Source
14 Million
Americans will suffer from
Alzheimer’s Disease by 2050
Source
$25 Billion
Total Addressable
Market by 2027
Source
No FDA Approved Drugs
for Agit-AD
Anorexia in Cancer
Drug Candidate: BEN-317B
(Open IND)
7 Million
Forecasted Anorexia by Cancer
Market Size from by 2030
Source
65 Percent
of Cancer Patients Report
Abnormalities of Eating Behavior
Source
$3 Billion
Estimated Cancer Anorexia
Market Size In 2020
Source
No FDA Approved Treatments
for Anorexia in Cancer
Pancreatic Cancer
Drug Candidate: BEN-2111M
(In Development)
355,317
New Pancreatic Cancer Cases Estimated
to Occur Globally by 2040
Source
2 Billion
Global Pancreatic Cancer
Estimated Market Size in 2020
Source
$4.2 Billion
Global Pancreatic Cancer
Estimated Market Size by 2025
Source
No FDA Approved
Non-Chemotherapy Drugs
We Leverage a Platform of Capabilities to Expedite our Drug Development Timeline
News
Benuvia, a Drug Developer Focused on Pharmaceutical Cannabinoids, and the owner of FDA Approved SYNDROS®, Receives Approval from the US DEA to Manufacture Psychedelic Active Pharmaceutical Ingredients including Psilocybin, MDMA and DMT
Active Pharmaceutical Ingredient Manufacturing Facility*
One of the Largest Captive Synthetic Cannabinoid and Psychedelics** Manufacturing Facilities in the US
DEA Permitted, FDA Registered, cGMP Facility for Manufacturing, Packaging and Testing of Active Pharmaceutical Ingredients
83,000 Sq. Ft. Manufacturing Space
Built in 2012, cGMP Manufacturing Facility for Both API and Drug Development
API Synthesis
cGMP Synthesis for Grams to Multi-Kilo Scale Including Purification Capabilities (Distillation, Crystallization, and Chromatography)
Drug Product Formulation
- Chemistry and Formulations Expertise
- Preclinical and Clinical Drug Product Formulations
- Dosage Form Development
- Packaging and Labelling
- Storage and Testing
QC Testing
Fully Equipped QC Lab Utilizing HPLC, UV, GC Instrumentation as Well as Wet Chemical Testing, All Employing Validated and/or USP Compendial Methods
Independent QA
QA Group Responsible for Independent Audits, FDA Communications, and Ensuring Compliance with all Applicable State and Federal Regulations
Manufacturing
- Multifunctional Manufacturing Capacity to Flexibly Accommodate Various Partner Needs
- Up to Metric Ton Annual Scale
Contact Us
info@benuvia.com
3950 N. Mays Street Round Rock, TX 78665
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