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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Based in Round Rock, just north of Austin, Texas, Benuvia provides small molecule active pharmaceutical ingredients, formulation development, and pre-clinical to commercial scale drug product manufacturing. Benuvia’s cGMP facility is DEA permitted and FDA registered for the manufacturing, packaging and testing of Active Pharmaceutical Ingredients.

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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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