Unrivaled Cannabinoid Expertise

We offer a comprehensive suite of solutions for pharmaceutical, biotechnology, and consumer product companies to achieve their development and commercial needs.

Benuvia Manufacturing is a leading developer and manufacturer of high-purity, pharmaceutical cannabinoid ingredients and products.

We offer a comprehensive suite of solutions for pharmaceutical, biotechnology, and consumer product companies to achieve their development and commercial needs.

We have over 100,000 square feet of state-of-the-art research, development and manufacturing space across two cGMP facilities in Chandler, Arizona and Round Rock, Texas. We began manufacturing pharmaceutical grade cGMP pure quality cannabidiol (CBD) in 2009 and our Round Rock facility has produced CBD since 2014 (DMF 32552). Today, Round Rock is the only CBD active pharmaceutical ingredient (API) contract manufacturing site in the U.S. producing an FDA approved cannabinoid drug (SYNDROS®).

Our team has decades of scientific, API production, quality control, and controlled substance expertise and has produced thousands of oral solution products and kilograms of CBD for multiple clinical trials.

We have fully integrated quality management systems in place including in-house certified auditors who conduct regular facility audits and external reviews of suppliers and contract manufacturing organizations to ensure the highest level of compliance. Our team of experienced quality control experts also conduct all in-house equipment, cleaning and process validations to certify all equipment is validated prior to use. This allows us to support a broad range of CBD product development and manufacturing activities including highly potent controlled substances. Our facilities are DEA and FDA registered cGMP production sites and are fully regulated and compliant with all DEA, EPA, and OSHA requirements.

PROPRIETARY CBD PROCESS

Our biomimetic natural product derived process enables us to produce CBD (and other cannabinoids) in a cGMP controlled environment. This proprietary process allows us to access all the rare cannabinoids, including their free-acid and varin (C3) forms, by replicating the elegance and efficiency that nature employs when constructing cannabinoid molecules.

cGMP-Compliant Process

Capabilities

Full-Scale Capabilities Under One Roof

High-purity

pharmaceutical cannabinoid ingredients and products

Pre-clinical to cGMP API manufacturing

up to metric ton annual scale

2 FDA registered

cGMP sites

Over 100,000 sqft

of state-of-the-art research, development and manufacturing space

Drug Development

  • Novel cannabinoid synthesis and route scouting
  • Custom synthesis from gram to multi-kilo scale including purification capabilities (distillation, crystallization, and chromatography)
  • Stability storage, testing and reporting using standard ICH conditions of:
    • 5°C/Ambient RH
    • 25°C/60%RH
    • 30°C/65%RH
    • 40°C/75%RH

Analytical Services

  • Raw materials testing
  • Analytical testing
  • Compendial / non-compendial and specialized testing
  • Method development and validation (HPLC, GC, Titrations, Spray Technology, USP Methods)

Quality Assurance & Validation

  • Quality management system including electronic document management system
  • Pharmacovigilance and complaint handling
  • Computer system validation/21CFR-Part 11 compliance
  • Outside analytical lab services

API Manufacturing

  • Significant cannabinoid production expertise
  • Botanical processing capability
  • Pre-clinical to cGMP API manufacturing up to metric ton annual scale
  • DEA schedules I-V material capabilities; Schedule I-II vault with over 500 pallet spaces, built in cooler for 2-8 C refrigeration

Drug Product

  • Preclinical and clinical drug product formulations
  • Dosage form development
  • Packaging and labeling
  • Storage and testing

News

Team

Todd C. Davis

Executive Chairman

Todd C. Davis has more than 30 years of operational...

 

Todd C. Davis

Position: Executive Chairman

Todd C. Davis has more than 30 years of operational and investment experience in the pharmaceutical and life science industries. He has led over $3 billion in healthcare deals including growth equity, structured debt and royalty acquisitions throughout his career. Mr. Davis has also led, structured and closed more than 40 intellectual property licenses, as well as hybrid royalty-debt deals. Prior to Benuvia, he held senior leadership roles at RoyaltyRx Capital, Healthcare Royalty Partners and Apax Partners. Previously, he held general management, business development, and licensing roles at Elan Pharmaceuticals and commercial and operational roles at Abbott Laboratories.

Mr. Davis is a Navy veteran, holds an MBA from Harvard University, and a BS from the U.S. Naval Academy. He currently serves on the board of BioDelivery Sciences International, Ligand Pharmaceuticals and Palvella Therapeutics.

Scott Watson

President, Benuvia Manufacturing

Scott Watson has more than 25 years of experience building...

 

Scott Watson

Position: President, Benuvia Manufacturing

Scott Watson has more than 25 years of experience building businesses that serve the pharmaceutical and biotechnology industries. Mr. Watson was previously VP, Head of Commercial Operations for Benuvia Manufacturing, where he was responsible for sales, business development and marketing for Benuvia’s manufacturing operation. Prior to joining Benuvia, he served as Principal of The C=C Bond Group which provides strategic and tactical advisory consulting services to  pharmaceutical and biotechnology companies. Previously, Mr. Watson held sales and operational leadership positions at Eastman Chemical Company, Durect Corporation, DSM, and AMPAC Fine Chemicals. Since 2000, he  has served as a Professor and Adjunct Professor at the University of Alabama at Birmingham (Collat School of Business). Mr. Watson received an MBA from George Mason University and a BS in Chemistry from the US Naval Academy where he also completed Qualifications as a Naval Nuclear Engineer. He holds the Chartered Financial Analyst ® (CFA) designation.

R. Scott Warlick

VP, Manufacturing

Scott Warlick has more than 25 years of experience leading...

 

R. Scott Warlick

Position: VP, Manufacturing

Scott Warlick has more than 25 years of experience leading chemical and pharmaceutical operations. Over the course of his career, Mr. Warlick  has led operations in bulk API, specialty API, orals solid dose, and drug delivery systems.  As VP, Manufacturing, he is responsible for Benuvia’s Texas manufacturing site overseeing  the production of commercial active pharmaceutical ingredients (API) and registration batches for new drug applications. Prior to joining Benuvia, Mr. Warlick served as Senior Director of Manufacturing at Mylan where he led  the granulation department (blending, roller compaction, and fluid bed granulation). Previously, Mr. Warlick served in numerous capital management and process improvement roles at Mallinckrodt including site lead at the company’s 200-employee bulk acetaminophen API site. Mr. Warlick received an MBA from Duke University and a BS in Chemical Engineering from North Carolina State University.

Thrimoorthy Potta

VP, Research & Development

Thrimoorthy Potta has more than 15 years of extensive product...

 

Thrimoorthy Potta

Position: VP, Research & Development

Thrimoorthy Potta has more than 15 years of extensive product development experience in both branded and generic pharmaceuticals across a broad range of technologies and dosage forms. As VP, Research & Development, he leads all operations in the development of liquid orals, sublingual sprays, Intranasal sprays inhalation aerosols and solid dosage forms from inception to the product launch. Mr. Potta’s team has launched several drug products and handled the submission of several IND’s and NDA’s. Prior to Benuvia, Mr. Potta held R&D leadership positions at some of the most successful generic pharmaceutical companies including Sun Pharmaceutical Industries Ltd and Gland Pharma Ltd. He has authored and co-authored more than 20 peer-reviewed publications and has several patents. Mr. Potta received a Master’s in pharmaceutical chemistry and a PhD in pharmaceutics and post-doctoral research in chemical engineering from Arizona State university. He serves as an Editorial Advisory Board Member of Recent Patents on Drug Delivery & Formulation.

Jim Mitchell

Principal Scientist, Research/Process Development

Jim Mitchell has more than 20 years of experience as...

 

Jim Mitchell

Position: Principal Scientist, Research/Process Development

Jim Mitchell has more than 20 years of experience as an organic chemist focused primarily on organic synthesis, natural products isolation, and structure elucidation with an emphasis on cannabinoid chemistry. He leads Benuvia’s research and process development group in process oversight; development and translation of new industrial cannabinoid processes; formulation and API impurity isolation and structure elucidation; in addition to custom synthesis campaigns for various cannabinoid derivatives of industrial importance. Mr. Mitchell is also responsible for the modernization of other cannabinoid scaffolds for industrial GMP production and preclinical/clinical investigations. Prior to Benuvia, he served in research and chemistry roles at several clinical research and manufacturing companies.

He received a BS  in Chemistry from the University of Texas at Austin and studied organic chemistry at the University of Hawaii at Manoa.

Monica Gorbet

Director, Quality Assurance

Monica Gorbet has more than 25 years of experience in...

 

Monica Gorbet

Position: Director, Quality Assurance

Monica Gorbet has more than 25 years of experience in pharmaceutical operations with expertise in quality systems, quality assurance, compliance, and quality control. As Director, Quality Assurance, she leads quality activities including compliance of regulatory requirements associated with manufacturing and development at Benuvia’s Texas site. Prior to joining Benuvia, she served as the Director of Quality Assurance for PharmaForm, a midsize contract development manufacturing organization where she successfully led the company through numerous regulatory and customer site inspections. Previously, Ms. Gorbet served in various quality roles at Astellas Pharma Technologies, Pfizer, Aventis-Behring (now CSL Behring) and Hoechst Celanese. Ms. Gorbet received a BS in Biology from Texas A&M – Kingsville.

Karon J. Morell

Compliance, Technical Operations Advisor

Karon J. Morell’s professional career spans over 50 years with...

 

Karon J. Morell

Position: Compliance, Technical Operations Advisor

Karon J. Morell’s professional career spans over 50 years with 27 of them in executive leadership roles in the biotech, tissue, medical and pharmaceutical industries. Ms. Morell has deep compliance, clinical, regulatory, quality affairs, manufacturing, and technical operational expertise. Over the course of her career, she has successfully led diverse teams globally, achieved international agency product and facility approvals and has never received a U.S. FDA or International FDA inspection observation or finding.

Prior to Benuvia, Ms. Morell held senior positions in compliance, regulatory, quality affairs and operations for Suneva Medical and its predecessor company for 12 years. During her tenure at the firm, Ms. Morell was responsible for the oversight of the company’s California corporate manufacturing facility for Artefill (now Bellafill) and its German facility which produced the critical raw component Polymethyl methacrylate (PMMA). Previously, Ms. Morell served as VP of Compliance, Regulatory, Quality Systems, Assurance & Control and as Tissue Bank Director at IsoTis Orthobiologics (now Integra LifeSciences). At IsoTis, she was instrumental in re-classifying some of the company’s biological human tissue products as medical devices. Prior to IsoTis, she held senior quality and regulatory roles at Medegen Medical Products, Nobel Biocare and Newport Medical Instruments.

Ms. Morell received a BS in Business Management from Southern California University.

Todd C. Davis

Position: Executive Chairman

Todd C. Davis has more than 30 years of operational and investment experience in the pharmaceutical and life science industries. He has led over $3 billion in healthcare deals including growth equity, structured debt and royalty acquisitions throughout his career. Mr. Davis has also led, structured and closed more than 40 intellectual property licenses, as well as hybrid royalty-debt deals. Prior to Benuvia, he held senior leadership roles at RoyaltyRx Capital, Healthcare Royalty Partners and Apax Partners. Previously, he held general management, business development, and licensing roles at Elan Pharmaceuticals and commercial and operational roles at Abbott Laboratories.

Mr. Davis is a Navy veteran, holds an MBA from Harvard University, and a BS from the U.S. Naval Academy. He currently serves on the board of BioDelivery Sciences International, Ligand Pharmaceuticals and Palvella Therapeutics.

Todd C. Davis

Executive Chairman

Todd C. Davis has more than 30 years of operational and investment experience in the pharmaceutical and life science industries. He has led over $3 billion in healthcare deals including...

Scott Watson

Position: President, Benuvia Manufacturing

Scott Watson has more than 25 years of experience building businesses that serve the pharmaceutical and biotechnology industries. Mr. Watson was previously VP, Head of Commercial Operations for Benuvia Manufacturing, where he was responsible for sales, business development and marketing for Benuvia’s manufacturing operation. Prior to joining Benuvia, he served as Principal of The C=C Bond Group which provides strategic and tactical advisory consulting services to  pharmaceutical and biotechnology companies. Previously, Mr. Watson held sales and operational leadership positions at Eastman Chemical Company, Durect Corporation, DSM, and AMPAC Fine Chemicals. Since 2000, he  has served as a Professor and Adjunct Professor at the University of Alabama at Birmingham (Collat School of Business). Mr. Watson received an MBA from George Mason University and a BS in Chemistry from the US Naval Academy where he also completed Qualifications as a Naval Nuclear Engineer. He holds the Chartered Financial Analyst ® (CFA) designation.

Scott Watson

President, Benuvia Manufacturing

Scott Watson has more than 25 years of experience building businesses that serve the pharmaceutical and biotechnology industries. Mr. Watson was previously VP, Head of Commercial Operations for Benuvia Manufacturing,...

R. Scott Warlick

Position: VP, Manufacturing

Scott Warlick has more than 25 years of experience leading chemical and pharmaceutical operations. Over the course of his career, Mr. Warlick  has led operations in bulk API, specialty API, orals solid dose, and drug delivery systems.  As VP, Manufacturing, he is responsible for Benuvia’s Texas manufacturing site overseeing  the production of commercial active pharmaceutical ingredients (API) and registration batches for new drug applications. Prior to joining Benuvia, Mr. Warlick served as Senior Director of Manufacturing at Mylan where he led  the granulation department (blending, roller compaction, and fluid bed granulation). Previously, Mr. Warlick served in numerous capital management and process improvement roles at Mallinckrodt including site lead at the company’s 200-employee bulk acetaminophen API site. Mr. Warlick received an MBA from Duke University and a BS in Chemical Engineering from North Carolina State University.

R. Scott Warlick

VP, Manufacturing

Scott Warlick has more than 25 years of experience leading chemical and pharmaceutical operations. Over the course of his career, Mr. Warlick  has led operations in bulk API, specialty API,...

Thrimoorthy Potta

Position: VP, Research & Development

Thrimoorthy Potta has more than 15 years of extensive product development experience in both branded and generic pharmaceuticals across a broad range of technologies and dosage forms. As VP, Research & Development, he leads all operations in the development of liquid orals, sublingual sprays, Intranasal sprays inhalation aerosols and solid dosage forms from inception to the product launch. Mr. Potta’s team has launched several drug products and handled the submission of several IND’s and NDA’s. Prior to Benuvia, Mr. Potta held R&D leadership positions at some of the most successful generic pharmaceutical companies including Sun Pharmaceutical Industries Ltd and Gland Pharma Ltd. He has authored and co-authored more than 20 peer-reviewed publications and has several patents. Mr. Potta received a Master’s in pharmaceutical chemistry and a PhD in pharmaceutics and post-doctoral research in chemical engineering from Arizona State university. He serves as an Editorial Advisory Board Member of Recent Patents on Drug Delivery & Formulation.

Thrimoorthy Potta

VP, Research & Development

Thrimoorthy Potta has more than 15 years of extensive product development experience in both branded and generic pharmaceuticals across a broad range of technologies and dosage forms. As VP, Research...

Jim Mitchell

Position: Principal Scientist, Research/Process Development

Jim Mitchell has more than 20 years of experience as an organic chemist focused primarily on organic synthesis, natural products isolation, and structure elucidation with an emphasis on cannabinoid chemistry. He leads Benuvia’s research and process development group in process oversight; development and translation of new industrial cannabinoid processes; formulation and API impurity isolation and structure elucidation; in addition to custom synthesis campaigns for various cannabinoid derivatives of industrial importance. Mr. Mitchell is also responsible for the modernization of other cannabinoid scaffolds for industrial GMP production and preclinical/clinical investigations. Prior to Benuvia, he served in research and chemistry roles at several clinical research and manufacturing companies.

He received a BS  in Chemistry from the University of Texas at Austin and studied organic chemistry at the University of Hawaii at Manoa.

Jim Mitchell

Principal Scientist, Research/Process Development

Jim Mitchell has more than 20 years of experience as an organic chemist focused primarily on organic synthesis, natural products isolation, and structure elucidation with an emphasis on cannabinoid chemistry....

Monica Gorbet

Position: Director, Quality Assurance

Monica Gorbet has more than 25 years of experience in pharmaceutical operations with expertise in quality systems, quality assurance, compliance, and quality control. As Director, Quality Assurance, she leads quality activities including compliance of regulatory requirements associated with manufacturing and development at Benuvia’s Texas site. Prior to joining Benuvia, she served as the Director of Quality Assurance for PharmaForm, a midsize contract development manufacturing organization where she successfully led the company through numerous regulatory and customer site inspections. Previously, Ms. Gorbet served in various quality roles at Astellas Pharma Technologies, Pfizer, Aventis-Behring (now CSL Behring) and Hoechst Celanese. Ms. Gorbet received a BS in Biology from Texas A&M – Kingsville.

Monica Gorbet

Director, Quality Assurance

Monica Gorbet has more than 25 years of experience in pharmaceutical operations with expertise in quality systems, quality assurance, compliance, and quality control. As Director, Quality Assurance, she leads quality...

Karon J. Morell

Position: Compliance, Technical Operations Advisor

Karon J. Morell’s professional career spans over 50 years with 27 of them in executive leadership roles in the biotech, tissue, medical and pharmaceutical industries. Ms. Morell has deep compliance, clinical, regulatory, quality affairs, manufacturing, and technical operational expertise. Over the course of her career, she has successfully led diverse teams globally, achieved international agency product and facility approvals and has never received a U.S. FDA or International FDA inspection observation or finding.

Prior to Benuvia, Ms. Morell held senior positions in compliance, regulatory, quality affairs and operations for Suneva Medical and its predecessor company for 12 years. During her tenure at the firm, Ms. Morell was responsible for the oversight of the company’s California corporate manufacturing facility for Artefill (now Bellafill) and its German facility which produced the critical raw component Polymethyl methacrylate (PMMA). Previously, Ms. Morell served as VP of Compliance, Regulatory, Quality Systems, Assurance & Control and as Tissue Bank Director at IsoTis Orthobiologics (now Integra LifeSciences). At IsoTis, she was instrumental in re-classifying some of the company’s biological human tissue products as medical devices. Prior to IsoTis, she held senior quality and regulatory roles at Medegen Medical Products, Nobel Biocare and Newport Medical Instruments.

Ms. Morell received a BS in Business Management from Southern California University.

Karon J. Morell

Compliance, Technical Operations Advisor

Karon J. Morell’s professional career spans over 50 years with 27 of them in executive leadership roles in the biotech, tissue, medical and pharmaceutical industries. Ms. Morell has deep compliance,...

Contact Us

Benuvia Manufacturing

2700 Oakmont Drive
Round Rock, TX 78665
(512) 543-1569