Customized Science, Made in the USA.

We offer comprehensive technology solutions for Active Pharmaceutical Ingredient (API) and drug product development for all industries.

Based in Round Rock, just north of Austin, Texas, Benuvia Manufacturing provides small molecule active pharmaceutical ingredients, formulation, and drug product manufacturing from preclinical to commercial scale.

We offer a comprehensive suite of solutions for pharmaceutical, biotechnology, and consumer product companies to achieve their development and commercial needs. Benuvia Manufacturing works with customers large and small to manufacture small molecule active pharmaceutical ingredients and drug products. We have over 83,000 square feet of state-of-the-art research, development and manufacturing space in a cGMP facility in Round Rock, Texas.

We have fully integrated quality management systems in place including in-house certified auditors who conduct regular facility audits and external qualifications of all raw material and component suppliers to ensure the highest level of compliance.

Our team of experienced QA, QC and Validation experts conduct all in-house equipment, cleaning and process validations to certify that all equipment is qualified and processes are validated prior to use. This allows us to support a broad range of small molecule API and finished drug product development and manufacturing activities including highly potent controlled substances. Our facility is a DEA and FDA registered cGMP production site and is fully regulated and compliant with DEA, EPA, and OSHA requirements.

Capabilities

Full-Scale Capabilities Under One Roof

High-purity

Pharmaceutical cannabinoid ingredients, small molecule APIs, drug, and consumer products

Pre-clinical, cGMP and commercial

up to metric ton annual scale

FDA registered

cGMP site

DEA Licensed

Over 83,000 sqft

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

Drug Product

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

API Synthesis and Development

  • Novel cannabinoid and small molecule API 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
  • Finished Product 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
  • Computer System Validation/21CFR-Part 11 compliant
  • Contract analytical lab services

API Manufacturing

  • Significant cannabinoid production expertise
  • Botanical capability
  • Pre-clinical to Commercial cGMP small molecule API manufacturing up to metric ton annual scale
  • DEA schedules I-V material capabilities; Schedule I-II vault with over 500 pallet spaces, environmentally controlled and monitored for 2-8 C refrigeration

Expert Pre-Formulation and Formulation Development

  • Pre-formulation studies
    • Biochemical and biophysical characterization
    • Saturation solubility studies
  • Formulation Development Studies
    • Excipients selection
    • Excipients compatibility studies
    • Dosage form
    • Drug-excipients compatibility studies
    • Selection and optimization of stabilizer antioxidants
    • Stability studies, accelerated and long term
    • In-vitro screening studies
    • Container/filter compatibility studies
    • Scale up and process optimization
    • Packaging and labeling
    • Storage and testing
    • Tech transfers

Analytical Method Development and Validation

  • Develop and Validate methods for use in the testing of APIs and drug products
  • Develop and validate analytical methods to analyze in process, finished product and stability samples, as well as swabs to verify the cleanliness of manufacturing equipment
  • Methods for in-process, content, uniformity of dosage units, disintegration and dissolution sample analysis are developed and validated using UV, HPLC, or GC procedures
  • Methods to perform identification, chemical assay, related substances/impurities or chiral purity testing on API and finished drug product are developed and validated using HPLC or GC
  • Methods for stability sample analysis are validated to ensure they are stability indicating
  • Analytical method development and validation performed according to FDA-ICH guidelines, client-approved protocols, and standard operating procedures
  • Extensive experience performing pharmaceutical stability studies on APIs, early prototype formulations and finished dosage forms

PROPRIETARY CBD PROCESS

Our team has decades of scientific, API production and quality control, and has produced thousands of oral solution products and kilograms of cannabinoid products for multiple clinical trials. We began manufacturing pharmaceutical grade cGMP pure quality cannabidiol (CBD) in 2009 and our Round Rock facility has produced CBD commercially since 2014 (DMF 32552). Today, we are the only cannabinoid active pharmaceutical ingredient (API) contract manufacturing site in the U.S. producing an FDA approved cannabinoid drug (SYNDROS®). 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

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.

James Doroz

VP, Finance and Controller

James Doroz has over 25 years of experience leading financial...

 

James Doroz

Position: VP, Finance and Controller

James Doroz has over 25 years of experience leading financial teams in various industries, including manufacturing, pharmaceuticals, natural resources and software.  As VP of Finance and Controller, Mr. Doroz is responsible for Benuvia Manufacturing’s financial controls and for financial planning and analysis.  Prior to joining Benuvia, Mr. Doroz was the Director of Finance at Adaptive Curriculum, a web based company devoted to helping students succeed in math and science mastery.  Prior to his work at Adaptive Curriculum, he served at iGo. He has served in various financial roles with Sanmina and BHP Billiton.

Mr. Doroz received a BS in Accounting and Finance from the University of Arizona.

Monica Gorbet

Senior Director, Quality Affairs

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

 

Monica Gorbet

Position: Senior Director, Quality Affairs

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.

Brandon F. Kidd

VP, Business Development

Brandon Kidd has more than 20 years of investment and...

 

Brandon F. Kidd

Position: VP, Business Development

Brandon Kidd has more than 20 years of investment and operational experience with deep experience in the cannabidiol industry. As the VP for Business Development, Mr. Kidd is responsible for new client relationships, joint ventures and strategic partnerships, as well as domestic and international sales. He previously served as a Managing Director at Mile High Labs, the global leader in industrial scale cannabidiol ingredient manufacturing. Prior to Mile High Labs, Mr. Kidd served as Managing Partner at Green Capital, a private investment firm focused on the cannabis industry. Earlier in his career, Mr. Kidd served as a strategic advisor to leading private equity and real estate firms including Kimco Realty Corporation.

Mr. Kidd received a BA in International Relations from the University of Colorado Boulder. He is fluent in Portuguese and Spanish.

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.

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.

Thrimoorthy Potta

VP, Formulation Research & Development

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

 

Thrimoorthy Potta

Position: VP, Formulation 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.

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,...

James Doroz

Position: VP, Finance and Controller

James Doroz has over 25 years of experience leading financial teams in various industries, including manufacturing, pharmaceuticals, natural resources and software.  As VP of Finance and Controller, Mr. Doroz is responsible for Benuvia Manufacturing’s financial controls and for financial planning and analysis.  Prior to joining Benuvia, Mr. Doroz was the Director of Finance at Adaptive Curriculum, a web based company devoted to helping students succeed in math and science mastery.  Prior to his work at Adaptive Curriculum, he served at iGo. He has served in various financial roles with Sanmina and BHP Billiton.

Mr. Doroz received a BS in Accounting and Finance from the University of Arizona.

James Doroz

VP, Finance and Controller

James Doroz has over 25 years of experience leading financial teams in various industries, including manufacturing, pharmaceuticals, natural resources and software.  As VP of Finance and Controller, Mr. Doroz is...

Monica Gorbet

Position: Senior Director, Quality Affairs

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

Senior Director, Quality Affairs

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...

Brandon F. Kidd

Position: VP, Business Development

Brandon Kidd has more than 20 years of investment and operational experience with deep experience in the cannabidiol industry. As the VP for Business Development, Mr. Kidd is responsible for new client relationships, joint ventures and strategic partnerships, as well as domestic and international sales. He previously served as a Managing Director at Mile High Labs, the global leader in industrial scale cannabidiol ingredient manufacturing. Prior to Mile High Labs, Mr. Kidd served as Managing Partner at Green Capital, a private investment firm focused on the cannabis industry. Earlier in his career, Mr. Kidd served as a strategic advisor to leading private equity and real estate firms including Kimco Realty Corporation.

Mr. Kidd received a BA in International Relations from the University of Colorado Boulder. He is fluent in Portuguese and Spanish.

Brandon F. Kidd

VP, Business Development

Brandon Kidd has more than 20 years of investment and operational experience with deep experience in the cannabidiol industry. As the VP for Business Development, Mr. Kidd is responsible for...

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,...

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....

Thrimoorthy Potta

Position: VP, Formulation 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, Formulation 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...

Contact Us

Benuvia Manufacturing

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