1. www.corerxpharma.com

2. CoreRx, Inc Overview
Our Core Business
CoreRx, Inc. is a Dosage Form Development company
specializing in formulation development, analytical
development and clinical manufacturing of various dosage
forms
• Drug Characterization
• Preformulation
• Formulation Development
• Analytical Development
• Clinical Trial Materials Manufacturing

3. Our Core Focus
• Complete client satisfaction
• Highest quality science
• Consistent and effective communications
• Strong timeline management
• Full attention to client goals at all levels

4. Why CoreRx?
• People and Expertise
It all boils down to people and trust..
• Communication
Effective, Scientist-to-Scientist communication is the cornerstone to
every CoreRx™ project’s success.
• Flexibility
CoreRx™ scientists, management, and systems ensure flexibility and
agility, allowing for direction changes without inflexible systems
and bureaucratic hassles.

5. Why CoreRx?
• Speed
CoreRx™ understands that developing innovative solutions for
improved patient care, combined with the bottom line, revenues
and profitability, are tied to getting your product on the market as
quickly as possible.
• Education
Affiliation with Univ. of South Florida as Center for Advanced
Pharmaceutical Learning. Students will learn hands-on techniques
in industrial pharmaceutics from member of CoreRx team who are
Associate Faculty at USF.
• Quality systems
Documentation, quality, and operational systems are a necessity in
a GLP/cGMP environment. Quality & timeliness must go hand in
hand.

6. Why CoreRx…?
• Oh yes… and
Location

7. Executive/Scientific Team
• Todd R. Daviau, Ph.D. - Chief Executive Officer
– 25+ years of pharmaceutical experience
– Director of the Analytical Group for MDS Pharma Services
– Guilford Pharmaceuticals (GliadelTM)
– Nova (later Scios) Pharmaceuticals
• Brian McMillan, Vice President, Formulation Development
– 20+ years of experience in pharmaceutical formulation development
– MDS Pharma Services
– Bausch and Lomb Pharmaceuticals
– Roxane Laboratories

8. Executive/Scientific Team
• Mark J. Licarde, Vice President, Technical Operations
– 28+ years in pharmaceutical manufacturing
– MDS Pharma Services
– Mylan Pharmaceuticals
– Bristol Myers Squibb
• Jim Davis, M.S., Vice President, Business Operations
– 16+ years of pharmaceutical experience
– MDS Pharma Services
– Bausch and Lomb
– Proceutics / Oread

9. History
• Founded in 2006
• Started with 5 employees
• Now at 41 employees
• Grown from 3300 sq. ft. to over 35,000 sq ft.

10. CoreRx’s Convenient Location
Clearwater, Florida
~15 minutes to Tampa Airport
(TPA)
Insert new map
cGMP Compliant
FDA/FL DOH Registered
DEA Licensed
Schedule II - V

11. CoreRx Facility Overview
• Approximately 35,000 square feet
• 19 Manufacturing suites
13 cGMP – including 1 for special projects (low RH, low light, etc.)
6 Non-GMP – formulation development
• Manufacturing capacity – up to ~500kg
• Expanded laboratory space:
•Formulation Development
•cGMP Manufacturing
•Stability storage testing
•Analytical
•R&D
•cGMP

12. Formulation Suites
cGMP Manufacturing New Location
Area
Warehouse
Analytical Labs
Admin areas

13. Core Competencies
by Business Unit
• Preformulation Services
– Drug substance characterization
• Analytical Services
– Method Development and Validation
• Formulation Development
– Liquids, Semi-solids and Solids
• Manufacturing, Packaging & Labeling
– API in Capsule or in Bottle
– Liquids, Semi-solids and Solids
– Matching Placebo manufacture
– Blinding of reference product (over-encapsulation)
• Stability Program Management
– ICH or customized stability parameters

14. Additional Capabilities
• CoreRx is committed to adding innovation where we see a client need
– API in capsule/bottle services
• Xcelodose ®
• Quantos®
– Multi-layer tablet (up to 3 layers)
• FlexiTab ®
– Liquid in capsule services
– Multi-particulate capsules
• CoreRx licensed with DEA
– Controlled substances (II – V)
• Overencapsulation services – comparator or “blinding” studies

15. Project Management/Logistics
• Project Manager is assigned to manage:
– Project planning and Execution
– Team leadership with integration of technical
– Manage all CoreRx-Client communications
• Project Teams are made up of subject matter experts which represent their
respective disciplines:
– Project Management/Logistics
– Analytical Chemistry
– Formulation Development
– Manufacturing
– Quality Assurance

16. SERVICES

17. Preformulation

18. Preformulation Characterization
Solid and/or Solution Characterization can be Conducted Utilizing the Following
Instrumentation/Procedures:
• Thermal evaluation
• DSC, TGA, Hot-stage microscope
• FTIR
• X-ray Diffraction
• Particle size/morphology
• Polarized microscopy
• Moisture content
• KF, moisture analyzer
• Moisture sorption profile
• pH solubility
• Partition coefficient
• Photostability
• Intrinsic dissolution

19. Analytical Services
Experienced Professionals in Analytical Chemistry
• Method Development, Qualification and Validation
• HPLC, uPLC, Dissolution, etc.
• Raw Material Testing (select)
• Stability Sample Analysis
• Dissolution Testing
• Chiral Analysis
• Cleaning Analysis/Verification
• CMC Technical Packages

20. Analytical Services
• Analytical Support for Formulation Development
• Stability and QC Release Testing
• API/Reference Standard Characterization
• Isolation and Identification of Impurities
• Physical Chemistry

21. Formulation Services
• Solids
• Tablets, Capsules, Modified Release, Coatings
• Semi-Solids
• Creams, Gels, Ointments, lotions, etc.
• Dispersed Systems
• Emulsions & Suspensions
• Liquids
• Oral, Ophthalmic, Parenteral

22. Formulation Services
Solid Oral Capabilities
• API in Bottle/Capsule
• Excipient Compatibility
• Oral Drug Delivery
• Tablets, Capsules, Powders, Pellets, Mini-Tablets
• Solutions, Suspensions, Emulsions, Powders for Reconstitution
• Solid Dispersions
• Lipid Formulation Delivery for Poorly Soluble/Bioavailable APIs
• Multi-Phasic, Extended and/or Delayed Release Drug Delivery
• Highly Potent Compounds

23. Contract Manufacturing Services
• Manufacturing
– API in Capsule/Bottles
– Tablets, Capsules, Pellets, Mini-Tablets
– Liquid in Capsule
• Solutions, Suspensions, Emulsions
• Over-Encapsulation, Reference Product Blinding
• Packaging & Labeling
• Other Services
– Matching Placebo Manufacturing
– Technology Transfer

24. Stability
• ICH Conditions
– 25oC/60%RH, 30oC/65%RH, 40oC/75%RH
– Custom conditions also available
• Protocol design
• Report generation
• Stability software management system
– SLIM/SLIMStat
• Sample analysis
• Secure storage

25. Why CoreRx…?
• Quality First Focus
– Numerous audits reinforcing compliance
• Responsiveness
– Flexible manufacturing model
– Unique project management team structure with client-centric focus
– Cross training program for employees
• Technology
– Investment in new equipment and expertise as they become available
• Expertise
– Ability to attract top-level talent with high-level benefits package
• Reliability
– Leveraging our company’s size to your advantage

26. Faster to Clinic with Xcelodose ® or Quantos®
• Manufacturing
– Advanced neat drug dosing directly into capsule or bottle
– Decreases lab to clinic development
– Decreases API requirements
– Decrease risk of stability
– Minimizes API waste

27. …and now even Faster to Clinic with
ClinicFirstSM 60Day Guarantee
• The CoreRx ClinicFirst program is designed for clients
requiring rapid supply of clinical trial materials for First-in-
Man (Phase I) clinical studies.
• API in Capsule
• Blend in Capsule
• API in Bottle
• Blend in Bottle

28. Introducing SuiteViewTM…
• Formulation & Manufacturing
– Real-time video feed (Pan, Tilt & Zoom)
– Remote/IP access
• Password controlled
– Two way communication
• Reduce travel time/costs

29. Choose CoreRx
The projects we work on may change....
our values won't...
quality, reliability, value, integrity

30. www.corerxpharma.com