1. CHEMPACIFIC CORPORATION
Contract Manufacturing of APIs,
Intermediates and Specialty Chemicals

2. PRESENTATION OUTLINE
 Company Overview
 Unique Business Model
 Chemistry and Technology
 Facilities and Equipment
 Zhejiang Chempacific
 Competitive Advantage
 Contact Information

3. COMPANY OVERVIEW
 Began as a New Jersey Corporation in 1995
 Moved to Baltimore, Maryland in 1999
 >20 employees in the U.S. operation
 100% U.S. owned subsidiary in China
• Zhejiang ChemPacific located near Shanghai
• Staffed with over 100 employees

4. COMPANY OVERVIEW
ZheJiang ChemPacific Growth History
2005 2008 2011
Started GMP Successful FDA Successful FDA
Training Program Inspection Inspection
1998
ChemPacific China
Established in
Hangzhou
2000-2004 2005-2006
Manufacture of China Operations
>100 Custom Consolidation
Products In Zhapu

5. COMPANY OVERVIEW
Executive Team
 Chen Zhou, Ph.D. CEO
Ph.D. New Mexico State Univ.
Post Dr. University of Maine
 Tony Liang, MS, MBA - COO/China & US
Operations, Sales Marketing
Worked at Novartis Pharmaceuticals
MBA New York
 Rebecca Chiu, MS - VP, Global QA/QC
Worked at Pfizer 2.5 years
Worked at Novartis Pharma 32.5 years

6. COMPANY OVERVIEW
Other Key Personnel
 Wuyi Wang, Ph.D. - Senior Director of cGMP
program, global
 Xianghui Tan, Ph.D. - US Director of cGMP
Production
 Jian Huang, Ph.D. - CTO of China Operations
 James Havlin, MBA - VP of Sales and Marketing
 Peter Wu, PhD. - Head of QC, US
 Jinliang Zhang - General Manager, China
 Liping Gao, Ph.D - Head of QA/QC, China

7. COMPANY OVERVIEW
 Core Business:
 Research and Production of Fine Chemicals, Industrial
Chemicals, Intermediates and APIs
 Resources:
 Research-driven U.S. Laboratories
• Discover and develop products
• Perform small scale cGMP/ Non-GMP manufacturing up to
50kg
 Cost-effective plants in China:
 Large scale non-GMP/cGMP manufacturing up to 100
metric ton

8. COMPANY OVERVIEW
 R&D Contract and Custom Synthesis:
 Unique Projects for Hard to Find Molecules
 High Levels of Communications with Researcher
 Tech Transfer to China for large scale production
 Custom Manufacturing/Intermediates:
 Starting with Customer Process or Just a Structure
 Process Development and Optimization performed in the
US
 Scale-Up to Commercial Quantities performed in China

9. UNIQUE BUSINESS MODEL
US Facility
 Non-GMP and cGMP Manufacturing
 Process Development
 Lab Scale (up to 1kg)
 Kilo Lab (up to 5 kg)
China Facility
 Non-GMP and cGMP Manufacturing
 Scale-Up Manufacturing
 Pilot Plant (5 kg to 1000kg)
 Commercial (1 MT to 100MT)

10. CHEMISTRY AND TECHNOLOGY
 HF and KF Fluorination
 Per-fluorinated Aromatics
 Suzuki Coupling Organics
 Organometallic/Oxygen Sensitive
 Chiral Synthesis
 Unnatural Amino Acids
 Indolines and Indoles
 Heterocyclic Synthesis

11. CHEMISTRY AND TECHNOLOGY
 Synthetic organic chemistry expertise
• Non-patent-infringed process route development
• Experience in handling a variety of chemistries with
chiral and non-chiral compounds
• Chemistry R&D and process validation
• Modern Analytical facilities

12. Chemistry and Technology
Example: Chemical Capability- Per-fluorinated Aromatics
A. Per-fluorinated Benzene
B. Per-fluorinated Naphthalene
Commercial Scale

13. CHEMISTRY AND TECHNOLOGY
Example: Chemical Capability- 2-bromo-indene
Functionization of 2-Br-Indene
A. 2-Br-Indene Chemistry
p-TSA
Br Br
-H2O
OH
Commercial Scale
B. Cyclopentadiene Chemistry Functionization
Tetramethyl Cp
Pentamethyl Cp

14. CHEMISTRY AND TECHNOLOGY
Example: Chemical Capability- Suzuki Coupling Organics
1. RLi handling capability (Organometallic Chemistry Expertise)
2. Low temperature reaction and handling capabilities

15. FACILITIES AND EQUIPMENT
Manufacturing Plant in China
ChemPacific Zhejiang:
 11 Acre site (expandable to
18 acres)
 Capable of Handling Complex
Projects
 Compartmentalized
structure gives us the
capability to expand with
customers’ market demands

16. ZHEJIANG CHEMPACIFIC

17. ZHEJIANG CHEMPACIFIC
Zhejiang ChemPacific
Corp. COO Global QA/QC
Organization Chart Tony Liang Rebecca Chiu
General Manager
Jinliang Zhang
Vice GM QA/QC
Jian Huang Liping Gao
Production R&D ESH & Engineering Sales QA QC
Materials Finance Administration
Project Project Xiaokang Hu Marketing Jianguo Gao Xingju Wei
Managers
Jiuwang.liu Xiaoyan Xi Yan Ding
Managers Huiling Zhu

18. ZHEJIANG CHEMPACIFIC

19. ZHEJIANG CHEMPACIFIC
Chemistry Capabilities:
Synthesis Leads to Manufacturing
Custom Synthesis
 Specialty Chemical Synthesis and Scale-up
 Chemistry from 100 mg to Kilo+
Manufacturing
 Scale-up Chemistry for Metric Ton Scale in
China Resulting in Commercial Manufacturing

20. ZHEJIANG CHEMPACIFIC
Chemistry Capabilities: Process Research and
Manufacturing
Process Research and Development
 Novel Synthetic Route Selection
 Process Optimization and Scale up
Manufacturing of Specialty Chemicals and APIs
 cGMP Synthesis
 Kilo-Scale for Clinical Trials

21. ZHEJIANG CHEMPACIFIC
RESEARCH to PROCESS DEVELOPMENT TO PRODUCTION
Zhapu (China)
Process Development and Scale up Cost Effective API Manufacturing
Facility & Engineering Design API Stability Program

22. ZHEJIANG CHEMPACIFIC
Competitive Advantage
Low Cost Supported by World-Class Quality
 Raw Material Sourcing Partners
 Locally Produced Equipment and Infrastructure
 Plentiful Supply of Low Cost Labor
 Experienced R&D Chemists and Process Engineers
 Dedicated QC and QA teams
 Complies to cGMP/FDA Q7 Guildance

23. ZHEJIANG CHEMPACIFIC
Quality Platform and Systems
Quality Systems Risk-based approach
Judgment based on good science
Total Quality Assurance on entire business cycle
ChemPacific Quality Program
Product
Platform
Chemistry and Technology
Facilities and Equipment,
FDA Inspected Facility
Corporation structure support

24. ZHEJIANG CHEMPACIFIC
Employees: There are 145 employees in Zhapu, 45% have BS degree and
above.
Hours of operation: 3 shifts in production.
Scheduled facility closures: weeks of Chinese New year, May 1 and Oct. 1.
Office
Support
/Sales
20%
10%
R&D
16%
QA/QC Production
9% 44%

25. ZHEJIANG CHEMPACIFIC
Facilities and Equipment Zhapu,
China Manufacturing Plant
ZHEJIANG ChemPacific, Zhapu
(Jan. 2006 in operation)
 Located in a Modern Industrial Park
 Reaction vessels Up to 5000L
 -78°C Reactor (300 L, 1000L and 2000L)
 Up to 1000 PSI H2 reactor (300L and 1000L)
 High Vacuum/Thin Film Distillation
 Particle Forming Spray Dryer Capability
 Large-Scale Column Chromatography
 Up to MT scale

26. ZHEJIANG CHEMPACIFIC
Generic API-Case#1–Pentostatin
Name: Nipent /Pentostatin
OH •Market: Anti-tumor Pharmaceutical
•Prior API Process: Fermentation
N
ChemPacific Process: Total Synthesis of 12 steps
HN Zhapu: step 1 to step 6 (non-GMP)
N Baltimore: step 7 to step 12 (GMP)
N
HO US Research-China Production:
O China: Supply of Advanced Intermediate;
Baltimore: API Manufacture/DMF Submission
Summary:
OH •ChemPacific Developed the First Chemical Process for API
•ChemPacific Owns the Pentostatin Process Patent
•US-China Synergy Made the Cost Manageable for this
DMF No. 18235 Complex Project

27. ZHEJIANG CHEMPACIFIC
China Production-Case#2
CO 2H
Name: 3,4,5-TricarboxylicAcid-
HO2 C CO2 H
1-Aminobenzene
Market: Specialty Electronic
Material
NH 2
15,000 kg/Y US Research-China Production:
Baltimore: Process Development
China: 3-step Custom Manufacture

28. ZHEJIANG CHEMPACIFIC
China Production-Case#3
H O
Name: p-(4-Formylcyclohexyl) Benzonitrile
O Market: Specialty Electronic Material
US Research-China Production:
R
Baltimore: Process Development
China: 5-step Reaction Sequence for Single
CN
Customer
200 kg

29. ZHEJIANG CHEMPACIFIC
China Production-Case#4
Name: 2,3-Difluorophenylacetic Acid
Market: Specialty Electronic Material
US Research-China Production:
Baltimore: Process Development
China: 3-step Reaction Sequence for a
Single Customer
F F
F F F OH
O
1000 kg

30. ZHEJIANG CHEMPACIFIC
Generic API –Case#5– Melphalan HCl
DMF No. 20544
Market: Anti-Cancer, Anti-Neoplastic,
Pharmaceutical API
ChemPacific Process:
 Total Synthesis of 8 steps
 4 steps to starting material – made in Zhapu (non-GMP)
 from SM to the step 7 – made in Zhapu (GMP)
 last step – was in US (GMP) – has been transferred to
China

31. COMPETITIVE ADVANTAGE
Domestic Presence
 Convenience for U.S.
customers
 Same time zone
 No language barrier
 Secure business practices
 Troubleshooting handled
locally
Small company
 Personal attention
 Flexibility
 Quick delivery time
 Low overhead- pass lower
costs to our clients

32. COMPETITIVE ADVANTAGE
Experience
 Expertise in a wide range of chemistries
 Experienced in manufacturing of hard to find molecules
 Experienced technical team who recognize the
challenges of transitioning from bench to pre-scale
operations.
 Reliable and Financially Stable
 A track record of completed projects and satisfied
customers

33. ZHEJIANG CHEMPACIFIC

34. ZHEJIANG CHEMPACIFIC

35. ZHEJIANG CHEMPACIFIC

36. ZHEJIANG CHEMPACIFIC

37. ZHEJIANG CHEMPACIFIC

38. ZHEJIANG CHEMPACIFIC

39. ZHEJIANG CHEMPACIFIC

40. CHEMPACIFIC CORPORATION
Some call it the best of both worlds;
we call it, The Best of One World.
For more information please contact Chris McRandal, cmcrandal@chempacific.com, (412) 973-9716