1. Where Western Pharmaceutical Performance meets
Eastern Manufacturing Potential

2. Amerigen’s Corporate Structure
Amerigen Pharmaceutical Co.,
Ltd
(Parent Holding Company)
Suzhou Amerigen
Amerigen Pharmaceuticals Inc. Suzhou Pharma Services
Pharmaceutical Co. Ltd.
(US Based) (US/China)
(China Based)
Marketing and Distribution Contract Development and
Development and
Generic Pharma Products Manufacturing Organization
Manufacturing

3. Suzhou Pharma Services
Suzhou Pharma Services combines Western Pharmaceutical Experience,
Expertise and Quality with China’s Productivity, Highly Skilled Workforce
and Cost Savings
 We are part of an elite group of Solid Dose Facilities in China to be
approved by the FDA and to be granted Chinese SFDA 2010 GMP
Certification
 We offer high quality oral solid dose product development &
manufacturing services for US and Global Markets and offer a Local China
development & manufacturing solution for access to the exploding Chinese
market

4. Suzhou, China
 120 km west of Shanghai Pudong Intl Airport
 Population ~ 10 Million
 Founded in 514BC, Suzhou has over 2500 years
of history, is known as the “Venice of the East” and
has a UNESCO World Heritage Site for the Gardens
of Suzhou
 Suzhou Industrial Park, built in the late 1990s in
conjunction with the Chinese and Singapore
Governments, is a modern, engineered, metropolis
and economic zone
 Suzhou area is home to numerous Global
Pharmaceutical Companies

5. Suzhou Plant Milestones
 2007
 Amerigen Pharmaceuticals founded
 Suzhou finished solid dose facility acquired from Tang Pharmaceuticals
 2008
 First US regulatory filing (PAS – alternate manufacturing site)
 2009
 First FDA PAI & General Inspection
 Passed SFDA Inspection – GMP Certificate Issued
 2010
 Received FDA approval for bulk tablet manufacturing
 First ANDA filing
 2011
 4 more ANDA Filings
 2011 – 2012
Major Plant Upgrades
 2012
 Contract Development and Manufacturing Division launched
 Passed SFDA Re-Inspection – New 2010 GMP Certificate Issued
 5th ANDA filing

6. The Amerigen Team
~140 People at the end of 2012
Corporate US Headquarters – Lyndhurst, NJ
 ~20 People including Senior Management Team
 R&D and Product Development Staff
 Quality and Regulatory Affairs Department Heads
 Business Development, Sales, Project Management
Chinese Operations – Suzhou, China (75 miles west of Shanghai)
 ~120 Employees with on-site Ex-Pat Western Trained Department Heads
 64 Manufacturing and Plant Operations Staff
 32 R&D Employees Jiling
Inner Mongolia
 24 Quality Employees (20% of Employees) (25.7%)
Shanxi
Ningxia (14.8%)
(21.9%)
Shaanxi Henan
(20.0%)(16.5%)Anhui
Hubei
Chongqing (18.4%)
(17.1%) HunanJiangxi
Guizhou(18.6%)
Yunnan (18.2%)
(15.5%) Guangxi
(18.1%)

7. Amerigen’s Senior Management Team
Amerigen
Pharmaceutical Ltd.
John Lowry
CEO
Michelle Valsera
Director, Office
Operations
Jonathan Embleton Joanne Marriott Julie Kessler Suzhou Pharma Suzhou Amerigen
Dennis Potter
PhD Senior Vice President, Vice President, Services Wenbin Dang PhD Jack Wu
CFO Senior Vice President,
Chief Business Officer Quality Sales Operations Oliver Mueller COO
Product Development
President China Operations
“Western Leadership, Experience and Expertise”
7

8. Meet Suzhou Pharma Services’ Senior Managers
John Lowry  30 years of experience in leading pharmaceutical and medical device
President and CEO companies in product development and global business
 Most recently CEO of Catalent Pharma Solutions
Dennis Potter  30 years of experience in the pharmaceutical industry, finance,
CFO acquisitions and pharmaceutical strategic alliances
 Most recently CFO of GeneraMedix Pharmaceuticals
Jack Wu  20 years of experience in manufacturing management operations focused on
COO operational excellence and building performance teams
 Most recently Manufacturing Director at Firmenich where he managed four
plants in Asia
 30 years of pharmaceutical industry experience in business development and
Oliver Mueller
corporate leadership
President, Suzhou
Pharma Services  Most recently Executive VP of Glatt Pharmaceutical Services
 20 years of experience in pharmaceutical R&D focused on drug delivery technologies
Wenbin Dang, Ph.D. and generic product development
Senior VP, Product
Development  Most recently VP, Product Development at Catalent Pharma Solutions
Joanne Marriott  35 Years of experience in pharmaceutical Quality Assuance, Quality Control,
Senior VP, Quality Compliance and Regulatory Affairs including international regulations
 Most recently VP, Regulatory Affairs at Catalent Pharma Solutions
8

9. The Suzhou Plant Management Team
Senior Vice President,
COO
Product Development Senior Vice President of Quality CFO
China Operations Executive Assistant
Generic Pharmaceuticals Joanne Marriott Dennis Potter
Jack Wu Julie Gu
Wenbin Dang PhD
Director of Technical Senior Director of General Manager
Projects Quality HR Manager Finance Controller
Plant Operations
Andy Tao PhD Karl Wagner Cecilia Wang Alex Hou
Bret Andrews
Director of Analytical
Services QC Director Director of Materials
Weixuan He PhD Jeff Parker Mgt
Flora Ji
Sr. Director of Product
Dev. Engineering Manager
QA Director Jiling
Wayne Wang PhD Peter Zhang
Shining Gu
Inner Mongolia
(25.7%)
Shanxi
Manufacturing Director Ningxia (14.8%)
Formulation Teams QA Compliance (21.9%)
Hua Hui Shaanxi Henan
Manager (20.0%)(16.5%) Anhui
Hubei
Raymond Chen Chongqing(18.4%)
(17.1%)
Calibration/ Validation Hunan Jiangxi
Guizhou (18.6%)
Manager (18.2%)
Yunnan Guangxi
(15.5%) (18.1%)
Benji Bai
“On-site Western Trained Leaders” EHS Supervisor
Chuck Cai
9

10. Meet the Suzhou Plant Management Team
 30 years of experience in pharmaceutical manufacturing
Bret Andrews operations in the US and internationally
Plant GM
 Specialized in automation, manufacturing, engineering,
project management, operations, critical facilities
operations
 20 years of experience in local and global pharmaceutical
Hua Hui and medical device companies
Director,
Manufacturing  Specialized in manufacturing operations, technical
services and operational excellence for tablets, capsules,
suspensions, and sterile powders
Flora Ji  13 years of experience in global pharmaceutical companies
Director, Materials
 Specialized in warehousing, materials management, production planning
Management
and logistics/supply chain management
Andy Tao  20 years of experience in project management, process R&D, scale up and
Director, Technical Projects manufacturing in the pharmaceutical industry
 Specialized in chemical process development
Weixuan He  10 years of experience in research development support for US
Director, ARD pharmaceutical companies
 Specialized in analytical method development and validation
Wayne Wang  15 years of US based experience in product formulation, process
Director, Product
development/scale up, regulatory filing, tech transfer & process validation
Development
10

11. The Suzhou Plant Quality Team
Senior Vice President
Senior Vice President
Joanne B. Marriott
Joanne B. Marriott
Senior Director of Quality
“Quality is our Priority”
Karl Wagner
QA Director QA Compliance Manager QC Director
Shining Gu Raymond Chen Jeffrey Parker
Technical Translator
Stephen Shen
QA Coordinator
QA Supervisor Cindy Yang Microbiology Lab
QC Manager
Supervisor
Ivan Yu QA Inspector Erica Zhang
Samuel Zhou
Document Yeping Gao
Senior Chemical
Coordinators Analysts
Jingya Dai and Jill Shen Microbiologists
Eileen Xiong / Leo Hu /
Karen Wang / Joanna Lisa Li, Kevin Yan
QA Coordinator Yang / Eason He /Pam
Cindy Yang Pam
RA Jassica QC Technicians Microbial Technician
Data Reviewers Camile Li and Jerry Anna Huang
Shen
Vivian Liu
Joy Cui
Chemical Analyst
Regulatory Specialist (open)
Jessica Bai

12. Meet the Suzhou Plant Quality Management Team
 35 Years of experience in pharmaceutical Quality Assuance, Quality
Joanne Marriott Control, Compliance and Regulatory Affairs including international
Senior VP, Quality regulations
 Most recently VP, Regulatory Affairs at Catalent Pharma Solutions
Jeff Parker  30 years of US based experience in development, registration and quality
Director, Quality Control control of regulated pharmaceuticals and chemicals
Karl Wagner
Director, Quality  15 years of US based quality management experience and regulation for
multi-national, generic and OTC products
Shining Gu  20 years of experience in local and global pharmaceutical companies
Director, Quality Assurance
 Specialized in Quality Assurance and cGMP compliance
12

13. Quality Systems & Operations
 Amerigen certifies that it conducts its Quality Systems
and Operations in compliance with applicable US, China
& International standards
 ICH Q10 Pharmaceutical Quality System
 US Code of Federal Regulations Title 21 Parts 210 and 211, Good
Manufacturing Practices
 US Code of Federal Regulations Title 21 Parts 310 (Post marketing
reports events) and Part 314 (Abbreviated New Drugs)
 SFDA Good Manufacturing Practice for Pharmaceutical Products
(Amended in 2010) SDA Order #79
 Administration Admission Law of People’s Republic of China, article #32
13

14. Suzhou FDA Inspection History
 September 2009 – FDA PAI Inspection
 ANDA supplement (PAS – alternate manufacturing site) and General
GMPs
 1 minor 483 observation
 Site approved as an alternate manufacturing site
 Next Anticipated inspection – H1 2013
14

15. Suzhou SFDA Inspection History
 August 2009 – SFDA GMP Inspection
 SFDA GMP Certificate issued September 2009
 June 2012 – SFDA GMP Inspection for compliance to
2010 GMP’s
 SFDA GMP Certificate issued September 2012
 First pharmaceutical company in Suzhou to attain GMP Certificate for
compliance to new SFDA GMP regulations of 2010
15

16. Suzhou Formulation and AR&D Team
Senior Vice President,
Product Development
Generic Pharmaceuticals “Committed to Customer Service”
Wenbin Dang PhD
Director of Technical Director of Analytical
Sr. Director of Product
Projects Services
Development
Wayne Wang PhD Andy Tao PhD Weixuan He PhD
Sr Formulation Scientist Project manager
Elliot Zheng
Erica Zhang Analytical Leader Instrumentation Specialist
Sr Project Leader
William Yu Allan Wu Fransic Wu
Formulation Scientist
Helena Zhang
Open Position Analytical Support Team #2
Analytical Support Team #1 Instrument Support Team
Daniel Shi Bruce Fei Nicole Guan
Sharon Li Elvis Fang Anne Liang
Lydia Ding Rainbow Liu
Formulation Team
Shirley Gu Lily Liu
Sr Formulation Scientist Tony Xu
Sid Wang Andy Chen
Tom Tang Jianbo Qin
Amy Qi Jodie Yue
Ralf Huang
(2) Open Positions David Qui
Alex Zhu
Apple Zhang
Jungxian Xu
Billy Gao
16

17. Project Management & Customer Service
“Local Project Management and Local Customer Service”
 Suzhou Pharma Services is a customer focused organization
 Project Management and Product Development Team Leaders are
located at both our US corporate office and Suzhou plant and serve to:
 Facilitate customer interactions
 Facilitate communication
 Experienced team from multi-national brand and generic companies

18. Suzhou Facility Information
3 Acre Campus with 55,000 ft2 facility
 Future Expansion: ~ 60,000 ft2
 Production Capacity ~ 1 Billion Units
 5 ANDA’s filed with Suzhou as Mfg site
 1 PAS approved as alternate MFG site
 Additional products in R&D
Our Team
 US experienced on site management team – averaging over 25 years
experience with multi-national brand and generic companies
 Local talent pool – 60% with bachelor degree and working understanding of
English, with experience from global pharmaceutical companies in Suzhou Area
Quality System
 US FDA inspected / approved in 2010 with Chinese SFDA 2010 GMP certificate

19. Oral Solid Dose Focus
Formulation Development to Pilot Scale to Commercial Manufacturing
 Tablets and Capsules
 Immediate Release
 Modified, Extended, Controlled
Release
 Bi-Layer Tablets
 Coated Pellets and Beads
 Aqueous and Solvent Processing
 Finished Bottle, Blister Packaging
and Labeling Solutions

20. Formulation and Development Services
Formulation Development
 Excipient compatibility studies
 Characterization of physical
properties
 Design of Experiments (DOE)
 Prototype formulations
 Preliminary process selection
 Process development
Clinical Trial Material (CTM)
 Phase I, II, III & registration
batches
 Pilot bio-study & ANDA
submission batches
Scale Up, Stability and Registration Support
 Process Scale-up and optimization, manufacturing, packaging and release testing of
registration batches
 Stability study design and monitoring using ICH guidelines
 Documents provided in submission ready format – IND, CMC Section, Customized Reports

21. Analytical Capabilities
Analytical Services
 Molecule characterization
 Method development and validation
 Cleaning residue development and
validation
 Dissolution and drug release profiling
 Forced degradation studies
 Stability monitoring to ICH guidelines
Western Analytical Instrumentation
 Twelve Agilent 1100/1200 HPLCs and two Shimadzu
 Ten Distek USP Apparatus 1 and 2 Dissolution Systems
 TwoThermo FTIR Spectrophotometers
 Two Agilent GCs
 State-of-the-art Stability Chamber Area
 Highly skilled chemists

22. Sourcing and Logistics
 Chinese API and Excipient sourcing and selection
 Logistics from China
 Import and Export
 External API site audits

23. Processing and Manufacturing Capabilities
Commercial Manufacturing
 Wet and Dry Milling
 V-Blending, 3D and Bin
Blending
 High Shear Granulation
 Fluid Bed Drying & Granulation
 Wurster HS Coating – Aqueous
and Solvent
 Encapsulation
 Tabletting and Direct Compression – Single and Bi-Layer Tablets
 Film Coating – Aqueous and Solvent

24. Development and Manufacturing Equipment
Processing Equipment
 Blenders – 10 ,30 and 400L  Manual Tablet– Single Station
 3D Blender – 50, 100, 200L  Rotary Tablet Press – 10 station
 V Blender – 200L  Rotary Tablet Press – 29 station
 Comil and Fitz Mill – 15 – 100L  PTK PR-3000 Bi-layer Tablet Press, Type D – 43
 High Shear Granulator – 2, 10, 110 and 300 L station, double sided
 Glatt “Midi” Fluid Bed System – 1 kg  Pan Coaters – 1.5L, 40, 75kg
 Fluid Bed Dryers 40-80 kg and 80-160 kg  Bosch GKF 700 Capsule Filler
 Glatt GPCG-15 Fluid Bed Dryer – Top, Bottom
(Wurster HS), side Spray, Aqueous/Organic
Solvent– 15 kg
24

25. Packaging Solutions
Final Product Packaging Provided through Strategic Partners
 Bottling
 Blister Packaging (Coldform & Thermoform)
 Pouches, sachets, etc.
25

26. Future Investments and Upgrades
Processing Equipment
 1200 L Bin Blender – ~400-500 kg
 60-Inch Tablet Pan Coater – Thomas Accela-Coata 60D - ~400-500 kg
 Additional Solvent & Aqueous Capabilities – ~200-400 kg
 XP Glatt GPCG-200 Fluid Bed with 32” Wurster HS & granulating/drying insert
 XP High Shear Granulator
 XP Tablet Pan Coater
 Production Fette Tablet Press
 Production Bosch Capsule Filler
 R&D/CTM Tablet Press – Fette 1200i –
20 Station (Type D)
Packaging
 Pilot & Production Scale Bottling Lines
 Production Scale Blister Line
Laboratory
 Stability LIMS System
 Atomic Adsorption Analyzer

27. The Suzhou Pharma Services Advantage
 Western Leadership and Management
 USA headquarters with on-site Western experienced leaders in Suzhou
 Western Quality Systems (part of an elite group of FDA approved facilities
in China)
 FDA inspected and approved
 Western cGMP practices
 Western Equipment
 Industry standard equipment
 Focused on Oral Solid Dosage
“Western Performance”

28. The Suzhou Pharma Services Advantage
 Chinese SFDA 2010 GMP Certificate
 Highly Skilled / Western Experienced
and Well Trained Workforce
 US and China based Project
Management and Customer Service
 Cost Advantages:
 Lower Labor Costs
 High Productivity
 Lower Cost Raw Material
 Local Sourcing
“Eastern Potential”

29. Looking for a high quality/low cost outsourcing
solution for US and Global Markets?
Or
A manufacturing solution to enter the growing
Chinese Pharmaceutical Market?
Suzhou Pharma Services is your partner.