Where Western Pharmaceutical Performance meets

Eastern Manufacturing Potential

Amerigen Pharmaceutical Co., Ltd

(Parent Holding Company)

Amerigen Pharmaceuticals Inc.

(US Based)

Marketing and Distribution Generic Pharma Products

Suzhou Amerigen Pharmaceutical Co. Ltd.

(China Based)

Development and Manufacturing

Suzhou Pharma Services

(US/China)

Contract Development and Manufacturing Organization

Amerigen’s Corporate Structure

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

Suzhou Pharma Services

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

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

The Amerigen Team

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

24 Quality Employees (20% of Employees) Inner Mongolia

(25.7%)

Jiling

Guizhou (18.2%)

Chongqing (17.1%)

Shanxi (14.8%)

Shaanxi (20.0%)

Hunan (18.6%)

Henan (16.5%) Hubei

(18.4%)

Anhui

Jiangxi

Guangxi (18.1%)

Ningxia (21.9%)

Yunnan (15.5%)

~140 People at the end of 2012

Amerigen’s Senior Management Team

Amerigen Pharmaceutical Ltd.

John Lowry

CEO

Michelle Valsera

Director, Office Operations

Dennis Potter

CFO

Jonathan Embleton PhD

Chief Business Officer

Joanne Marriott

Senior Vice President, Quality

Julie Kessler

Vice President, Sales Operations

Suzhou Pharma Services

Oliver Mueller

President

Wenbin Dang PhD

Senior Vice President, Product Development

Suzhou Amerigen

Jack Wu

COO

China Operations

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“Western Leadership, Experience and Expertise”

8

Meet Suzhou Pharma Services’ Senior Managers

30 years of experience in leading pharmaceutical and medical device

companies in product development and global business

Most recently CEO of Catalent Pharma Solutions

30 years of experience in the pharmaceutical industry, finance,

acquisitions and pharmaceutical strategic alliances

Most recently CFO of GeneraMedix Pharmaceuticals

John Lowry President and CEO

Jack Wu COO

Dennis Potter CFO

20 years of experience in manufacturing management operations focused on

operational excellence and building performance teams

Most recently Manufacturing Director at Firmenich where he managed four

plants in Asia

Oliver Mueller President, Suzhou Pharma Services

Wenbin Dang, Ph.D. Senior VP, Product Development

Joanne Marriott Senior VP, Quality

30 years of pharmaceutical industry experience in business development and

corporate leadership

Most recently Executive VP of Glatt Pharmaceutical Services

35 Years of experience in pharmaceutical Quality Assuance, Quality Control,

Compliance and Regulatory Affairs including international regulations

Most recently VP, Regulatory Affairs at Catalent Pharma Solutions

20 years of experience in pharmaceutical R&D focused on drug delivery technologies

and generic product development

Most recently VP, Product Development at Catalent Pharma Solutions

COO

China Operations

Jack Wu

Director of Technical Projects

Andy Tao PhD

Finance Controller

Alex Hou

HR Manager

Cecilia Wang

General Manager

Plant Operations

Bret Andrews

Senior Director of Quality

Karl Wagner

EHS Supervisor

Chuck Cai

Calibration/ Validation

Manager

Benji Bai

Manufacturing Director

Hua Hui

Engineering Manager

Peter Zhang

Director of Materials Mgt

Flora Ji

QA Director

Shining Gu

QC Director

Jeff Parker

Sr. Director of Product Dev.

Wayne Wang PhD

Director of Analytical Services

Weixuan He PhD

QA Compliance Manager

Raymond Chen

Senior Vice President,

Product Development

Generic Pharmaceuticals

Wenbin Dang PhD

CFO

Dennis Potter

Executive Assistant

Julie Gu

Senior Vice President of Quality

Joanne Marriott

The Suzhou Plant Management Team

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Inner Mongolia (25.7%)

Jiling

Guizhou (18.2%)

Chongqing (17.1%)

Shanxi (14.8%)

Shaanxi (20.0%)

Hunan (18.6%)

Henan (16.5%) Hubei

(18.4%)

Anhui

Jiangxi

Guangxi (18.1%)

Ningxia (21.9%)

Yunnan (15.5%)

“On-site Western Trained Leaders”

Formulation Teams

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Meet the Suzhou Plant Management Team

30 years of experience in pharmaceutical manufacturing

operations in the US and internationally

Specialized in automation, manufacturing, engineering,

project management, operations, critical facilities

operations

20 years of experience in local and global pharmaceutical

and medical device companies

Specialized in manufacturing operations, technical

services and operational excellence for tablets, capsules,

suspensions, and sterile powders

Bret Andrews Plant GM

Flora Ji Director, Materials Management

Hua Hui Director, Manufacturing

13 years of experience in global pharmaceutical companies

Specialized in warehousing, materials management, production planning

and logistics/supply chain management

Andy Tao Director, Technical Projects

Weixuan He Director, ARD

Wayne Wang Director, Product Development

10 years of experience in research development support for US

pharmaceutical companies

Specialized in analytical method development and validation

15 years of US based experience in product formulation, process

development/scale up, regulatory filing, tech transfer & process validation

20 years of experience in project management, process R&D, scale up and

manufacturing in the pharmaceutical industry

Specialized in chemical process development

Microbial Technician

Anna Huang

Senior Vice President

Joanne B. Marriott

Senior Director of Quality

Karl Wagner

QA Director

Shining Gu

QA Compliance Manager

Raymond Chen

QC Director

Jeffrey Parker

Technical Translator

Stephen Shen

Senior Chemical Analysts

Eileen Xiong / Leo Hu / Karen Wang / Joanna Yang / Eason He /Pam

Pam

Microbiologists

Lisa Li, Kevin Yan

QA Supervisor

Ivan Yu

Document Coordinators

Jingya Dai and Jill Shen

Data Reviewers

Vivian Liu

Joy Cui

Regulatory Specialist

Jessica Bai

QC Technicians

Camile Li and Jerry Shen

Chemical Analyst

(open)

Microbiology Lab Supervisor

Samuel Zhou

QC Manager

Erica Zhang

“Quality is our Priority”

QA Coordinator

Cindy Yang

QA Inspector

Yeping Gao

QA Coordinator

Cindy Yang

RA Jassica

Senior Vice President

Joanne B. Marriott

Senior Vice President

Joanne B. Marriott

The Suzhou Plant Quality Team

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35 Years of experience in pharmaceutical Quality Assuance, Quality

Control, Compliance and Regulatory Affairs including international

regulations

Most recently VP, Regulatory Affairs at Catalent Pharma Solutions

30 years of US based experience in development, registration and quality

control of regulated pharmaceuticals and chemicals

Joanne Marriott Senior VP, Quality

Karl Wagner Director, Quality

Jeff Parker Director, Quality Control

15 years of US based quality management experience and regulation for

multi-national, generic and OTC products

Shining Gu Director, Quality Assurance

20 years of experience in local and global pharmaceutical companies

Specialized in Quality Assurance and cGMP compliance

Meet the Suzhou Plant Quality Management Team

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

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Quality Systems & Operations

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

Suzhou FDA 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

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Suzhou SFDA Inspection History

Suzhou Formulation and AR&D Team

16

Senior Vice President,

Product Development

Generic Pharmaceuticals

Wenbin Dang PhD

Sr. Director of Product Development

Wayne Wang PhD

Director of Technical Projects

Andy Tao PhD

Sr Formulation Scientist Elliot Zheng

Formulation Scientist

Helena Zhang

Open Position

Formulation Team

Tony Xu

Jianbo Qin

Ralf Huang

Alex Zhu

Jungxian Xu

Instrumentation Specialist

Fransic Wu

Sr Project Leader

Allan Wu

“Committed to Customer Service”

Project manager

Erica Zhang

Sr Formulation Scientist

Tom Tang

Director of Analytical Services

Weixuan He PhD

Analytical Leader

William Yu

Analytical Support Team #1

Daniel Shi

Sharon Li

Lydia Ding

Shirley Gu

Sid Wang

Amy Qi

(2) Open Positions

Analytical Support Team #2

Bruce Fei

Elvis Fang

Rainbow Liu

Lily Liu

Andy Chen

Jodie Yue

David Qui

Apple Zhang

Billy Gao

Instrument Support Team

Nicole Guan

Anne Liang

“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

Project Management & Customer Service

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

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

Suzhou Facility Information

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

Formulation Development to Pilot Scale to Commercial Manufacturing

Oral Solid Dose Focus

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

Formulation and Development Services

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

Sourcing and Logistics

Chinese API and Excipient sourcing and selection

Logistics from China

Import and Export

External API site audits

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

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Processing Equipment

Blenders – 10 ,30 and 400L

3D Blender – 50, 100, 200L

V Blender – 200L

Comil and Fitz Mill – 15 – 100L

High Shear Granulator – 2, 10, 110 and 300 L

Glatt “Midi” Fluid Bed System – 1 kg

Fluid Bed Dryers 40-80 kg and 80-160 kg

Glatt GPCG-15 Fluid Bed Dryer – Top, Bottom

(Wurster HS), side Spray, Aqueous/Organic

Solvent– 15 kg

Manual Tablet– Single Station

Rotary Tablet Press – 10 station

Rotary Tablet Press – 29 station

PTK PR-3000 Bi-layer Tablet Press, Type D – 43

station, double sided

Pan Coaters – 1.5L, 40, 75kg

Bosch GKF 700 Capsule Filler

Development and Manufacturing Equipment

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Packaging Solutions

Final Product Packaging Provided through Strategic Partners

Bottling

Blister Packaging (Coldform & Thermoform)

Pouches, sachets, etc.

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

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

The Suzhou Pharma Services Advantage

“Western Performance”

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

The Suzhou Pharma Services Advantage

“Eastern Potential”

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.