Where Western Pharmaceutical Performance meets Eastern Manufacturing Potential

Suzhou Pharma Services combines Western Pharmaceutical Experience, Expertise and Quality with China’s Productivity, Highly Skilled Workforce

and Cost Savings

• We are one of the First Solid Dose Facilities in China to be approved by the FDA and licensed by the Chinese SFDA

• We deliver quality products and services for US and Global Markets AND offer a Local China manufacturing solution for access to the exploding Chinese market

Our mission at Suzhou Pharma Services is to provide our customers innovative and reliable solutions to their solid oral

dosage development and manufacturing needs, under the highest levels of quality and customer service standards

available in the industry

Why Suzhou Pharma Services?

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 Based)

Contract Development and Manufacturing Organization

Who we are?

The Amerigen / Suzhou Pharma Services Team

New Corporate US Headquarters – Lyndhurst, NJ (June 2012)

• 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 2011 → 32 additional hires planned for 2012

Amerigen Senior Management TeamAmerigen

Pharmaceutical Ltd.John Lowry

CEO

Michelle ValseraDirector, Office Operations

Dennis PotterCFO

Jonathan Embleton PhD

Chief Business Officer

Joanne MarriottSenior Vice President,

Quality

Julie KesslerVice President, Sales Operations

Suzhou Pharma Services

Oliver MuellerPresident

Wenbin Dang PhDSenior Vice President, Product Development

Suzhou AmerigenJack WuCOO

China Operations

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“Western Leadership, Experience and Expertise”

COOChina Operations

Jack Wu

Director of Technical Projects

Andy Tao PhD

Finance ControllerAlex Hou

HR ManagerCecilia Wang

General ManagerPlant OperationsBret Andrews

Senior Director of Quality

Karl Wagner

EHS SupervisorChuck Cai

Calibration/ Validation ManagerBenji Bai

Manufacturing DirectorHua Hui

Engineering ManagerPeter Zhang

Director of Materials Mgt

Flora Ji

QA ManagerShining Gu

QC DirectorJeff Parker

Sr. Director of Product Development

Wayne Wang PhD

Director of Analytical Services

Weixuan He PhD

Director of Analytical Services

Rex Roberts PhD

QA Compliance Manager

Raymond Chen

Senior Vice President, Product Development

Generic PharmaceuticalsWenbin Dang PhD

CFODennis PotterExecutive Assistant

Julie Gu

Senior Vice President of QualityJoanne Marriott

Suzhou Amerigen 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

Quality Leadership

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Microbial TechnicianAnna Huang

Senior Vice PresidentJoanne B. Marriott

Senior Director of QualityKarl Wagner

QA ManagerShining Gu

QA Compliance ManagerRaymond Chen

QC DirectorJeffrey Parker

Technical TranslatorStephen Shen

Senior Chemical Analysts

Eileen Xiong / Leo Hu / Karen Wang /

Joanna Yang / Eason He /Pam Pam

MicrobiologistLisa Li

QA SupervisorIvan Yu

Document CoordinatorsJingya Dai and

Jill Shen

Data ReviewersVivian LiuJoy Cui

Regulatory SpecialistJessica Bai

QC TechnicianCamile Li

Chemical Analystand QC Technician

(open)

Microbiology Lab SupervisorSamuel Zhou

QC ManagerRyan Tu

“Quality is our Priority”

Microbial Technician(open)

QA CoordinatorCindy Yang

QA InspectorYepingGao

QA CoordinatorCindy YangRA Jassica

Product Development Team

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Senior Vice President, Product Development

Generic PharmaceuticalsWenbin Dang PhD

Sr. Director of Product Development

Wayne Wang PhD

Director of Technical Projects

Andy Tao PhD

Director of Analytical Services

Rex Roberts PhD

Sr Formulation Scientist Elliot Zheng

Formulation ScientistHelena ZhangOpen Position

Formulation TeamTony Xu

JianboQinRalf HuangAlex Zhu

Jungxian Xu

Instrumentation SpecialistFransicWu

Sr Project LeaderAllan Wu

“Committed to Customer Service”

Project managerErica Zhang

Sr Formulation ScientistTom Tang

Director of Analytical Services

Weixuan He PhD

Analytical LeaderWilliam Yu

Analytical Support TeamDaniel ShiSharon LiLydia DingShirley GuSid WangAmy Qi

(2) Open Positions

Analytical Support TeamBruce FeiElvis FangRainbow Liu

Lily LiuAndy ChenJodie YueDavid Qui

Apple ZhangOpen Position

Instrument Support TeamNicole GuanAnne 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 coming from multi-national brand and generic companies

Product Development/Project Management

Our Team• Experienced Western on site management team, averaging over 25 years

experience with multinational branded and generic companies• 60% bachelor degree or higher• Bilingual Workforce

Quality System• US FDA inspected and approved in 2010• China SFDA GMP certificate

3 Acre Campus with 55,000 ft2 facility

Future Expansion: 61,148 ft2

4 Successful ANDA filings and one ANDA approval preparing for tech transfer and launch

Suzhou Facility Information

• Immediate Release Tablets and Capsules

• Bi-Layer Tablets• Modified, Extended and Controlled

Release• Coated Pellets and Beads• Aqueous and Solvent Processing • Finished Bottle, Blister Packaging

and Labeling Solutions

Formulation Development to Pilot Scale and Tech Transfer to Commercial Manufacturing

Our Specialty

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• Pilot & ANDA submission batches

Scale Up and Registration• 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/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 (under

construction)• Highly skilled chemists

Sourcing and Logistics

• Chinese API and Excipient Sourcing and Selection• Logistics from China• Import and Export Licensing• Regulatory Guidance Services for Chinese requirements

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/

Solvent• Encapsulation

• Tabletting and Direct Compression – Single and Bi-Layer Tablets• Film Coating – Aqueous and Solvent

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Pilot and Production Scale EquipmentBin Blenders - 10 ,30 and 400L3D Blender- 50, 100, 200LV Blender – 200LComil and Fitz Mill – 15 – 100LHigh Shear Granulator – 2, 10, 110 and 300 LGlatt “Midi” Fluid Bed System – 1 kg Fluid Bed Dryers 40-80 kg and 80-160 kgGlatt GPCG-15 Fluid Bed Dryer - Top, Side, Bottom Spray, Aqueous/Organic Solvent– 15 kg

Manual Tablet– Single StationRotary Tablet Press – 10 stationRotary Tablet Press - 29 stationPTK PR-3000 Bi-layer Tablet Press, Type DPan Coaters – 1.5L, 40, 75kgBosch GKF 700 Capsule Filler

Development and Manufacturing Equipment

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Packaging Solutions

• Bottling• Blister Packaging ( Coldform and Thermoform) • Pouches (Tablets, capsules, Granules)• Labeling Solutions

• Western Leadership and Management– USA headquarters with on-site Western Leaders

• Western Quality Systems– FDA inspected and approved(Next PAI – Q4 2012)– Western cGMP practices

• Western Equipment– Industry standard equipment

What Suzhou Pharma Services Offers?

• Focused only on Oral Solid Dosage

• Highly Skilled and Well TrainedWorkforce

• US and China based Project Management and Customer Service

• Lower Costs– Lower Labor Costs– High Productivity– Lower Cost Raw Materials

The Suzhou China Advantage

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.