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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
7
“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
9
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
10
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
12
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
13
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
15
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
24
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
25
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.