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Suzhou pharma services corporate presentation 2013


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Suzhou pharma services corporate presentation 2013

  1. 1. Where Western Pharmaceutical Performance meets Eastern Manufacturing Potential
  2. 2. Amerigen’s Corporate Structure Amerigen Pharmaceutical Co., Ltd (Parent Holding Company) Suzhou AmerigenAmerigen 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. 3. Suzhou Pharma ServicesSuzhou 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. 4. Suzhou, China 120 km west of Shanghai Pudong Intl Airport Population ~ 10 Million Founded in 514BC, Suzhou has over 2500 yearsof history, is known as the “Venice of the East” andhas a UNESCO World Heritage Site for the Gardensof Suzhou Suzhou Industrial Park, built in the late 1990s inconjunction with the Chinese and SingaporeGovernments, is a modern, engineered, metropolisand economic zone Suzhou area is home to numerous GlobalPharmaceutical Companies
  5. 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. 6. The Amerigen Team ~140 People at the end of 2012Corporate 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 ManagementChinese 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. 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. 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. 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. 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 pharmaceuticalHua Hui and medical device companiesDirector,Manufacturing  Specialized in manufacturing operations, technical services and operational excellence for tablets, capsules, suspensions, and sterile powdersFlora Ji  13 years of experience in global pharmaceutical companiesDirector, Materials  Specialized in warehousing, materials management, production planningManagement and logistics/supply chain managementAndy Tao  20 years of experience in project management, process R&D, scale up andDirector, Technical Projects manufacturing in the pharmaceutical industry  Specialized in chemical process developmentWeixuan He  10 years of experience in research development support for USDirector, ARD pharmaceutical companies  Specialized in analytical method development and validationWayne Wang  15 years of US based experience in product formulation, processDirector, Product development/scale up, regulatory filing, tech transfer & process validationDevelopment 10
  11. 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 WagnerQA Director QA Compliance Manager QC DirectorShining 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. 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. 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. 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. 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. 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 AnalyticalSr. 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. 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 arelocated 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. 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. 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. 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 ofregistration batches Stability study design and monitoring using ICH guidelines Documents provided in submission ready format – IND, CMC Section, Customized Reports
  21. 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. 22. Sourcing and Logistics Chinese API and Excipient sourcing and selection Logistics from China Import and Export External API site audits
  23. 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. 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/OrganicSolvent– 15 kg 24
  25. 25. Packaging SolutionsFinal Product Packaging Provided through Strategic Partners Bottling Blister Packaging (Coldform & Thermoform) Pouches, sachets, etc. 25
  26. 26. Future Investments and UpgradesProcessing 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 LineLaboratory Stability LIMS System Atomic Adsorption Analyzer
  27. 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. 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. 29. Looking for a high quality/low cost outsourcing solution for US and Global Markets? OrA manufacturing solution to enter the growing Chinese Pharmaceutical Market? Suzhou Pharma Services is your partner.