Jiuzhou Pharma Established iN 1973 Strong History oF Chemical Manufacture
Jiuzhou Introduction 01
Brand Name Introduced iN 1998 Head Quarters Taizhou City Zhejiang Province 5 Production Sites 3,118 Employees 5
Discrete Business Units Generic Apis & Intermediates Contract Manufacturing & Associated Service Offerings 6
Ipo 2014 Shanghai Stock Exchange Annual Sales Approx. $250 Million Positioned for Continued Growth
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Worldwide Customer Base Portfolio oF Big Pharma & Bio Pharma Customers Balanced Geographic Split Across Europe, North America & Asia
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Jiuzhou Production Capabilities 02
5 Production Sites iN China 2 Sites Key Focus Back Integration fOr Key Raw Materials & Intermediates 3 Full cGmp Sites Manufacture oF Higher Value Rsm, Ri & Apis 10
Extensive Range oF Reactors & Isolation Equipment Over 1,000 Reators with Total Capacity in Excess of 6,000 M3 Configured iN Over 30 Discrete Workshops 11
Pilotation & Scale Up Capabilities Multiple Kilo Lab & Small Scale Reactor Workshops Supply of Initial KGs & Proof of Manufacturing Process 12
Broad Range of Chemistry Capabilities
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Extensive Waste Treatment Facilities 14
Efficient, Environmental Control oF Solid Liquid, & Gaseous Emissions
Instrumentation at Ar&D - Hplc/Pda/Elsd/Fluo/Ri (33) - Gc/Fid-Pfd/Fid-Tcd (15) - Ion Chromatography - Prep Hplc - Uplc/Pda (1290 Agilent) - Nmr (Avance Iii 400 Mhz, Bruker) - Pxrd (Phaser Ii, Bruker) 15
- Hplc-Ms (Agilent 6530 Q-Tof) - Uplc-Ms (Agilent 6460 Triple Quad) - Gc-Ms (Agilent 5975C) - Tga/Dsc - Particle Size Analyzer (Malvern 2000) - Ft-Ir, Uv, Kf, Titration - Others
Jiuzhou Manufacturing Facilities 03
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China Provinces Map Waisha Zhejiang Linhai Zhejiang Zhongbei Zhejiang Yantou Zhejiang Ruike Jiangsu
Jiangsu Zhejiang
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Waisha Zhejiang Province
Products
Capacity
Apis & Intermediates
1,588 M3 16 Production Workshops
Employees Over 562
Temperature
Reactors
High 350OC, Low -80OC
265 (200 up to 10,000 L)
Inspected By Edqm, Aifa, Tga, Cfda, Kfda, Anvisa, Fda, Ogyi, Cofepris
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Linhai Zhejiang Province
Products
Reactors
Sterile & Non-Sterile Api Contract Manufacturing Service
476 Reactors
Employees
2,400 M3 12 Production Workshops
Over 1,057
(500 to 15,000 L)
Capacity Inspected By Pmda Fda Anivisa ,Ogyi, Cofepris
20
Zhongbei Zhejiang Province
Products
Reactors
Intermediates
93 Reactors
Employees
(300 to 5,000 L)
Over 226
Capacity 249 M3 1 Production Workshop
Yantou Zhejiang Province
Products
Reactors
Intermediates
293 Reactors
Employees
(300 to 20,000 L)
Over 215
Capacity 963 M3 4 Production Workshops 21
Ruike Jiangsu Province
Products
Reactors
Apis & Intermediates
203 Reactors
Employees
(2,000 to 20,000 L)
Over 340
Capacity 1,600 M3 22 Workshops Planned 6 Production Workshops in use 1 Workshop ready to be installed
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Jiuzhou R&D Locations 04
24
Hangzhou Rd
Employees
Focus
50, Phd 8, Ms 20, Bs 22 Area 2,000 M2
Route Scouting Process Development New Analytical Method Custom Synthesis New Technology
Function Organic Synthesis, Analytical, Formulation, Bio-Engineering
Waisha Rd
Employees
Focus
217, Phd 7, Ms 52, Bs 86, Operator 72 Area 3,500 M2
Process Development Cpp/Cma Scale Up & Hazop Method Development Facility Pre-Validation Kilo Lab Pilot Plant Non-Gmp Production New Facilities In Progress Tech Transfer
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26
Shanghai Rd
Employees
Focus
14, Phd 2, Ms 6, Bs 6
Fluorinated Compounds Building Blocks Custom Synthesis
Area 1,000 M2
Hangzhou New Rd Centre
Employees
Stage
Concept fOr Over 300 Concept Design Scientists Over 400 Fume Hoods Currently Ca 50 Chemists
Area 12,000 M2 27
Jiuzhou Capabilities 05
R&D - R&D Building ~ 6,000 M2 - 110 New Fume Hoods - Over 230 Chemists Including 8 Phds with Overseas Experience - Capability to Perform Diverse Chemistry - State-Of-The-Art Analytical Instrumentation 29
Pilot Plant - 4 Production Workshops ~ 1206 M2 - More tHan 90 Reactors - High Temperature 350℃ - Low Temperature -80℃ 200 Up To 3000 L
31
Kilo Lab - 1 to 5 Kg Intermediates & Apis to Support Preclinical Phase Studies - 20 L~30 L Glass Reactor
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CGmp
Production
- 38 Production Workshops - Total Reaction Capacity C. 6700 M3 - 576 Reactors - Sterile & Non-Sterile Api 500 up to 20,000 L
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Compliance Track Record 06
Global Accreditations Spanning 15 Years
1998
2000
Kick-off Iso International Organization fOr Standardization
Europe EDQM 2007
Directorate for the quality of Medicines & HealthCare 2007 / 2014
2007
Italy AIFA Drug Agency 2007 / 2011
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2009
Korea KFDA Food & Drug Administration
Mexico Cofepris 2013
Federal Commission for tHe Protection Against Health Risks 2013 / 2014 / 2015
2010
Australia TGA Health & Safety Regulation 2008 / 2010
2016
America Fda Food & Drug Administration 2004 / 2007 / 2011 / 2013 / 2014 / 2016
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2011
Brazil ANVISA Agecia National de Vigilancia Sanitaria 2011 / 2012 / 2014 / 2016
2013
Russia Cfda 2000 to 2016
Italy GYEMSZI 2013
2014
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National Institute for Quality & Organizational Development in HealthCare
Japan Pmda Pharmaceuticals & Medical Devices Agency
Thank You Jiuzhoupharma.com / E-mail Xxxxxx@Jiuzhoupharma.com / Copyright Jiuzhou Pharmaceutical 2017 / Created by Spear Design Group
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Cheers! FIONA SPEAR Spear Design Group 16 Greene St, New York, NY 10013 Fiona@SpearDesignGroup.com SPEARDESIGNGROUP.COM