Page 1

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

7


Worldwide Customer Base Portfolio oF Big Pharma & Bio Pharma Customers Balanced Geographic Split Across Europe, North America & Asia

8


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

13


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


17

China Provinces Map Waisha Zhejiang Linhai Zhejiang Zhongbei Zhejiang Yantou Zhejiang Ruike Jiangsu

Jiangsu Zhejiang


18

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


19

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

22


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

25


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

30


CGmp

Production

- 38 Production Workshops - Total Reaction Capacity C. 6700 M3 - 576 Reactors - Sterile & Non-Sterile Api 500 up to 20,000 L

32


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

34


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

35


2011

Brazil ANVISA Agecia National de Vigilancia Sanitaria 2011 / 2012 / 2014 / 2016

2013

Russia Cfda 2000 to 2016

Italy GYEMSZI 2013

2014

36

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


BEFORE


BEFORE


BEFORE


BEFORE


BEFORE


Cheers! FIONA SPEAR Spear Design Group 16 Greene St, New York, NY 10013 Fiona@SpearDesignGroup.com SPEARDESIGNGROUP.COM

Profile for speardesigngroup

PITCH DECK / JIUZHOU PHARMACEUTICALS / BEFORE & AFTER  

For animated version please visit our Vimeo page https://vimeo.com/244862505

PITCH DECK / JIUZHOU PHARMACEUTICALS / BEFORE & AFTER  

For animated version please visit our Vimeo page https://vimeo.com/244862505

Advertisement