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Shijiazhuang Yiling Pharmaceutical Co., Ltd.
Yiling Pharmaceuticals
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Our Mission OUR MISSION
An integrated and highly motivated company committed to innovation, cost-effective and efficient development and manufacture of drug products Value added Providing products and services of HIGH QUALITY ON TIME Fostering mutually beneficial relations with all our business partners Managing our operations – to maintain high regulatory cGMP standards and full compliance with health, safety and environmental regulations Being a responsible corporate citizen Yiling Pharmaceuticals
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Contents 1 Services and Management 2 Capability 3 Products 4
Yiling Phamaceutical Group 4 Yiling Pharmaceuticals
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CMO Services Yiling offers contract manufacturing services in:
Contract manufacturing of generics oral solid dosage forms Packaging and labeling Formulation development Analytical method development and validation Stability study Release testing Shipping and custom clearance Yiling Pharmaceuticals
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Our People Yiling understands that only high level of quality and service will be accepted IP protection is strictly required and committed by all employees The company recruits and retains a globalized management team with cGMP practical experience in terms of CMO Service and Rx supply chain management Yiling Pharmaceuticals
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Experience of Management Team
Name Responsibility Previous working experience Jingjian Shen CEO More than 35 years in Pharm. Industry. Including 10 years as Quality and RD director at Apotex, New Zealand and 5 years as VP in Hisun, China Jack Yin VP, Operation More than 20 years (Production, Quality and Operations) at GSK, China Robert Wan VP, International Business development 15 years as CEO/CFO at CTI (generic pharm. Company), USA Leong Goh Director, Quality More than 10 years as GMP inspector at Medsafe, New Zealand Himankar Baishya Director, R&D More than 10 years (R&D), India
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Organization Jinjian Shen CEO Robert Wan VP, BD Tianqiang Wang
Manager, BD BD staff(7) VP, Operation Jack Yin Director, TD Yiming Liu Huifen Lu, Manager Technician(7) Chunmei Zhang Manager, PD Manager, Equip&Facil Lijuan Tian Director, Quality Leong Manhui Qiao Manager, QA IPQA(6), QA(5) Manager, Laboratary Guoqiang Wu,
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QC Organization _____ ______________ Yiling Pharmaceuticals
Guoqiang Wu, Manager, QC Nan Chen, Presentation, Comprehensive Validation(3) Stability(3) Testing(2) Xuejun Li, Chargehand, Raw material Sampling(3) Instrumental testing(2) Testing(3) Chunxia Wang, Chargehand, Finished product Sampling(2) Supporting staff(2) microbiological assay(3) _____ ______________ Yiling Pharmaceuticals
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Contents Services and Management 1 2 Capability 3 Products 4
Yiling Phamaceutical Group 4 Yiling Pharmaceuticals
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Yiling Pharma Sites for international business and Contract manufacture Site Location Scope Capability 1 Shijiazhuang OSD plant 2.5 billion 2 Pilot OSD plant 15kg-30kg per batch Yiling Pharmaceuticals _____ ______________
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Facility and Quality Facility: ~5,000m2 of manufacture,
~1,800m2 warehouse space The facility was designed by European consultants (NNE Pharmaplan) to meet with regulatory requirements of the SFDA, EU, USFDA GMP certificates from MHRA, TGA, Canada, Medsafe, SFDA are available. Yiling Pharmaceuticals
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GMP Certificates CHINA UK Yiling Pharmaceuticals _____ ______________
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GMP Certificates Australia Canada Yiling Pharmaceuticals
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GMP Certificates Ethiopia New Zealand Yiling Pharmaceuticals
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Audit Information Year Audit by 2009 Medsafe New Zealand
Client audit from USA DACA Ethiopia Client audit from UK Client audit from New Zealand 2010 MHRA UK Client audit from Brazil 2011 MHRA UK Re-audit Client audit from Canada 2012 MHRA UK re-audit
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US FDA One ANDA has been submitted to US FDA in May 2011 pending for FDA inspection.
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Tablets Manufacturing Process
Dispensing &Sieving Granulation Blending Compression Coating Primary Packaging Secondary Packaging Yiling Pharmaceuticals
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Key Equipments of Workshop
Vendors Capacity Granulation 1 Wet Granulator Cannan, China 600L Fluid Bed Processor Yen Cheng Taiwan 200kg Granulation 2 Roller Compactor Powtec, Germany 200kg/hr Blending 1 Blender 500L, 1000L, 1200L, 1500L Blending 2 2000L Tab Press 1 Tablet Press Fette, Germany 200,000’s/hr Tab Press 2 Longli, China 300,000’s/hr Tab Press 3 Cap Filling 1 Capsule Filler Bosch, Germany 120,000’s/hr Cap Filling 2 Feiyun, China 90,000’s/hr Film Coating 1 Film Coater Gansons, India 300~550kg Film Coating 2 Yuancheng, Taiwan 150~300kg Packing 1 Blister Packing Line Hoonga, Korea 300 packs/min Packing 2 Bottle Packing Line Pharmapack, Hongkong 160 bottles/min Yiling Pharmaceuticals
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Key Equipments of QC Equipments Vendors Mode
Atomic Absorption Spectrophotometer SHIMADZU AA6300 HPLC(3) Waters Waters 2695/e2695 HPLC(2) LC20A/SIL-20A Infrared Spectrometer Thermo SCIENTIFIC NICOLET is10 Double leaf Sterilization Cabinet(2) XINHUA, Shandong XGL.GWX-0.24B/ XGL.GWX-0.36B Biochemical Incubator(5) YIHENG, SHANGHAI LRH-250F UV VARIAN 50 Bic Incubator Binder FD240/ BD240 GC GC-2010 Dissolution Tester(2) TIANDATIANFA RCZ-8M TOC YUANTAI, Germany liquid Toc trace Titrimeter(3) METTLER TOLEDO DL31/ T50 Conductivity Meter S30K Biological Safety Cabinet Frontline, USA FHC-1200A Yiling Pharmaceuticals
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Key Equipments of Workshop
Vendors Capacity Granulation 1 Wet Granulator Cannan, China 600L Fluid Bed Processor Yen Cheng Taiwan 200kg Granulation 2 Roller Compactor Powtec, Germany 200kg/hr Blending 1 Blender 500L, 1000L, 1200L, 1500L Blending 2 2000L Tab Press 1 Tablet Press Fette, Germany 200,000’s/hr Tab Press 2 Longli, China 300,000’s/hr Tab Press 3 Cap Filling 1 Capsule Filler Bosch, Germany 120,000’s/hr Cap Filling 2 Feiyun, China 90,000’s/hr Film Coating 1 Film Coater Gansons, India 300~550kg Film Coating 2 Yuancheng, Taiwan 150~300kg Packing 1 Blister Packing Line Hoonga, Korea 300 packs/min Packing 2 Bottle Packing Line Pharmapack, Hongkong 160 bottles/min Yiling Pharmaceuticals
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Contents Services and Management 1 2 Capability 3 Products 4
Yiling Phamaceutical Group 4 Yiling Pharmaceuticals
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Contract Manufacture Experiences 1/3
Products Dosage Forms Strength Market Atenolol Tablets 25mg UK 50mg 100mg Bendroflumethiazide 2.5mg Indomethacin Capsules Allopurinol 300mg Naproxen 250mg 500mg Furosemide 20mg 40mg Yiling Pharmaceuticals
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Contract Manufacture Experiences 2/3
Products Dosage Forms Strength Market Warfarin Tablets 1mg UK 3mg 5mg Paracetamol 500mg Ciprofloxcin 250mg Spain 750mg Ferrous sulfate 300mg Canada Yiling Pharmaceuticals
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Contract Manufacture Experiences 3/3
Products Dosage Forms Strength Market Folic Acid Tablets 0.8mg(120s) New Zealand 0.8mg(1000s) 5mg Nicotinic acid 50mg 500mg Pyridoxine Thiamine Yiling Pharmaceuticals
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Yiling’s MA in UK1/2 Products Dosage Forms Strength Market Enalapril
Tablets 5mg UK 10mg 20mg Lisinopril 2.5mg Simvastatin 40mg 80mg Yiling Pharmaceuticals
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Yiling’s MA in UK 2/2 Products Dosage Forms Strength Market
Pravastatin Tablets 10mg UK 20mg 40mg Paroxetine Yiling Pharmaceuticals
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Yiling’s OSD Products Products Strength Clarithromycin Tablets 250mg
Erythromycin Ethylsuccinate Tablets 125mg Gliclazide Tablets(Ⅱ) 80mg Aciclovir Dispersible Tablets 100mg Captopril Tablets 25mg Gliquidone Tablets 30mg Ranitidine Hydrochloride Capsules 150mg Isosorbide Mononitrate Tablets 20mg Glipizide Tablets 5mg Tinidazole Tablets 500mg Azithromycin Tablets Levofloxacin Hydrochloride Tablets Aciclovir Tablets Dextromethorphani Hydrobromidi Tablets 15mg Metformin Hydrochloride Tablets Metoprolol Tartrate Tablets Ciprofloxacin Hydrochloride Tablets Irbesartan Dispersible Tabelts 75mg Roxithromycin Tablets Yiling Pharmaceuticals
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Contents Services and Management 1 2 Capability 3 Products 4
Yiling Phamaceutical Group 4 Yiling Pharmaceuticals
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Yiling Pharmaceutical Group
Shijiazhuang Yiling Pharmaceuticals is one of the strategic business units of the Yiling Pharmaceutical Group whose headquarter is located in Shijiazhuang City, Hebei Province. Yiling Pharmaceutical Group was established in 1992 and has been being publicly traded since The Group has over 3000 employees with a sales force of 2000 covering 90% of leveled hospitals throughout China. 3 billion RMB (US$500 million) annual sales in 2011. Yiling Pharmaceuticals
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Location Beijing Shijiazhuang Yiling Pharmaceuticals
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Organization Chart Yiling R&D Institutes Hebei Yiling Hospital
OSD Plant (Highly potent drugs) Beijing Yiling Biopharm Board of Directors& Executive Committee OSD Plant (Hormone) Beijing Yiling Pharmaceuticals Yiling Ltd. (UK) OSD Plant (Generics) Including a Pilot Lab Shijiazhuang Yiling Pharmaceutical Co Yiling Pharmaceuticals
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Subsidiary Companies Yiling Group Beijing Yiling Biopharm
Shijiazhuang Yiling Pharmaceutical Co Yiling Ltd. (UK) Yiling R&D Institutes Beijing Yiling Pharmaceuticals Hebei Yiling Hospital Yiling Group Yiling Pharmaceuticals
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How Yiling adds to your value?
Yiling Adding to your value Yiling’s integrated supply services Quality Deliverable Cost- Effective R&D Thank You! Yiling Pharmaceuticals
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