Yiling Pharmaceuticals Shijiazhuang Yiling Pharmaceutical Co., Ltd.
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Transcript of Yiling Pharmaceuticals Shijiazhuang Yiling Pharmaceutical Co., Ltd.
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Yiling PharmaceuticalsYiling Pharmaceuticals
Shijiazhuang Yiling Pharmaceutical Co., Ltd.
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Yiling PharmaceuticalsYiling Pharmaceuticals
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
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Yiling PharmaceuticalsYiling Pharmaceuticals
Contents
1
Capability2
Products3
Yiling Phamaceutical Group4
Services and Management
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Yiling PharmaceuticalsYiling Pharmaceuticals
CMO Services
Yiling offers contract manufacturing services in:
① Contract manufacturing of generics oral solid
dosage forms
② Packaging and labeling
③ Formulation development
④ Analytical method development and validation
⑤ Stability study
⑥ Release testing
⑦ Shipping and custom clearance
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Yiling PharmaceuticalsYiling Pharmaceuticals
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
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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
J ack 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
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QC Organization
_____ ___________________ ______________Yiling PharmaceuticalsYiling Pharmaceuticals
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Yiling PharmaceuticalsYiling Pharmaceuticals
Contents
1
Capability2
Products3
Yiling Phamaceutical Group4
Services and Management
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Yiling Pharma
_____ ___________________ ______________Yiling PharmaceuticalsYiling Pharmaceuticals
Site Location Scope Capability
1 Shijiazhuang OSD plant 2.5 billion
2 Shijiazhuang Pilot OSD plant 15kg-30kg per batch
Sites for international business and Contract manufacture
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Yiling PharmaceuticalsYiling Pharmaceuticals
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.
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GMP Certificates
_____ ___________________ ______________Yiling PharmaceuticalsYiling Pharmaceuticals
CHINA UK
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GMP Certificates
_____ ___________________ ______________Yiling PharmaceuticalsYiling Pharmaceuticals
Australia Canada
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GMP Certificates
_____ ___________________ ______________Yiling PharmaceuticalsYiling Pharmaceuticals
Ethiopia New Zealand
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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 UK
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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Yiling PharmaceuticalsYiling Pharmaceuticals
Tablets Manufacturing Process
Dispensing &Sieving
Granulation
Blending
Compression
Coating
Primary Packaging
Secondary Packaging
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Yiling PharmaceuticalsYiling Pharmaceuticals
Key Equipments of Workshop
Equipments Vendors Capacity
Granulation 1Wet Granulator Cannan, China 600L
Fluid Bed Processor Yen Cheng Taiwan 200kg
Granulation 2 Roller Compactor Powtec, Germany 200kg/hr
Blending 1 Blender Cannan, China500L, 1000L, 1200L,
1500L
Blending 2 Blender Cannan, China 2000L
Tab Press 1 Tablet Press Fette, Germany 200,000’s/hr
Tab Press 2 Tablet Press Longli, China 300,000’s/hr
Tab Press 3 Tablet Press Longli, China 300,000’s/hr
Cap Filling 1 Capsule Filler Bosch, Germany 120,000’s/hr
Cap Filling 2 Capsule Filler Feiyun, China 90,000’s/hr
Film Coating 1 Film Coater Gansons, India 300~550kg
Film Coating 2 Film Coater Yuancheng, Taiwan 150~300kg
Packing 1 Blister Packing Line Hoonga, Korea 300 packs/min
Packing 2 Bottle Packing LinePharmapack, Hongkong
160 bottles/min
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Yiling PharmaceuticalsYiling Pharmaceuticals
Key Equipments of QC
Equipments Vendors Mode
Atomic Absorption Spectrophotometer
SHIMADZU AA6300
HPLC(3) Waters Waters 2695/e2695
HPLC(2) SHIMADZU LC20A/SIL-20A
Infrared Spectrometer Thermo SCIENTIFIC NICOLET is10
Double leaf Sterilization Cabinet(2) XINHUA, ShandongXGL.GWX-0.24B/XGL.GWX-0.36B
Biochemical Incubator(5) YIHENG, SHANGHAI LRH-250F
UV VARIAN 50 Bic
Incubator Binder FD240/ BD240
GC SHIMADZU GC-2010
Dissolution Tester(2) TIANDATIANFA RCZ-8M
TOC YUANTAI, Germany liquid Toc trace
Titrimeter(3) METTLER TOLEDO DL31/ T50
Conductivity Meter METTLER TOLEDO S30K
Biological Safety Cabinet Frontline, USA FHC-1200A
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Yiling PharmaceuticalsYiling Pharmaceuticals
Key Equipments of Workshop
Equipments Vendors Capacity
Granulation 1Wet Granulator Cannan, China 600L
Fluid Bed Processor Yen Cheng Taiwan 200kg
Granulation 2 Roller Compactor Powtec, Germany 200kg/hr
Blending 1 Blender Cannan, China500L, 1000L, 1200L,
1500L
Blending 2 Blender Cannan, China 2000L
Tab Press 1 Tablet Press Fette, Germany 200,000’s/hr
Tab Press 2 Tablet Press Longli, China 300,000’s/hr
Tab Press 3 Tablet Press Longli, China 300,000’s/hr
Cap Filling 1 Capsule Filler Bosch, Germany 120,000’s/hr
Cap Filling 2 Capsule Filler Feiyun, China 90,000’s/hr
Film Coating 1 Film Coater Gansons, India 300~550kg
Film Coating 2 Film Coater Yuancheng, Taiwan 150~300kg
Packing 1 Blister Packing Line Hoonga, Korea 300 packs/min
Packing 2 Bottle Packing LinePharmapack, Hongkong
160 bottles/min
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Yiling PharmaceuticalsYiling Pharmaceuticals
Contents
1
Capability2
Products3
Yiling Phamaceutical Group4
Services and Management
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Yiling PharmaceuticalsYiling Pharmaceuticals
Contract Manufacture Experiences 1/3
Products Dosage Forms Strength Market
Atenolol Tablets
25mg UK
50mg UK
100mg UK
Bendroflumethiazide Tablets 2.5mg UK
Indomethacin Capsules25mg UK
50mg UK
Allopurinol Tablets100mg UK
300mg UK
Naproxen Tablets250mg UK
500mg UK
Furosemide Tablets20mg UK
40mg UK
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Yiling PharmaceuticalsYiling Pharmaceuticals
Contract Manufacture Experiences 2/3
Products Dosage Forms Strength Market
Warfarin Tablets
1mg UK
3mg UK
5mg UK
Paracetamol Tablets 500mg UK
Ciprofloxcin Tablets
250mg Spain
500mg Spain
750mg Spain
Ferrous sulfate Tablets 300mg Canada
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Yiling PharmaceuticalsYiling Pharmaceuticals
Contract Manufacture Experiences 3/3
Products Dosage Forms Strength Market
Folic Acid Tablets 0.8mg(120s) New Zealand
Tablets 0.8mg(1000s) New Zealand
Tablets 5mg New Zealand
Nicotinic acid
Tablets 50mg New Zealand
Tablets 500mg New Zealand
Pyridoxine Tablets 50mg New Zealand
Thiamine Tablets 50mg New Zealand
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Yiling PharmaceuticalsYiling Pharmaceuticals
Yiling’s MA in UK1/2
Products Dosage Forms Strength Market
Enalapril Tablets
5mg UK
10mg UK
20mg UK
Lisinopril Tablets
2.5mg UK
5mg UK
10mg UK
20mg UK
Simvastatin Tablets
10mg UK
20mg UK
40mg UK
80mg UK
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Yiling PharmaceuticalsYiling Pharmaceuticals
Yiling’s MA in UK 2/2
Products Dosage Forms Strength Market
Pravastatin Tablets
10mg UK
20mg UK
40mg UK
Paroxetine Tablets 20mg UK
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Yiling PharmaceuticalsYiling Pharmaceuticals
Yiling’s OSD Products
Products Strength Products Strength
Clarithromycin Tablets 250mg Erythromycin Ethylsuccinate Tablets125mg
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 250mg Levofloxacin Hydrochloride Tablets 100mg
Aciclovir Tablets 100mgDextromethorphani Hydrobromidi Tablets
15mg
Metformin Hydrochloride Tablets 250mg Metoprolol Tartrate Tablets 25mg
Ciprofloxacin Hydrochloride Tablets 250mg Irbesartan Dispersible Tabelts 75mg
Roxithromycin Tablets 150mg Erythromycin Ethylsuccinate Tablets125mg
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Yiling PharmaceuticalsYiling Pharmaceuticals
Contents
1
Capability2
Products3
Yiling Phamaceutical Group4
Services and Management
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Yiling PharmaceuticalsYiling Pharmaceuticals
Yiling Pharmaceutical Group
Yiling Pharmaceutical Group was established in 1992 and
has been being publicly traded since 2011. 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.
Shijiazhuang Yiling Pharmaceuticals is one of the
strategic business units of the Yiling
Pharmaceutical Group whose headquarter is
located in Shijiazhuang City, Hebei Province.
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Yiling PharmaceuticalsYiling Pharmaceuticals
Location
Shijiazhuang
Beijing
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Yiling PharmaceuticalsYiling Pharmaceuticals
Organization Chart
Board of Directors&Executive Committee
Yiling R&D Institutes
Hebei Yiling Hospital
Beijing Yiling Biopharm
Beijing Yiling Pharmaceuticals
Yiling Ltd. (UK)
Shijiazhuang Yiling Pharmaceutical Co
OSD Plant(Generics)Including a Pilot Lab
OSD Plant(Hormone)
OSD Plant(Highly potent drugs)
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Yiling PharmaceuticalsYiling Pharmaceuticals
Subsidiary Companies
Beijing Yiling BiopharmShijiazhuang YilingPharmaceutical Co
Yiling Ltd. (UK)
Yiling R&D Institutes
Beijing Yiling Pharmaceuticals
Hebei Yiling Hospital
Yiling Group
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Yiling PharmaceuticalsYiling Pharmaceuticals
How Yiling adds to your value?
Yiling Adding to your valueYiling Adding to your valueYiling Adding to your valueYiling Adding to your value
Yiling’s integrated supply services
QualityQuality DeliverableDeliverable Cost-Cost-EffectiveEffective
Effective Effective R&DR&D