Transcript Shijiazhuang Yiling Pharmaceutical Co., Ltd. Yiling Pharmaceuticals

Shijiazhuang Yiling Pharmaceutical Co., Ltd.
Yiling 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
Yiling Pharmaceuticals
Contents
Yiling Pharmaceuticals
1
Services and Management
2
Capability
3
Products
4
Yiling Phamaceutical Group
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
Yiling 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
Yiling Pharmaceuticals
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
Leong Goh
VP, International
15 years as CEO/CFO at CTI (generic
Business development
pharm. Company), USA
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
Organization
Robert Wan
Tianqiang Wang
VP, BD
Manager, BD
Yiming Liu
Director, TD
Jinjian Shen
CEO
Jack Yin
Chunmei Zhang
VP, Operation
Manager, PD
BD staff(7)
Huifen Lu,
Manager
Lijuan Tian
Manager,
Equip&Facil
Leong
Director,
Quality
Manhui Qiao
Manager, QA
Guoqiang Wu,
Manager,
Laboratary
IPQA(6), QA(5)
Technician(7)
QC Organization
Guoqiang Wu,
Manager, QC
Nan Chen,
Presentation,
Comprehensive
Yiling
_____
Pharmaceuticals
______________
Xuejun Li,
Chargehand,
Raw material
Chunxia Wang,
Chargehand,
Finished product
Validation(3)
Sampling(3)
Sampling(2)
Stability(3)
Instrumental
testing(2)
Supporting
staff(2)
Testing(2)
Testing(3)
microbiological
assay(3)
Contents
Yiling Pharmaceuticals
1
Services and Management
2
Capability
3
Products
4
Yiling Phamaceutical Group
Yiling Pharma
Sites for international business and Contract manufacture
Site
Location
Scope
Capability
1
Shijiazhuang
OSD plant
2.5 billion
2
Shijiazhuang
Pilot OSD plant
15kg-30kg per
batch
Yiling
_____
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.
Yiling Pharmaceuticals
GMP Certificates
CHINA
Yiling
_____
Pharmaceuticals
______________
UK
GMP Certificates
Australia
Yiling
_____
Pharmaceuticals
______________
Canada
GMP Certificates
Ethiopia
Yiling
_____
Pharmaceuticals
______________
New Zealand
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
US FDA
One ANDA has
been submitted
to US FDA in
May 2011
pending for
FDA inspection.
Tablets Manufacturing Process
Dispensing &Sieving
Granulation
Blending
Compression
Coating
Primary Packaging
Secondary Packaging
Yiling Pharmaceuticals
Key Equipments of Workshop
Equipments
Vendors
Capacity
Wet Granulator
Cannan, China
600L
Fluid Bed Processor
Yen Cheng Taiwan
200kg
Granulation 2
Roller Compactor
Powtec, Germany
200kg/hr
Blending 1
Blender
Cannan, China
500L, 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 Line
Pharmapack,
Hongkong
160 bottles/min
Granulation 1
Yiling 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, 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
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
Yiling Pharmaceuticals
Key Equipments of Workshop
Equipments
Vendors
Capacity
Wet Granulator
Cannan, China
600L
Fluid Bed Processor
Yen Cheng Taiwan
200kg
Granulation 2
Roller Compactor
Powtec, Germany
200kg/hr
Blending 1
Blender
Cannan, China
500L, 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 Line
Pharmapack,
Hongkong
160 bottles/min
Granulation 1
Yiling Pharmaceuticals
Contents
Yiling Pharmaceuticals
1
Services and Management
2
Capability
3
Products
4
Yiling Phamaceutical Group
Contract Manufacture Experiences 1/3
Products
Atenolol
Dosage Forms
Tablets
Bendroflumethiazide Tablets
Indomethacin
Capsules
Allopurinol
Tablets
Naproxen
Furosemide
Yiling Pharmaceuticals
Tablets
Tablets
Strength
Market
25mg
UK
50mg
UK
100mg
UK
2.5mg
UK
25mg
UK
50mg
UK
100mg
UK
300mg
UK
250mg
UK
500mg
UK
20mg
UK
40mg
UK
Contract Manufacture Experiences 2/3
Products
Warfarin
Paracetamol
Ciprofloxcin
Ferrous sulfate
Yiling Pharmaceuticals
Dosage Forms
Tablets
Tablets
Tablets
Tablets
Strength
Market
1mg
UK
3mg
UK
5mg
UK
500mg
UK
250mg
Spain
500mg
Spain
750mg
Spain
300mg
Canada
Contract Manufacture Experiences 3/3
Products
Folic Acid
Dosage Forms
Strength
Market
Tablets
0.8mg(120s)
New Zealand
Tablets
0.8mg(1000s)
New Zealand
Tablets
5mg
New Zealand
Tablets
50mg
New Zealand
Tablets
500mg
New Zealand
Pyridoxine
Tablets
50mg
New Zealand
Thiamine
Tablets
50mg
New Zealand
Nicotinic acid
Yiling Pharmaceuticals
Yiling’s MA in UK1/2
Products
Enalapril
Lisinopril
Simvastatin
Yiling Pharmaceuticals
Dosage Forms
Tablets
Tablets
Tablets
Strength
Market
5mg
UK
10mg
UK
20mg
UK
2.5mg
UK
5mg
UK
10mg
UK
20mg
UK
10mg
UK
20mg
UK
40mg
UK
80mg
UK
Yiling’s MA in UK 2/2
Products
Pravastatin
Paroxetine
Yiling Pharmaceuticals
Dosage Forms
Tablets
Tablets
Strength
Market
10mg
UK
20mg
UK
40mg
UK
20mg
UK
Yiling’s OSD Products
Products
Strength
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
250mg
Levofloxacin Hydrochloride Tablets
100mg
Aciclovir Tablets
100mg
Dextromethorphani Hydrobromidi
Tablets
15mg
Metformin Hydrochloride Tablets
250mg
Metoprolol Tartrate Tablets
25mg
Ciprofloxacin Hydrochloride Tablets 250mg
Irbesartan Dispersible Tabelts
75mg
Roxithromycin Tablets
Erythromycin Ethylsuccinate Tablets 125mg
Yiling Pharmaceuticals
150mg
Contents
Yiling Pharmaceuticals
1
Services and Management
2
Capability
3
Products
4
Yiling Phamaceutical Group
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
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.
Yiling Pharmaceuticals
Location
Beijing
Shijiazhuang
Yiling Pharmaceuticals
Organization Chart
Yiling R&D Institutes
Hebei Yiling Hospital
Board of Directors&
Executive Committee
Beijing Yiling
Biopharm
Beijing Yiling
Pharmaceuticals
Yiling Ltd. (UK)
Shijiazhuang Yiling
Pharmaceutical Co
Yiling Pharmaceuticals
OSD Plant
(Highly potent
drugs)
OSD Plant
(Hormone)
OSD Plant
(Generics)
Including a Pilot
Lab
Subsidiary Companies
Shijiazhuang Yiling
Pharmaceutical Co
Beijing Yiling
Pharmaceuticals
Hebei Yiling Hospital
Yiling Pharmaceuticals
Beijing Yiling Biopharm
Yiling
Group
Yiling Ltd. (UK)
Yiling R&D Institutes
How Yiling adds to your value?
Yiling Adding to your value
Yiling’s integrated supply services
Effective
R&D
Yiling Pharmaceuticals
Quality
Deliverable
CostEffective