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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

1 Services and Management

2 Capability

3 Products

4 Yiling Phamaceutical Group

Yiling 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

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 VP, International 15 years as CEO/CFO at CTI (generic


Business development pharm. Company), USA

Leong Goh Director, Quality More than 10 years as GMP inspector at


Medsafe, New Zealand

Himankar Director, R&D More than 10 years (R&D), India


Baishya
Organization

Robert Wan Tianqiang Wang


BD staff(7)
VP, BD Manager, BD

Yiming Liu Huifen Lu,


Technician(7)
Director, TD Manager

Jack Yin Chunmei Zhang


Jinjian Shen VP, Operation Manager, PD
CEO
Lijuan Tian
Manager,
Equip&Facil

Manhui Qiao
IPQA(6), QA(5)
Manager, QA
Leong
Director,
Quality Guoqiang Wu,
Manager,
Laboratary
QC Organization

Guoqiang Wu,
Manager, QC

Nan Chen, Xuejun Li, Chunxia Wang,


Presentation, Chargehand, Chargehand,
Comprehensive Raw material Finished product

Validation(3) Sampling(3) Sampling(2)

Instrumental Supporting
Stability(3)
testing(2) staff(2)

microbiological
Testing(2) Testing(3)
assay(3)

Yiling
_____ Pharmaceuticals
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Contents

1 Services and Management

2 Capability

3 Products

4 Yiling Phamaceutical Group

Yiling Pharmaceuticals
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
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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
GMP Certificates
CHINA UK

Yiling
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GMP Certificates

Australia Canada

Yiling
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GMP Certificates

Ethiopia New Zealand

Yiling
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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
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
Granulation 1
Fluid Bed Processor Yen Cheng Taiwan 200kg
Granulation 2 Roller Compactor Powtec, Germany 200kg/hr

500L, 1000L, 1200L,


Blending 1 Blender Cannan, China
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

Pharmapack,
Packing 2 Bottle Packing Line 160 bottles/min
Hongkong

Yiling Pharmaceuticals
Key Equipments of QC

Equipments Vendors Mode


Atomic Absorption
SHIMADZU AA6300
Spectrophotometer
HPLC(3) Waters Waters 2695/e2695
HPLC(2) SHIMADZU LC20A/SIL-20A

Infrared Spectrometer Thermo SCIENTIFIC NICOLET is10

XGL.GWX-0.24B/
Double leaf Sterilization Cabinet(2) XINHUA, Shandong
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
Granulation 1
Fluid Bed Processor Yen Cheng Taiwan 200kg
Granulation 2 Roller Compactor Powtec, Germany 200kg/hr

500L, 1000L, 1200L,


Blending 1 Blender Cannan, China
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

Pharmapack,
Packing 2 Bottle Packing Line 160 bottles/min
Hongkong

Yiling Pharmaceuticals
Contents

1 Services and Management

2 Capability

3 Products

4 Yiling Phamaceutical Group

Yiling Pharmaceuticals
Contract Manufacture Experiences 1/3

Products Dosage Forms Strength Market

25mg UK

Atenolol Tablets 50mg UK

100mg UK

Bendroflumethiazide Tablets 2.5mg UK

25mg UK
Indomethacin Capsules
50mg UK

100mg UK
Allopurinol Tablets
300mg UK

250mg UK
Naproxen Tablets
500mg UK

20mg UK
Furosemide Tablets
40mg UK

Yiling Pharmaceuticals
Contract Manufacture Experiences 2/3

Products Dosage Forms Strength Market

1mg UK

Warfarin Tablets 3mg UK

5mg UK

Paracetamol Tablets 500mg UK

250mg Spain

Ciprofloxcin Tablets 500mg Spain

750mg Spain

Ferrous sulfate Tablets 300mg Canada

Yiling 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

Tablets 50mg New Zealand


Nicotinic acid
Tablets 500mg New Zealand

Pyridoxine Tablets 50mg New Zealand

Thiamine Tablets 50mg New Zealand

Yiling Pharmaceuticals
Yiling’s MA in UK1/2

Products Dosage Forms Strength Market

5mg UK

Enalapril Tablets 10mg UK

20mg UK

2.5mg UK

5mg UK
Lisinopril Tablets
10mg UK

20mg UK

10mg UK

20mg UK
Simvastatin Tablets
40mg UK

80mg UK

Yiling Pharmaceuticals
Yiling’s MA in UK 2/2

Products Dosage Forms Strength Market

10mg UK

Pravastatin Tablets 20mg UK

40mg UK

Paroxetine Tablets 20mg UK

Yiling Pharmaceuticals
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


Dextromethorphani Hydrobromidi
Aciclovir Tablets 100mg 15mg
Tablets
Metformin Hydrochloride Tablets 250mg Metoprolol Tartrate Tablets 25mg

Ciprofloxacin Hydrochloride Tablets 250mg Irbesartan Dispersible Tabelts 75mg

Roxithromycin Tablets 150mg Erythromycin Ethylsuccinate Tablets 125mg

Yiling Pharmaceuticals
Contents

1 Services and Management

2 Capability

3 Products

4 Yiling Phamaceutical Group

Yiling Pharmaceuticals
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


OSD Plant
(Highly potent
Beijing Yiling
drugs)
Board of Directors& Biopharm
Executive Committee OSD Plant
(Hormone)
Beijing Yiling
Pharmaceuticals

Yiling Ltd. (UK) OSD Plant


(Generics)
Including a Pilot
Shijiazhuang Yiling
Lab
Pharmaceutical Co

Yiling Pharmaceuticals
Subsidiary Companies

Shijiazhuang Yiling Beijing Yiling Biopharm


Pharmaceutical Co

Beijing Yiling
Yiling Yiling Ltd. (UK)
Pharmaceuticals Group

Hebei Yiling Hospital Yiling R&D Institutes

Yiling Pharmaceuticals
How Yiling adds to your value?

Yiling Adding to your value

Yiling’s integrated supply services

Effective Quality Deliverable Cost-


R&D Effective

Yiling Pharmaceuticals