Yiling Pharmaceuticals Shijiazhuang Yiling Pharmaceutical Co., Ltd

Yiling PharmaceuticalsYiling Pharmaceuticals

Shijiazhuang Yiling Pharmaceutical Co., Ltd.


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


Contents

1

Capability2

Products3

Yiling Phamaceutical Group4

Services and Management


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


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

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

Organization

QC Organization

_____ ___________________ ______________Yiling PharmaceuticalsYiling Pharmaceuticals


Contents

1

Capability2

Products3



Yiling Pharma


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


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.

GMP Certificates


CHINA UK

GMP Certificates


Australia Canada

GMP Certificates


Ethiopia 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


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


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


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


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



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


Contents

1

Capability2

Products3




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




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




Folic Acid Tablets 0.8mg(120s) New Zealand

Tablets 0.8mg(1000s) New Zealand

Tablets 5mg New Zealand

Nicotinic acid



Pyridoxine Tablets 50mg New Zealand

Thiamine Tablets 50mg New Zealand


Yiling’s MA in UK1/2


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


Yiling’s MA in UK 2/2


Pravastatin Tablets

10mg UK

20mg UK

40mg UK

Paroxetine Tablets 20mg UK


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


Contents

1

Capability2

Products3




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.


Location

Shijiazhuang

Beijing


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)


Subsidiary Companies

Beijing Yiling BiopharmShijiazhuang YilingPharmaceutical Co

Yiling Ltd. (UK)

Yiling R&D Institutes

Beijing Yiling Pharmaceuticals

Hebei Yiling Hospital

Yiling Group


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

Documents

Yiling Pharmaceuticals Shijiazhuang Yiling Pharmaceutical Co., Ltd