lihua presentation

Dear customer,Welcome to

Henan Lihua Pharmaceutical Co., Ltd

河南利华制药有限公司

Company Profile

• Established in 1994• Located in Anyang • National leader in production

of APIs and related ingredients

• Became the wholly-owned sub-company of Guangdong VTR Bio-Tech Co., Ltd. in September, 2015.

About Us Our Core Value

+ Innovation

+ High Efficiency

+ Quality is Personality

Business Policy

Company Mission

Creativity makes Lihua more professional and stronger!

Satisfy the customers; Improve employees happiness; Fulfill the society responsibility.

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Company Plants (93,000m2)

West Plant• Established in1994• Located at Qilidian• Total Area: 67,000m2

• GPS location: N 36°03 18.58″ ′ E 114°20 13.59″′

East Plant (H)• Established in 2004• Located at High-tech

Industry Development Zone• Total Area: 26,000m2

• GPS location: N 36°03 45.31″ ′ E 114°22 23.76″′

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Staff Allocation (Total 399)

Timeline of Honor

2011

2013 Advanced Unit in Enterprise Contribution AwardAdvanced Unit in Technological Innovation AwardTop 50 High Improved Enterprise

Enterprises of Class AA in Custom Management

Top 50 Anyang High-Tech Industry

2014

Top 50 High Improved Enterprise 2015 Advanced Unit in Technological Innovation

Award

Global Marketing

Main Products of East Plant

Main Products of West Plant

PrednisolonePrednisone

HydrocortisoneBetamethasone

Prednisolone AcetateHydrocortisone Acetate

Prednisolone Sodium Phosphate

Prednisone AcetateCortisone Acetate

Hydrocortisone Sodium Succinate

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Quality Policy

Quality Management System

Quality Management System

QA• Control of documents & records• Supplier audit, deviation, change, complaint, recall, return,

product release ， etc.

QC• Sampling, retaining samples, testing of raw materials,

intermediates and finished products and issuing CoAs• Testing water system & purified water system & issuing • Performing qualification of analysis instruments• Validation of analytical method• Stability study

Quality Management SystemManufacture Dept.• Manufacturing, packaging and labelling APIs• Validation of manufacturing process and equipment (PQ)• Cleaning of manufacturing equipment

Warehouse Dept.• Accepting, stocking and dispensing of raw materials,

intermediates & finished products• Managing substances stored in warehouse

Engineering Dept.

• Repair, maintenance, management and qualification of equipment and facilities (DQ,IQ ＆ OQ)• Calibration & management of measuring instrument

Time Certification Granted By Time Certification Granted By

National

2002.07 GMP (West plant) CFDA 2006.03 GMP

(East plant) HFDA

2016.01 GMP (West plant) HFDA 2012.04 GMP

(East plant) HFDA

2014.08 ISO14001 CMSC 2014.02 GMP(Betamethasone) HFDA

2014.08 OHSAS CMSC

International

2006.06 GMP BGV 2010.05 GMP FDA

2009.10 GMP BGV 2010.09 GMP PMDA

2013.01 GMP BGV 2016.08 GMP FDA

2016.04 GMP BGV

Regulatory Milestone

Register File

File Name File No. Issued By

CEP (Prednisolone) R1-CEP 2005-248-Rev01 EDQM

CEP (Prednisolone A) R0-CEP 2014-153-Rev01 EDQM

CEP (Prednisone) R1-CEP 2005-240-Rev02 EDQM

Form41 BD-917 & BD-1391 DCGI

File Name File No. DMF fee CA PAI

Prednisone 24749 √ √ √

Prednisolone 24795

Prednisolone （ Process

I）30625

Prednisolone acetate 28518

Hydrocortisone 28066 √ In process

Hydrocortisone acetate 29685 √ In process

Prednisolone sodium

phosphate

29751 √ √

Register File - FDA

GMP Certificate

GMP Certificate of East Plant

April.12, 2012

GMP Certificate

GMP Certificate of West Plant

Jan.6, 2016

GMP Certificate

GMP Certificate of Betamethasone

Feb.18, 2014

EU-GMP Certificate

EU-GMP Certificate

April 4, 2016

FDA Approved Letter

FDA Approved Letter

August 3, 2016

CEP Certificate for Prednisolone

Sep. 12, 2013

CEP Certificate

CEP Certificate

for Prednisone

Mar. 30, 2016

CEP Certificate

CEP Certificate for Prednisolone

(process A)

Aug. 7, 2015

CEP Certificate

Environment Management System

Certificate of ISO14001：

2004

August.15.2014

Occupational Health And Safety Management System

Certificate of OHSAS 18001：

2007

August.15.2014

Photos of Our Company

IR Lab.

Thank You for Your Time

lihua presentation

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