2. Table of Contents
01 | Company Profile
02 | Products Presentation
03 | Quality Management System
04 | Showcase Group of Certificates
05 | Photos of Company
3. 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
4. Business Policy
Company Mission
Creativity makes Lihua more professional and stronger!
Satisfy the customers; Improve employees happiness;
Fulfill the society responsibility.
4
5. 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′ ″
7. Timeline of Honor
2011
2013 Advanced Unit in Enterprise Contribution Award
Advanced Unit in Technological Innovation Award
Top 50 High Improved Enterprise
Enterprises of Class AA in Custom Management
Top 50 Anyang High-Tech Industry
2014
Top 50 High Improved EnterpriseTop 50 High Improved Enterprise
2015
Advanced Unit in Technological Innovation Award
9. Main Products of East Plant
Main Products of West Plant
Prednisolone
Prednisone
Hydrocortisone
Betamethasone
Prednisolone Acetate
Hydrocortisone Acetate
Prednisolone Sodium Phosphate
Prednisone Acetate
Cortisone Acetate
Hydrocortisone Sodium Succinate
9
12. 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
13. Quality Management System
Manufacture 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
14. 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
15. 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
16. 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
Products are presently sold to Germany, Italy, USA, Japan, India, etc.
We have more than 300 customers in almost 60 countries and regions in Europe, North and South America, Asia, Africa, etc.
and have developed cooperation partnership with several pharmaceutical giants which are in Fortune 500 (such as Pfizer, Sanofi, Merck and etc.).
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