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Dear customer,Welcome to
Henan Lihua Pharmaceutical Co., Ltd
河南利华制药有限公司
Table of Contents01 | Company Profile
02 | Products Presentation
03 | Quality Management System
04 | Showcase Group of Certificates
05 | Photos of Company
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.
4
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″′
6
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
9
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