CORYRIGHT (C) DONGBANG FUTURE TECH & LIFE CO.,LTD. ALL RIGHTS RESERVED. CUSTOMER CENTER 82-2-741-7516 Welcome to DongBang FTL.

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Presentation transcript:

CORYRIGHT (C) DONGBANG FUTURE TECH & LIFE CO.,LTD. ALL RIGHTS RESERVED. CUSTOMER CENTER Welcome to DongBang FTL

KOREA HEAD OFFICE 3FL ILYANG BLDG., 62 TONUY-DONG, CHONGNO-KU, SEOUL, , KOREA TEL : ~8 FAX : FACTORY 904-5, SANGSIN-RI, HYANGNAM-MYUN, HWASUNG-SI, KYONGGI-DO, , KOREA TEL : FAX :  Address

 DONGBANG Future Tech & Life Co., Ltd Organic synthesis Fragrance Separation of effective material Herbalextraction Finished Product Dong Bang FTL Cosmetic  Major Activities PlaceArea Area of plant total13, m 2 Work place (Organic synthesis) 3, m 2 Work place (Herbal extraction) m 2 Laboratory m 2 Storage m 2 Others9, m 2

 Product Amount Year Product amount 20039,679, ,026, ,097, ,000, ,858, ,903, ,010, ,467,220

 History Corporate Organization Completion of factory Acquisition of permission for pharmaceutical raw material manufacturing Finished enlargement of building for management office and factory Establishment of affiliated technique research institute Authentication of ISO 9002/EN ISO 9002/ KS A Increase of pharmaceutical raw material manufacturing facilities Change company name to DONG BANG FUTURE CHEMICAL CO., LTD Completion of Cosmetic factory (Amiesay cosmetic) Authentication of Australian GMP (TGA) Award of prize for the minister of the industry resources administration in the trade day Award of prize for the foreign frontier field of Gyeonggi-Do Authentication of BGMP by Korea Food and Drug Administration Increase of Cosmetic manufacturing facilities selected INNO-BIZ enterprise(medium sized business office)

 History Change company name to DongBang Future Tech & Life co., LTD Authentication of KS Q ISO 9001 :2001 / ISO 9001 : Authentication of BGMP for Herbal product by Korea Food and Drug Administration Authentication of Australian GMP (TGA) following ICH guideline Acquisition of certificate of suitability for mefenamic acid from EDQM Authentication of KGMP Authentication of Australian GMP (TGA) Acquisition of certificate of suitability for Ketoprofen from EDQM Inspection of KGMP by Korea Food and Drug Administration Authentication of KS Q ISO 9001 :2009 / ISO 9001 : Authentication of BGMP for Loperamide by Korea Food and Drug Administration Authentication of BGMP for Pelargonium sidoides by Korea Food and Drug Administration Inspection of KGMP by Korea Food and Drug Administration Authentication of Australian GMP (TGA)

Company Certificate 1.  Company Certificate 1. TGA AuthenticationBGMP Authentication

Company Certificate 2.  Company Certificate 2. ISO Authentication

Company Certificate 3.  Company Certificate 3. Mefenamic acid COS-2Mefenamic acid COS-1Mefenamic acid COS-3

Company Certificate 4.  Company Certificate 4. Ketoprofen COS-1Ketoprofen COS-2

COS & DMF Status 1.  COS & DMF Status 1. APIs NameCAS NumberCategory Regulatory Status Aceclofenac Anti-Inflammatory- KDMF Bosentan Anti-Hypertensive- KDMF Ciprofloxacin HCl Anti-Bacterial- KDMF Diclofenac sodium Anti-Inflammatory- KDMF Enalapril malate Anti-Hypertensive- KDMF Eperisone HCl Muscle Relaxant- KDMF Entacavir Anti-Hepatitis B- KDMF Felbinac Anti-Inflammatory- EDMF - JDMF - KDMF Fluconazole Anti-Bacteria- KDMF

APIs NameCAS NumberCategory Regulatory Status Ketoprofen Anti-Inflammatory- COS - KDMF Levofloxacin Anti-Bacteria- JDMF - KDMF Loxoprofen sodium Anti-Inflammatory- JDMF - KDMF Losartan potassium Anti-Hypertensive- KDMF Lafutidine Anti-Ulcerative agent- KDMF Mefenamic acid Anti-Inflammatory- COS - EDMF - KDMF Meloxicam Anti-Inflammatory- JDMF Ofloxacin Anti-Bacterial- KDMF Olmesartan medoxomil Anti-Hypertensive- KDMF COS & DMF Status 2.  COS & DMF Status 2.

APIs NameCAS NumberCategory Regulatory Status Propiverine HCl Treatment of Incontinence- EDMF Pitavastatin calcium Anti-Hyperlipidemic- KDMF Rebamipide Anti-Ulcerative agent- KDMF Terazosine HCl Treatment of Incontinence- KDMF Valsartan Anti-Hypertensive- KDMF COS & DMF Status 3.  COS & DMF Status 3.

 Dong Bang GMP Organization Chart GMP Chairperson Manufacturing Manager Hygienic Control Manager Manufacturing Director Warehouse DirectorUtility Director Hygienic Control First workshop Quality Manager QA directorQC director APQR / Complain / Release Deviation / OOS / Change control Self inspection / Returns / Training Raw material test Packing material test API material test Microbial test Maintenance Utility API warehouse Raw material warehouse Packing material warehouse Document SOP/ Vendor audit Second workshop Quality Related Systems QC15 QA8 Production31 R&D, Regulatory10 Warehouse4 Others Sales & Marketing5 Administration5 Other support services5  The number of employees

 GMP Documentation system Documentation System The Number of Documentation GMP Documentation General Management 7 Manufacture Management 24 Quality Management 31 Hygiene Management 5 Total67 Standard Of Practice (SOP) Synthesis UNIT 53 Quality Assurance Team 20 Quality Control Team 55 Total128 The Number of GMP Documentation

Quality Equipment  Quality Equipment UV-VIS Spectrophotometer High Performance Liquid Chromatography Particle size analyzer Fourier Transform Infrared Spectroscopy Karl fisher Convection oven Muffle Furnace Gas Chromatography Total Organic Carbon Analyzer pH Meter

Production Facility  Production Facility 1) Reactor

Production Facility  Production Facility 2) Dryer 3) Filter

Thank you CORYRIGHT (C) DONGBANG FUTURE TECH & LIFE CO.,LTD. ALL RIGHTS RESERVED. CUSTOMER CENTER ISO 9001Authentication T G AAuthentication BGMPAuthentication KGMPAuthentication DONGBANG FUTURE TECH & LIFE CO., LTD. SEOUL, KOREA - HEAD OFFICE 3FL ILYANG BLDG., 62 TONUY-DONG, CHONGNO-KU, SEOUL, , KOREA TEL : ~8 FAX : dongbangchem.co.kr - FACTORY 904-5, SANGSIN-RI, HYANGNAM-MYUN, HWASUNG-SI, KYONGGI-DO, , KOREA TEL : FAX : dongbangchem.co.kr