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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 on theme: "CORYRIGHT (C) DONGBANG FUTURE TECH & LIFE CO.,LTD. ALL RIGHTS RESERVED. CUSTOMER CENTER 82-2-741-7516 Welcome to DongBang FTL."— Presentation transcript:

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

2 KOREA HEAD OFFICE 3FL ILYANG BLDG., 62 TONUY-DONG, CHONGNO-KU, SEOUL, 110-807, KOREA TEL : 82-2-741-7516~8 FAX : 82-2-741-7525 FACTORY 904-5, SANGSIN-RI, HYANGNAM-MYUN, HWASUNG-SI, KYONGGI-DO, 445-922, KOREA TEL : 82-31-354-1114 FAX : 82-31-353-4120  Address

3  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 total13,486.08 m 2 Work place (Organic synthesis) 3,024.99 m 2 Work place (Herbal extraction) 262.94 m 2 Laboratory493.23 m 2 Storage636.60 m 2 Others9,068.32 m 2

4  Product Amount Year Product amount 20039,679,042 200410,026,941 200511,097,803 200611,000,681 200712,858,675 200814,903,158 200916,010,489 201018,467,220

5  History 1. 1990.02Corporate Organization 1991.06Completion of factory 1991.08Acquisition of permission for pharmaceutical raw material manufacturing 1994.01Finished enlargement of building for management office and factory 1996.02Establishment of affiliated technique research institute 1996.04Authentication of ISO 9002/EN ISO 9002/ KS A 9002 1996.12Increase of pharmaceutical raw material manufacturing facilities 1997.03Change company name to DONG BANG FUTURE CHEMICAL CO., LTD. 1999.04Completion of Cosmetic factory (Amiesay cosmetic) 1999.06Authentication of Australian GMP (TGA) 1999.11 Award of prize for the minister of the industry resources administration in the trade day 1999.12Award of prize for the foreign frontier field of Gyeonggi-Do 2000.05Authentication of BGMP by Korea Food and Drug Administration 2000.06 Increase of Cosmetic manufacturing facilities 2001.11selected INNO-BIZ enterprise(medium sized business office)

6  History 2. 2002.11Change company name to DongBang Future Tech & Life co., LTD 2003.12Authentication of KS Q ISO 9001 :2001 / ISO 9001 : 2000 2004.04 Authentication of BGMP for Herbal product by Korea Food and Drug Administration 2006.04Authentication of Australian GMP (TGA) following ICH guideline 2006.10Acquisition of certificate of suitability for mefenamic acid from EDQM 2009.03Authentication of KGMP 2009. 05Authentication of Australian GMP (TGA) 2009. 10Acquisition of certificate of suitability for Ketoprofen from EDQM 2010.10Inspection of KGMP by Korea Food and Drug Administration 2010.12Authentication of KS Q ISO 9001 :2009 / ISO 9001 : 2008 2011.03 Authentication of BGMP for Loperamide by Korea Food and Drug Administration 2011.05 Authentication of BGMP for Pelargonium sidoides by Korea Food and Drug Administration 2011.07Inspection of KGMP by Korea Food and Drug Administration 2011. 11Authentication of Australian GMP (TGA)

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

8 Company Certificate 2.  Company Certificate 2. ISO Authentication

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

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

11 COS & DMF Status 1.  COS & DMF Status 1. APIs NameCAS NumberCategory Regulatory Status Aceclofenac89796-99-6Anti-Inflammatory- KDMF Bosentan157212-55-0Anti-Hypertensive- KDMF Ciprofloxacin HCl85721-33-1Anti-Bacterial- KDMF Diclofenac sodium15307-79-6Anti-Inflammatory- KDMF Enalapril malate76095-16-4Anti-Hypertensive- KDMF Eperisone HCl56839-43-1Muscle Relaxant- KDMF Entacavir209216-23-9Anti-Hepatitis B- KDMF Felbinac5728-52-9Anti-Inflammatory- EDMF - JDMF - KDMF Fluconazole86386-73-4Anti-Bacteria- KDMF

12 APIs NameCAS NumberCategory Regulatory Status Ketoprofen22071-15-4Anti-Inflammatory- COS - KDMF Levofloxacin100986-85-4Anti-Bacteria- JDMF - KDMF Loxoprofen sodium80382-23-6Anti-Inflammatory- JDMF - KDMF Losartan potassium124750-99-8Anti-Hypertensive- KDMF Lafutidine118288-08-7Anti-Ulcerative agent- KDMF Mefenamic acid61-68-7Anti-Inflammatory- COS - EDMF - KDMF Meloxicam71125-38-7Anti-Inflammatory- JDMF Ofloxacin82419-36-1Anti-Bacterial- KDMF Olmesartan medoxomil144689-63-4Anti-Hypertensive- KDMF COS & DMF Status 2.  COS & DMF Status 2.

13 APIs NameCAS NumberCategory Regulatory Status Propiverine HCl54556-98-8Treatment of Incontinence- EDMF Pitavastatin calcium147526-32-7Anti-Hyperlipidemic- KDMF Rebamipide90098-04-7Anti-Ulcerative agent- KDMF Terazosine HCl70024-40-7Treatment of Incontinence- KDMF Valsartan137862-53-4Anti-Hypertensive- KDMF COS & DMF Status 3.  COS & DMF Status 3.

14  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

15  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

16 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

17 Production Facility  Production Facility 1) Reactor

18 Production Facility  Production Facility 2) Dryer 3) Filter

19 Thank you CORYRIGHT (C) DONGBANG FUTURE TECH & LIFE CO.,LTD. ALL RIGHTS RESERVED. CUSTOMER CENTER 82-2-741-7516 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, 110-807, KOREA TEL : 82-2-741-7516~8 FAX : 82-2-741-7525 e-mail : expo1 @ dongbangchem.co.kr - FACTORY 904-5, SANGSIN-RI, HYANGNAM-MYUN, HWASUNG-SI, KYONGGI-DO, 445-922, KOREA TEL : 82-31-354-1114 FAX : 82-31-353-4120 e-mail : qc1 @ dongbangchem.co.kr


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