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KDMF APIs

의약품을 만드는데 중요한 성분으로 들어가는 원료로서 API(Active Pharmaceutical Ingredient)라고 한다. 
원료의약품은 의약품의 유효한 성분으로서 질병의 진단, 치료, 경감, 처치, 예방에 직접적인 효과를 보이거나 약리를 활성화시키거나 신체의 구조와 기능에 영향을 주는 물질이다. (KDMF-Holder, 허여등록 품목을 모두 표시하였습니다.)

  • [화학료법제 9품목]Ethambutol Hydrochloride (에탐부톨염산염)

    Manufacturer

    Wuhan Wuyao Pharmaceutical Co.,Ltd.

     

    Specification

    EP

     

    KDMF 등록번호

    20190404-211-J-331

     

    IUPAC Name

    (2S)-2-[(2-{[(2S)-1-hydroxybutan-2-yl]amino}ethyl)amino]butan-1-ol

     

    Synonyms

    • (+)-2,2'-(ethylenediimino)di-1-butanol
    • (+)-ethambutol
    • (+)-N,N'-bis(1-(hydroxymethyl)propyl)ethylenediamine
    • (+)-S,S-ethambutol
    • (2S,7S)-2,7-diethyl-3,6-diazaoctane-1,8-diol
    • (S,S)-ethambutol

     

    Description

    An antitubercular agent that inhibits the transfer of mycolic acids into the cell wall of the tubercle bacillus. It may also inhibit the synthesis of spermidine in mycobacteria. The action is usually bactericidal, and the drug can penetrate human cell membranes to exert its lethal effect. (From Smith and Reynard, Textbook of Pharmacology, 1992, p863)

     

    CAS No.

    74-55-5

     

    Certificate of Analysis

    If you need more information, please contact us.

     

  • [중추신경계 21품목]Etoricoxib (에토리콕시브)

    Manufacturer

    Mylan Laboratories Limited

     

    Specification

    In-house

     

    KDMF 등록번호

    20190220-209-J-133

     

    IUPAC Name

    5-chloro-3-(4-methanesulfonylphenyl)-2-(6-methylpyridin-3-yl)pyridine

     

    Synonyms

    5-chloro-2-(6-methylpyridin-3-yl)-3-(4-(methylsulfonyl)phenyl)pyridine

    5-Chloro-3-(4-methanesulfonyl-phenyl)-6'-methyl-[2,3']bipyridinyl

    5-chloro-6'-methyl-3-(p-(methylsulfonyl)phenyl)-2,3'-bipyridine

     

    Description

    Etoricoxib is a new COX-2 selective inhibitor. Current therapeutic indications are: treatment of rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, chronic low back pain, acute pain and gout. Like any other COX-2 selective inhibitor, Etoricoxib selectively inhibits isoform 2 of cyclo-oxigenase enzyme (COX-2) to reduce the generation of prostaglandins (PGs) from arachidonic acid. It is approved in more than 60 countries worldwide but not in the US.

     

    CAS No.

    202409-33-4

     

    Certificate of Analysis

    If you need more information, please contact us.

     

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