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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.)

  • [호르몬제(항호르몬제를 포함) 1품목]Methylprednisolone (메틸프레드니솔론)

    Manufacturer

    Tianjin Tianyao Pharmaceuticals Co., Ltd

     

    Specification

    EP/USP

     

    KDMF 등록번호

    20180706-209-J-239

     

    IUPAC Name

    (1R,3aS,3bS,5S,9aR,9bS,10S,11aS)-1,10-dihydroxy-1-(2-hydroxyacetyl)-5,9a,11a-trimethyl-1H,2H,3H,3aH,3bH,4H,5H,7H,9aH,9bH,10H,11H,11aH-cyclopenta[a]phenanthren-7-one

     

    Synonyms

    (6α,11β)-11,17,21-trihydroxy-6-methylpregna-1,4-diene-3,20-dione

    1-dehydro-6α-methylhydrocortisone

    6α-methyl-11β,17α,21-triol-1,4-pregnadiene-3,20-dione

    delta(1)-6alpha-Methylhydrocortisone

     

    Description

    Methylprednisolone is a prednisolone derivative glucocorticoid with higher potency than prednisone.9 It was first described in the literature in the late 1950s.

    Methylprednisolone was granted FDA approval on 24 October 1957.

     

    CAS No.

    83-43-2

     

    Certificate of Analysis

    If you need more information, please contact us.

  • [외피 10품목]Metronidazole (메트로니다졸)

    Manufacturer

    Wuhan Wuyao Pharmaceutical Co., Ltd

     

    Specification

    EP

     

    KDMF 등록번호

    20160114-104-F-83-03(6)

     

    IUPAC Name

    2-(2-methyl-5-nitro-1H-imidazol-1-yl)ethan-1-ol

     

    Synonyms

    1-(2-hydroxy-1-ethyl)-2-methyl-5-nitroimidazole

    1-(2-hydroxyethyl)-2-methyl-5-nitroimidazole

    1-(β-ethylol)-2-methyl-5-nitro-3-azapyrrole

    1-(β-hydroxyethyl)-2-methyl-5-nitroimidazole

    1-(β-oxyethyl)-2-methyl-5-nitroimidazole

    2-methyl-1-(2-hydroxyethyl)-5-nitroimidazole

    2-methyl-3-(2-hydroxyethyl)-4-nitroimidazole

    2-methyl-5-nitroimidazole-1-ethanol

     

    Description

    Metronidazole is a commonly used antibiotic, belonging to the nitroimidazole class of antibiotics. It is frequently used to treat gastrointestinal infections as well as trichomoniasis and giardiasis, and amebiasis which are parasitic infections. Metronidazole has been used as an antibiotic for several decades, with added antiparasitic properties that set it apart from many other antibacterial drugs, allowing it to treat a wide variety of infections. It is available in capsule form, tablet form, and topical form, and suppository preparations for the treatment of various infections.

     

    CAS No.

    443-48-1

     

    Certificate of Analysis

    If you need more information, please contact us.

     

  • [외피 10품목]Mometasone Furoate (모메타손푸로에이트)

    Manufacturer

    Symbiotica Speciality Ingredients Sdn. Bhd.

     

    Specification

    EP

     

    KDMF 등록번호

    20210225-211-J-570

     

    IUPAC Name

    9,21-Dichloro-11β-hydroxy-16α-methyl-3,20-dioxopregna-1,4-diene-17-yl furan-2-carboxylate

     

    Synonyms

    Sch-32088

    Elocon

    Nasonex

     

    Description

    Mometasone furoate is a topical corticosteroids of moderate efficacy.

    The mechanism of action of topical corticosteroids is not well defined. However, it is thought that the three important actions: anti-inflammatory action, immunosuppressive action, and proliferation inhibitory action, are combined to show the effect.

     

    CAS No.

    83919-23-7

     

    Certificate of Analysis

    If you need more information, please contact us.

     

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