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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.)

  • [외피 10품목]Ketoconazole (케토코나졸)

    Manufacturer

    Zhejiang East-Asia Phamaceutical Co.,Ltd

     

    Specification

    USP

     

    KDMF 등록번호

    20190111-167-I-565-06

     

    IUPAC Name

    1-[4-(4-{[2-(2,4-dichlorophenyl)-2-(1H-imidazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy}phenyl)piperazin-1-yl]ethan-1-one

     

    Synonyms

    N/A 

     

    Description

    Ketoconazole is an imidazole antifungal agent used in the prevention and treatment of a variety of fungal infections.Label It functions by preventing the synthesis of ergosterol, the fungal equivalent of cholesterol, thereby increasing membrane fluidity and preventing growth of the fungus.5,11 Ketoconazole was first approved in an oral formulation for systemic use by the FDA in 1981.9 At this time it was considered a significant improvement over previous antifungals, miconazole and clotrimazole, due to its broad spectrum and good absorption. However, it was discovered that ketoconazole produces frequent gastrointestinal side effects and dose-related hepatitis.9,10 These effects combined with waning efficacy led to its eventual replacement by triazole agents, fluconazole, itraconazole, [voraconazole], and posaconazole. Ketoconazole and its predecessor clotrimazole continue to be used in topical formulations.

     

    CAS No.

    65277-42-1

     

    Certificate of Analysis

    If you need more information, please contact us

     

  • [중추신경계 21품목]Ketorolac Tromethamine (케토롤락트로메타민)

    Manufacturer

    Saurav Chemicals Limited

     

    Specification

    USP

     

    KDMF 등록번호

    20170926-61-C-362-12

     

    IUPAC Name

    5-benzoyl-2,3-dihydro-1H-pyrrolizine-1-carboxylic acid

     

    Synonyms

    rac-Ketorolac

     

    Description

    Ketorolac is a Non-steroidal anti-inflammatory drug (NSAID) and is commercially available as an oral tablet, injectable, nasal spray and as an ophthalmic solution. It's analgesic properties make it a useful pain management tool across many settings including postoperative pain, rheumatoid arthritis, osteoarthritis, menstrual disorders, headaches, spinal and soft tissue pain, and ankylosing spondylitis. Impressively, ketorolac has a similar efficacy to standard doses of morphine and meperidine making it a useful opioid sparing agent.

     

    CAS No.

    74103-07-4

     

    Certificate of Analysis

    If you need more information, please contact us.

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