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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.)

  • [중추신경계 21품목]Rasagiline Mesylate (라사길린메실산염)

    Manufacturer

    Mylan Laboratories Limited

     

    Specification

    In-house

     

    KDMF 등록번호

    수289-6-ND

     

    IUPAC Name

    (1R)-N-(prop-2-yn-1-yl)-2,3-dihydro-1H-inden-1-amine

     

    Synonyms

    (1R)-N-propargylindan-1-amine

    (R)-indan-1-yl-prop-2-ynyl-amine

    (R)-N-2-Propynyl-1-indanamine

     

    Description

    Rasagiline is an irreversible inhibitor of monoamine oxidase and is used as a monotherapy in early Parkinson's disease or as an adjunct therapy in more advanced cases.

     

    CAS No.

    136236-51-6

     

    Certificate of Analysis

    If you need more information, please contact us.

     

  • [소화기관 7품목]Rebamipide (레바미피드)

    Manufacturer

    Suzhou Tianma Specialty Chemicals Co.,Ltd
    Jiangxi Synergy Pharmaceutical Co., Ltd

     

    Specification

    JP

     

    KDMF 등록번호

    20160725-4-B-387-21(2)
    20070504-4-B-240-14(3)

     

    IUPAC Name

    90098-04-7

     

    Synonyms

    N/A

     

    Description

    Rebamipide has been investigated for the treatment of Stomach Ulcer, Keratoconjunctivitis Sicca, and Gastric Adenoma and Early Gastric Cancer.

     

    CAS No.

    90098-04-7

     

    Certificate of Analysis

    If you need more information, please contact us.

     

  • [중추신경계 21품목]Risperidone (리스페리돈)

    Manufacturer

    Mylan Laboratories Limited
    Aurobindo Pharma ltd.

     

    Specification

    EP

     

    KDMF 등록번호

    20151130-10-C-349-20
    20070521-10-C-231-14(1)

     

    IUPAC Name

    RAPZEAPATHNIPO-UHFFFAOYSA-N

     

    Synonyms

    N/A

     

    Description

    Risperidone is a second-generation antipsychotic (SGA) medication used in the treatment of a number of mood and mental health conditions including schizophrenia, bipolar mania, and as an adjunct in severe depression for example. It is one of the most widely used SGAs.

    Schizophrenia and various mood disorders are thought to be caused by an excess of dopaminergic D2 and serotonergic 5-HT2A activity, resulting in overactivity of central mesolimbic pathways and mesocortical pathways, respectively. Risperidone is thought to reduce this overactivity through inhibition of dopaminergic D2 receptors and serotonergic 5-HT2A receptors in the brain.

    Risperidone binds with a very high affinity to 5-HT2A receptors, approximately 10-20 fold greater than the drug's binding affinity to D2 receptors

     

    CAS No.

    106266-06-2

     

    Certificate of Analysis

    If you need more information, please contact us.

     

  • [항생물질제제 2품목]Roxithromycin (록시트로마이신)

    Manufacturer

    Zhejiang Zhenyuan Pharmaceutical Co. Ltd.

     

    Specification

    EP/In-house

     

    KDMF 등록번호

    20050831-9-A-2-02(12)

     

    IUPAC Name

    (3R,4S,5S,6R,7R,9R,11S,12R,13S,14R)-6-{[(2S,3R,4S,6R)-4-(dimethylamino)-3-hydroxy-6-methyloxan-2-yl]oxy}-14-ethyl-7,12,13-trihydroxy-4-{[(2R,4R,5S,6S)-5-hydroxy-4-methoxy-4,6-dimethyloxan-2-yl]oxy}-3,5,7,9,11,13-hexamethyl-10-(2,4,7-trioxa-1-azaoctan-1-ylidene)-1-oxacyclotetradecan-2-one

     

    Synonyms

    (9E)-erythromycin 9-(O-((2-methoxyethoxy)methyl)oxime)

     

    Description

    Roxithromycin is a semi-synthethic macrolide antibiotic that is structurally and pharmacologically similar to erythromycin, azithromycin, or clarithromycin. It was shown to be more effective against certain Gram-negative bacteria, particularly Legionella pneumophila. Roxithromycin exerts its antibacterial action by binding to the bacterial ribosome and interfering with bacterial protein synthesis. It is marketed in Australia as a treatment for respiratory tract, urinary and soft tissue infections.

     

    CAS No.

    80214-83-1

     

    Certificate of Analysis

    If you need more information, please contact us.

     

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