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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]Gabapentin (가바펜틴)

    Manufacturer

    Jiangxi Synergy Pharmaceutical Co., Ltd

     

    Specification

    USP

     

    KDMF 등록번호

    20120831-142-I-75-05(6)

     

    IUPAC Name

    2-[1-(aminomethyl)cyclohexyl]acetic acid

     

    Synonyms

    1-(Aminomethyl)cyclohexaneacetic acid

     

    Description

    Gabapentin is a structural analogue of the inhibitory neurotransmitter gamma-aminobutyric acid (GABA) that was first approved for use in the United States in 1993. It was originally developed as a novel anti-epileptic for the treatment of certain types of seizures - today it is also widely used to treat neuropathic pain. Gabapentin has some stark advantages as compared with other anti-epileptics, such as a relatively benign adverse effect profile, wide therapeutic index, and lack of appreciable metabolism making it unlikely to participate in pharmacokinetic drug interactions. It is structurally and functionally related to another GABA derivative, pregabalin.

     

    CAS No.

    60142-96-3

     

    Certificate of Analysis

    If you need more information, please contact us.

     

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