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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]Naftifine Hydrochloride (나프티핀염산염)

    Manufacturer

    Chongqing Huapont Shengchem Pharmaceutical Co., Ltd.

     

    Specification

    USP

     

    KDMF 등록번호

    20200618-211-J-455

     

    IUPAC Name

    1-naphthalenemethanamine,N-methyl-N-(3-phenyl-2-propenyl)-,hydrochloride(E)-(E)-N-Cinnamyl-N-methyl-1-naphthalenemethylamine hydrochloride

     

    Description

    It is a synthetic alkylamine derivative with a broad antifungal range.

    It inhibits squalene epoxidases, which are important enzymes for sterol biosynthesis, and exhibits antifungal action by depleting ergosterol in the fungal cell membrane.

     

    CAS No.

    65473-14-5

     

    Certificate of Analysis

    If you need more information, please contact us.

     

  • [중추신경계 21품목]Naproxen (나프록센)

    Manufacturer

    Divi’s Laboratories Limited.

     

    Specification

    USP

     

    KDMF 등록번호

    20130821-143-I-336-08(3)

     

    IUPAC Name

    (2S)-2-(6-methoxynaphthalen-2-yl)propanoic acid

     

    Synonyms

    (+)-(S)-6-Methoxy-α-methyl-2-naphthaleneacetic acid

    (+)-(S)-Naproxen

    (+)-2-(6-Methoxy-2-naphthyl)propionic acid

    (+)-2-(Methoxy-2-naphthyl)-propionic acid

    (+)-2-(Methoxy-2-naphthyl)-propionsäure

    (+)-Naproxen

    (S)-(+)-2-(6-Methoxy-2-naphthyl)propionic acid

    (S)-(+)-Naproxen

    (S)-2-(6-Methoxy-2-naphthyl)propanoic acid

    (S)-2-(6-Methoxy-2-naphthyl)propionic acid

    (S)-6-Methoxy-alpha-methyl-2-naphthaleneacetic acid

    (S)-Naproxen

    Description

    Naproxen is classified as a nonsteroidal anti-inflammatory dug (NSAID) and was initially approved for prescription use in 1976 and then for over-the-counter (OTC) use in 1994. It can effectively manage acute pain as well as pain related to rheumatic diseases, and has a well studied adverse effect profile. Given it's overall tolerability and effectiveness, naproxen can be considered a first line treatment for a variety of clinical situations requiring analgesia. Naproxen is available in both immediate and delayed release formulations, in combination with sumatriptan to treat migraines, and in combination with esomeprazole to lower the risk of developing gastric ulcers.

     

    CAS No.

    22204-53-1

     

    Certificate of Analysis

    If you need more information, please contact us.

     

  • [중추신경계 21품목]Naproxen Sodium (나프록센나트륨)

    Manufacturer

    Zhejiang Charioteer Pharmaceutical Co., Ltd.

     

    Specification

    USP

     

    KDMF 등록번호

    20130121-143-I-209-04(6)

     

    IUPAC Name

    sodium (2S)-2-(6-methoxynaphthalen-2-yl)propanoate

     

    Synonyms

    N/A

     

    Description

    Naproxen is classified as a nonsteroidal anti-inflammatory dug (NSAID) and was initially approved for prescription use in 1976 and then for over-the-counter (OTC) use in 1994. It can effectively manage acute pain as well as pain related to rheumatic diseases, and has a well studied adverse effect profile. Given it's overall tolerability and effectiveness, naproxen can be considered a first line treatment for a variety of clinical situations requiring analgesia. Naproxen is available in both immediate and delayed release formulations, in combination with sumatriptan to treat migraines, and in combination with esomeprazole to lower the risk of developing gastric ulcers

     

    CAS No.

    26159-34-2

     

    Certificate of Analysis

    If you need more information, please contact us.

     

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