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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]Paroxetine Hydrochloride Hydrate (파록세틴염산염수화물)

    Manufacturer

    Mylan Laboratories Limited

     

    Specification

    EP

     

    KDMF 등록번호

    20191217-209-J-318

     

    IUPAC Name

    (3S,4R)-3-[(2H-1,3-benzodioxol-5-yloxy)methyl]-4-(4-fluorophenyl)piperidine

     

    Synonyms

    (−)-(3S,4R)-4-(p-fluorophenyl)-3-((3,4-(methylenedioxy)phenoxy)methyl)piperidine

    (3S-trans)-3-((1,3-benzodioxol-5-yloxy)methyl)-4-(4-fluorophenyl)piperidine

     

    Description

    Paroxetine is a selective serotonin reuptake inhibitor (SSRI) drug commonly known as Paxil. It has a variety of uses, including the treatment of anxiety disorders, major depression, posttraumatic stress disorder, and symptoms of menopause, among others. It was approved by the FDA in the early 1990s and marketed by SmithKline Beecham. A unique feature of this drug is that it is highly potent and selective in its inhibition of serotonin reuptake and has little effect on other neurotransmitters. Because of its potent inhibition of serotonin reuptake, paroxetine is more likely to cause withdrawal effects upon cessation. Paroxetine is well tolerated in most patients with a similar adverse effect profile to other members of its drug class. The controlled release formulation was designed to decrease the likelihood of nausea that is sometimes associated with paroxetine.

     

    CAS No.

    61869-08-7

     

    Certificate of Analysis

    If you need more information, please contact us.

     

  • [알레르기 3품목]Pranlukast Hydrate (프란루카스트수화물)

    Manufacturer

    Chongqing Shenghuaxi Pharmaceutical Co., Ltd.

     

    Specification

    JP

     

    KDMF 등록번호

    20180809-171-I-571-08

     

    IUPAC Name

    N-[4-oxo-2-(1H-tetrazol-5-yl)-4H-chromen-8-yl]-4-(4-phenylbutoxy)benzamide

     

    Synonyms

    N/A

     

    Description

    Pranlukast is a cysteinyl leukotriene receptor-1 antagonist. It antagonizes or reduces bronchospasm caused, principally in asthmatics, by an allergic reaction to accidentally or inadvertently encountered allergens.

     

    CAS No.

    150821-03-7

     

    Certificate of Analysis

    If you need more information, please contact us.

     

  • [외피 10품목]Prednisolone Acetate (프레드니솔론아세테이트)

    Manufacturer

    Symbiotica Speciality Ingredients Sdn. Bhd.

     

    Specification

    EP

     

    KDMF 등록번호

    20210302-71-B-441-11

     

    IUPAC Name

    11β,17-dihydroxy-3,20-dioxopregna-1,4-dien-21-yl acetate

     

    Synonyms

    Ak-tate

    Hostacortin H

    Inflanefran

    Pred Forte

    Pred Mild

    Sterane

     

    Description

    Prednisolone acetate inhibits the migration of polymorphonuclear luekocytes and reduces the inflammatory response by reducing the increased capillary permeability.

    It suppresses the immune response by reducing the activity and volume of the lymphatic system.

     

    CAS No.

    52-21-1

     

    Certificate of Analysis

    If you need more information, please contact us.

     

  • [외피 10품목]Prednisolone Valeroacetate (프레드니솔론발레로아세테이트)

    Manufacturer

    NEWCHEM S.p.A
    [프레드니솔론 제조소①] Hanan Lihua Pharmaceutical Co., Ltd.
    [프레드니솔론 제조소②] Tianjin Tianyao Pharmaceuticals co., Ltd
    [프레드니솔론 제조소③] Zhejiang Xianju Pharmaceutical Co., Ltd.

     

    Specification

    In-house

     

    KDMF 등록번호

    2011209-71-B-322-06(6)

     

    IUPAC Name

    (1S,2R,10S,11S,14R,15S)-14-hydroxy-14-(2-hydroxyacetyl)-2,15-dimethyltetracyclo[8.7.0.0²,⁷.0¹¹,¹⁵]heptadeca-3,6-diene-5,17-dione

     

    Synonyms

    1,2-Dehydrocortisone

    1,4-Pregnadiene-17α,21-diol-3,11,20-trione

    17,21-Dihydroxypregna-1,4-diene-3,11,20-trione

     

    Description

    A synthetic anti-inflammatory glucocorticoid derived from cortisone. It is biologically inert and converted to prednisolone in the liver.

    Prednisone was granted FDA approval on 21 February 1955.

     

    CAS No.

    53-03-2

     

    Certificate of Analysis

    If you need more information, please contact us.

     

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