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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.)

  • [호르몬제(항호르몬제를 포함) 1품목]Methylprednisolone (메틸프레드니솔론)

    Manufacturer

    Tianjin Tianyao Pharmaceuticals Co., Ltd

     

    Specification

    EP/USP

     

    KDMF 등록번호

    20180706-209-J-239

     

    IUPAC Name

    (1R,3aS,3bS,5S,9aR,9bS,10S,11aS)-1,10-dihydroxy-1-(2-hydroxyacetyl)-5,9a,11a-trimethyl-1H,2H,3H,3aH,3bH,4H,5H,7H,9aH,9bH,10H,11H,11aH-cyclopenta[a]phenanthren-7-one

     

    Synonyms

    (6α,11β)-11,17,21-trihydroxy-6-methylpregna-1,4-diene-3,20-dione

    1-dehydro-6α-methylhydrocortisone

    6α-methyl-11β,17α,21-triol-1,4-pregnadiene-3,20-dione

    delta(1)-6alpha-Methylhydrocortisone

     

    Description

    Methylprednisolone is a prednisolone derivative glucocorticoid with higher potency than prednisone.9 It was first described in the literature in the late 1950s.

    Methylprednisolone was granted FDA approval on 24 October 1957.

     

    CAS No.

    83-43-2

     

    Certificate of Analysis

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  • [외피 10품목]Metronidazole (메트로니다졸)

    Manufacturer

    Wuhan Wuyao Pharmaceutical Co., Ltd

     

    Specification

    EP

     

    KDMF 등록번호

    20160114-104-F-83-03(6)

     

    IUPAC Name

    2-(2-methyl-5-nitro-1H-imidazol-1-yl)ethan-1-ol

     

    Synonyms

    1-(2-hydroxy-1-ethyl)-2-methyl-5-nitroimidazole

    1-(2-hydroxyethyl)-2-methyl-5-nitroimidazole

    1-(β-ethylol)-2-methyl-5-nitro-3-azapyrrole

    1-(β-hydroxyethyl)-2-methyl-5-nitroimidazole

    1-(β-oxyethyl)-2-methyl-5-nitroimidazole

    2-methyl-1-(2-hydroxyethyl)-5-nitroimidazole

    2-methyl-3-(2-hydroxyethyl)-4-nitroimidazole

    2-methyl-5-nitroimidazole-1-ethanol

     

    Description

    Metronidazole is a commonly used antibiotic, belonging to the nitroimidazole class of antibiotics. It is frequently used to treat gastrointestinal infections as well as trichomoniasis and giardiasis, and amebiasis which are parasitic infections. Metronidazole has been used as an antibiotic for several decades, with added antiparasitic properties that set it apart from many other antibacterial drugs, allowing it to treat a wide variety of infections. It is available in capsule form, tablet form, and topical form, and suppository preparations for the treatment of various infections.

     

    CAS No.

    443-48-1

     

    Certificate of Analysis

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  • [외피 10품목]Mometasone Furoate (모메타손푸로에이트)

    Manufacturer

    Symbiotica Speciality Ingredients Sdn. Bhd.

     

    Specification

    EP

     

    KDMF 등록번호

    20210225-211-J-570

     

    IUPAC Name

    9,21-Dichloro-11β-hydroxy-16α-methyl-3,20-dioxopregna-1,4-diene-17-yl furan-2-carboxylate

     

    Synonyms

    Sch-32088

    Elocon

    Nasonex

     

    Description

    Mometasone furoate is a topical corticosteroids of moderate efficacy.

    The mechanism of action of topical corticosteroids is not well defined. However, it is thought that the three important actions: anti-inflammatory action, immunosuppressive action, and proliferation inhibitory action, are combined to show the effect.

     

    CAS No.

    83919-23-7

     

    Certificate of Analysis

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  • [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

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  • [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

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  • [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

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  • [화학료법제 9품목]Ofloxacin (오플록사신)

    Manufacturer

    Zhejiang East- Asia Pharmaceutical Co., LTd

     

    Specification

    USP

     

    KDMF 등록번호

    20070723-89-E-2-02(20)

     

    IUPAC Name

    7-fluoro-2-methyl-6-(4-methylpiperazin-1-yl)-10-oxo-4-oxa-1-azatricyclo[7.3.1.0⁵,¹³]trideca-5(13),6,8,11-tetraene-11-carboxylic acid

     

    Synonyms

    8-Fluoro-3-methyl-9-(4-methyl-piperazin-1-yl)-6-oxo-2,3-dihydro-6H-1-oxa-3a-aza-phenalene-5-carboxylic acid

     

    Description

    A synthetic fluoroquinolone (fluoroquinolones) antibacterial agent that inhibits the supercoiling activity of bacterial DNA gyrase, halting DNA replication.

     

    CAS No.

    82419-36-1

     

    Certificate of Analysis

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  • [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

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  • [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

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  • [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

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  • [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

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  • [중추신경계 21품목]Quetiapine Fumarate (쿠에티아핀푸마르산염)

    Manufacturer

    Mylan Laboratories Limited

    Qilu Tianhe Pharmaceutical Co., Ltd.

     

    Specification

    USP

     

    KDMF 등록번호

    20120713-172-I-90-05

     

    IUPAC Name

    2-[2-(4-{2-thia-9-azatricyclo[9.4.0.0³,⁸]pentadeca-1(15),3,5,7,9,11,13-heptaen-10-yl}piperazin-1-yl)ethoxy]ethan-1-ol

     

    Synonyms

    2-[2-(4-Dibenzo[b,f][1,4]thiazepin-11-yl-1-piperazinyl)ethoxy]ethanol

     

    Description

    Initially approved by the FDA in 1997, quetiapine is a second-generation atypical antipsychotic used in schizophrenia, major depression, and bipolar disorder. Quetiapine demonstrates a high level of therapeutic efficacy and low risk of adverse effects during long-term treatment. It is well-tolerated and a suitable option for some patients with high sensitivity to other drugs, such as Clozapine and Olanzapine.

     

    CAS No.

    111974-72-2

     

    Certificate of Analysis

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  • [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

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  • [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

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  • [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

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