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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.)

  • [순환계 9품목]Lercanidipine Hydrochloride (레르카니디핀염산염)

    Manufacturer

    Sun Pharmacetical Industries Ltd.

     

    Specification

    In-house

     

    KDMF 등록번호

    20101130-128-H-34-05(3)

     

    IUPAC Name

    3-{1-[(3,3-diphenylpropyl)(methyl)amino]-2-methylpropan-2-yl} 5-methyl 2,6-dimethyl-4-(3-nitrophenyl)-1,4-dihydropyridine-3,5-dicarboxylate

     

    Synonyms

    N/A

     

    Description

    Lercanidipine is a calcium channel blocker of the dihydropyridine class. It is sold under various commercial names including Zanidip.

     

    CAS No.

    100427-26-7

     

    Certificate of Analysis

    If you need more information, please contact us.

     

  • [중추신경계 21품목]Levetiracetam (레비티라세탐)

    Manufacturer

    Aurobindo Pharma Limited (Unit-XI)

     

    Specification

    USP

     

    KDMF 등록번호

    20120302-183-I-34-01(1)

     

    IUPAC Name

    (2S)-2-(2-oxopyrrolidin-1-yl)butanamide

     

    Synonyms

    N/A

     

    Description

    Levetiracetam is a drug within the pyrrolidine class that is used to treat various types of seizures stemming from epileptic disorders. It was first approved for use in the United States in 1999 and is structurally and mechanistically unrelated to other anti-epileptic drugs (AEDs). Levetiracetam possesses a wide therapeutic index and little-to-no potential to produce, or be subject to, pharmacokinetic interactions - these characteristics make it a desirable choice over other AEDs, a class of drugs notorious for having generally narrow therapeutic indexes and a propensity for involvement in drug interactions.

     

    CAS No.

    102767-28-2

     

    Certificate of Analysis

    If you need more information, please contact us.

  • [알레르기 3품목]Levocetirizine dihydrochloride (레보세티리진염산염)

    Manufacturer

    RA Chem Pharma Limitied

     

    Specification

    USP

     

    KDMF 등록번호

    20110429-40-C-279-18

     

    IUPAC Name

    2-(2-{4-[(R)-(4-chlorophenyl)(phenyl)methyl]piperazin-1-yl}ethoxy)acetic acid

     

    Synonyms

    2-(2-{4-[(R)-(4-chlorophenyl)(phenyl)methyl]piperazin-1-yl}ethoxy)acetic acid

     

    Description

    Levocetirizine is a selective histamine H1 antagonist used to treat a variety of allergic symptoms. It is the R enantiomer of cetirizine. Levocetirizine has greater affinity for the histamine H1 receptor than cetirizine.

     

    Levocetirizine was granted FDA approval in 1995.

     

    CAS No.

    130018-87-C

     

    Certificate of Analysis

    If you need more information, please contact us.

  • [감각기관 2품목]Levofloxacin Hydrate (레보플로사신수화물)

    Manufacturer

    Zhejiang East-asia Pharmaceutical Co., Ltd.

     

    Specification

    USP

     

    KDMF 등록번호

    20100414-102-F-50-10(10)

     

    IUPAC Name

    (2S)-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

    (-)-Ofloxacin

    (3S)-(-)-9-fluoro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-2,3-dihydro-7H-pyrido[1,2,3-de][1,4]benzoxazine-6-carboxylic acid

    (S)-(-)-9-fluoro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-2,3-dihydro-7H-pyrido[1,2,3-de][1,4]benzooxazine-6-carboxylic acid

    (S)-9-Fluoro-2,3-dihydro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-7H-pyrido(1,2,3-de)-1,4-benzoxazine-6-carboxylic acid

    (S)-Ofloxacin

    L-Ofloxacin

    Levofloxacin

     

    Description

    Levofloxacin is a fluoroquinolone antibiotic and the optical S-(-) isomer of racemic ofloxacin. It reportedly carries 8 to 128-fold more activity against both gram-negative and gram-positive bacteria compared to R-(+)-ofloxacin and remains stereochemically stable following administration (i.e. it does not invert to the inactive isomer).Levofloxacin, along with other quinolones such as gatifloxacin and moxifloxacin, is a member of the third generation of fluoroquinolones, colloquially referred to as the "respiratory quinolones" due to improved activity against gram-positive bacteria commonly implicated in respiratory infections.

    Levofloxacin was first approved by the FDA in 1996, and was approved in Canada and several South American countries soon after.

     

    CAS No.

    100986-85-4

     

    Certificate of Analysis

    If you need more information, please contact us.

     

  • [화학료법제 9품목]Levofloxacin hydrate (레보플록사신수화물)

    Manufacturer

    Zhejiang East-Asia Pharmaceutical Co., Ltd.

     

    Specification

    USP

     

    KDMF 등록번호

    20100414-102-F-50-10(10)

     

    IUPAC Name

    bis((2S)-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) hydrate

     

    Synonyms

    L-ofloxacin / Levofloxacin / Levofloxacin (as hemihydrate) / Levofloxacin hydrate / Ofloxacin S-(-)-form hemihydrate

     

    Description

    Levofloxacin is a fluoroquinolone antibiotic and the optical S-(-) isomer of racemic ofloxacin. It reportedly carries 8 to 128-fold more activity against both gram-negative and gram-positive bacteria compared to R-(+)-ofloxacin1 and remains stereochemically stable following administration (i.e. it does not invert to the inactive isomer). Levofloxacin, along with other quinolones such as gatifloxacin and moxifloxacin, is a member of the third generation of fluoroquinolones, colloquially referred to as the "respiratory quinolones" due to improved activity against gram-positive bacteria commonly implicated in respiratory infections.

    Levofloxacin was first approved by the FDA in 1996, and was approved in Canada and several South American countries soon after.1

     

    CAS No.

    1381997-71-0

     

    Certificate of Analysis

    If you need more information, please contact us.

     

  • [소화기관 7품목]Levosulpiride (레보설피리드)

    Manufacturer

    Jiangsu Tasly DiYi Pharmaceutical Co., Ltd

     

    Specification

    KP

     

    KDMF 등록번호

    20190226-5-B-415-12

     

    IUPAC Name

    N/A

     

    Synonyms

    N/A

     

    Description

    N/A

     

    CAS No.

    N/A

     

    Certificate of Analysis

    If you need more information, please contact us.

     

  • [순환계 9품목]Losartan Potassium (로사르탄칼륨)

    Manufacturer

    IPCA Laboratories Limited / Zhejiang Huahai Pharmacetical Co., Ltd / Zhejiang Tianyu Pharmaceutical Co., Ltd

     

    Specification

    USP

     

    KDMF 등록번호

    20100226-122-G-47-16(2) / 20100226-122-G-72-17(7) / 20100616-122-G-60-22(12)

     

    IUPAC Name

    potassium 5-[2-(4-{[2-butyl-4-chloro-5-(hydroxymethyl)-1H-imidazol-1-yl]methyl}phenyl)phenyl]-1,2,3,4-tetrazol-2-uide

     

    Synonyms

    N/A

     

    Description

    Losartan is an angiotensin II receptor blocker (ARB) used to treat hypertension. Angiotensin-converting enzyme (ACE) inhibitors are used for a similar indication but are associated with a cough. When patients with ACE inhibitor associated coughs are switched to ARBs like losartan, they have an incidence of cough similar to placebo or hydrochlorothiazide. Losartan is available as losartan potassium oral tablets as well as a combination tablet of losartan potassium and hydrochlorothiazide. Patients taking losartan should have their renal function and potassium levels monitored. Losartan was granted FDA approval on 14 April 1995.

     

    CAS No.

    124750-99-8

     

    Certificate of Analysis

    If you need more information, please contact us.

     

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