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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.)

  • [호흡기관 3품목]Formoterol Fumarate (포르모테롤푸마르산염)

    Manufacturer

    Mylan Laboratories Limited (Unit-11)

     

    Specification

    EP

     

    KDMF 등록번호

    20111202-187-I-22-11

     

    IUPAC Name

    N-[2-hydroxy-5-(1-hydroxy-2-{[1-(4-methoxyphenyl)propan-2-yl]amino}ethyl)phenyl]formamide

     

    Synonyms

    2'-hydroxy-5'-(1-hydroxy-2-((p-methoxy-α-methylphenethyl)amino)ethyl)formanilide, Formoterol

     

    Description

    Formoterol is an inhaled beta2-agonist used in the management of COPD and asthma that was first approved for use in the United States in 2001. It acts on bronchial smooth muscle to dilate and relax airways, and is administered as a racemic mixture of its active (R;R)- and inactive (S;S)-enantiomers. A major clinical advantage of formoterol over other inhaled beta-agonists is its rapid onset of action (2-3 minutes), which is at least as fast as salbutamol, combined with a long duration of action (12 hours) - for this reason, treatment guidelines for asthma recommend its use as both a reliever and maintenance medication. It is available as a single-entity product and in several formulations in combination with both inhaled corticosteroids and long-acting muscarinic antagonists.

     

    CAS No.

    43229-80-7

     

    Certificate of Analysis

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  • [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

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  • [혈액 및 체액 1품목]Heparin Sodium (헤파린나트륨)

    Manufacturer

    Yantai Dongcheng Biochemicals Co., Ltd.

     

    Specification

    EP

     

    KDMF 등록번호

    20100211-124-G-17-01(13)

     

    IUPAC Name

    N/A

     

    Synonyms

    N/A

     

    Description

    Unfractionated heparin (UH) is a heterogenous preparation of anionic, sulfated glycosaminoglycan polymers with weights ranging from 3000 to 30,000 Da. It is a naturally occurring anticoagulant released from mast cells. It binds reversibly to antithrombin III (ATIII) and greatly accelerates the rate at which ATIII inactivates coagulation enzymes thrombin (factor IIa) and factor Xa. UH is different from low molecular weight heparin (LMWH) in the following ways: the average molecular weight of LMWH is about 4.5 kDa whereas it is 15 kDa for UH; UH requires continuous infusions; activated partial prothrombin time (aPTT) monitoring is required when using UH; and UH has a higher risk of bleeding and higher risk of osteoporosis in long term use. Unfractionated heparin is more specific than LMWH for thrombin. Furthermore, the effects of UH can typically be reversed by using protamine sulfate.

     

    CAS No.

    9005-49-6

     

    Certificate of Analysis

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  • [비타민제 2품목]Isotretinoin (이소트레티노인)

    Manufacturer

    Chongqing Huapont Shengchem Pharmaceutical Co., Ltd.

     

    Specification

    USP+In-house

     

    KDMF 등록번호

    20171226-209-J-4

     

    IUPAC Name

    (2Z,4E,6E,8E)-3,7-dimethyl-9-(2,6,6-trimethylcyclohex-1-en-1-yl)nona-2,4,6,8-tetraenoic acid

     

    Synonyms

    (7E,9E,11E,13Z)-retinoic acid

    13-cis-retinoic acid

    13-cis-Vitamin A acid

    13-RA

    cis-RA

     

    Description

    Isotretinoin is a retinoid derivative of vitamin A used in the treatment of severe recalcitrant acne.It was most widely marketed under the brand name Accutane, which has since been discontinued.Isotretinoin is associated with major risks in pregnancy and so it is only available under the iPLEDGE program in the United States. The first isotretinoin containing product was FDA approved on 7 May 1982.

     

    CAS No.

    4759-48-2

     

    Certificate of Analysis

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  • [외피 8품목]Ketoconazole (케토코나졸)

    Manufacturer

    Zhejiang East-Asia Phamaceutical Co.,Ltd

     

    Specification

    USP

     

    KDMF 등록번호

    20190111-167-I-565-06

     

    IUPAC Name

    1-[4-(4-{[2-(2,4-dichlorophenyl)-2-(1H-imidazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy}phenyl)piperazin-1-yl]ethan-1-one

     

    Synonyms

    N/A 

     

    Description

    Ketoconazole is an imidazole antifungal agent used in the prevention and treatment of a variety of fungal infections.Label It functions by preventing the synthesis of ergosterol, the fungal equivalent of cholesterol, thereby increasing membrane fluidity and preventing growth of the fungus.5,11 Ketoconazole was first approved in an oral formulation for systemic use by the FDA in 1981.9 At this time it was considered a significant improvement over previous antifungals, miconazole and clotrimazole, due to its broad spectrum and good absorption. However, it was discovered that ketoconazole produces frequent gastrointestinal side effects and dose-related hepatitis.9,10 These effects combined with waning efficacy led to its eventual replacement by triazole agents, fluconazole, itraconazole, [voraconazole], and posaconazole. Ketoconazole and its predecessor clotrimazole continue to be used in topical formulations.

     

    CAS No.

    65277-42-1

     

    Certificate of Analysis

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  • [중추신경계 21품목]Ketorolac Tromethamine (케토롤락트로메타민)

    Manufacturer

    Saurav Chemicals Limited

     

    Specification

    USP

     

    KDMF 등록번호

    20170926-61-C-362-12

     

    IUPAC Name

    5-benzoyl-2,3-dihydro-1H-pyrrolizine-1-carboxylic acid

     

    Synonyms

    rac-Ketorolac

     

    Description

    Ketorolac is a Non-steroidal anti-inflammatory drug (NSAID) and is commercially available as an oral tablet, injectable, nasal spray and as an ophthalmic solution. It's analgesic properties make it a useful pain management tool across many settings including postoperative pain, rheumatoid arthritis, osteoarthritis, menstrual disorders, headaches, spinal and soft tissue pain, and ankylosing spondylitis. Impressively, ketorolac has a similar efficacy to standard doses of morphine and meperidine making it a useful opioid sparing agent.

     

    CAS No.

    74103-07-4

     

    Certificate of Analysis

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  • [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

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  • [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

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  • [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

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  • [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

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  • [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

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  • [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

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  • [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

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  • [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 8품목]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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