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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 8품목]Ciclopirox Olamine (시클로피록스올아민)

    Manufacturer

    Shanghai Pharma Group Changzhou Kony Pharmaceutical Co.,Ltd.

     

    Specification

    USP

     

    KDMF 등록번호

    20180921-209-J-46

     

    IUPAC Name

    6-cyclohexyl-1-hydroxy-4-methyl-1,2-dihydropyridin-2-one

     

    Synonyms

    6-cyclohexyl-1-hydroxy-4-methyl-2(1H)-pyridinone

     

    Description

    Ciclopirox olamine (used in preparations called Batrafen, Loprox, Mycoster, Penlac and Stieprox) is a synthetic antifungal agent for topical dermatologic treatment of superficial mycoses. In particular, the agent is especially effective in treating Tinea versicolor.

     

    CAS No.

    41621-49-2

     

    Certificate of Analysis

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  • [소화기관 7품목]Cimetidine (시메티딘)

    Manufacturer

    Union quimico farmaceutica, S.A

     

    Specification

    USP

     

    KDMF 등록번호

    20060302-27-B-229-04(3)

     

    IUPAC Name

    (Z)-N''-cyano-N-methyl-N'-(2-{[(5-methyl-1H-imidazol-4-yl)methyl]sulfanyl}ethyl)guanidine

     

    Synonyms

    1-Cyano-2-methyl-3-(2-(((5-methyl-4-imidazolyl)methyl)thio)ethyl)guanidine

    2-cyano-1-methyl-3-(2-(((5-methylimidazol-4-yl)methyl)thio)ethyl)guanidine

     

    Description

    A histamine congener, it competitively inhibits histamine binding to histamine H2 receptors. Cimetidine has a range of pharmacological actions. It inhibits gastric acid secretion, as well as pepsin and gastrins output. It also blocks the activity of cytochrome P-450 which might explain proposals for use in neoadjuvant therapy.

     

    CAS No.

    51481-61-9

     

    Certificate of Analysis

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  • [외피 8품목]Clobetasol Propionate (클로베타솔프로피오네이트)

    Manufacturer

    Symbiotica Speciality Ingredients Sdn. Bhd

     

    Specification

    USP

     

    KDMF 등록번호

    20170516-93-E-131-08

     

    IUPAC Name

    (1R,2S,10S,11S,13S,14R,15S,17S)-14-(2-chloroacetyl)-1-fluoro-17-hydroxy-2,13,15-trimethyl-5-oxotetracyclo[8.7.0.0²,⁷.0¹¹,¹⁵]heptadeca-3,6-dien-14-yl propanoate

     

    Synonyms

    21-chloro-9-fluoro-11β,17-dihydroxy-16β-methylpregna-1,4-diene-3,20-dione 17-propionate

     

    Description

    Clobetasol propionate is a prednisolone derivative with higher specificity for glucocorticoid receptors than mineralocorticoid receptors. It has demonstrated superior activity compared to fluocinonide and was first described in the literature in 1974.

     

    Clobetasol Propionate was granted FDA approval on 27 December 1985.

     

    CAS No.

    25122-46-7

     

    Certificate of Analysis

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  • [기타의 대사성 의약품 3품목]Deferasirox (데페라시록스)

    Manufacturer

    Mylan Laboratories Limitted

     

    Specification

    In-house

     

    KDMF 등록번호

    수2816-1ND(2)

     

    IUPAC Name

    4-[bis(2-hydroxyphenyl)-1H-1,2,4-triazol-1-yl]benzoic acid

     

    Synonyms

    Deferasirox

    Deferasiroxum

     

    Description

    Deferasirox is an iron chelator and the first oral medication FDA approved for chronic iron overload in patients receiving long term blood transfusions.

     

    CAS No.

    201530-41-8

     

    Certificate of Analysis

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  • [중추신경계 21품목]Dexibuprofen (덱시부프로펜)

    Manufacturer

    Hubei Biocause Heilen Pharmaceutical

    Solara Active Pharma Sciences Limited

     

    Specification

    In-house

     

    KDMF 등록번호

    20120330-145-I-36-01(5) / 20130208-145-I-184-04(16)

     

    IUPAC Name

    (2S)-2-[4-(2-methylpropyl)phenyl]propanoic acid

     

    Synonyms

    (+)-(S)-p-isobutylhydratropic acid

    (2S)-2-(4-isobutylphenyl)propanoic acid

    (S)-α-methyl-4-(2-methylpropyl)benzeneacetic acid

    d-ibuproten

     

    Description

    Dexibuprofen, S(+)-ibuprofen, is a non-steroidal anti-inflammatory drug (NSAID). It is a pharmacologically effective enantiomer of racemic ibuprofen that differs in physicochemical properties. It is proposed to be more pharmacologically active and tolerable with a better safety profile than ibuprofen due to higher concentration of active S enantiomer. Dexibuprofen has a slower dissolution rate in the simulated gastric and enteric juices compared with the racemic ibuprofen and displays improved oral bioavilability. For Metabolism, Enzymes, Carriers, Transporters Sections, refer to Ibuprofen.

     

    CAS No.

    51146-56-6

     

    Certificate of Analysis

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  • [중추신경계 21품목]Dexibuprofen D.C. (덱시부프로펜디.씨.)

    Manufacturer

    Hubei Biocause Heilen Pharmaceutical

    Specification

    KP

    KDMF 등록번호

    20120406-145-I-37-02(3)

     

    IUPAC Name

    (2S)-2-[4-(2-methylpropyl)phenyl]propanoic acid

     

    Synonyms

    (+)-(S)-p-isobutylhydratropic acid
    (2S)-2-(4-isobutylphenyl)propanoic acid
    (S)-α-methyl-4-(2-methylpropyl)benzeneacetic acid
    d-ibuproten
    Dexibuprofeno

     

    Description

    Dexibuprofen, S(+)-ibuprofen, is a non-steroidal anti-inflammatory drug (NSAID). It is a pharmacologically effective enantiomer of racemic ibuprofen that differs in physicochemical properties. It is proposed to be more pharmacologically active and tolerable with a better safety profile than ibuprofen due to higher concentration of active S enantiomer. Dexibuprofen has a slower dissolution rate in the simulated gastric and enteric juices compared with the racemic ibuprofen and displays improved oral bioavilability 4. For Metabolism, Enzymes, Carriers, Transporters Sections, refer to Ibuprofen.

     

    CAS No.

    51146-56-6

     

    Certificate of Analysis

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  • [소화기관 7품목]Dexlansoprazole (덱스란소프라졸)

    Manufacturer

    Mylan Laboratories Limited (Unit-7)

     

    Specification

    In-house

     

    KDMF 등록번호

    20171024-209-J-174

     

    IUPAC Name

    2-[(R)-[3-methyl-4-(2,2,2-trifluoroethoxy)pyridin-2-yl]methanesulfinyl]-1H-1,3-benzodiazole

     

    Synonyms

    2-((R)-((3-methyl-4-(2,2,2-trifluoroethoxy)-2-pyridinyl)methyl)sulfinyl)-1H-benzimidazol

     

    Description

    Dexlansoprazole is a new generation proton pump inhibitor (PPI) used for the management of symptoms associated with gastroesophageal reflux disease (GERD) and erosive esophagitis. Dexlansoprazole is the R-enantiomer of Lansoprazole, which is composed of a racemic mixture of the R- and S-enantiomers. Compared to the older generation of PPIs (which includes Pantoprazole, Omeprazole, and Lansoprazole), dexlansoprazole MR has a unique pharmacokinetic profile due to its delayed-release and dual-delivery release system. The active ingredient is released in two phases at different pH values and at different time points, resulting in two peak concentrations in the blood; 25% of the dose is released at pH 5.5 in the proximal duodenum, while the remaining 75% is released at pH 6.75 in the distal small intestine. As a result, dexlansoprazole has a peak concentration within 1-2 hours after dosing and another within 4-5 hours. Dexlansoprazole's unique pharmacokinetics addresses limitations of the older generation PPIs including short plasma half-life, break-through symptoms, and need for meal-associated dosing. These characteristics make dexlansoprazole a good option for people who struggle with adherence and strict dosage timing before meals.

     

    CAS No.

    138530-94-6

     

    Certificate of Analysis

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  • [순환계 9품목]Dobesilate Calcium Hydrate (도베실산칼슘수화물)

    Manufacturer

    FSP Galena

     

    Specification

    EP

     

    KDMF 등록번호

    수289-5-ND

     

    IUPAC Name

    calcium 2,5-dihydroxybenzenesulfonate

     

    Synonyms

    Calcium 2,5-Dihydroxybenzenesulfonate Hydrate

    2,5-Dihydroxybenzenesulfonic Acid Calcium Salt Hydrate

     

    Description

    Calcium dobesilate is a vasoprotective. It is the calcium salt of dobesilic acid. It is a synthetic molecule with the ability to reduce capillary permeability in the body. In Italy the drug is sold by the pharmaceutical company OM Pharma under the trade name of Doxium in capsules containing 500 mg of active ingredient.

     

    CAS No.

    20123-80-2

     

    Certificate of Analysis

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  • [호흡기관 3품목]Doxofylline (독소필린)

    Manufacturer

    Ami Lifesciences Private Limited.

     

    Specification

    In-house

     

    KDMF 등록번호

    20181029-209-J-98

     

    IUPAC Name

    7-[(1,3-dioxolan-2-yl)methyl]-1,3-dimethyl-2,3,6,7-tetrahydro-1H-purine-2,6-dione

     

    Synonyms

    Doxophylline

     

    Description

    Doxofylline is a methylxanthine derivative with the presence of a dioxolane group in position 7. As a drug used in the treatment of asthma, doxofylline has shown similar efficacy to theophylline but with significantly fewer side effects in animal and human studies. In contrast with other xanthine derivatives, doxofylline does not significantly bind to adenosine alpha-1 or alpha-2 receptors and lacks stimulating effects. Decreased affinity for adenosine receptors may account for the better safety profile of doxofylline compared to theophylline . Unlike theophylline, doxofylline does not affect calcium influx and does not antagonize the actions of calcium channel blockers which could explain reduced cardiac adverse reactions associated with the drug. The anti-asthmatic effects of doxophylline are mediated by other mechanisms, primarily through inhibiting the activities of the phosphodiesterase (PDE) enzyme.

     

    CAS No.

    69975-86-6

     

    Certificate of Analysis

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  • [화학료법제 9품목]Ethambutol Hydrochloride (에탐부톨염산염)

    Manufacturer

    Wuhan Wuyao Pharmaceutical Co.,Ltd.

     

    Specification

    EP

     

    KDMF 등록번호

    20190404-211-J-331

     

    IUPAC Name

    (2S)-2-[(2-{[(2S)-1-hydroxybutan-2-yl]amino}ethyl)amino]butan-1-ol

     

    Synonyms

    • (+)-2,2'-(ethylenediimino)di-1-butanol
    • (+)-ethambutol
    • (+)-N,N'-bis(1-(hydroxymethyl)propyl)ethylenediamine
    • (+)-S,S-ethambutol
    • (2S,7S)-2,7-diethyl-3,6-diazaoctane-1,8-diol
    • (S,S)-ethambutol

     

    Description

    An antitubercular agent that inhibits the transfer of mycolic acids into the cell wall of the tubercle bacillus. It may also inhibit the synthesis of spermidine in mycobacteria. The action is usually bactericidal, and the drug can penetrate human cell membranes to exert its lethal effect. (From Smith and Reynard, Textbook of Pharmacology, 1992, p863)

     

    CAS No.

    74-55-5

     

    Certificate of Analysis

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  • [중추신경계 21품목]Etoricoxib (에토리콕시브)

    Manufacturer

    Mylan Laboratories Limited

     

    Specification

    In-house

     

    KDMF 등록번호

    20190220-209-J-133

     

    IUPAC Name

    5-chloro-3-(4-methanesulfonylphenyl)-2-(6-methylpyridin-3-yl)pyridine

     

    Synonyms

    5-chloro-2-(6-methylpyridin-3-yl)-3-(4-(methylsulfonyl)phenyl)pyridine

    5-Chloro-3-(4-methanesulfonyl-phenyl)-6'-methyl-[2,3']bipyridinyl

    5-chloro-6'-methyl-3-(p-(methylsulfonyl)phenyl)-2,3'-bipyridine

     

    Description

    Etoricoxib is a new COX-2 selective inhibitor. Current therapeutic indications are: treatment of rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, chronic low back pain, acute pain and gout. Like any other COX-2 selective inhibitor, Etoricoxib selectively inhibits isoform 2 of cyclo-oxigenase enzyme (COX-2) to reduce the generation of prostaglandins (PGs) from arachidonic acid. It is approved in more than 60 countries worldwide but not in the US.

     

    CAS No.

    202409-33-4

     

    Certificate of Analysis

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  • [화학료법제 9품목]Famciclovir (팜시클로버)

    Manufacturer

    Changzhou Kony Pharmaceutical Co.Ltd.

     

    Specification

    USP

     

    KDMF 등록번호

    20180208-209-J-153(2)

     

    IUPAC Name

    2-[(acetyloxy)methyl]-4-(2-amino-9H-purin-9-yl)butyl acetate

     

    Synonyms

    2-(2-(2-amino-9H-purin-9-yl)ethyl)-1,3-propanediol diacetate

    9-[4-acetoxy-3-(acetoxymethyl)but-1-yl]-2-aminopurine

    acetic acid 2-acetoxymethyl-4-(2-amino-purin-9-yl)-butyl ester

     

    Description

     

    Famciclovir, marketed as Famvir by Novartis, is a guanine analogue used to treat herpes virus infections. It is most commonly used to treat herpes zoster (shingles). Famciclovir is a prodrug of penciclovir with higher oral bioavailability.

     

    CAS No.

    104227-87-4

     

    Certificate of Analysis

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  • [비뇨생식기관 및 항문 3품목]Finasteride (피나스테리드)

    Manufacturer

    Aurobindo Pharma Limited

     

    Specification

    EP

     

    KDMF 등록번호

    20071025-94-E-50-02(10)

     

    IUPAC Name

    (1S,2R,7R,10S,11S,14S,15S)-N-tert-butyl-2,15-dimethyl-5-oxo-6-azatetracyclo[8.7.0.0²,⁷.0¹¹,¹⁵]heptadec-3-ene-14-carboxamide

     

    Synonyms

    (5alpha,17beta)-(1,1-Dimethylethyl)-3-oxo-4-azaandrost-1-ene-17-carboxamide

     

    Description

    Finasteride is a synthetic 4-azasteroid compound and specific inhibitor of steroid Type II 5α-reductase, which is an intracellular enzyme that converts the androgen testosterone into 5α-dihydrotestosterone (DHT). It works in a similar fashion as dutasteride, which is another 5-alpha-reductase inhibitor, by exerting antiandrogenic effects. Finasteride is an orally active drug that was first approved by the FDA in 1992 for the treatment of benign prostatic hyperplasia to improve symptoms and reduce the risk for acute urinary retention or the need for surgical procedures. In 1998, it was approved by the FDA to treat male pattern hair loss. Finasteride is commonly marketed under the brand names Propecia and Proscar to be used aloneo or in combination with doxazosin, an alpha-blocker.

    Both benign prostatic hyperplasia and androgenic alopecia are androgen-dependent disorders that are characterized by in situ high levels of DHT. In the treatment of benign prostate hyperplasia, alpha-blockers such as tamsulosin and terazosin are also used. Compared to alpha-blockers that focus on providing the rapid relief of symptoms, 5α-reductase inhibitors aim to target the underlying disease by blocking the effects of the primary androgen involved in benign prostate hyperplasia and androgenic alopecia, thus reducing the risk for secondary complications while providing symptom control.

     

    CAS No.

    98319-26-7

     

    Certificate of Analysis

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  • [화학료법제 9품목]Fluconazole (플루코나졸)

    Manufacturer

    Ipca Laboratories Limited

     

    Specification

    USP

     

    KDMF 등록번호

    20050831-74-A-153-07(6)

     

    IUPAC Name

    2-(2,4-difluorophenyl)-1,3-bis(1H-1,2,4-triazol-1-yl)propan-2-ol

     

    Synonyms

    N/A

     

    Description

    Fluconazole, commonly known as Diflucan, is an antifungal drug used for the treatment of both systemic and superficial fungal infections in a variety of tissues. It was initially approved by the FDA in 1990. This drug is an azole antifungal, in the same drug family as ketoconazole and itraconazole. Fluconazole has many advantages over the other antifungal drugs including the option of oral administration. The side effect profile of this drug is minimal. It has been demonstrated as an efficacious treatment for vaginal yeast infections in one single dose

     

    CAS No.

    86386-73-4

     

    Certificate of Analysis

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  • [중추신경계 21품목]Fluoxetine Hydrochloride (플루옥세틴염산염)

    Manufacturer

    Cadila Pharmaceuticals Limited

     

    Specification

    BP/EP

     

    KDMF 등록번호

    20081031-51-C-246-08(2)

     

    IUPAC Name

    methyl({3-phenyl-3-[4-(trifluoromethyl)phenoxy]propyl})amine hydrochloride

     

    Synonyms

    N/A

     

    Description

    Fluoxetine is a 2nd generation antidepressant categorized as a selective serotonin reuptake inhibitor (SSRI). It gained FDA approval in 1987 and although it was initially intended for the treatment of depression, today it is commonly prescribed to manage depression in addition to various other pathologies.

     

    CAS No.

    56296-78-7

     

    Certificate of Analysis

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