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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.)

  • [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

    If you need more information, please contact us.

     

  • [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

    If you need more information, please contact us.

  • [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

    If you need more information, please contact us.

  • [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

    If you need more information, please contact us.

  • [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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