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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 10품목]Calcipotriol Hydrate (칼시포트리올수화물)

    Manufacturer

    Chongqing Huapont Shengchem Phamaceutical Co., Ltd.

     

    Specification

    EP

     

    KDMF 등록번호

    20200702-211-J-456

     

    IUPAC Name

    (5Z,7E,22E,24S)-24-cyclopropyl-9,10-secochola-5,7,10(19),22-tetraene-1α,3β,24-triol monohydrate

     

    Description

    Vitamin D3 receptors are widely distributed in the body, and among them, they exist in keratinocytes in the skin. The bright red papules in psoriasis result from abnormal growth and production of keratinocytes. Calcipotriol is a synthetic vitamin D3 analogue that regulates the production and proliferation of skin cells.

     

    CAS No.

    147657-22-5

     

    Certificate of Analysis

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  • [소화기관 7품목]Calcium Polycarbophil (칼슘폴리카르보필)

    Manufacturer

    Shandong Xiuhua Pharmaceutical Co. Ltd

     

    Specification

    USP

     

    KDMF 등록번호

    20180528-209-J-22

     

    IUPAC Name

    N/A

     

    Synonyms

    N/A

     

    Description

    Calcium polycarbophil is a stool stabilizer. Based on its chemical structure, it is a synthetic polymer of polyacrylic acid cross-linked with divinyl glycol presenting a calcium atom as a counter-ion. Polycarbophil is used to treat constipation. This drug may also be used to help relieve the symptoms of irritable bowel syndrome or diarrhea.

     

    CAS No.

    9003-97-8

     

    Certificate of Analysis

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  • [순환계 9품목]Chlorthalidone (클로르탈리돈)

    Manufacturer

    IPCA

     

    Specification

    EP

     

    KDMF 등록번호

    20180406-209-J-47(1)

     

    IUPAC Name

    2-chloro-5-(1-hydroxy-3-oxo-2,3-dihydro-1H-isoindol-1-yl)benzene-1-sulfonamide

     

    Synonyms

    1-keto-3-(3'-sulfamyl-4'-chlorophenyl)-3-hydroxyisoindoline

    1-oxo-3-(3-sulfamyl-4-chlorophenyl)-3-hydroxyisoindoline

    2-chloro-5-(1-hydroxy-3-oxo-1-isoindolinyl)benzenesulfonamide

    2-chloro-5-(2,3-dihydro-1-hydroxy-3-oxo-1H-isoindol-1-yl)benzenesulfonamide

    3-(4'-chloro-3'-sulfamoylphenyl)-3-hydroxyphthalimidine

    3-hydroxy-3-(4-chloro-3-sulfamylphenyl)phthalimidine

    Chlorphthalidolone

     

    Description

    Chlorthalidone is a thiazide-like diuretic used for the treatment of hypertension and for management of edema caused by conditions such as heart failure or renal impairment. Chlorthalidone improves blood pressure and swelling by preventing water absorption from the kidneys through inhibition of the Na+/Cl− symporter in the distal convoluted tubule cells in the kidney. The exact mechanism of chlorthalidone's anti-hypertensive effect is under debate, however, it is thought that increased diuresis results in decreased plasma and extracellular fluid volume, decreased cardiac output and therefore overall reduction in blood pressure.

    Chlorthalidone is considered first-line therapy for management of uncomplicated hypertension as there is strong evidence from meta-analyses that thiazide diuretics such as chlorthalidone reduce the risk of stroke, myocardial infarction, heart failure, and cardiovascular all-cause mortality in patients with hypertension. In particular, the ALLHAT trial confirmed the role of thiazide diuretics as first-line therapy and demonstrated that chlorthalidone had a statistically significant lower incidence of stroke and heart failure when compared to Lisinopril, Amlodipine, or Doxazosin. Further studies have indicated that low-dose thiazides are as good as, and in some secondary endpoints, better than β-blockers, ACE inhibitors, Calcium Channel Blockers or ARBs.

    Chlorthalidone has been shown to have a number of pleiotropic effects that differentiate it from other diuretics such as Hydrochlorothiazide. In addition to its antihypertensive effects, chlorthalidone has also been shown to decrease platelet aggregation and vascular permeability, as well as promote angiogenesis in vitro, which is thought to be partly the result of reductions in carbonic anhydrase–dependent pathways. These pathways may play a role in chlorthalidone's cardiovascular risk reduction effects

     

    CAS No.

    77-36-1

     

    Certificate of Analysis

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  • [중추신경계 21품목]Choline Fenofibrate (페노피브레이트콜린)

    Manufacturer

    Alembic Pharmaceuticals Limited(API Unit-1)

     

    Specification

    In-house

     

    KDMF 등록번호

    20180814-209-J-48(3)

     

    IUPAC Name

    N/A

     

    Synonyms

    Fenofibric acid choline salt

     

    Description

    Fenofibrate is a third generation fibric acid derivative that is predominantly administered as monotherapy to decrease elevated low-density lipoprotein cholesterol, total cholesterol, triglycerides, apolipoprotein B and alternatively to increase high-density lipoprotein cholesterol in patients diagnosed with primary hyperlipidemia or mixed dyslipidemia and to reduce triglycerides in patients with severe hypertriglyceridemia. Fenofibrate however is generally extremely lipophilic, largely insoluble in water, and poorly absorbed 1. As the primary active metabolite of fenofibrate however, various hydrophilic salt formulations of fenofibric acid have since been developed, resulting in therapeutic agents that demonstrate far greater solubility, absorption throughout the gastrointestinal tract, bioavailability, and capability to be administered irrespective of patient food intake

     

    CAS No.

    856676-23-8

     

    Certificate of Analysis

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  • [기타의 대사성 의약품 3품목]Chondroitin Sodium Sulfate (콘드로이틴설페이트나트륨)

    Manufacturer

    Yantai Dongcheng Biochemicals Co., Ltd.

     

    Specification

    KP

     

    KDMF 등록번호

    20130122-173-I-229-01(11)

     

    IUPAC Name

    N/A

     

    Synonyms

    Chondroitin sulfates

    Chondroitin 4-sulfate disodium salt

    Description

    Chondroitin sulfate is a glycosaminoglycan considered as a symptomatic slow-acting drug for osteoarthritis (SYSADOA).The SYSADOA status suggested a pain relief and increased joint mobility after a relative long regular administration, as well as a long-lasting effect after the end of the treatment. Chondroitin sulfate is composed of alternating 1,3-N-acetyl-β-d-galactosamine and 1,4-β-d-glucuronic acid units which bear 4-O- and/or 6-O-sulfations at the N-acetylgalactosamine units disposed of in specific patterns. Depending on the predominating disaccharide unit, it will present different biological activities. Chondroitin sulfate is sold as an OTC dietary supplement in North America and it is a prescription drug under the EMA in Europe.

     

    CAS No.

    24967-93-9

     

    Certificate of Analysis

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  • [외피 10품목]Ciclopirox (시클로피록스)

    Manufacturer

    Shanghai Pharma Group Changzhou Kony Pharmaceutical Co.,Ltd.

     

    Specification

    USP

     

    KDMF 등록번호

    20190111-209-J-300

     

    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.

    29342-05-0

     

    Certificate of Analysis

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  • [외피 10품목]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 10품목]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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