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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.)

  • [항생물질제제 2품목]Roxithromycin (록시트로마이신)

    Manufacturer

    Zhejiang Zhenyuan Pharmaceutical Co. Ltd.

     

    Specification

    EP/In-house

     

    KDMF 등록번호

    20050831-9-A-2-02(12)

     

    IUPAC Name

    (3R,4S,5S,6R,7R,9R,11S,12R,13S,14R)-6-{[(2S,3R,4S,6R)-4-(dimethylamino)-3-hydroxy-6-methyloxan-2-yl]oxy}-14-ethyl-7,12,13-trihydroxy-4-{[(2R,4R,5S,6S)-5-hydroxy-4-methoxy-4,6-dimethyloxan-2-yl]oxy}-3,5,7,9,11,13-hexamethyl-10-(2,4,7-trioxa-1-azaoctan-1-ylidene)-1-oxacyclotetradecan-2-one

     

    Synonyms

    (9E)-erythromycin 9-(O-((2-methoxyethoxy)methyl)oxime)

     

    Description

    Roxithromycin is a semi-synthethic macrolide antibiotic that is structurally and pharmacologically similar to erythromycin, azithromycin, or clarithromycin. It was shown to be more effective against certain Gram-negative bacteria, particularly Legionella pneumophila. Roxithromycin exerts its antibacterial action by binding to the bacterial ribosome and interfering with bacterial protein synthesis. It is marketed in Australia as a treatment for respiratory tract, urinary and soft tissue infections.

     

    CAS No.

    80214-83-1

     

    Certificate of Analysis

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  • [비뇨생식기관 및 항문 4품목]Sildenafil Citrate (실데나필시트르산염)

    Manufacturer

    Mylan Laboratories Limited

     

    Specification

    EP

     

    KDMF 등록번호

    20200602-211-J-644

     

    IUPAC Name

    Piperazine,1-[[3-(6,7-dihydro-1-methyl-7-oxo-3-propyl-1H-pyrazolo[4,3-d]pyrimidin-5-yl)-4-ethoxyphenyl]sulfonyl]-4-methyl-,2-hydroxy-1,2,3-propanetricarboxylate (1:1)

     

    Synonyms

    1-[[3-(6,7-dihydro-1-methyl-7-oxo-3-propyl-1H-pyrazolo[4,3-d]pyrimidin-5-yl)-4-ethoxyphenyl]sulfonyl]-4-methylpiperazine citrate (1:1)

    5-[2-ethoxy-5-(4-methylpiperazinylsulfonyl)phenyl]-1-methyl-3-n-propyl-1,6-dihydro-7H-pyrazolo[4,3-d]pyrimidin-7-one citrate

    1-[[3-(6,7-dihydro-1-methyl-7-oxo-3-propyl-1H-pyrazolo[4,3-d]pyrimidin-5-yl)-4-ethoxyphenyl]sulfonyl]-4-methylpiperazine citrate

     

    Description

    When NO is locally released from sexual stimulation, sildenafil inhibits PDE5 and increases the amount of cGMP in the corpus cavernosum, which relaxes smooth muscles and increases blood flow into the corpus cavernosum, producing an erection.

    Recommended dose of sildenafil has no effect in the absence of sexual stimulation.

    PDE5 is present in other tissues including platelets, abdominal smooth muscle, skeletal muscle, which may be the basis for inhibition of platelet thrombogenesis and peripheral arteriovenous dilatation.

     

    CAS No.

    171599-83-0

     

    Certificate of Analysis

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  • [순환계 9품목]Simvastatin (심바스타틴)

    Manufacturer

    Zhejiang jiangbei Pharm Co.ltd

     

    Specification

    EP

     

    KDMF 등록번호

    20120217-29-B-327-26

     

    IUPAC Name

    (1S,3R,7S,8S,8aR)-8-{2-[(2R,4R)-4-hydroxy-6-oxooxan-2-yl]ethyl}-3,7-dimethyl-1,2,3,7,8,8a-hexahydronaphthalen-1-yl 2,2-dimethylbutanoate

     

    Synonyms

    2,2-dimethylbutyric acid, 8-ester with (4R,6R)-6-(2-((1S,2S,6R,8S,8aR)-1,2,6,7,8,8a-hexahydro-8-hydroxy-2,6-dimethyl-1-naphthyl)ethyl)tetrahydro-4-hydroxy-2H-pyran-2-one

     

    Description

    Simvastatin, also known as the brand name product Zocor, is a lipid-lowering drug derived synthetically from a fermentation product of Aspergillus terreus. It belongs to the statin class of medications, which are used to lower the risk of cardiovascular disease and manage abnormal lipid levels by inhibiting the endogenous production of cholesterol in the liver. More specifically, statin medications competitively inhibit the enzyme hydroxymethylglutaryl-coenzyme A (HMG-CoA) Reductase, which catalyzes the conversion of HMG-CoA to mevalonic acid and is the third step in a sequence of metabolic reactions involved in the production of several compounds involved in lipid metabolism and transport including cholesterol, low-density lipoprotein (LDL) (sometimes referred to as "bad cholesterol"), and very low-density lipoprotein (VLDL). Prescribing of statin medications is considered standard practice following any cardiovascular events and for people with a moderate to high risk of development of CVD, such as those with Type 2 Diabetes. The clear evidence of the benefit of statin use coupled with very minimal side effects or long term effects has resulted in this class becoming one of the most widely prescribed medications in North America.

     

    CAS No.

    79902-63-9

     

    Certificate of Analysis

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  • [기타의 대사성 의약품 3품목]Sitagliptin Phosphate (시타글립틴인산염)

    Manufacturer

    Mylan Laboratories Limited(Unit-1)

     

    Specification

    In-house

     

    KDMF 등록번호

    수5217-4-ND

     

    IUPAC Name

    (3R)-3-amino-1-[3-(trifluoromethyl)-5H,6H,7H,8H-[1,2,4]triazolo[4,3-a]pyrazin-7-yl]-4-(2,4,5-trifluorophenyl)butan-1-one

     

    Synonyms

    Sitagliptin

     

    Description

    Sitagliptin is an oral dipeptidyl peptidase-4 (DPP-4) inhibitor used in conjunction with diet and exercise to improve glycemic control in patients with type 2 diabetes mellitus. The effect of this medication leads to glucose dependent increases in insulin and decreases in glucagon to improve control of blood sugar. Sitagliptin was granted FDA approval on October 16, 2006.

     

    CAS No.

    654671-78-0

     

    Certificate of Analysis

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  • [감각기관 2품목]Sodium Hyaluronate (히알루론산나트륨)

    Manufacturer

    Contipro Pharma a.s.

     

    Specification

    EP

     

    KDMF 등록번호

    20071228-96-E-38-09(11)

     

    IUPAC Name

    (2S,3S,4R,5R,6R)-3-{[(2S,3R,5S,6R)-4-{[(2R,3R,4S,5S,6S)-6-carboxy-3,4,5-trihydroxyoxan-2-yl]oxy}-3-acetamido-5-hydroxy-6-(hydroxymethyl)oxan-2-yl]oxy}-6-{[(2R,3R,5S,6R)-3-acetamido-2,5-dihydroxy-6-(hydroxymethyl)oxan-4-yl]oxy}-4,5-dihydroxyoxane-2-carboxylic acid

     

    Synonyms

    N/A

     

    Description

    Hyaluronic acid (HA) is an anionic, nonsulfated glycosaminoglycan distributed widely throughout connective, epithelial, and neural tissues. It is unique among glycosaminoglycans in that it is nonsulfated, forms in the plasma membrane instead of the Golgi, and can be very large, with its molecular weight often reaching the millions. One of the chief components of the extracellular matrix, hyaluronic acid contributes significantly to cell proliferation and migration, and may also be involved in the progression of some malignant tumors.

     

    CAS No.

    9067-32-7

     

    Certificate of Analysis

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  • [소화기관 7품목]Sulpiride (설피리드)

    Manufacturer

    Jiangsu Tasly Diyi Pharmaceutical Co., Ltd.

     

    Specification

    JP

     

    KDMF 등록번호

    20170907-124-H-319-02

     

    IUPAC Name

    N-[(1-ethylpyrrolidin-2-yl)methyl]-2-methoxy-5-sulfamoylbenzamide

     

    Synonyms

    5-(Aminosulfonyl)-N-((1-ethyl-2-pyrrolidinyl)methyl)-2-methoxybenzamide

    N-((1-Ethyl-2-pyrrolidinyl)methyl)-2-methoxy-5-sulfamoylbenzamide

    N-((1-Ethyl-2-pyrrolidinyl)methyl)-5-sulfamoyl-o-anisamid

     

    Description

    A dopamine D2-receptor antagonist. It has been used therapeutically as an antidepressant, antipsychotic, and as a digestive aid. 

     

    CAS No.

    15676-16-1

     

    Certificate of Analysis

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  • [비뇨생식기관 및 항문 4품목]Tadalafil (타다라필)

    Manufacturer

    Mylan Laboratories Limited

     

    Specification

    EP

     

    KDMF 등록번호

    20190808-203-I-589-15

     

    IUPAC Name

    (2R,8R)-2-(2H-1,3-benzodioxol-5-yl)-6-methyl-3,6,17-triazatetracyclo[8.7.0.0³,⁸.0¹¹,¹⁶]heptadeca-1(10),11,13,15-tetraene-4,7-dione

     

    Synonyms

    (6R-trans)-6-(1,3-Benzodioxol-5-yl)-2,3,6,7,12,12a-hexahydro-2-methyl-pyrazino(1',2':1,6)pyrido(3,4-b)indole-1,4-dione
    (6R,12aR)-2,3,6,7,12,12a-Hexahydro-2-methyl-6-(3,4-(methylenedioxy)phenyl) pyrazino(1',2':1,6)pyrido(3,4-b)indole-1,4-dione

     

    Description

    Tadalafil is an orally administered drug used to treat male erectile dysfunction (impotence). It is marketed worldwide under the brand name Cialis. It is a phosphodiesterase 5 (PDE5) inhibitor. Tadalafil's distinguishing pharmacologic feature is its longer half-life (17.5 hours) compared with Viagra and Levitra (4-5 hours). This longer half-life results in a longer duration of action and is, in part, responsible for the Cialis nickname of the "weekend pill." This longer half-life also is the basis of current investigation for tadalafil's use in pulmonary arterial hypertension as a once-daily therapy.

     

    CAS No.

    171596-29-5

     

    Certificate of Analysis

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  • [중추신경계 21품목]Tadalafil (타다라필)

    Manufacturer

    Zhejiang Huahai pharmaceutical Co., Ltd.

     

    Specification

    USP

     

    KDMF 등록번호

    20140829-203-I-455-10(2)

     

    IUPAC Name

    (2R,8R)-2-(2H-1,3-benzodioxol-5-yl)-6-methyl-3,6,17-triazatetracyclo[8.7.0.0³,⁸.0¹¹,¹⁶]heptadeca-1(10),11,13,15-tetraene-4,7-dione

     

    Synonyms

    (6R-trans)-6-(1,3-Benzodioxol-5-yl)-2,3,6,7,12,12a-hexahydro-2-methyl-pyrazino(1',2':1,6)pyrido(3,4-b)indole-1,4-dione

    (6R,12aR)-2,3,6,7,12,12a-Hexahydro-2-methyl-6-(3,4-(methylenedioxy)phenyl) pyrazino(1',2':1,6)pyrido(3,4-b)indole-1,4-dione

     

    Description

    Tadalafil is an orally administered drug used to treat male erectile dysfunction (impotence). It is marketed worldwide under the brand name Cialis. It is a phosphodiesterase 5 (PDE5) inhibitor. Tadalafil's distinguishing pharmacologic feature is its longer half-life (17.5 hours) compared with Viagra and Levitra (4-5 hours). This longer half-life results in a longer duration of action and is, in part, responsible for the Cialis nickname of the "weekend pill." This longer half-life also is the basis of current investigation for tadalafil's use in pulmonary arterial hypertension as a once-daily therapy.

     

    CAS No.

    171596-29-5

     

    Certificate of Analysis

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  • [중추신경계 21품목]Talniflumate (탈니플루메이트)

    Manufacturer

    Pen Tsao Chemical & Pharmaceutical Industry Co., Ltd.

     

    Specification

    KP

     

    KDMF 등록번호

    20100331-119-G-45-10(7)

     

    IUPAC Name

    3-oxo-1,3-dihydro-2-benzofuran-1-yl 2-{[3-(trifluoromethyl)phenyl]amino}pyridine-3-carboxylate

     

    Synonyms

    N/A

     

    Description

    Talniflumate, is an anti-inflammatory molecule studied and used as a mucin regulator in the treatment of cystic fibrosis, chronic obstructive pulmonary disease (COPD) and asthma. In addition, it is used in inflammatory conditions such as rheumatoid arthritis. Phase I trials with talniflumate for the treatment of cystic fibrosis and COPD were completed in August 2001, and phase II trials were performed in Ireland for the treatment of cystic fibrosis but this research has now been discontinued. Talniflumate has been approved for approximately 20 years in Argentina other countries (excluding the United States, Europe, and Japan).

     

    CAS No.

    66898-62-2

     

    Certificate of Analysis

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  • [순환계 9품목]Telmisartan (텔미사르탄)

    Manufacturer

    Jiangsu Zhongbang Pharmaceutical Co., Ltd

     

    Specification

    EP

     

    KDMF 등록번호

    20180706-209-J-112(1)

     

    IUPAC Name

    2-(4-{[4-methyl-6-(1-methyl-1H-1,3-benzodiazol-2-yl)-2-propyl-1H-1,3-benzodiazol-1-yl]methyl}phenyl)benzoic acid

     

    Synonyms

    4'-((1,4'-dimethyl-2'-propyl(2,6'-bi-1H-benzimidazol)-1'-yl)methyl)-(1,1'-biphenyl)-2-carboxylic acid

    4'-((4-methyl-6-(1-methyl-2-benzimidazolyl)-2-propyl-1-benzimidazolyl)methyl)-2-biphenylcarboxylic acid

    4'-[(1,4'-dimethyl-2'propyl[2,6'-bi-1H-benzimidazol]-1'-yl)methyl]-[1,1'-biphenyl]-2-carboxylic acid

    4'-[(1,7'-dimethyl-2'-propyl-1H,3'H-2,5'-bibenzimidazol-3'-yl)methyl]biphenyl-2-carboxylic acid

     

    Description

    Telmisartan is an angiotensin II receptor antagonist (ARB) used in the management of hypertension. Generally, angiotensin II receptor blockers (ARBs) such as telmisartan bind to the angiotensin II type 1 (AT1) receptors with high affinity, causing inhibition of the action of angiotensin II on vascular smooth muscle, ultimately leading to a reduction in arterial blood pressure. Recent studies suggest that telmisartan may also have PPAR-gamma agonistic properties that could potentially confer beneficial metabolic effects.

     

    CAS No.

    114701-48-4

     

    Certificate of Analysis

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  • [화학료법제 9품목]Tenofovir Disoproxil Orotate(micronized) (테노포비르디소프록실오로트산염(미분화))

    Manufacturer

    Mangalam Drugs and Organics Ltd.(Unit-2)

     

    Specification

    In-house

     

    KDMF 등록번호

    수247-15-ND(1)

     

    IUPAC Name

    bis({[(propan-2-yloxy)carbonyl]oxy}methyl) {[(2R)-1-(6-amino-9H-purin-9-yl)propan-2-yl]oxy}methanephosphonate

     

    Synonyms

    Bis(POC)PMPA

    Tenofovir bis(isopropyloxycarbonyloxymethyl) ester

     

    Description

    Tenofovir disoproxil fumarate (a prodrug of tenofovir), marketed by Gilead Sciences under the trade name Viread, belongs to a class of antiretroviral drugs known as nucleotide analogue reverse transcriptase inhibitors (nRTIs). This drug is prescribed in combination with other drugs in the management of HIV infection as well as in Hepatitis B therapy. Tenofovir disoproxil was initially approved in 2001

     

    CAS No.

    201341-05-1

     

    Certificate of Analysis

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  • [외피 10품목]Terbinafine Hydrochloride (테르비나핀염산염)

    Manufacturer

    Zhejiang East-Asia Pharmaceutical Co., Ltd.

     

    Specification

    EP

     

    KDMF 등록번호

    20190322-49-A-349-21
    20050905-49-A-94-10(11)

     

    IUPAC Name

    [(2E)-6,6-dimethylhept-2-en-4-yn-1-yl](methyl)[(naphthalen-1-yl)methyl]amine

     

    Synonyms

    (E)-N-(6,6-Dimethyl-2-hepten-4-ynyl)-N-methyl-1-naphthalene methanamine

    (E)-N-(6,6-Dimethyl-2-hepten-4-ynyl)-N-methyl-1-naphthalenemethylamine

     

    Description

    Terbinafine hydrochloride (Lamisil) is a synthetic allylamine antifungal. It is highly lipophilic in nature and tends to accumulate in skin, nails, and fatty tissues. Like other allylamines, terbinafine inhibits ergosterol synthesis by inhibiting the fungal squalene monooxygenase (also called squalene epoxidase), an enzyme that is part of the fungal cell wall synthesis pathway.

    Terbinafine hydrochloride was granted FDA approval on 30 December 1992.

     

    CAS No.

    91161-71-6

     

    Certificate of Analysis

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  • [호흡기관 3품목]Theobromine (테오브로민)

    Manufacturer

    BAKUL PHARMA PRIVATE LIMITED

     

    Specification

    BP/EP

     

    KDMF 등록번호

    20180202-205-I-560-03

     

    IUPAC Name

    3,7-dimethyl-2,3,6,7-tetrahydro-1H-purine-2,6-dione

     

    Synonyms

    3,7-dihydro-3,7-dimethyl-1H-purine-2,6-dione

    3,7-dimethylpurine-2,6-dione

    3,7-dimethylxanthine

     

    Description

    Theobromine (3,7-dimethylxanthine) is the principle alkaloid in Theobroma cacao (the cacao bean) and other plants. A xanthine alkaloid that is used as a bronchodilator and as a vasodilator. It has a weaker diuretic activity than theophylline and is also a less powerful stimulant of smooth muscle. It has practically no stimulant effect on the central nervous system. It was formerly used as a diuretic and in the treatment of angina pectoris and hypertension. (From Martindale, The Extra Pharmacopoeia, 30th ed, pp1318-9)

     

    CAS No.

    83-67-0

     

    Certificate of Analysis

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  • [중추신경계 21품목]Topiramate (토피라메이트)

    Manufacturer

    Bal Pharma Limited

    Nifty Labs Pvt.,Ltd.

     

    Specification

    USP

     

    KDMF 등록번호

    20130912-170-I-365-10(2)

    20160713-170-I-472-16(1)

     

    IUPAC Name

    [(1R,2S,6S,9R)-4,4,11,11-tetramethyl-3,5,7,10,12-pentaoxatricyclo[7.3.0.0²,⁶]dodecan-6-yl]methyl sulfamate

     

    Synonyms

    2,3:4,5-bis-O-(1-methylethylidene)-β-D-fructopyranose sulfamate

    2,3:4,5-di-O-isopropylidene-β-D-fructopyranose sulfamate

     

    Description

    Topiramate is a anti-epileptic drug used to manage seizures and prevent migraines. It was initially approved by the FDA in 1996. In 2004, topiramate was approved for the prevention of migraine in adults. Since 2012, the extended-release formulation has been approved in combination with phentermine for chronic weight management therapy in adults.

    Characteristics that distinguish topiramate from other antiepileptic drugs are a monosaccharide chemical structure containing a sulfamate, and 40% of its mass accounted for by oxygen. Interestingly, topiramate was discovered by chance when attempts were made to formulate a novel antidiabetic drug

     

    CAS No.

    97240-79-4

     

    Certificate of Analysis

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  • [중추신경계 21품목]Tramadol Hydrochloride (트라마돌염산염)

    Manufacturer

    Sun Pharmacetical Industries Ltd / Wanbury Limited

     

    Specification

    EP

     

    KDMF 등록번호

    20120608-161-I-50-01(6) / 20130315-161-I-231-07(3)

     

    IUPAC Name

    (1R,2R)-2-[(dimethylamino)methyl]-1-(3-methoxyphenyl)cyclohexan-1-ol hydrochloride

     

    Synonyms

    N/A

     

    Description

    Tramadol is a centrally acting synthetic opioid analgesic and SNRI (serotonin/norepinephrine reuptake-inhibitor) that is structurally related to codeine and morphine. Due to its good tolerability profile and multimodal mechanism of action, tramadol is generally considered a lower-risk opioid option for the treatment of moderate to severe pain. It is considered a Step 2 option on the World Health Organization's pain ladder and has about 1/10th of the potency of morphine.

    Tramadol differs from other traditional opioid medications in that it doesn't just act as a μ-opioid agonist, but also affects monoamines by modulating the effects of neurotransmitters involved in the modulation of pain such as serotonin and norepinpehrine which activate descending pain inhibitory pathways.Tramadol's effects on serotonin and norepinephrine mimic the effects of other SNRI antidepressants such as duloxetine and venlafaxine.

    Tramadol exists as a racemic mixture consisting of two pharmacologically active enantiomers that both contribute to its analgesic property through different mechanisms and are also themselves metabolized into active metabolites: (+)-tramadol and its primary metabolite (+)-O-desmethyl-tramadol (M1) are agonists of the μ opioid receptor while (+)-tramadol inhibits serotonin reuptake and (-)-tramadol inhibits norepinephrine reuptake. These pathways are complementary and synergistic, improving tramadol's ability to modulate the perception of and response to pain.

    Tramadol has also been shown to affect a number of other pain modulators within the central nervous system as well as non-neuronal inflammatory markers and immune mediators. Due to the broad spectrum of targets involved in pain and inflammation, it's not surprising that the evidence has shown that tramadol is effective for a number of pain types including neuropathic pain, post-operative pain, lower back pain, as well as pain associated with labour, osteoarthritis, fibromyalgia, and cancer. Due to its SNRI activity, tramadol also has anxiolytic, antidepressant, and anti-shivering effects which are all frequently found as comorbidities with pain.

    Similar to other opioid medications, tramadol poses a risk for development of tolerance, dependence and abuse. If used in higher doses, or with other opioids, there is a dose-related risk of overdose, respiratory depression, and death. However, unlike other opioid medications, tramadol use also carries a risk of seizure and serotonin syndrome, particularly if used with other serotonergic medications.

     

    CAS No.

    36282-47-0

     

    Certificate of Analysis

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