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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.)

  • [비뇨생식기관 및 항문 3품목]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 8품목]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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  • [소화기관 7품목]Trimebutine Maleate (트리메부틴말레산염)

    Manufacturer

    Zhejiang East-Asia Pharmaceutical Co.,Ltd

     

    Specification

    KP

     

    KDMF 등록번호

    20060302-13-B-231-05(1)

     

    IUPAC Name

    (2Z)-but-2-enedioic acid; 2-(dimethylamino)-2-phenylbutyl 3,4,5-trimethoxybenzoate

     

    Synonyms

    2-Dimethylamino-2-phenylbutyl 3,4,5-trimethoxybenzoat

     

    Description

    Trimebutine is a spasmolytic agent that regulates intestinal and colonic motility and relieves abdominal pain with antimuscarinic and weak mu opioid agonist effects. It is marketed for the treatment of irritable bowel syndrome (IBS) and lower gastrointestinal tract motility disorders, with IBS being one of the most common multifactorial GI disorders. It is used to restore normal bowel function and is commonly present in pharmaceutical mixtures as trimebutine maleate salt form. Trimebutine is not a FDA-approved drug, but it is available in Canada and several other international countries.

     

    CAS No.

    34140-59-5

     

    Certificate of Analysis

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  • [화학료법제 9품목]Valaciclovir Hydrochloride (발라시클로비르염산염)

    Manufacturer

    Shanghai Pharma Group Changzhou Kony Pharmaceutical Co., Ltd

     

    Specification

    USP

     

    KDMF 등록번호

    20190816-209-J-407

     

    IUPAC Name

    2-[(2-amino-6-oxo-6,9-dihydro-3H-purin-9-yl)methoxy]ethyl (2S)-2-amino-3-methylbutanoate

     

    Synonyms

    L-Valine ester with 9-((2-hydroxyethoxy)methyl)guanine

    L-Valine, 2-((2-amino-1,6-dihydro-6-oxo-9H-purin-9-yl)methoxy)ethyl ester

     

    Description

    Valaciclovir (valacyclovir), also known as Valtrex, is an antiviral drug that has been used to manage and treat various herpes infections for more than 2 decades. It was initially approved by the FDA in 1995 and marketed by GlaxoSmithKline. Valacyclovir is the L-valine ester of aciclovir. It is a member of the purine (guanine) nucleoside analog drug class. This class of drugs forms an important part of hepatitis, HIV, and cytomegalovirus drug regimens.

    One major use of valacyclovir is the treatment of genital herpes episodes or outbreaks. Genital herpes is a frequently diagnosed sexually transmitted disease which currently affects more than 400 million individuals worldwide. It is caused by infection with the herpes simplex virus (HSV). Infection with this virus is lifelong with periodic episodes of reactivation.

     

    CAS No.

    124832-26-4

     

    Certificate of Analysis

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  • [화학료법제 9품목]Valacyclovir Hydrochloride Hydrate (발라시클로비르염산염수화물)

    Manufacturer

    Shanghai Pharma Group Changzhou Kony Pharmaceutical Co.,Ltd.

     

    Specification

    USP

     

    KDMF 등록번호

    20190123-209-J-75

     

    IUPAC Name

    2-[(2-amino-6-oxo-6,9-dihydro-3H-purin-9-yl)methoxy]ethyl (2S)-2-amino-3-methylbutanoate

     

    Synonyms

    L-Valine ester with 9-((2-hydroxyethoxy)methyl)guanine

    L-Valine, 2-((2-amino-1,6-dihydro-6-oxo-9H-purin-9-yl)methoxy)ethyl ester

     

    Description

    Valaciclovir (valacyclovir), also known as Valtrex, is an antiviral drug that has been used to manage and treat various herpes infections for more than 2 decades. It was initially approved by the FDA in 1995 and marketed by GlaxoSmithKline. Valacyclovir is the L-valine ester of aciclovir. It is a member of the purine (guanine) nucleoside analog drug class . This class of drugs forms an important part of hepatitis, HIV, and cytomegalovirus drug regimens .

    Valaciclovir (valacyclovir), also known as Valtrex, is an antiviral drug that has been used to manage and treat various herpes infections for more than 2 decades. It was initially approved by the FDA in 1995 and marketed by GlaxoSmithKline . Valacyclovir is the L-valine ester of aciclovir. It is a member of the purine (guanine) nucleoside analog drug class . This class of drugs forms an important part of hepatitis, HIV, and cytomegalovirus drug regimens .

     

    CAS No.

    124832-26-4

     

    Certificate of Analysis

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  • [순환계 9품목]Valsartan (발사르탄)

    Manufacturer

    Shanghai Pharma Group Changzhou Kony Pharmaceutical CO.,Ltd
    Ipca Laboratories Limited

     

    Specification

    USP

     

    KDMF 등록번호

    20191016-135-H-364-46
    20101011-135-H-8-02(3)

     

    IUPAC Name

    (2S)-3-methyl-2-[N-({4-[2-(2H-1,2,3,4-tetrazol-5-yl)phenyl]phenyl}methyl)pentanamido]butanoic acid

     

    Synonyms

    (S)-N-Valeryl-N-{[2'-(1H-tetrazol-5-yl)biphenyl-4-yl]-methyl}-valine

    N-(P-(O-1H-Tetrazol-5-ylphenyl)benzyl)-N-valeryl-L-valine

    N-pentanoyl-N-{[2'-(1H-tetrazol-5-yl)biphenyl-4-yl]methyl}-L-valine

     

    Description

    Valsartan belongs to the angiotensin II receptor blocker (ARB) family of drugs, which also includes telmisartan, candesartan, losartan, olmesartan, and irbesartan. ARBs selectively bind to angiotensin receptor 1 (AT1) and prevent the protein angiotensin II from binding and exerting its hypertensive effects, which include vasoconstriction, stimulation and synthesis of aldosterone and ADH, cardiac stimulation, and renal reabsorption of sodium, among others. Overall, valsartan's physiologic effects lead to reduced blood pressure, lower aldosterone levels, reduced cardiac activity, and increased excretion of sodium.

    Valsartan also affects the renin-angiotensin aldosterone system (RAAS), which plays an important role in hemostasis and regulation of kidney, vascular, and cardiac functions. Pharmacological blockade of RAAS via AT1 receptor blockade inhibits negative regulatory feedback within RAAS, which is a contributing factor to the pathogenesis and progression of cardiovascular disease, heart failure, and renal disease. In particular, heart failure is associated with chronic activation of RAAS, leading to inappropriate fluid retention, vasoconstriction, and ultimately a further decline in left ventricular function. ARBs have been shown to have a protective effect on the heart by improving cardiac function, reducing afterload, increasing cardiac output and preventing ventricular hypertrophy and remodelling.

    By comparison, the angiotensin-converting enzyme inhibitor (ACEI) class of medications (which includes drugs such as ramipril, lisinopril, and perindopril) inhibit the conversion of angiotensin I to angiotensin II through inhibition of the ACE enzyme. However, this does not prevent the formation of all angiotensin II within the body. The angiotensin II receptor blocker (ARB) family of drugs unique in that it blocks all angiotensin II activity, regardless of where or how it was synthesized.

    Valsartan is commonly used for the management of hypertension, heart failure, and Type 2 Diabetes-associated nephropathy, particularly in patients who are unable to tolerate ACE inhibitors. ARBs such as valsartan have been shown in a number of large-scale clinical outcomes trials to improve cardiovascular outcomes including reducing risk of myocardial infarction, stroke, the progression of heart failure, and hospitalization. Valsartan also slows the progression of diabetic nephropathy due to its renoprotective effects. Improvements in chronic kidney disease with valsartan include both clinically and statistically significant decreases in urinary albumin and protein excretion in patients diagnosed with type 2 diabetes and in nondiabetic patients diagnosed with chronic kidney disease.

    Valsartan was initially approved in 1996 in Europe for the treatment of hypertension in adults. Shortly after, in 1997, this drug was approved in the United States. Valsartan is generally well-tolerated with a side-effect profile superior to that of other antihypertensive drugs.

     

    CAS No.

    137862-53-4

     

    Certificate of Analysis

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