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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.)

  • [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

    If you need more information, please contact us.

     

  • [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

    If you need more information, please contact us.

     

  • [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

    If you need more information, please contact us.

     

  • [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

    If you need more information, please contact us.

     

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