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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.)

  • [중추신경계 21품목]Aceclofenac (아세클로페낙)

    Manufacturer

    Jiangxi Synergy Pharmaceutical Co., Ltd

     

    Specification

    EP

     

    KDMF 등록번호

    20120905-31-C-301-18(6)

     

    IUPAC Name

    2-[(2-{2-[(2,6-dichlorophenyl)amino]phenyl}acetyl)oxy]acetic acid

     

    Synonyms

    2-[(2,6-dichlorophenyl)amino]benzeneacetic acid carboxymethyl ester

    2-[(2,6-dichlorophenyl)amino]phenylacetoxyacetic acid

    2-[(2',6'-dichlorophenyl)amino]phenylacetoxyacetic acid

    glycolic acid [o-(2,6-dichloroanilino)phenyl]acetate ester

     

    Description

    Aceclofenac is an oral non-steroidal anti-inflammatory drug (NSAID) with marked anti-inflammatory and analgesic properties used to treat osteoarthritis, rheumatoid arthritis and ankylosing spondylitis. It is reported to have a higher anti-inflammatory action or at least comparable effects than conventional NSAIDs in double-blind studies. Aceclofenac potently inhibits the cyclo-oxygenase enzyme (COX) that is involved in the synthesis of prostaglandins, which are inflammatory mediators that cause pain, swelling, inflammation, and fever. Aceclofenac belongs to BCS Class II as it possesses poor aqueous solubility. It displays high permeability to penetrate into synovial joints where in patients with osteoarthritis and related conditions, the loss of articular cartilage in the area causes joint pain, tenderness, stiffness, crepitus, and local inflammation. Aceclofenac is also reported to be effective in other painful conditions such as dental and gynaecological conditions. In 1991, aceclofenac was developed as an analog of a commonly prescribed NSAID, Diclofenac, via chemical modification in effort to improve the gastrointestinal tolerability of the drug. It is a more commonly prescribed drug in Europe.

     

    CAS No.

    89796-99-6

     

    Certificate of Analysis

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  • [중추신경계 21품목]Acetaminophen (아세트아미노펜)

    Manufacturer

    Anhui BBCA LiKang Pharmaceutical CO., LTD

    Lianyungang Kangle Pharmaceutical Co.,Ltd,

     

    Specification

    EP

     

    KDMF 등록번호

    20141022-32-C-325-19(6) / 20151015-32-C-350-20(22)

     

    IUPAC Name

    N-(4-hydroxyphenyl)acetamide

     

    Synonyms

    4-(Acetylamino)phenol

    4-acetamidophenol

    4'-hydroxyacetanilide

    Acenol

    APAP

    N-acetyl-p-aminophenol

    p-acetamidophenol

    p-acetaminophenol

    p-Acetylaminophenol

    p-hydroxy-acetanilid

    p-hydroxyacetanilide

    p-hydroxyphenolacetamide

     

    Description

    Acetaminophen (paracetamol), also commonly known as Tylenol, is the most commonly taken analgesic worldwide and is recommended as first-line therapy in pain conditions by the World Health Organization (WHO). It is also used for its antipyretic effects, helping to reduce fever. This drug was initially approved by the U.S. FDA in 1951 and is available in a variety of forms including syrup form, regular tablets, effervescent tablets, injection, suppository, and other forms.

    Acetaminophen is often found combined with other drugs in more than 600 over the counter (OTC) allergy medications, cold medications, sleep medications, pain relievers, and other products. Confusion about dosing of this drug may be caused by the availability of different formulas, strengths, and dosage instructions for children of different ages. Due to the possibility of fatal overdose and liver failure associated with the incorrect use of acetaminophen, it is important to follow current and available national and manufacturer dosing guidelines while this drug is taken or prescribed.

     

    CAS No.

    103-90-2

     

    Certificate of Analysis

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  • [화학료법제 9품목]Acyclovir (아시클로버)

    Manufacturer

    Zhejiang Charioteer Pharmaceutical Co., Ltd.

     

    Specification

    USP

     

    KDMF 등록번호

    20050831-33-A-81-08(14)

     

    IUPAC Name

    2-amino-9-[(2-hydroxyethoxy)methyl]-6,9-dihydro-3H-purin-6-one

     

    Synonyms

    Acycloguanosine

     

    Description

    Acyclovir is a nucleotide analog antiviral used to treat herpes simplex, Varicella zoster, herpes zoster, herpes labialis, and acute herpetic keratitis. Acyclovir is generally used first line in the treatment of these viruses and some products are indicated for patients as young as 6 years old.

    Acyclovir was granted FDA approval on 29 March 1982

     

    CAS No.

    59277-89-3

     

    Certificate of Analysis

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  • [비뇨생식기관 및 항문 3품목]Alfuzosine Hydrochloride (알푸조신염산염)

    Manufacturer

    Unichem Laboratories Limited

     

    Specification

    EP

     

    KDMF 등록번호

    20191010-209-J-253

     

    IUPAC Name

    N-{3-[(4-amino-6,7-dimethoxyquinazolin-2-yl)(methyl)amino]propyl}oxolane-2-carboxamide

     

    Synonyms

    (±)-N-[3-[(4-amino-6,7-dimethoxy-2-quinazolinyl)methylamino]propyl]tetrahydro-2-furamide

     

    Description

    Alfuzosin (INN, provided as the hydrochloride salt) is an alpha-adrenergic blocker used to treat benign prostatic hyperplasia (BPH). It works by relaxing the muscles in the prostate and bladder neck, making it easier to urinate.

     

    CAS No.

    81403-80-7

     

    Certificate of Analysis

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  • [비타민제 2품목]Alitretinoin(micronized) (알리트레티노인(미분화))

    Manufacturer

    Chongqing Huapont Shengchem Pharmaceutical Co., Ltd.

     

    Specification

    In house

     

    KDMF 등록번호

    20190110-209-J-298

     

    IUPAC Name

    (2E,4E,6Z,8E)-3,7-dimethyl-9-(2,6,6-trimethylcyclohex-1-en-1-yl)nona-2,4,6,8-tetraenoic acid

     

    Synonyms

    (2E,4E,6Z,8E)-3,7-dimethyl-9-(2,6,6-trimethyl-1-cyclohexen-1-yl)-2,4,6,8-nonatetraenoic acid

    (7E,9Z,11E,13E)-retinoic acid

    9-CIS-RETINOIC ACID

    9-cis-Tretinoin

     

     

    Description

    An important regulator of gene expression during growth and development, and in neoplasms. Tretinoin, also known as retinoic acid and derived from maternal vitamin A, is essential for normal growth; and embryonic development. An excess of tretinoin can be teratogenic. It is used in the treatment of psoriasis; acne vulgaris; and several other skin diseases. It has also been approved for use in promyelocytic leukemia (leukemia, promyelocytic, acute).

     

    CAS No.

    5300-03-8

     

    Certificate of Analysis

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  • [순환계 9품목]Amlodipine Besylate (암로디핀베실산염)

    Manufacturer

    Mylan Laboratories Limited

     

    Specification

    USP/EP

     

    KDMF 등록번호

    20120911-130-H-215-39(2)

     

    IUPAC Name

    3-ethyl 5-methyl 2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-6-methyl-1,4-dihydropyridine-3,5-dicarboxylate

     

    Synonyms

    (RS)-3-ethyl 5-methyl 2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-6-methyl-1,4-dihydropyridine-3,5-dicarboxylate

     3-Ethyl 5-methylester, (±)-2-[(2-aminoethoxy)methyl]-4-(o-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate

     

    Description

    Amlodipine, initially approved by the FDA in 1987, is a popular antihypertensive drug belonging to the group of drugs called dihydropyridine calcium channel blockers. Due to their selectivity for the peripheral blood vessels, dihydropyridine calcium channel blockers are associated with a lower incidence of myocardial depression and cardiac conduction abnormalities than other calcium channel blockers.

    Amlodipine is commonly used in the treatment of high blood pressure and angina. Amlodipine has antioxidant properties and an ability to enhance the production of nitric oxide (NO), an important vasodilator that decreases blood pressure. The option for single daily dosing of amlodipine is an attractive feature of this drug.

     

    CAS No.

    88150-42-9

     

    Certificate of Analysis

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  • [외피 8품목]Amorolfine Hydrochloride (아모롤핀염산염)

    Manufacturer

    Zhejiang Hisoar Pharmaceutical Co., Ltd

     

    Specification

    EP-In house

     

    KDMF 등록번호

    20191204-211-J-495

     

    IUPAC Name

    (2R,6S)-2,6-dimethyl-4-(2-{[4-(2-methylbutan-2-yl)phenyl]methyl}propyl)morpholine

     

    Synonyms

    N/A

     

    Description

    Amorolfine or amorolfin, is a morpholine antifungal drug that inhibits the fungal enzymes D14 reductase and D7-D8 isomerase. This inhibition affects fungal sterol synthesis pathways, depleting ergosterol and causing ignosterol to accumulate in the fungal cytoplasmic cell membranes.
    Amorolfine is marketed as Curanail, Loceryl, Locetar, and Odenil. It is available in the form of a 5% amorolfine nail lacquer used to treat onychomycosis (fungal infection of the toe- and fingernails). Amorolfine 5% nail lacquer in once or twice weekly applications is 60-71% effective in treating toenail onychomycosis; complete cure rates three months after stopping treatment (after six months of treatment) were 38-46%. However, full experimental details of these trials were not available and since they were first reported in 1992 there have been no subsequent trials.

    It is a topical solution for the treatment of toenail infections. Systemic treatments may be considered more effective.

    It is approved for sale over the counter in Australia and the UK (recently re-classified to over the counter status), and is approved for the treatment of toenail fungus by prescription in other countries. It is not approved for the treatment of onychomycosis in the United States or Canada.

     

    CAS No.

    78613-35-1

     

    Certificate of Analysis

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  • [순환계 9품목]Atorvastatin Calcium Hydrate (아토르바스타틴칼슘수화물)

    Manufacturer

    Zhejiang Neo-Dankong Pharmaceutical Co.Limited / Mylan Laboratories Limited

     

    Specification

    USP

     

    KDMF 등록번호

    20130618-132-H-238-23 / 20120525-132-H-208-17(2)

     

    IUPAC Name

    SHZPNDRIDUBNMH-NIJVSVLQSA-L

     

    Synonyms

    Atorvastatin

     

    Description

    Atorvastatin, also known as the brand name product Lipitor, is a lipid-lowering drug belonging to the statin class of medications. By inhibiting the endogenous production of cholesterol in the liver, statins lower abnormal cholesterol and lipid levels and ultimately reduce the risk of cardiovascular disease. More specifically, statin medications competitively inhibit the enzyme hydroxymethylglutaryl-coenzyme A (HMG-CoA) Reductase, which catalyzes the conversion of HMG-CoA to mevalonic acid. This conversion is a critical metabolic reaction 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 a standard practice following any cardiovascular events and for people with a moderate to high risk of development of the cardiovascular disease, such as those with Type 2 Diabetes. The clear evidence of the benefit of statin use, coupled with minimal side effects or beneficial long term effects, has resulted in this drug class becoming one of the most widely prescribed medications in North America.

    Atorvastatin and other drugs from the statin drug class of medications includinlovastatinpravastatinrosuvastatinfluvastatin, and simvastatin are considered first-line treatment options for dyslipidemia. The increasing use of the statin class of drugs is largely due to cardiovascular diseases (CVD) (such as heart attack, atherosclerosis, angina, peripheral artery disease, and stroke) becoming a leading cause of death in many countries and a major cause of morbidities. An elevated cholesterol level (elevated low-density lipoprotein (LDL) levels in particular) is an important risk factor for the development of CVD. Several landmark studies showed a reduction in LDL levels and the risk of CVD development associated with the use of statins.Stains were shown to reduce the incidences of all-cause mortality, including fatal and non-fatal CVD, as well as the need for surgical revascularization or angioplasty following a heart attack. Some evidence has shown that even for low-risk individuals (with <10% risk of a major vascular event occurring within five years) statins cause a 20%-22% relative reduction the number of major cardiovascular events (heart attack, stroke, coronary revascularization, and coronary death) for every 1 mmol/L reduction in LDL without any significant side effects or risks.

    Atorvastatin was first synthesized in 1985 by Dr. Bruce Roth and approved by the FDA in 1996. It is a pentasubstituted pyrrole formed by two contrasting moieties with an achiral heterocyclic core unit and a 3,5-dihydroxypentanoyl side chain identical to its parent compound. Unlike other members of the statin group, atorvastatin is an active compound and therefore does not require activation.

     

    CAS No.

    344423-98-9

     

    Certificate of Analysis

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  • [항생물질제제 2품목]Azithromycin (아지트로마이신)

    Manufacturer

    Zhejiang Guobang Pharmaceutical Co., Ltd.

     

    Specification

    EP

     

    KDMF 등록번호

    20130123-191-I-119-05(1)

     

    IUPAC Name

    (2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-11-{[(2S,3R,4S,6R)-4-(dimethylamino)-3-hydroxy-6-methyloxan-2-yl]oxy}-2-ethyl-3,4,10-trihydroxy-13-{[(2R,4R,5S,6S)-5-hydroxy-4-methoxy-4,6-dimethyloxan-2-yl]oxy}-3,5,6,8,10,12,14-heptamethyl-1-oxa-6-azacyclopentadecan-15-one

     

    Synonyms

    N/A

     

    Description

    Azithromycin is a broad-spectrum macrolide antibiotic with a long half-life and a high degree of tissue penetration. It was initially approved by the FDA in 1991

    It is primarily used for the treatment of respiratory, enteric and genitourinary infections and may be used instead of other macrolides for some sexually transmitted and enteric infections. It is structurally related to erythromycin

    Azithromycin [9-deoxo-9a-aza-9a-methyl-9a-homoerythromycin] is a part of the azalide subclass of macrolides, and contains a 15-membered ring, with a methyl-substituted nitrogen instead of a carbonyl group at the 9a position on the aglycone ring, which allows for the prevention of its metabolism. This differentiates azithromycin from other types of macrolides

     

    CAS No.

    83905-01-5

     

    Certificate of Analysis

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  • [알레르기 3품목]Bepotastine besilate (베포타스틴베실산염)

    Manufacturer

    Bal Pharma Limited

     

    Specification

    JP

     

    KDMF 등록번호

    20190926-209-J-357

     

    IUPAC Name

    4-{4-[(4-chlorophenyl)(pyridin-2-yl)methoxy]piperidin-1-yl}butanoic acid

     

    Synonyms

    N/A

     

    Description

    Bepotastine is a non-sedating, selective antagonist of the histamine 1 (H1) receptor. Bepotastine was approved in Japan for use in the treatment of allergic rhinitis and uriticaria/puritus in July 2000 and January 2002, respectively, and is marketed by Tanabe Seiyaku Co., Ltd. under the brand name Talion. It is available in oral and opthalmic dosage forms in Japan. The opthalmic solution is FDA approved since Sept 8, 2009 and is under the brand name Bepreve. 

     

    CAS No.

    125602-71-3

     

    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 8품목]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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