바이오소재 전문기업

Dong Jin Pharma

We have the solution you need

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]Naproxen (나프록센)

    Manufacturer

    Divi’s Laboratories Limited.

     

    Specification

    USP

     

    KDMF 등록번호

    20130821-143-I-336-08(3)

     

    IUPAC Name

    (2S)-2-(6-methoxynaphthalen-2-yl)propanoic acid

     

    Synonyms

    (+)-(S)-6-Methoxy-α-methyl-2-naphthaleneacetic acid

    (+)-(S)-Naproxen

    (+)-2-(6-Methoxy-2-naphthyl)propionic acid

    (+)-2-(Methoxy-2-naphthyl)-propionic acid

    (+)-2-(Methoxy-2-naphthyl)-propionsäure

    (+)-Naproxen

    (S)-(+)-2-(6-Methoxy-2-naphthyl)propionic acid

    (S)-(+)-Naproxen

    (S)-2-(6-Methoxy-2-naphthyl)propanoic acid

    (S)-2-(6-Methoxy-2-naphthyl)propionic acid

    (S)-6-Methoxy-alpha-methyl-2-naphthaleneacetic acid

    (S)-Naproxen

    Description

    Naproxen is classified as a nonsteroidal anti-inflammatory dug (NSAID) and was initially approved for prescription use in 1976 and then for over-the-counter (OTC) use in 1994. It can effectively manage acute pain as well as pain related to rheumatic diseases, and has a well studied adverse effect profile. Given it's overall tolerability and effectiveness, naproxen can be considered a first line treatment for a variety of clinical situations requiring analgesia. Naproxen is available in both immediate and delayed release formulations, in combination with sumatriptan to treat migraines, and in combination with esomeprazole to lower the risk of developing gastric ulcers.

     

    CAS No.

    22204-53-1

     

    Certificate of Analysis

    If you need more information, please contact us.

     

  • [중추신경계 21품목]Naproxen Sodium (나프록센나트륨)

    Manufacturer

    Zhejiang Charioteer Pharmaceutical Co., Ltd.

     

    Specification

    USP

     

    KDMF 등록번호

    20130121-143-I-209-04(6)

     

    IUPAC Name

    sodium (2S)-2-(6-methoxynaphthalen-2-yl)propanoate

     

    Synonyms

    N/A

     

    Description

    Naproxen is classified as a nonsteroidal anti-inflammatory dug (NSAID) and was initially approved for prescription use in 1976 and then for over-the-counter (OTC) use in 1994. It can effectively manage acute pain as well as pain related to rheumatic diseases, and has a well studied adverse effect profile. Given it's overall tolerability and effectiveness, naproxen can be considered a first line treatment for a variety of clinical situations requiring analgesia. Naproxen is available in both immediate and delayed release formulations, in combination with sumatriptan to treat migraines, and in combination with esomeprazole to lower the risk of developing gastric ulcers

     

    CAS No.

    26159-34-2

     

    Certificate of Analysis

    If you need more information, please contact us.

     

  • [화학료법제 9품목]Ofloxacin (오플록사신)

    Manufacturer

    Zhejiang East- Asia Pharmaceutical Co., LTd

     

    Specification

    USP

     

    KDMF 등록번호

    20070723-89-E-2-02(20)

     

    IUPAC Name

    7-fluoro-2-methyl-6-(4-methylpiperazin-1-yl)-10-oxo-4-oxa-1-azatricyclo[7.3.1.0⁵,¹³]trideca-5(13),6,8,11-tetraene-11-carboxylic acid

     

    Synonyms

    8-Fluoro-3-methyl-9-(4-methyl-piperazin-1-yl)-6-oxo-2,3-dihydro-6H-1-oxa-3a-aza-phenalene-5-carboxylic acid

     

    Description

    A synthetic fluoroquinolone (fluoroquinolones) antibacterial agent that inhibits the supercoiling activity of bacterial DNA gyrase, halting DNA replication.

     

    CAS No.

    82419-36-1

     

    Certificate of Analysis

    If you need more information, please contact us.

     

  • [중추신경계 21품목]Paroxetine Hydrochloride Hydrate (파록세틴염산염수화물)

    Manufacturer

    Mylan Laboratories Limited

     

    Specification

    EP

     

    KDMF 등록번호

    20191217-209-J-318

     

    IUPAC Name

    (3S,4R)-3-[(2H-1,3-benzodioxol-5-yloxy)methyl]-4-(4-fluorophenyl)piperidine

     

    Synonyms

    (−)-(3S,4R)-4-(p-fluorophenyl)-3-((3,4-(methylenedioxy)phenoxy)methyl)piperidine

    (3S-trans)-3-((1,3-benzodioxol-5-yloxy)methyl)-4-(4-fluorophenyl)piperidine

     

    Description

    Paroxetine is a selective serotonin reuptake inhibitor (SSRI) drug commonly known as Paxil. It has a variety of uses, including the treatment of anxiety disorders, major depression, posttraumatic stress disorder, and symptoms of menopause, among others. It was approved by the FDA in the early 1990s and marketed by SmithKline Beecham. A unique feature of this drug is that it is highly potent and selective in its inhibition of serotonin reuptake and has little effect on other neurotransmitters. Because of its potent inhibition of serotonin reuptake, paroxetine is more likely to cause withdrawal effects upon cessation. Paroxetine is well tolerated in most patients with a similar adverse effect profile to other members of its drug class. The controlled release formulation was designed to decrease the likelihood of nausea that is sometimes associated with paroxetine.

     

    CAS No.

    61869-08-7

     

    Certificate of Analysis

    If you need more information, please contact us.

     

  • [알레르기 3품목]Pranlukast Hydrate (프란루카스트수화물)

    Manufacturer

    Chongqing Shenghuaxi Pharmaceutical Co., Ltd.

     

    Specification

    JP

     

    KDMF 등록번호

    20180809-171-I-571-08

     

    IUPAC Name

    N-[4-oxo-2-(1H-tetrazol-5-yl)-4H-chromen-8-yl]-4-(4-phenylbutoxy)benzamide

     

    Synonyms

    N/A

     

    Description

    Pranlukast is a cysteinyl leukotriene receptor-1 antagonist. It antagonizes or reduces bronchospasm caused, principally in asthmatics, by an allergic reaction to accidentally or inadvertently encountered allergens.

     

    CAS No.

    150821-03-7

     

    Certificate of Analysis

    If you need more information, please contact us.

     

  • [외피 8품목]Prednisolone Valeroacetate (프레드니솔론발레로아세테이트)

    Manufacturer

    NEWCHEM S.p.A
    [프레드니솔론 제조소①] Hanan Lihua Pharmaceutical Co., Ltd.
    [프레드니솔론 제조소②] Tianjin Tianyao Pharmaceuticals co., Ltd
    [프레드니솔론 제조소③] Zhejiang Xianju Pharmaceutical Co., Ltd.

     

    Specification

    In-house

     

    KDMF 등록번호

    2011209-71-B-322-06(6)

     

    IUPAC Name

    (1S,2R,10S,11S,14R,15S)-14-hydroxy-14-(2-hydroxyacetyl)-2,15-dimethyltetracyclo[8.7.0.0²,⁷.0¹¹,¹⁵]heptadeca-3,6-diene-5,17-dione

     

    Synonyms

    1,2-Dehydrocortisone

    1,4-Pregnadiene-17α,21-diol-3,11,20-trione

    17,21-Dihydroxypregna-1,4-diene-3,11,20-trione

     

    Description

    A synthetic anti-inflammatory glucocorticoid derived from cortisone. It is biologically inert and converted to prednisolone in the liver.

    Prednisone was granted FDA approval on 21 February 1955.

     

    CAS No.

    53-03-2

     

    Certificate of Analysis

    If you need more information, please contact us.

     

  • [중추신경계 21품목]Quetiapine Fumarate (쿠에티아핀푸마르산염)

    Manufacturer

    Mylan Laboratories Limited

    Qilu Tianhe Pharmaceutical Co., Ltd.

     

    Specification

    USP

     

    KDMF 등록번호

    20120713-172-I-90-05

     

    IUPAC Name

    2-[2-(4-{2-thia-9-azatricyclo[9.4.0.0³,⁸]pentadeca-1(15),3,5,7,9,11,13-heptaen-10-yl}piperazin-1-yl)ethoxy]ethan-1-ol

     

    Synonyms

    2-[2-(4-Dibenzo[b,f][1,4]thiazepin-11-yl-1-piperazinyl)ethoxy]ethanol

     

    Description

    Initially approved by the FDA in 1997, quetiapine is a second-generation atypical antipsychotic used in schizophrenia, major depression, and bipolar disorder. Quetiapine demonstrates a high level of therapeutic efficacy and low risk of adverse effects during long-term treatment. It is well-tolerated and a suitable option for some patients with high sensitivity to other drugs, such as Clozapine and Olanzapine.

     

    CAS No.

    111974-72-2

     

    Certificate of Analysis

    If you need more information, please contact us.

     

  • [중추신경계 21품목]Rasagiline Mesylate (라사길린메실산염)

    Manufacturer

    Mylan Laboratories Limited

     

    Specification

    In-house

     

    KDMF 등록번호

    수289-6-ND

     

    IUPAC Name

    (1R)-N-(prop-2-yn-1-yl)-2,3-dihydro-1H-inden-1-amine

     

    Synonyms

    (1R)-N-propargylindan-1-amine

    (R)-indan-1-yl-prop-2-ynyl-amine

    (R)-N-2-Propynyl-1-indanamine

     

    Description

    Rasagiline is an irreversible inhibitor of monoamine oxidase and is used as a monotherapy in early Parkinson's disease or as an adjunct therapy in more advanced cases.

     

    CAS No.

    136236-51-6

     

    Certificate of Analysis

    If you need more information, please contact us.

     

  • [소화기관 7품목]Rebamipide (레바미피드)

    Manufacturer

    Suzhou Tianma Specialty Chemicals Co.,Ltd
    Jiangxi Synergy Pharmaceutical Co., Ltd

     

    Specification

    JP

     

    KDMF 등록번호

    20160725-4-B-387-21(2)
    20070504-4-B-240-14(3)

     

    IUPAC Name

    90098-04-7

     

    Synonyms

    N/A

     

    Description

    Rebamipide has been investigated for the treatment of Stomach Ulcer, Keratoconjunctivitis Sicca, and Gastric Adenoma and Early Gastric Cancer.

     

    CAS No.

    90098-04-7

     

    Certificate of Analysis

    If you need more information, please contact us.

     

  • [중추신경계 21품목]Risperidone (리스페리돈)

    Manufacturer

    Mylan Laboratories Limited
    Aurobindo Pharma ltd.

     

    Specification

    EP

     

    KDMF 등록번호

    20151130-10-C-349-20
    20070521-10-C-231-14(1)

     

    IUPAC Name

    RAPZEAPATHNIPO-UHFFFAOYSA-N

     

    Synonyms

    N/A

     

    Description

    Risperidone is a second-generation antipsychotic (SGA) medication used in the treatment of a number of mood and mental health conditions including schizophrenia, bipolar mania, and as an adjunct in severe depression for example. It is one of the most widely used SGAs.

    Schizophrenia and various mood disorders are thought to be caused by an excess of dopaminergic D2 and serotonergic 5-HT2A activity, resulting in overactivity of central mesolimbic pathways and mesocortical pathways, respectively. Risperidone is thought to reduce this overactivity through inhibition of dopaminergic D2 receptors and serotonergic 5-HT2A receptors in the brain.

    Risperidone binds with a very high affinity to 5-HT2A receptors, approximately 10-20 fold greater than the drug's binding affinity to D2 receptors

     

    CAS No.

    106266-06-2

     

    Certificate of Analysis

    If you need more information, please contact us.

     

  • [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

    If you need more information, please contact us.

     

  • [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

    If you need more information, please contact us.

  • [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

    If you need more information, please contact us.

  • [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

    If you need more information, please contact us.

     

  • [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

    If you need more information, please contact us.

[06784] 서울 서초구 동산로 8길 41 (양재동, 동진빌딩)
대표 : 민병규  /  TEL : 02-579-1056  /  FAX : 02-6008-3356  /  E-mail : djp@dj-pharma.com

Copyright © 2010 DJP company. All Rights Reserved.