바이오소재 전문기업

Ace Bio Pharm

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.)

  • [화학료법제 9품목]Famciclovir (팜시클로버)

    Manufacturer

    Changzhou Kony Pharmaceutical Co.Ltd.

     

    Specification

    USP

     

    KDMF 등록번호

    20180208-209-J-153(2)

     

    IUPAC Name

    2-[(acetyloxy)methyl]-4-(2-amino-9H-purin-9-yl)butyl acetate

     

    Synonyms

    2-(2-(2-amino-9H-purin-9-yl)ethyl)-1,3-propanediol diacetate

    9-[4-acetoxy-3-(acetoxymethyl)but-1-yl]-2-aminopurine

    acetic acid 2-acetoxymethyl-4-(2-amino-purin-9-yl)-butyl ester

     

    Description

     

    Famciclovir, marketed as Famvir by Novartis, is a guanine analogue used to treat herpes virus infections. It is most commonly used to treat herpes zoster (shingles). Famciclovir is a prodrug of penciclovir with higher oral bioavailability.

     

    CAS No.

    104227-87-4

     

    Certificate of Analysis

    If you need more information, please contact us.

     

  • [비뇨생식기관 및 항문 4품목]Finasteride (피나스테리드)

    Manufacturer

    Aurobindo Pharma Limited

     

    Specification

    EP

     

    KDMF 등록번호

    20071025-94-E-50-02(10)

     

    IUPAC Name

    (1S,2R,7R,10S,11S,14S,15S)-N-tert-butyl-2,15-dimethyl-5-oxo-6-azatetracyclo[8.7.0.0²,⁷.0¹¹,¹⁵]heptadec-3-ene-14-carboxamide

     

    Synonyms

    (5alpha,17beta)-(1,1-Dimethylethyl)-3-oxo-4-azaandrost-1-ene-17-carboxamide

     

    Description

    Finasteride is a synthetic 4-azasteroid compound and specific inhibitor of steroid Type II 5α-reductase, which is an intracellular enzyme that converts the androgen testosterone into 5α-dihydrotestosterone (DHT). It works in a similar fashion as dutasteride, which is another 5-alpha-reductase inhibitor, by exerting antiandrogenic effects. Finasteride is an orally active drug that was first approved by the FDA in 1992 for the treatment of benign prostatic hyperplasia to improve symptoms and reduce the risk for acute urinary retention or the need for surgical procedures. In 1998, it was approved by the FDA to treat male pattern hair loss. Finasteride is commonly marketed under the brand names Propecia and Proscar to be used aloneo or in combination with doxazosin, an alpha-blocker.

    Both benign prostatic hyperplasia and androgenic alopecia are androgen-dependent disorders that are characterized by in situ high levels of DHT. In the treatment of benign prostate hyperplasia, alpha-blockers such as tamsulosin and terazosin are also used. Compared to alpha-blockers that focus on providing the rapid relief of symptoms, 5α-reductase inhibitors aim to target the underlying disease by blocking the effects of the primary androgen involved in benign prostate hyperplasia and androgenic alopecia, thus reducing the risk for secondary complications while providing symptom control.

     

    CAS No.

    98319-26-7

     

    Certificate of Analysis

    If you need more information, please contact us.

     

  • [화학료법제 9품목]Fluconazole (플루코나졸)

    Manufacturer

    Ipca Laboratories Limited

     

    Specification

    USP

     

    KDMF 등록번호

    20050831-74-A-153-07(6)

     

    IUPAC Name

    2-(2,4-difluorophenyl)-1,3-bis(1H-1,2,4-triazol-1-yl)propan-2-ol

     

    Synonyms

    N/A

     

    Description

    Fluconazole, commonly known as Diflucan, is an antifungal drug used for the treatment of both systemic and superficial fungal infections in a variety of tissues. It was initially approved by the FDA in 1990. This drug is an azole antifungal, in the same drug family as ketoconazole and itraconazole. Fluconazole has many advantages over the other antifungal drugs including the option of oral administration. The side effect profile of this drug is minimal. It has been demonstrated as an efficacious treatment for vaginal yeast infections in one single dose

     

    CAS No.

    86386-73-4

     

    Certificate of Analysis

    If you need more information, please contact us.

     

  • [중추신경계 21품목]Fluoxetine Hydrochloride (플루옥세틴염산염)

    Manufacturer

    Cadila Pharmaceuticals Limited

     

    Specification

    BP/EP

     

    KDMF 등록번호

    20081031-51-C-246-08(2)

     

    IUPAC Name

    methyl({3-phenyl-3-[4-(trifluoromethyl)phenoxy]propyl})amine hydrochloride

     

    Synonyms

    N/A

     

    Description

    Fluoxetine is a 2nd generation antidepressant categorized as a selective serotonin reuptake inhibitor (SSRI). It gained FDA approval in 1987 and although it was initially intended for the treatment of depression, today it is commonly prescribed to manage depression in addition to various other pathologies.

     

    CAS No.

    56296-78-7

     

    Certificate of Analysis

    If you need more information, please contact us.

     

  • [호흡기관 3품목]Formoterol Fumarate (포르모테롤푸마르산염)

    Manufacturer

    Mylan Laboratories Limited (Unit-11)

     

    Specification

    EP

     

    KDMF 등록번호

    20111202-187-I-22-11

     

    IUPAC Name

    N-[2-hydroxy-5-(1-hydroxy-2-{[1-(4-methoxyphenyl)propan-2-yl]amino}ethyl)phenyl]formamide

     

    Synonyms

    2'-hydroxy-5'-(1-hydroxy-2-((p-methoxy-α-methylphenethyl)amino)ethyl)formanilide, Formoterol

     

    Description

    Formoterol is an inhaled beta2-agonist used in the management of COPD and asthma that was first approved for use in the United States in 2001. It acts on bronchial smooth muscle to dilate and relax airways, and is administered as a racemic mixture of its active (R;R)- and inactive (S;S)-enantiomers. A major clinical advantage of formoterol over other inhaled beta-agonists is its rapid onset of action (2-3 minutes), which is at least as fast as salbutamol, combined with a long duration of action (12 hours) - for this reason, treatment guidelines for asthma recommend its use as both a reliever and maintenance medication. It is available as a single-entity product and in several formulations in combination with both inhaled corticosteroids and long-acting muscarinic antagonists.

     

    CAS No.

    43229-80-7

     

    Certificate of Analysis

    If you need more information, please contact us.

[06664] 서울 서초구 방배로20길 5 세명빌딩
대표 : 민병규  /  TEL : 02-579-1056  /  FAX : 02-6008-3356  /  E-mail : ace@acebiopharm.com

Copyright © 2010 ABP company. All Rights Reserved.