에이스바이오팜

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]Ibuprofen (이부프로펜)
Manufacturer

IOL Chemicals and Pharmaceuticals Limited

Specification

BP

KDMF 등록번호

20210727-209-J-555

IUPAC Name

(RS)-2-(4-(2-methylpropyl)phenyl)propanoic acid

Synonyms

Advil

Motrin

Nuprin

Medipren

p-isobutyl hydratropic acid

p-isobutyl phenylpropionic acid

4-isobutyl-alpha-methylphenylacetic acid

2,4-isobutylphenyl propanoic acid

Description

Ibuprofen reduces the production of prstaglandin precursors from blocking the synthesis of prostaglandin by non-selectively inhibiting cycloxygenase-1 and 2.

It reversibly changes platelat function and prolongs bleeding time.

CAS No.

15687-27-1

Certificate of Analysis

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[비타민제 2품목]Isotretinoin (이소트레티노인)
Manufacturer

Chongqing Huapont Shengchem Pharmaceutical Co., Ltd.

Specification

USP+In-house

KDMF 등록번호

20171226-209-J-4

IUPAC Name

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

Synonyms

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

13-cis-retinoic acid

13-cis-Vitamin A acid

13-RA

cis-RA

Description

Isotretinoin is a retinoid derivative of vitamin A used in the treatment of severe recalcitrant acne.It was most widely marketed under the brand name Accutane, which has since been discontinued.Isotretinoin is associated with major risks in pregnancy and so it is only available under the iPLEDGE program in the United States. The first isotretinoin containing product was FDA approved on 7 May 1982.

CAS No.

4759-48-2

Certificate of Analysis

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KDMF APIs

[중추신경계 21품목]Ibuprofen (이부프로펜)

[비타민제 2품목]Isotretinoin (이소트레티노인)