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]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

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KDMF APIs

[중추신경계 21품목]Quetiapine Fumarate (쿠에티아핀푸마르산염)