China Quality Inspection for Sofosbuvir Daclatasvir Dose - Agomelatine – CPF manufacturers and suppliers

Quality Inspection for Sofosbuvir Daclatasvir Dose - Agomelatine – CPF

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Quality Inspection for Sofosbuvir Daclatasvir Dose - Agomelatine – CPF Detail:

Background

Agomelatine is an agonist of melatonin receptors and an antagonist of the serotonin 5-HT2C receptor with Ki values of 0.062nM and 0.268nM and IC50 value of 0.27μM, respectively for MT1, MT2 and 5-HT2C [1].

Agomelatine is a unique antidepressant and is developed for treatment of major depressive disorder (MDD). Agomelatine is selective against 5-HT2C. It shows low affinities to cloned human 5-HT2A and 5-HT1A. For melatonin receptors, agomelatine shows similar affinities to cloned human MT1 and MT2 with Ki values of 0.09nM and 0.263nM, respectively. In the in vivo studies, agomelatine causes increase of dopamine and noradrenaline levels via blocking the inhibitory input of 5-HT2C. Moreover, the administration of agomelatine counteractes the stress-induced decrease in sucrose consumption in a rat model of depression. Besides that, agomelatine exerts alleviated anxiety efficacy in a rodent model of anxiety [1].

References:
[1] Zupancic M, Guilleminault C. Agomelatine. CNS drugs, 2006, 20(12): 981-992.

Chemical structure

Agomelatine

2018 GMP-2
原料药GMP证书201811（captopril ,thalidomide etc）
GMP-of-PMDA-in-Chanyoo-平成28年08月03日　Nantong-Chanyoo-Pharmatech-Co
FDA-EIR-Letter-201901

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Quality management1

Proposal 18 Quality Consistency Evaluation projects which have approved 4, and 6 projects are under approving.

Quality management2

Advanced international quality management system has laid solid foundation for sales.

Quality management3

Quality supervision runs through the whole life cycle of the product to ensure the quality and therapeutic effect.

Quality management4

Professional Regulatory Affairs team supports the quality demands during the application and registration.

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