Ledipasvir Actone /PVP

Short Description:

API’s Name Indication Specification US DMF  EU DMF  CEP
Ledipasvir Actone /PVP HCV In-House    


Product Detail

Product Tags

PRODUCT DETAIL

雷迪帕韦丙酮/聚维酮 Ledipasvir actone/PVP 1256388-51-8 In-House
    LPSM1   1256387-87-7 In-House
    LPSM1-5   291775-59-2 In-House
    LPSM2   1129634-44-1 In-House
    LPS-6   1441670-89-8 In-House

Ledipasvir acetone (GS-5885 acetone) is the active ingredient of Ledipasvir. Ledipasvir is an inhibitor of the hepatitis C virus NS5A, with EC50 values of 34 pM against GT1a and 4 pM against GT1b replicon.

In Vitro

Ledipasvir acetone is considered the active ingredient, which is converted to Ledipasvir spray-dried dispersion, an amorphous free base.

Storage

4°C, protect from light

*In solvent : -80°C, 6 months; -20°C, 1 month (protect from light)

 

Description

Ledipasvir acetone (GS-5885 acetone) is the active ingredient of Ledipasvir. Ledipasvir is an inhibitor of the hepatitis C virus NS5A, with EC50 values of 34 pM against GT1a and 4 pM against GT1b replicon.

 

In Vitro

Ledipasvir acetone is considered the active ingredient, which is converted to Ledipasvir spray-dried dispersion, an amorphous free base.

 

Storage

4°C, protect from light

 

*In solvent : -80°C, 6 months; -20°C, 1 month (protect from light)

 

Chemical structure

Ledipasvir Actone

CERTIFICATE

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

QUALITY MANAGEMENT

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.

PRODUCTION MANAGEMENT

cpf5
cpf6

Korea Countec Bottled Packaging Line

cpf7
cpf8

Taiwan CVC Bottled Packaging Line

cpf9
cpf10

Italy CAM Board Packaging Line

cpf11

German Fette Compacting Machine

cpf12

Japan Viswill Tablet Detector

cpf14-1

DCS Control Room

PARTNER

International cooperation
International cooperation
Domestic cooperation
Domestic cooperation

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