Sofosbuvir

Short Description:

API’s Name Indication Specification US DMF  EU DMF  CEP
Sofosbuvir HCV In-House 32048  


Product Detail

Product Tags

PRODUCT DETAIL

索非布韦 Sofosbuvir 1190307-88-0 In-House
    SFBM 1256490-31-9 In-House
    SFB-8 874638-80-9 In-House
    SFB-10 817204-32-3 In-House
    SFBA-1 863329-66-2 In-House
    SFBMA 1334513-02-8 In-House

Generic Name: sofosbuvir (soe FOS bue vir)
Brand Names: Sovaldi

Sofosbuvir is an antiviral medicine that is used to treat chronic hepatitis C in adults and children who are at least 3 years old and an HCV RNA replication inhibitor with an EC50 of 92 nM.

Sofosbuvir must be given in combination with other antiviral medications (usually ribavirin with or without peginterferon alfa). Sofosbuvir should not be used alone.

Sofosbuvir treats specific genotypes of hepatitis C, and only in certain people. Use only the medications prescribed for you. Do not share your medicine with other people.

Sofosbuvir is sometimes used in people who also have HIV, or people who have liver cancer and are going to have a liver transplant. This medicine is not a treatment for HIV or AIDS.

Storage

Powder

-20°C

3 years

4°C

2 years
In solvent

-80°C

6 months

-20°C

1 month

Chemical structure

Sofosbuvir

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

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Korea Countec Bottled Packaging Line

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Taiwan CVC Bottled Packaging Line

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Italy CAM Board Packaging Line

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German Fette Compacting Machine

cpf12

Japan Viswill Tablet Detector

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DCS Control Room

PARTNER

International cooperation
International cooperation
Domestic cooperation
Domestic cooperation

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