Paxlovid

Short Description:

API’s Name Indication Innovator Patent Expiry Date(The U.S)
Paxlovid Covid-19  Pfizer  

 


Product Detail

Product Tags

PRODUCT DETAIL

Paxlovid is an investigational medicine used to treat mild-to-moderate COVID-19 in adults and children [12 years of age and older weighing at least 88 pounds (40 kg)] with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death. Paxlovid is investigational because it is still being studied. There is limited information about the safety and effectiveness of using Paxlovid to treat people with mild-to-moderate COVID-19.
The FDA has authorized the emergency use of Paxlovid for the treatment of mild-to-moderate COVID-19 in adults and children [12 years of age and older weighing at least 88 pounds (40 kg)] with a positive test for the virus that causes COVID-19, and who are at high risk for progression to severe COVID-19, including hospitalization or death, under an EUA.

Paxlovid is not an FDA-approved medicine in the United States. Talk to your healthcare provider about your options or if you have any questions. It is your choice to take Paxlovid.

Paxlovid contains two medicines: nirmatrelvir and ritonavir.

Nirmatrelvir [PF-07321332] is a SARS-CoV-2 main protease (Mpro) inhibitor (also known as SARS-CoV2 3CL protease inhibitor) that works by inhibiting viral replication in the early stages of the disease to prevent progression to severe COVID-19.

Ritonavir is co-administered with nirmatrelvir to help slow its metabolism in order for it to remain active in the body for longer periods of time at higher concentrations to help combat the virus.

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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