Remdesivir

Short Description:

API’s Name Indication Innovator Patent Expiry Date(The U.S)
Remdesivir Antiviruls(Ebola, Covid-19) Gilead  

 


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PRODUCT DETAIL

Remdesivir is an antiviral medication that targets a range of viruses. It was originally developed over a decade ago to treat hepatitis C and a cold-like virus called respiratory syncytial virus (RSV). Remdesivir wasn’t an effective treatment for either disease. But it showed promise against other viruses.

Researchers tested remdesivir in clinical trials during the Ebola outbreak. Other investigational medications worked better, but it was shown to be safe for patients. Studies in cells and animals suggested that remdesivir was effective against viruses in the coronavirus family, such as Middle East Respiratory Syndrome (MERS) and Severe Acute Respiratory Syndrome (SARS).

Remdesivir works by interrupting production of the virus. Coronaviruses have genomes made up ribonucleic acid (RNA). Remdesivir interferes with one of the key enzymes the virus needs to replicate RNA. This prevents the virus from multiplying.

Researchers began a randomized, controlled trial of the antiviral in February 2020 to test whether remdesivir could be used to treat SARS-CoV-2, the coronavirus that causes COVID-19. By April, early results indicated that remdesivir accelerated recovery for hospitalized patients with severe COVID-19. It became the first drug to receive emergency use authorization from the U.S. Food and Drug Administration (FDA) to treat people hospitalized with COVID-19.

Researchers have now completed the trial, known as the Adaptive COVID-19 Treatment Trial (ACTT-1). The study was funded by the National Institute of Allergy and Infectious Diseases (NIAID). The final report appeared in the New England Journal of Medicine on October 8, 2020.

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.

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

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

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

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