Gujarat FDCA: Manufacturing license granted to Glenmark for producing API for antiviral drug favipiravir

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Glenmark Pharmaceuticals has been granted manufacturing license by the Gujarat Food and Drug Control Administration (FDCA) for producing API for the antiviral drug favipiravir at its Ankleshwar plant based on Drugs Controller General of India (DCGI)’s approval to manufacture favipiravir for mild and moderate COVID-19 patients in the country.

Dr H G Koshia said that, “It is a new drug in India for mild COVID-19 treatment. Company’s tableting unit is in Himachal Pradesh at Baddi. Post production of the API in Ankleshwar, the API will go for tableting and the drug will be available pan India in a couple of days time based on my correspondence with the company. We fast tracked the license approval based on DCGI permission to Glenmark Pharmaceuticals for commercial production of the drug favipiravir.

Strong clinical evidences has shown results that Favipiravir helps in treating patients having symptoms from mild to moderate. It offers broad spectrum RNA virus coverage with clinical improvement noted across age groups 20 to >90 years. The drug can also be used in the treatment of COVID-19 patients with co-morbid conditions such as diabetes and heart disease with mild to moderate COVID-19 symptoms. The antiviral drug reduces the viral load within 4 days and provides faster symptomatic and radiological improvement.
Glenmark filed the product for clinical trial with India’s drug regulator DCGI and became the first pharmaceutical company in India to receive approval for conducting phase 3 clinical trial on mild to moderate COVID-19 patients.

Favipiravir has been approved in Japan since 2014 for the treatment of novel or re-emerging influenza virus infections. It is converted into an active phosphoribosylated form (favipiravir-RTP) in cells and recognized as a substrate by viral RNA polymerase, thereby inhibiting RNA polymerase activity.

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