Date: 26-Jun-2020

Gujarat FDCA Grants Manufacturing License To Glenmark For Producing API For Antiviral Drug Favipiravir

The Gujarat Food and Drug Control Administration (FDCA) has given manufacturing license to Glenmark Pharmaceuticals for manufacturing 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.

According to Gujarat FDCA Commissioner Dr H G Koshia, “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, he added.

Favipiravir is backed by strong clinical evidence showing encouraging results in patients with mild to moderate COVID-19. The antiviral offers broad spectrum RNA virus coverage with clinical improvement noted across age groups 20 to >90 years. Favipiravir can be used in COVID-19 patients with co-morbid conditions such as diabetes and heart disease with mild to moderate COVID-19 symptoms. It offers rapid reduction in viral load within 4 days and provides faster symptomatic and radiological improvement. Of most importance, favipiravir has shown clinical improvement of up to 88% in COVID-19 mild to moderate COVID-19 cases.

Glenmark successfully developed the active pharmaceutical ingredient (API) and the formulation for FabiFlu through its own in-house R&D team. 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 is approved in Japan since 2014 for the treatment of novel or re-emerging influenza virus infections. It has a unique mechanism of action: 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.