It is for restricted emergency use in India. Restricted use entails responsible medication use where every patient must have signed informed consent before treatment initiation, Glenmark Pharmaceuticals said in a statement.
The company has received the manufacturing and marketing approval from Drugs Controller General of India (DCGI) to launch favipiravir for the treatment of mild to moderate COVID-19 patients, it said.
"This approval has been granted based on evaluation of data and in consultation with the Subject Expert Committee, as part of accelerated approval process, considering the emergency situation and unmet medical need of the COVID-19 outbreak," Glenmark said.
Shares of Glenmark Pharmaceuticals closed at Rs 409.10 per scrip on the BSE, up 0.93 per cent from its previous close. AKT BAL