Drug firm Strides Pharma Science on Thursday said it has received approval from Drug Controller General of India (DCGI) to conduct bio-equivalence study for antiviral drug favipiravir in the country. The drug is a generic version of Japan-based Toyama Chemical’s Avigan and was initially developed to treat influenza in Japan. It has shown positive outcomes in several studies on COVID-19 patients.
The company has received approval from the Indian drug authorities for conducting human studies on favipiravir in the country, a Strides Pharma Science spokesperson said in a conference call.
The approval is for carrying out bio-equivalence study to the innovator product (Avigan), he added. The company in an earlier regulatory filing in April had said that it had developed and commercialised favipiravir tablets, and?the product is currently being exported to GCC (Gulf Cooperation Council) countries to treat patients under their treatment programme for COVID-19.
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It had said that it would immediately apply to Indian drug authorities to commence necessary studies and make the drug available to Indian patients expeditiously.
Another domestic pharma firm Glenmark Pharmaceuticals had earlier this month said it has initiated Phase 3 clinical trials on favipiravir to check its efficacy on COVID-19 patients in India.
Shares of Strides Pharma Science were trading at Rs 426.75 per scrip on the BSE, up 1.35 per cent from its previous close.