Strides Pharma Gets DGCI Approval To Test Potential Covid-19 Drug

Strides Pharma Science has got approval from the Drug Controller General of India (DCGI) to conduct trials of antiviral drug Favipiravir in India, which is considered a potential treatment for Covid-19.

“We have the approval to conduct human study and we will be starting the trials soon in India,” the Bengaluru-based company said on Thursday.

Favipiravir is a generic version of Avigan, initially developed in Japan to treat influenza. The product is being exported to Gulf countries by Strides to treat patients under a programme for Covid-19. The tablets are being manufactured at Strides’ flagship facility in Bengaluru, which can produce up to six billion units of solid orals annually.

Mumbai-based Glenmark had earlier received approval from the regulator to conduct clinical trials on Favipiravir tablets for Covid-19 patients.

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Strides said Covid-19 did not have any significant impact on their Q4 revenue. “There were some minor aberrations in manufacturing that led to some depletion in our inventory but there was no major impact,” said R Ananthanarayanan, chief executive officer and managing director.

The company has said it had several antiviral drugs in its basket of approved drugs, which may be repurposed for Covid-19 in FY21 and could result in business opportunities.

The company’s revenue has been hurt in the US as USFDA had ordered withdrawal of Ranitidine from the market on the last day of FY20.

Strides Founder and Non-Executive Chairman Arun Kumar said it would take at least two years for Ranitidine to be reintroduced in the US. “But we still believe in the molecule and will continue to invest time and money to see if we can bring the product back. For us, this is clearly a setback,” he said. The firm had posted a consolidated loss of ~206.5 crore for the March quarter because of the Ranitidine setback. The drug resulted in a $9 million business for Strides in the first half of FY20.