Mumbai: Drug maker Cipla Ltd. on Friday said it has received regulatory approval from Drug Controller General of India (DCGI) for the launch of Favipiravir in the country under the brand name Ciplenza to treat mild to moderate Covid-19 patients.
Favipiravir is an off patent, oral antiviral drug that has been shown to hasten clinical recovery in Covid-19 patients with mild to moderate symptoms.
The accelerated approval for manufacturing and marketing of the drug is aimed at meeting the urgent and unmet medical need for Covid-19 treatment options in the country through restricted emergency use.
Cipla said it will commercially launch Ciplenza in the first week of August priced at Rs 68 per tablet.
The price of Favipiravir has become a matter of great concern in the country as Glenmark Pharmaceuticals faced flak after it initially launched its Favipiravir drug under the brand name FabiFlu at Rs 103 per tablet.
Subsequently on July 13, Glenmark reduced the price of FabiFlu to Rs 75 per tablet.
Cipla said to ensure fair and equitable distribution of the drug, supplies will be undertaken predominantly through hospital channels and via open channels, prioritised for regions with a high burden of Covid-19 cases.
The drug has been jointly developed by Cipla and CSIR-Indian Institute of Chemical Technology (IICT).
As part of this partnership, CSIR-IICT has successfully developed a convenient and cost-effective synthetic process for Favipiravir.
The entire process and active pharmaceutical ingredient (API) of the drug has been transferred to Cipla to manufacture and market the drug at scale.
Towards providing drugs for coronavirus patients in India, CSIR late in April said it had identified top 25 drugs/drug candidates for repurposing.
Among these top 25 drugs, Favipiravir, a broad spectrum inhibitor of viral RNA polymerase emerged as one of the most promising drugs.
Favipiravir was developed by Fujifilm Toyama Chemical Ltd., and is used for treatment of common influenza in some markets.