Favipiravir, an experimental antiviral drug that is used to treat new influenza viruses in Japan, is being eyed by Indian pharma companies for export. It has not yet received approvals from the Drug Controller General of India to manufacture or import the drug for domestic use.

On Wenesday, Mumbai-based Institute of Chemical Technology said they have successfully synthesised a molecule of Favipiravir in their lab. “The synthesis was carried out on lab scale and further pilot scale-up is needed,” said Vikas Telvekar, professor at ICT, Mumbai.

Maharashtra-based Lasa Supergenerics has filed a declaration to the exchanges, stating that they are looking to manufacture the first 10,000 doses on a pilot scale and also apply for drug licence with the competent authorities for its use in India. The company is making the drug from scratch and has tied up with ICT, which developed the key starting material and active pharmaceutical ingredients required to manufacture the drug.

Omkar Herlekar, Chairman, Lasa Supergenerics, said the company will export the doses in the absence of DCGI approvals for the drug to be used in India.

“We already have export orders from abroad. The drug is in demand in Turkey, Jordan, Spain, Portugal and so on where it is being used in Covid-19 patients. Export has no restrictions since it would be based on our in-house specifications and not under the name of any particular pharmacopeia. We have an export licence for pharma products,” said Herlekar.

Favipiravir is a generic version of Fujifilm Toyama Chemical’s influenza drug, Avian. It is approved in Japan for treating new influenza virus infections. The drug possesses activity against many RNA viruses and can effectively inhibit conditions such as influenza, Ebola, yellow fever, chikungunya, norovirus and enterovirus. It is believed to be showing efficacy against Covid-19 in certain cases in China, which has led to the starting of clinical trials there.

Trial results

In India, Glenmark Pharmaceuticals has started Phase III clinical trials of the drug. Glenmark trial results, which enroll up to 150 patients, will be available in July or August.

Last month, Delhi-based Brinton Pharmaceuticals said they will market Favipiravir under the brand name Faviton, which will be available in 200mg and 400mg tablets for export. Faviton will be initially launched in 18 countries where Brinton has its own presence, the company said. “In India, It will be launched once the DCGI approval process is completed,” said Rahul Kumar Darda, Chairman and Managing Director of the company.

Also, in April-end, another Indian pharma company, Strides Pharma, said that it had developed Favipiravir tablets at its Bangalore facility and was exporting it to Gulf countries to treat patients.