Cipla Limited announced that it has been granted regulatory approval by the Drug Controller General of India (DCGI) for the launch of Favipiravir in the country under the brand name Ciplenza. 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.
As part of its efforts to enable speedy access to cater to the demand, Cipla will commercially launch Ciplenza in the first week of August priced at Rs 68 per tablet. 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 constituent lab CSIR-Indian Institute of Chemical Technology (CSIR-IICT) has developed a cost effective process using locally available chemicalsto synthesize this Active Pharmaceutical Ingredient (API) and transferred the technology to Cipla Limited.
Cipla has scaled up the process in their manufacturing facility and approached DCGI for permission to launch the product in India. Given that DCGI has given restricted emergency use for Favipiravir in the country, Cipla is now all set to launch the product to help patients suffering from Covid-19.
Commenting on the development, Director CSIR-IICR, Dr. S Chandrashekhar said that the technology provided by CSIR-IICT is very efficient and makes it affordable and allows Cipla to make large quantities of the product within a short span of time.
DG-CSIR, Dr. Shekhar C Mande observed that CSIR is working with industry in developing quick solutions and products for mitigation of Covid-19 and this partnership with Cipla is an example of how CSIR is committed to bringing repurposed drugs on a fast track.
Favipiravir is an off-patent, an oral anti-viral drug that has been shown to hasten clinical recovery in COVID -19 patients with mild to moderate symptoms.
Meanwhile, the Brinton Pharmaceuticals, a Pune-based pharmaceutical company, said it has received approval from Drugs Controller General of India (DCGI) to market an antiviral drug Favipiravir under the brand name Faviton. It will be available in 200 mg tablets at Rs 59.
Faviton will be available in a strip of 10 tablets and 50 tablets in a box, which is a rational pack for the treatment. It comes with 90 days shelf-life with an MRP of Rs 59. Brinton is one of the few companies to market this drug in India. It has also planned to export it.
Rahul Kumar Darda, Chairman and Managing Director of Brinton, said the company has a strong distribution network that will help to make Faviton available across all Covid-19 treatment centres.