New Delhi: Hyderabad-based Zenara Pharma has received approval from the Drugs Controller General India (DCGI) to manufacture and sell favipiravir in India, the company said in a press statement Wednesday.
Zenara Pharma, a subsidiary of Biophore, is one of several Indian companies that have received the government’s approval to develop or sell favipiravir, a drug meant for emergency use among mild to moderate patients who fulfil certain criteria. The others are Hetero, Glenmark Pharmaceuticals, Cipla, Brinton Pharma and Jenburkt Pharmaceuticals.
The tablets sold by Zenara will be branded ‘Favizen’, the company said, adding that they will be manufactured at its “US FDA-approved facility in Hyderabad”.
“In the ongoing pandemic, it has become extremely critical for pharmaceutical companies to quickly provide safe and effective treatment options for patients with Covid-19,” Zenara managing director Dr Jagadeesh Babu Rangisetty said in the press statement.
“I am proud to say that we have our own in-house API (active pharmaceutical ingredients) and are not dependent on any imports for the production,” he added. “We believe that this will ensure stability and rapid production and availability of this treatment for the Indian market. We are also in talks with various institutions to make the tablets available at discounted or no cost to underprivileged patients.”
The pharma company said they are in talks with hospitals and institutions to ensure the drug is readily available for patients’ use. In order to increase patient coverage, the company is also likely to tie up with other partners across the country, it added.
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Favipiravir side-effects
Favipiravir was originally developed in the late 1990s by a company that was later purchased by Japanese firm Fujifilm as part of its transition from the photo business to healthcare.
It is one of the drugs that has been associated with some promise in treating Covid-19 patients. While it has received regulatory approval for emergency use in India, it remains a subject of multiple trials in the country and abroad.
The drug comes with side-effects such as possible birth defects and liver damage. At a press meet in June, Glenmark said the drug can be used in Covid-19 patients with comorbid conditions such as diabetes and heart disease, but added that it is not to be administered to those with severe kidney and liver impairment, or pregnant and lactating women.
The drug should also be used with caution in patients with history of abnormalities in metabolism of uric acid or having gout, it added.
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