Molnupiravir: Merck to seek EUA from USFDA; trials on in India

By: |
October 05, 2021 8:07 AM

The company also plans to submit marketing applications to regulatory agencies worldwide. If authorised, Molnupiravir could become the oral drug for treating Covid-19.

MolnupiravirIf authorised, Molnupiravir could become the oral drug for treating Covid-19. (Photo source: Reuters)

Pharma major Merck has announced its plans to seek emergency use authorisation (EUA) from the USFDA for using Molnupiravir as a antiviral medicine for Covid-19. The company also plans to submit marketing applications to regulatory agencies worldwide. If authorised, Molnupiravir could become the oral drug for treating Covid-19. The Molnupiravir drug is also undergoing trials in India.

The Indian companies are looking at the implications of the USFDA approval on the ongoing trials and timeline in India. Merck, known as MSD India, has tied up with eight Indian companies to manufacture the drug in India. In April this year, the company had entered into voluntary licensing agreements with generic manufacturers in India to supply its investigational oral antiviral drug candidate, Molnupiravir.

Cipla, Dr Reddy’s Laboratories, Sun Pharma, Hetero Labs and Emcure Pharmaceuticals have signed deals with MSD. Torrent Pharma, Aurobindo Pharma and Viatris Pharma, too, inked deals with Merck. These agreements were expected to accelerate the availability of Molnupiravir in India and in 100 other low- and middle-income countries after regulatory approvals.

Cipla, Dr Reddy’s, Emcure, Sun and Torrent are collaborating with MSD for clinical trials of the Monupiravir in India.
On completion of the trials, each company would independently approach the Indian regulator for approval to manufacture and supply the Molnupiravir for treatment of Covid in India. Divi’s Labs will be supplying active pharmaceutical ingredients for Molnupiravir to Merck’s partners in India.

Get live Stock Prices from BSE, NSE, US Market and latest NAV, portfolio of Mutual Funds, Check out latest IPO News, Best Performing IPOs, calculate your tax by Income Tax Calculator, know market’s Top Gainers, Top Losers & Best Equity Funds. Like us on Facebook and follow us on Twitter.

Financial Express is now on Telegram. Click here to join our channel and stay updated with the latest Biz news and updates.

Next Stories
1Biocon consolidated net profit dips 18 pc to Rs 138 cr in Q2
2iPhone 13 Pro review: Little things make ‘pro’ things happen
3How bank-fintech partnerships have evolved in India to ease lending, payments for MSMEs, others