Sun Pharma receives DCGI approval for Molnupiravir in India

Mumbai, December 28, 2021

Pharma major Sun Pharmaceutical Industries Limited today said that one of its wholly owned subsidiaries has received Emergency Use Authorization (EUA) from the Drugs Controller General of India (DCGI) to manufacture and market a generic version of MSD (a trade name of Merck & Co., USA) and Ridgeback’s molnupiravir under the brand name Molxvir in India for treatment of certain categories of adult patients with COVID-19.

Earlier this year, Sun Pharma had signed a non-exclusive voluntary licensing agreement with MSD to manufacture and supply a generic version of molnupiravir in over 100 low and middle-income countries (LMICs) including India, a press release from the company said.

The DCGI, based on the review of clinical data of molnupiravir, has approved it for treatment of adult patients with Covid-19, with SpO2 > 93% and who have high risk of progression of the disease including hospitalisation or death, the release said.

“Molnupiravir is an important addition to the portfolio of oral therapies available for treating Covid-19 patients,” said Kirti Ganorkar, CEO of India Business, Sun Pharma. “In line with our consistent efforts to accelerate access to new drugs for Covid-19 treatment, we will make Molxvir available to patients at an affordable price. We are also in the process of launching a toll-free helpline to ensure the availability of Molxvir to doctors and patients across India. Our endeavour is to make the product available in a week’s time.”

The recommended dose of the drug is 800 mg twice a day for five days. The duration of treatment of molnupiravir is much shorter compared to other therapies which is a significant advantage as it reduces the pill burden and enhances compliance, it said.

Molnupiravir has been developed by MSD and Ridgeback Biotherapeutics. It has been approved by the U.S. Food and Drug Administration (FDA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA) for Emergency Use Authorization (EUA), the release added.

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