Sun Pharma receives DCGI approval to manufacture and market Molxvir in India

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Sun Pharma, on Tuesday, announced that they have received Emergency Use Authorization (EUA) from the Drugs Controller General of India (DCGI) to manufacture and market a generic version of Merck and Ridgeback’s molnupiravir under the brand name Molxvir® in India. 

The firm, earlier this year, had signed a non-exclusive voluntary licensing agreement with MSD to manufacture and supply molnupiravir to over 100 low and middle-income countries and in India.

Based on the review of clinical data of molnupiravir, DGCI has approved the drug for the treatment of adult patients with Covid-19. Individuals with more than 93% of oxygen saturation level and a high risk of progression of the disease including hospitalization or death can be administered with Molxvir. 

“Molnupiravir is an important addition to the portfolio of oral therapies available for treating Covid-19 patients. 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 endeavor is to make the product available in a week’s time.” 

Kirti Ganorkar, CEO of India Business, Sun Pharma

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. 

Molnupiravir is the first oral antiviral that got approval from the UK Medicines and Healthcare products Regulatory Agency (MHRA) to treat mild-to-moderate COVID -19 infected adults. The U.S. Food and Drug Administration (FDA) is alsMolnupiraviro reviewing the drug for Emergency Use Authorisation (EUA). 

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