Preety Chaudhary/Mumbai/Updated on: Dec 28th ,2021: Sun Pharma receives DCGI approval for Molxvir® (Molnupiravir) in India
Sun Pharmaceutical Industries Limited (Reuters: SUN.BO, Bloomberg: SUNP IN, NSE: SUNPHARMA, BSE: 524715, “Sun Pharma” and includes its subsidiaries and/or associate companies) today announced 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., Inc, Kenilworth, NJ, USA) and Ridgeback’s molnupiravir under the brand name Molxvir® in India. Earlier this year, Sun Pharma had signed a nonexclusive 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.
The Drugs Controller General of India (DCGI), based on the review of clinical data of molnupiravir has approved molnupiravir 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.
“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.
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).
Molxvir® is a registered trade mark of Sun Pharma.
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About Sun Pharmaceutical Industries Limited (CIN – L24230GJ1993PLC019050):
Sun Pharma is the world’s fourth largest specialty generic pharmaceutical company and India’s top pharmaceutical company. A vertically integrated business and a skilled team enables it to deliver high-quality products, trusted by customers and patients in over 100 countries across the world, at affordable prices. Its global presence is supported by manufacturing facilities spread across 6 continents and approved by multiple regulatory agencies, coupled with a multi-cultural workforce comprising over 50 nationalities. Sun Pharma fosters excellence through innovation supported by strong R &D capabilities across multiple R&D centers, with investments of approximately 6-7% of annual revenues in R&D. For further information, please visit www.sunpharma.com & follow us on Twitter@SunPharma_Live.