Last Updated on January 3, 2024 by The Health Master
Sun Pharmaceutical Industries Limited 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, New Jersey, USA) and Ridgeback’s molnupiravir under the brand name Molxvir in India.
Earlier this year, Sun Pharma 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.
The Drugs Controller General of India, based on the review of clinical data of molnupiravir has approved molnupiravir for treatment of adult patients with C-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 C-19 patients,” said Kirti Ganorkar, CEO of India business, Sun Pharma. “In line with our consistent efforts to accelerate access to new drugs for C-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 US Food and Drug Administration (FDA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA) for Emergency Use Authorization (EUA).
Covaxin gets emergency use approval from DCGI for children above 12 years
DCGI seeks more data from Serum Institute for Covovax Vaccine
SII seeks DCGI’s nod for Covishield as booster dose
Zydus seeks DCGI nod for chronic Kidney disease drug
DCGI: Regulators & inventors should face no obstacles during developing new drugs
Pharma companies are awaiting DCGI nod to launch Covid-19 drug in India
E-pharmacies, Telemedicine to help cut health expenses
Won’t allow drug peddlers to ruin lives of youth: HM
What is ‘Delmicron’ ? Is it a cause of concern?
Hospital fined Rs 50,000 over waste disposal
Side-Effect of Ibuprofen – Painful Skin Disorders: India to act soon
CDSCO panel weighing risks and benefits of Covid drug Molnupiravir
5 reasons why e-Rx (electronic prescription) is better than paper Rx
Schedule for 19 FDCs permitted pre-1988 to give online presentation
Drug alert: 22 out of 1102 samples declared as NSQ in…
Latest Notifications regarding Pharmaceuticals
For informative videos by The Health Master, click on the below YouTube icon:
For informative videos on Medical Store / Pharmacy, click on the below YouTube icon:
For informative videos on the news regarding Pharma / Medical Devices / Cosmetics / Homoeopathy etc., click on the below YouTube icon:
For informative videos on consumer awareness, click on the below YouTube icon: