The regulator also granted EUA to Hyderabad-based Biological E. for Corbevax, India’s first indigenously developed RBD protein sub-unit vaccine against Covid-19, and to Serum Institute of India (SII) for Covovax, the recombinant nanoparticle protein-based vaccine that has been developed by the American biotechnology firm Novavax.Molnupiravir, which has been developed by US-based biotechnology company Ridgeback Biotherapeutics in collaboration with the American pharma giant Merck, works by introducing errors in the genetic code of SARS-CoV-2, which prevents the virus from replicating.
“Considering the emergency and unmet medical need in Covid-19”, the subject expert committee (SEC) of the Central Drugs Standard Control Organisation (CDSCO) had advised the regulator to grant permission for manufacture and marketing of 200 mg capsules of molnupiravir with a recommended dose of 800 mg twice daily for 5 days, the Health Ministry said on Tuesday.
The recommendation is for treatment of adult patients of Covid-19 with blood oxygen saturation (SpO2) >93%, and who have a “high risk of progression of the disease including hospitalisation or death”, the Ministry said. The SEC has recommended the sale of the drug only against a prescription from a medical specialist.
“Based on the recommendation of the SEC…, the drug is being approved for 13 companies who have submitted their clinical trial report, interim or complete report,” the Ministry said. CDSCO had received a total 22 applications to manufacture and market molnupiravir in the country, it said.
The drug will be manufactured by seven Hyderabad-based companies: Dr Reddy’s, Natco, MSN, Hetero, Optimus, Aurobindo, and Mylan; two Mumbai-based companies, Cipla and Sun Pharma; Ahmedabad-based Torrent and BDR; Bengaluru-based Strides; and Pune-based Emcure.
Sun Pharma said on Tuesday that its product, brand name Molxvir, was likely to be available within a week “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,” the company said.
Cipla said its molnupiravir pill, brand name Cipmolnu 200 mg, will be available soon at all leading pharmacies and Covid treatment centres across the country. “The company has adequate manufacturing capacities and a solid distribution mechanism in place to ensure speedy access to this effective treatment pan India,” Cipla said.
Dr Reddy’s said it would soon launch its molnupiravir capsule under the brand name Molflu. “(The) company…is able to manufacture the active pharmaceutical ingredient (API) as well as the formulation for molnupiravir, and has made adequate capacity preparations to ensure that it is able to help patients in India (and)…around the world,” Dr Reddy’s said.
Ahmedabad-headquartered Torrent Pharmaceuticals, which had announced a collaboration for clinical trial of molnupiravir with Cipla, Dr Reddy’s, Emcure, and Sun Pharma this June, said its drug would be sold in India under the brand name Molnutor.
Usage Of Molnupiravir To Treat SARS-CoV-2
- Molnupiravir (MK-4482, EIDD-2801) has been repurposed for a cause!
- So the medicine was developed to treat influenza not covid. But the medicine “Molnupiravir (MK-4482, EIDD-2801)” can prevent the SARS-CoV-2 virus from replicating further by introducing errors into its genetic code.
- The drug is given orally in four 200 milligramme capsules every 12 hours for five days, totalling 40 capsules. Molnupiravir should not be used for more than five days in a row, according to the USFDA.
- Molnupiravir was cleared in “certain adults” in the United States on December 23.
The USFDA said. “It is not authorized for the pre-exposure or post-exposure prevention of COVID-19 or for initiation of treatment in patients hospitalized due to COVID-19 because the benefit of treatment has not been observed in people when treatment started after hospitalization due to COVID-19,”
Molnupiravir: Restrictions And Conditions
- The medicine sold by retail under the supervision of medical specialists.
- The recommended dose is 800mg twice daily for five days.
- Molnupiravir should not be used for more than five days in a row, according to the USFDA.
- Molnupiravir is not approved for use in patients younger than 18 years old because it can disrupt bone and cartilage formation…Read more>>
Source:-techiyogiz
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