Last Updated on January 3, 2022 by The Health Master
New Delhi: Thirteen Indian pharmaceutical companies, including Torrent, Cipla, Sun Pharma, Dr Reddy’s, Natco, Mylan, Hetero, and Optimus, will be manufacturing Molnupiravir, which is being developed by US-based biotechnology company Ridgeback Biotherapeutics in collaboration with US pharmaceutical giant Merck.
EUA by DCGI: With the Drugs Controller General of India (DCGI) emergency use authorisation for the generic version of Merck and Ridgeback’s oral COVID-19 antiviral medicine Molnupiravir, pharma majors including Cipla, Sun Pharma, Torrent, Natco, Optimus, Hetero, Dr Reddys, and others, are gearing up to launch the oral anti-covid drug Molnupiravr with the aim of strengthening the COVID-19 battle in the country.
Strides, Dr. Reddy’s, Sun Pharma, Cipla, Hetero, Torrent, and Optimus announced that the Drugs Controller General of India (DCGI) has shown a green flag to them to manufacture and market Molnupiravir, an oral COVID-19 medicine, for restricted use in emergency situations (EUA) in India.
Development of Molnupiravir: Molnupiravir is being developed by Merck & Co., Inc. in collaboration with Ridgeback Biotherapeutics. Earlier this year, the majority of the companies, including Strides, Dr. Reddy’s, Sun Pharma, Cipla, Hetero, Torrent, and Optimus, signed non-exclusive voluntary licensing agreements with MSD to manufacture and supply the generic version of Molnupiravir in over 100 low and middle-income countries (LMICs), including India.
Molnupiravir is an investigational: Molnupiravir is an investigational, orally administered form of a potent ribonucleoside analogue that works by introducing RNA-like building blocks into the SARS-CoV-2 virus, the causative agent of the COVID-19 genome as it multiplies, creating numerous mutations, disrupting replication, and killing the virus.
According to findings from an interim analysis of the Phase 3 MOVe-OUT trial, the drug reduced hospitalization or death by approximately 50% in non-hospitalized adult patients with mild-to-moderate COVID-19.
DR. Reddy’s Lab: A Dr Reddy’s-led consortium of pharma companies collaborated to jointly sponsor, supervise, and monitor a Phase III clinical trial in India, and accordingly presented the observations to the Subject Expert Committee (SEC) committee functional under the Central Drugs Standard Control Organization (CDSCO).
Cipla: Recently, Cipla announced that it has been granted Emergency Use Authorization (EUA) permission by the Drug Controller General of India (DCGI) for the launch of Molnupiravir in the country. Accordingly, Cipla is planning to launch Molnupiravir under the brand name Cipmolnu.
With respect to the Molnupiravir launch, Dr. Reddy’s said that its Molnupiravir 200mg capsules will be available in the country shortly under the brand name Molflu.
Sun Pharma: Sun Pharmaceutical Industries stated one of its wholly owned subsidiaries has acquired an EUA from the DCGI to manufacture and commercialise molnupiravir under the brand name Molxvir, which is a generic version of MSD and Ridgeback’s Molnupiravir.
Torrent: Torrent Pharmaceuticals said that it will market MSD and Ridgeback’s molnupiravir under the brand name Molnutor in India to treat COVID-19.
Mankind: On the other hand, taking a significant step towards countering COVID-19 in India, drug major Mankind Pharma announced the launch of the oral anti-COVID pill “Molulife” (Molnupiravir 200mg).
Natco Pharma: Similarly, Natco Pharma hopes to launch its version of the antiviral medication Molnupiravir capsules for the treatment of COVID-19.
The pharmaceutical manufacturer stated in a statement that it has got permission for Molnupiravir capsules (200 mg), which will be sold in the country under the brand name Molnunat.
Hetero: Further, regarding the launch of Molnupiravir, Hyderabad-based pharmaceuticals firm Hetero also announced that the company will market the capsule under the brand Movfor, which will be made available in a 40 capsule pack (200 mg per capsule) and will be marketed by its associate company ‘Hetero Healthcare’ in India with the support of its strong distribution network across the country.
Optimus: Optimus Pharma, an Indian bulk medicine producer, has also announced that it will introduce Molnupiravir, a frontline Covid-19 prescription, to the Indian market in a day or two, after receiving authorization from the Drug Controller General of India for restricted emergency treatment for the virus.
Cost of Monupiravir: The anti-viral Covid pill, Molnupiravir, may be priced at Rs 40 to Rs 75 per tablet thus making the cost of the entire treatment around Rs 3,000 for five days, the head of Optimus Pharma, one of the 13 companies launching the drug in India, told News18.
Conditions: As per conditions of the DCGI’s approval, the drug should be sold by retail only under the prescription of medical specialists, reported PTI.
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