Jan 6 (LiveMint) – Pharmaceutical firm Aurobindo Pharma Limited has announced that it has introduced Covid-19 treatment drug Molnupiravir under brand name “Molnaflu” in India.
Molnupiravir is for treatment of adult patients hospitalised with COVID-19, under certain conditions, drug maker said.
Earlier this week, the pharmaceutical major Dr Reddy’s Laboratories Ltd had announced that it will soon launch the generic version of Merck’s antiviral Covid-19 pill, Molnupiravir, news agency Reuters reported.
Dr Reddy’s Molflu will be priced at ₹35 per capsule with 10 capsules contained per strip, and the total course of 40 capsules over 5 days costing ₹1,400.
Molnupiravir was earlier approved under Emergency Use Authorisation from the Central Drugs Standard Control Organisation. Earlier last year, Aurobindo had signed a bi-lateral non-exclusive voluntary licensing agreement with Merck Sharpe Dohme, Singapore (MSD), a subsidiary of Merck & Co. (US) to manufacture and supply Molnupiravir to over 100 low and middle-income countries (LMIC), including India.
K Nithyananda Reddy, Vice Chairman and Managing Director, Aurobindo said, “We are delighted with the timely permission from DCGI for the licensed version of Molnupiravir (Molnaflu) as it opens up access to an affordable treatment option for COVID-19 patients and enable us to help battle the pandemic with effective and high-quality pharmaceutical products.”
For the licensed version of Molnupiravir, Aurobindo enjoys backward integration with in-house API (active pharmaceutical ingredient) manufacturing which equips it with stronger control on the Quality systems and Supply chain.
The product will be made at the Company’s manufacturing facilities in India that are approved by global regulatory agencies including USFDA and UK MHRA.
The company has adequate capacities to meet the global demand across the over 100 LMI Countries for the product, Aurobindo said.
For the generic version of Molnupiravir, the company said it enjoys backward integration with in-house API manufacturing which equips it with stronger control on supply chain and cost efficiencies.
“The product will be manufactured at the company’s manufacturing facilities in India that are approved by global regulatory agencies including USFDA and UKMHRA.
The company has adequate capacities to meet the global demand across the 100 plus LMIC for the product,” it noted.
The DCGI, based on the review of clinical data of Molnupiravir, has given permission to manufacture and market anti COVID-19 pill Molnupiravir for restricted emergency use in India for treatment of adult patients, subject to certain conditions.
Molnupiravir is the first oral antiviral approved by the UK Medicines and Healthcare products Regulatory Agency (UKMHRA) for the treatment of mild-to-moderate COVID-19 in adults.
It has also been recently approved by the US Food and Drug Administration (USFDA) and under Emergency Use Authorisation (EUA).