Dr Reddy’s Lab Obtains DCGI Approval to Manufacture and Market the Oral Antiviral Drug Molnupiravir under the Brand Name “Molflu”


Dr Reddy’s Laboratories has received emergency use authorization from the Drugs Controller General of India (DCGI) to manufacture and market the oral antiviral drug Molnupiravir 200 mg capsules for the treatment of adult patients with COVID-19, with SpO2> 93 % who are at high risk of disease progression, including hospitalization or death.

The company will soon launch its molnupiravir 200 mg capsules under the Molflu brand across India. As a vertically integrated company, Dr Reddy’s can manufacture the active pharmaceutical ingredient (API) as well as the formulation of molnupiravir, and has made adequate capacity preparations to ensure that it can help patients in India as well. as needy patient populations around the world.

GV Prasad, Co-Chair and Managing Director of Dr Reddy’s, said: “Molnupiravir is a continuation of our ongoing efforts since the start of the pandemic to ensure access to all possible treatment options for COVID-19 , from prevention to mild, moderate and severe. disease for patients in India and around the world. The approval to launch molnupiravir is an important development not only as a treatment option, but also for the collaborative way in which Indian pharmaceutical companies have come together. Throughout the pandemic, we have sought to create various collaborations and partnerships to address the unmet medical needs of the largest number of patients around the world.

Molnupiravir is an oral antiviral drug that inhibits the replication of several RNA viruses, including SARS-CoV-2. It has been studied by Merck & Co., Inc., in collaboration with Ridgeback Biotherapeutics in a Phase III trial for the treatment of outpatients with confirmed COVID-19 worldwide. It has received regulatory approvals from the UK, US and Japan.

Dr Reddy’s previously entered into a voluntary non-exclusive license agreement with Merck Sharpe Dohme (MSD) to manufacture and supply Molnupiravir to India and more than 100 low and middle income countries (LMICs). In a unique collaboration in the Indian pharmaceutical industry, a consortium of pharmaceutical companies led by Dr Reddy’s collaborated to jointly sponsor, supervise and monitor the Phase III clinical trial in India, and presented their findings to the committee. subject matter experts. (SECOND).

On Wednesday, Dr. Reddy’s stock will be the center of attention.


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