Hetero gets DCGI nod to manufacture, market Molnupiravir capsules
Hyderabad-based pharmaceuticals firm Hetero on Tuesday said it has received permission from the Drug Controller General of India (DCGI) for manufacturing and marketing Molnupiravir capsules of 200 mg strength that is used to treat high-risk COVID-19 adult patients.
The company will market the capsule under the brand Movfor. It will be produced at the company’s facilities in Telangana and Himachal Pradesh, Hetero said in a statement. “Hetero’s Movfor 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,” it added.
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Commenting on the development, Hetero Group of Companies Chairman B Partha Saradhi Reddy said, “This approval consolidates India’s efforts to address the world’s greatest health threats, i.e., COVID-19. Improving access to critical medicines will always remain the highest of priorities to us.” Hetero said Molnupiravir, an investigational oral antiviral, is indicated for restricted emergency use in India to treat adult patients with COVID-19 and with SpO2 93 per cent and who have high risk of progression of the disease.
The company said it has entered into a non-exclusive voluntary licensing agreement with MSD for the manufacturing and distribution of investigational oral therapeutic antiviral drug ‘Molnupiravir’ for the treatment of COVID-19. Molnupiravir is an orally bioavailable form of a potent ribonucleoside analog that inhibits the replication of multiple RNA viruses including SARS-CoV2, the causative agent of COVID-19, it added.
Under the licensing deal, Hetero will be allowed to expand access of Molnupiravir in India and in other low-and middle-income countries, following the approvals for emergency use authorisation by local regulatory agencies. It has completed a phase 3 clinical trial, approved by Central Drugs Standard Control Organisation (CDSCO), in about 1,218 COVID-19 patients, the data of which was approved by subject expert committee and recommended for marketing authorisation. Subsequently, CDSCO provided the approval for manufacturing and marketing, the company added.
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