India, Hyderabad; 28 December, 2021: Hetero, a globally renowned vertically integrated pharmaceutical organization announced today that the Drug Controller General of India (DCGI) has granted it permission for manufacture and marketing of Molnupiravir capsules 200 mg (Movfor). Molnupiravir, an investigational oral antiviral, is indicated for restricted emergency use in India to treat adult patients with COVID-19 and with SpO2>93% and who have high risk of progression of the disease.
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
Dr. B. Partha Saradhi Reddy, Chairman, Hetero Group of Companies, 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."
Under the aegis of ‘Make in India’ campaign, commercial production of ‘Movfor’ will be undertaken at Hetero’s world-class facilities in Telangana and Himachal Pradesh, where it is ensured to meet highest quality standards.
Molnupiravir (EIDD-2801/MK-4482) is an investigational, orally bioavailable form of a potent ribonucleoside analog that inhibits the replication of multiple RNA viruses including SARS-CoV2, the causative agent of COVID19. Molnupiravir has been shown to be active in several models of SARS-CoV-2, including for prophylaxis, treatment and prevention of transmission, as well as SARS-CoV-1 and MERS. EIDD-2801 was invented at Drug Innovations at Emory (DRIVE), LLC, a not-for-profit biotechnology company wholly owned by Emory University. Since licensed by Ridgeback, all funds used for the development of EIDD-2801 by Ridgeback have been provided by Wayne and Wendy Holman and MSD.
Hetero 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. Under this licensing deal, Hetero will be allowed to expand access of Molnupiravir in India and in other low-and middle-income countries (LMICs), following the approvals for emergency use authorization by local regulatory agencies.
Hetero completed a phase 3 clinical trial (approved by CDSCO) in about 1218 COVID-19 patients, the data of which was approved by subject expert committee (SEC) and recommended for marketing authorisation. Subsequently, CDSCO provided the approval for manufacturing and marketing (M&M).
Hetero is a globally renowned vertically integrated pharmaceutical organization engaged in research and development, manufacturing, and marketing of high-quality chemical and biologic medicines across diverse therapeutic areas. Backed by 27+ years of expertise in the pharmaceutical industry, Hetero’s strategic business areas spread across APIs, Global Generics, Biosimilars and Custom Pharmaceutical Services. The company is among the largest producers of Active Pharmaceutical Ingredients (APIs) in the world. For more information on Hetero, please visit www.heteroworld.com.
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