Comments
Hetero, a vertically integrated pharmaceutical organisation, launched Molnupiravir capsules 200 mg ( Movfor ).
Molnupiravir is an investigational oral antiviral for high risk adult Covid-19 patients.
The Hyderabad-based company has received approval from the Drug Controller General of India (DCGI) to manufacture and market 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 a high risk of disease progression.
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.
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 the highest quality standards,'' he added.
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 Covid-19
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 being licensed by Ridgeback, all funds used for developing 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 to manufacture and distribute investigational oral therapeutic antiviral drug ‘Molnupiravir’ for the treatment of Covid-19. Under this licensing deal, Hetero will be allowed to expand access to 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 the subject expert committee (SEC) and recommended for marketing authorisation. Subsequently, CDSCO provided the approval for manufacturing and marketing.
Comments
COMMENT NOW
Comments
Comments have to be in English, and in full sentences. They cannot be abusive or personal. Please abide by our community guidelines for posting your comments.
We have migrated to a new commenting platform. If you are already a registered user of TheHindu Businessline and logged in, you may continue to engage with our articles. If you do not have an account please register and login to post comments. Users can access their older comments by logging into their accounts on Vuukle.