Hetero receives DCGI nod for Remdesivir
Hetero, one of India’s leading generic pharmaceutical companies, announced today that it has received the manufacturing and marketing approval for the investigational antiviral medicine ‘Remdesivir’ from the Drug Controller General of India (DCGI) for the treatment of Covid-19. Hetero’s generic version of Remdesivir will be marketed under the brand name ‘COVIFOR’ in India.
Dr. B. Partha Saradhi Reddy, Chairman, Hetero Group of Companies, commented: “In the light of increasing COVID-19 cases in India, the approval of ‘COVIFOR’ (Remdesivir) can prove to be a game-changer given its positive clinical outcomes. Backed by strong backward integration capabilities, we can ensure that the product is immediately made available to patients across the country. We are prepared for ensuring enough stocks required to cater to the present needs. We will continue to work closely with the government and medical community to make a difference in the fight against COVID-19. This product is made indigenously in line with ‘Make in India’ campaign as envisioned by our Hon’ble Prime Minister.”
The drug ‘Remdesivir’ has been granted approval by DCGI for the treatment of suspected or laboratory-confirmed cases of COVID-19 in adults and children, hospitalized with severe symptoms of the disease. COVIFOR (Remdesivir) will be available in 100 mg vial (Injectable) which has to be administered intravenously in a hospital setting under the supervision of a healthcare practitioner.
The product is launched under a licensing agreement with Gilead Sciences Inc. to expand access to COVID-19 treatment in low and middle-income countries.