The company has received the manufacturing and marketing approval for Remdesivir from the Drug Controller General of India (DCGI) for the treatment of COVID-19, it said in a statement.
Drug firm Hetero on Sunday said it has received approval from regulator DCGI to launch investigational antiviral drug Remdesivir for the treatment of COVID-19 after getting. The company has received the manufacturing and marketing approval for Remdesivir from the Drug Controller General of India (DCGI) for the treatment of COVID-19, it said in a statement.
The company’s generic version of Remdesivir will be marketed under the brand name ‘Covifor’ in India. The drug has been granted approval by DCGI for the treatment of suspected or laboratory-confirmed cases of COVID-19 in adults and children, hospitalised with severe symptoms of the disease, it added.
“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,”Hetero Group of Companies Chairman B Partha Saradhi Reddy said.
The company is prepared for ensuring enough stock to cater to the present needs, he added. The drug 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,Hetero said.
The product is being launched under a licensing agreement with Gilead Sciences Inc to expand access to COVID-19 treatment in low and middle-income countries, it added.