Hetero had earlier told Business Standard that it had the active pharmaceutical ingredients (API) to make one million doses of remdesivir for starters
Hyderabad-based Hetero Labs on Sunday said it had received regulatory approval to manufacture and market antiviral drug remdesivir for treating coronavirus
Hetero's generic version of remdesivir will be marketed under the brand name 'Covifor' in India, said the company after getting approval from the Drug Controller General of India (DCGI).
“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," said B Partha Saradhi Reddy, chairman of Hetero Group
He said that the company will ensure enough stocks to cater to present needs.
Hetero had earlier told Business Standard that it had the active pharmaceutical ingredients (API) to make one million doses of remdesivir for starters. It is fully vertically integrated and would also make the key starting material (KSM) for the drug.
DCGI approved remdesivir for the treatment of suspected or laboratory-confirmed cases of Covid-19 in adults and children, hospitalised 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.
Remdesivir, which is administered intravenously in hospital, is the first drug to show improvement in Covid-19 patients in formal clinical trials and is at the forefront of the battle against coronavirus
disease Covid-19, which has no approved treatment or vaccine.