India-based pharma company Hetero on Sunday announced it has received both manufacturing and marketing approval for the investigational antiviral drug Remdesivir, from the Drug Controller General of India (DCGI) to treat Covid-19 patients.
Hetero’s generic version of Remdesivir will be sold under the brand name COVIFOR in India soon. Barely a day earlier, another India-based pharma firm Glenmark Pharmaceuticals launched antiviral drug Favipiravir, to be sold under the brand name FabiFlu, for the treatment of patients with mild to moderate Covid-19 symptoms.
“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,” Dr. B Partha Saradhi Reddy, Chairman, Hetero Group of Companies said on the DCGI nod.
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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 infectious disease.
{{/usCountry}}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 infectious disease.
{{/usCountry}}COVIFOR will be available in 100 mg vials (injectable) which needs to be administered intravenously in a hospital facility under the proper supervision of a doctor or trained healthcare worker.
“We are prepared to ensure supply of enough stocks required to cater to the present need. 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 Prime Minister Narendra Modi’s Make in India campaign,” Dr Reddy said.
The medicine will be launched in the country under a licensing agreement with Gilead Sciences Inc. to expand access to affordable Covid-19 treatment in low and middle-income countries.
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Pharma company Hetero is one of India’s leading generic pharmaceutical firms and the world’s largest producer of anti-retroviral drugs.
Earlier in June, the Union Health Ministry included the use of anti-viral drug Remdesivir as part of “investigational therapy” only for restricted emergency-use in its updated Clinical Management Protocol for Covid-19 patients.
Off-label application of immunomodulator tocilizumab and convalescent plasma therapy for treating coronavirus patients in moderate stage of criticality, were also approved by the ministry.