The drug is approved for the treatment of suspected or laboratory confirmed incidences of Covid-19 in adults and children hospitalised with severe presentations of the disease, Mylan said in a statement.
Remdesivir continues to be an investigational drug that has not been approved by the FDA.Global pharma major Mylan commercially launched Desrem, the generic version of Remdesivir drug in India for treatment of coronavirus patients. The company had earlier said that its Remdesivir will be available at a price of Rs 4,800 per 100 mg vial as against Hetero’s Covifor at Rs 5,400 per vial and Cipla’s Cipremi costing Rs 4,000.
The drug is approved for the treatment of suspected or laboratory confirmed incidences of Covid-19 in adults and children hospitalised with severe presentations of the disease, Mylan said in a statement.
Remdesivir continues to be an investigational drug that has not been approved by the FDA. The company has released the first batch of its generic Remdesivir and will continue to increase its supply across the country in the wake of the rising demand for the drug, it added.
It has also launched a helpline number for accessing information about the availability of Desrem in India, the statement said.
Mylan will manufacture Desrem in its injectable facility in Bengaluru, which will work to service the demand in India and other export markets where Mylan has received a licence from Gilead for the commercialisation of Remdesivir, it added.
“With the launch of Desrem and our national helpline, we aim to enhance access to this critical medicine, used for treating adults and children with severe presentations of Covid-19,” said Rakesh Bamzai, India and Emerging Markets, President, Mylan. The previously announced agreement between Mylan and Gilead for manufacturing and distribution of Remdesivir is part of a long-standing history between the two organisations to tackle key public health issues beginning with expanding access to high quality, affordable HIV/AIDS antiretrovirals, Mylan said.
To recall, the US-based Gilead Sciences has signed 22 non-exclusive voluntary agreements with generic pharmaceutical companies to manufacture and distribute the investigational medicine, Remdesivir, to 127 countries. The manufacturers include Cipla Ltd, Ferozsons Laboratories, Hetero Labs Ltd, Jubilant Life Sciences and Mylan. Under the licensing agreements, the generic companies have the right to receive technology transfer of Gilead manufacturing process for Remdesivir to enable them to scale-up production more quickly.
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