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Hyderabad: In a development that will focus the capabilities of Hyderabad’s pharmaceutical firms, Hetero, based in the city, will manufacture Remdesivir, licensed to treat patients with severe Covid-19 disease, at its formulation facility in Hyderabad. The facility has been approved by regulatory authorities such as the USFDA and the EU, among others.
Hetero, one of India’s generic pharmaceutical companies and the world’s largest producer of antiretroviral drugs, announced on Wednesday that it has signed a license agreement with Gilead Sciences, Inc for the manufacture and distribution of ‘Remdesivir’ for the treatment of Covid-19 .
Under this license agreement, Hetero will supply Remdesivir in 127 countries, including India, subject to regulatory approvals in the respective countries.
Dr. B Partha Saradhi Reddy, Chairman of the Hetero Group of Companies, commented in a statement: “Hetero is pleased to partner with Gilead to allow access of this important drug to India and other developing countries at this crucial time. This agreement also illustrates the importance of global collaboration and the need to unite to combat the health crises that affect humanity. Hetero has developed this product in India and has already been working with the government, ICMR, and DCGI for the necessary studies and approvals to bring this product to treat Covid-19 patients in India. “
Dr. Vamsi Krishna Banda, MD of Hetero Labs Limited said: “Hetero has several licensing alliances with Gilead through key therapies like ARV, Hepatitis etc. We have been partners for a long time for more than a decade. The key approach is to allow access to Remdesivir to patients living in India and other developing countries. “
“We have a fully vertically integrated supply chain for this product that complements the Make in India campaign as defined by our Prime Minister. And it is also a source of pride for the Telangana region that the product is being developed here in Hyderabad, ”he said of the impetus the agreement will give Hyderabad. He said it is too early to comment on the volumes under this agreement.
The FDA has issued an Emergency Use Authorization (USA) for the investigational Antiviral Remdesivir to treat Covid-19. Remdesivir is licensed for the treatment of hospitalized patients with severe Covid-19 disease. The optimal duration of treatment is still being studied in ongoing clinical trials, the statement added.
According to the EUA, treatment durations of 5 and 10 days are suggested, depending on the severity of the disease. The authorization is temporary and does not replace the formal process for submitting, reviewing and approving new drug applications, he said.
The USA allows the distribution and emergency use of Remdesivir only for the treatment of Covid-19. Remdesivir remains an investigational drug and is not approved anywhere in the world, including the USA. USA And India said. Gilead is also working with two other companies: Cipla and Jubilant Life Sciences on this.
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