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Generic pharmaceutical firm and leading producer of antiretroviral drugs Hetero has signed a licensing agreement with Gilead Sciences Inc. for the manufacture and distribution of Remdesivir in 127 countries, including India.
Also read: Coronavirus | About 30 Indian attempts at the COVID-19 vaccine, says chief scientific adviser
An investigational drug, Gilead’s Remdesivir had received Emergency Use Authorization (USA) from the United States Food and Drug Administration (USFDA) for the treatment of hospitalized patients with COVID-19.
In announcing the deal, Hetero said Remdesivir will be manufactured at its formulation facility in Hyderabad. The facility has been approved by regulators such as the USFDA and the EU, among others.
Also Read: Glenmark Begins Phase 3 Clinical Trials on Antiviral Drug Favipiravir for COVID-19 Patients in India
Hetero Group of Companies President B. Partha Saradhi Reddy said Hetero has developed this product in India. A fully vertically integrated supply chain for the product has been developed.
The company was working with the government, ICMR and DCGI for the necessary studies and approvals to bring this product to treat patients with COVID-19 in India.
Also read: When will a COVID-19 vaccine be ready?
The agreement with Gilead illustrates the importance of global collaboration and the need to unite to combat health crises that affect humanity, it said in a statement.
Hetero’s announcement Wednesday of the licensing agreement with Gilead follows yet another announcement by Jubilant Life Sciences on Tuesday of Jubilant Generics, a subsidiary, which forged a non-exclusive licensing agreement with Gilead for the manufacture and distribution of Remdesivir.
The EUA is temporary and does not replace the formal process for submitting, reviewing, and approving new drug applications. The EU allows the distribution and emergency use of Remdesivir only for the treatment of COVID-19.
In addition to Remdesivir, other antiviral drugs that are being considered for the treatment of COVID-19 globally are Favipiravir and the antimalarial drug Hydroxychloroquine. Glenmark Pharmaceuticals had recently announced the approval of the Indian Director General for Drugs to conduct clinical trials of Favipiravir in patients with COVID-19.
Strides Pharma also recently said that it has developed, marketed, and exported Favipiravir antiviral tablets. For the Indian market, the company said it will request the Indian pharmaceutical authorities to start the necessary studies.
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