Under this license agreement, Hetero will provide Remdesivir in 127 countries, including India, subject to regulatory approvals in the respective countries.
Remdesivir is manufactured at the company’s formulation facility in Hyderabad. The facility is approved by global regulatory authorities such as the USFDA and the EU among others. Hetero said it has developed a fully vertical integrated supply chain for this product, complementing the ‘Make in India’ campaign as defined by Prime Minister Narendra Modi.
Dr B Partha Saradhi Reddy, Chairman of the Hetero Group of Companies, said: “Hetero has developed this product in India and has already worked with the government, ICMR and DCGI for the necessary studies and approvals to bring this product to COVID treatment. -19 patients in India. ”
“Hetero is pleased to partner with Gilead to provide access to this important substance to India and other developing countries at this crucial time. This agreement also illustrates the importance of global cooperation and the need to meet to combat the health crises affecting humanity, ”I added.
US drug regulator US Food and Drug Administration (USFDA) has authorized emergency use (EUA) for the antiviral study of Remdesivir for the treatment of patients hospitalized with severe Covid-19.
Hetero has 36 manufacturing facilities worldwide approved by global regulators and has a portfolio of 300 plus products across key therapeutic categories such as HIV / AIDS, Oncology, Cardiovascular, Neurology, Hepatitis, Nephrology, Urology, diabetes, ophthalmologist, hepatology and hepatology Immunology etc.