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Contributor: PR Newswire Europe
Thursday, May 14 2020 - 03:25
AsiaNet
Hetero Enters Into a Licensing Agreement With Gilead Sciences, Inc. for the Manufacturing and Distribution of "Remdesivir" in 127 Countries, Including India, for COVID-19
HYDERABAD, India, May 14, 2020 /PRNewswire-AsiaNet/ --

Hetero, one of India's leading generic pharmaceutical companies and the world's 
largest producer of anti-retroviral drugs, announced today that it has entered 
into a licensing agreement with Gilead Sciences, Inc. for the manufacturing and 
distribution of "Remdesivir" for the treatment of Covid-19. Under this 
licensing deal, Hetero will be supplying Remdesivir in 127 countries, including 
India, subject to regulatory approvals in respective countries. 

Dr. B. Partha Saradhi Reddy, Chairman, Hetero Group of Companies, commented: 
"Hetero is pleased to partner with Gilead to enable access for this important 
drug to India and other developing countries at this crucial time. This 
agreement also illustrates the significance of global collaboration and the 
need for coming together to fight the health crises impacting humanity. Hetero 
has developed this product in India and has already been working with the 
government, ICMR, and DCGI for necessary studies and approvals to bring this 
product to treat COVID-19 patients in India." 

Remdesivir will be manufactured in our formulation facility in Hyderabad, 
India, which has been approved by stringent global regulatory authorities such 
as USFDA and EU, among others. Hetero has developed the fully vertically 
integrated supply chain for this product complementing the "Make in India" 
campaign as defined by our Hon'ble Prime Minister.

Important Information about Remdesivir

U.S. Food and Drug Administration (FDA) has granted emergency use authorization 
(EUA) for the investigational antiviral Remdesivir to treat COVID-19. 
Remdesivir is authorized for the treatment of hospitalized patients with severe 
COVID-19 disease. The optimal duration of treatment is still being studied in 
ongoing clinical trials. Under the EUA, both 5-day and 10-day treatment 
durations are suggested, based on the severity of disease. The authorization is 
temporary and does not take the place of the formal new drug application 
submission, review and approval process. The EUA allows for the distribution 
and emergency use of Remdesivir only for the treatment of COVID-19; Remdesivir 
remains an investigational drug and is not approved anywhere globally including 
US and India. 

About Hetero

Hetero is one of India's leading generic pharmaceutical companies and the 
world's largest producer of anti-retroviral drugs. With 25 years of expertise 
in the pharmaceutical industry, Hetero's strategic business areas spread across 
APIs, generics, biosimilars, custom pharmaceutical services and branded 
generics. 

Hetero has 36 state-of-the-art manufacturing facilities, 300 plus products in 
its portfolio and has a strong global presence in over 126 countries. For more 
information on Hetero, please visit www.heteroworld.com.

Logo - https://mma.prnewswire.com/media/1167815/Hetero_Logo.jpg

Media Contact: 
Jeyasingh Balakrishnan 
Head – Corporate Communications 
Hetero Labs Limited 
Mobile: (+91) 9989626541, (+91) 9833836185

Source: Hetero
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