Jubilant Generics Limited ("Jubilant") has signed a non-exclusive licensing agreement with Gilead Sciences Inc. ("Gilead") for the manufacturing & distribution of Remdesivir ("API"), which has received an Emergency Use Authorisation (EUA) by US FDA for the treatment of Covid-19 and is currently at the forefront in tackling Covid-19 pandemic.

Jubilant has been authorised by Gilead to manufacture Remdesivir, and the finished injectable formulation (containing Remdesivir) and to market it in 127 countries including India.

What is Jubi-R™

Jubi-R™ contains Remdesivir. Remdesivir is an investigational nucleotide analog with broad-spectrum antiviral activity both in vitro and in vivo in animal models against multiple emerging viral pathogens. In vitro testing conducted by Gilead has demonstrated that remdesivir is active against the virus that causes COVID-19.

Dosing and Administration

Jubi-R™ supplied as a vial for intravenous injection use only.

Remdesivir for injection, 100 mg, is supplied as a single-dose vial containing a sterile, preservative-free white to off-white to yellow lyophilized powder that is to be reconstituted with 19 mL of Sterile Water for Injection and diluted into 0.9% saline prior to administration by intravenous infusion.

Essential Information

• The Secretary of the Department of Health and Human Services, USA has declared a public health emergency that justifies the emergency use of Remdesivir to treat coronavirus disease 2019 (COVID-19) caused by SARS-CoV-2 infection
• In response, the U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for the unapproved product, Remdesivir, for the treatment of COVID-19
• The distribution of Remdesivir has been authorized only for the treatment of hospitalized patients with severe COVID-19. It is not authorized for the treatment of any other viruses or pathogens

Emergency Use Authorization (EUA)

Remdesivir has been approved/authorized for emergency use for the treatment of COVID-19 by several other regulatory agencies such as the EMA (European Medicines Agency), MHLW (Ministry of Health, Labour and Welfare), Japan, etc. CDSCO (Central Drugs Standard Control Organisation), India has also approved the restricted emergency use of Remdesivir for the treatment of suspected or laboratory confirmed COVID-19 cases.

Click here to view all 127 countries list

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