Jubilant Life Sciences gets DCGI nod to JUBI-R for treating COVID-19 patients
Noida: Jubilant Life Sciences Limited, an integrated global pharmaceutical and life sciences company, has announced that its subsidiary, Jubilant Generics Limited ("Jubilant"), has received approval from the Drug Controller General of India (DCGI) to manufacture and market the investigational antiviral drug remdesivir for 100 mg/vial (lyophilized injection) for restricted emergency use in India for the treatment of severe COVID-19.
Jubilant's remdesivir product will be marketed under the brand name 'JUBI-R' in India and will be made available in 100 mg vials (injectable). It would be administered intravenously in a hospital setting under the supervision of a medical practitioner. The Company will distribute the drug in the Indian market through its distribution network and will be available by the first week of August 2020.
In May 2020, Jubilant entered into a non-exclusive Licensing Agreement with Gilead Sciences, Inc. that granted it the right to register, manufacture and sell Gilead's investigational drug remdesivir in 127 countries including India. Remdesivir is the only antiviral drug that has received Emergency Use Authorization (EUA) by the USFDA for treatment of suspected or laboratory-confirmed COVID-19 in adults and children hospitalized with severe disease.
"We are very pleased to launch 'JUBI-R', a drug with potential to save lives of people who have contracted COVID-19," stated Mr Shyam S. Bhartia, Chairman and Mr Hari S. Bhartia, Co-Chairman & Managing Director, Jubilant Life Sciences Limited. "At Jubilant, we are focused on quickly making this drug available in India in required quantities and at affordable prices. This milestone underscores our continued commitment to provide leading healthcare solutions as well as demonstrates our ability to leverage our broad capabilities to deliver important new medicines."
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