Jubilant Gets a Nod from DGCI to Manufacture and Market Remdesivir in India

Jubilant Generics Limited, the subsidiary of Jubilant Life Sciences Limited (JLL), an integrated global pharma and life sciences company, has recently crossed another milestone in its journey of providing healthcare solutions by receiving approval from the Drug Controller General of India (DCGI) to synthesize and market the drug ‘Remdesivir’. Remdesivir is the only antiviral drug that has received Emergency Use Authorization (EUA) by the USFDA for treatment of COVID-19 patients hospitalized for treatment. JLL’s Remdesivir will be sold under the brand name 'JUBI-R' in India and will be made available in 100 mg vials and administered intravenously under the supervision of a medical practitioner. The drug will be made available in the Indian market through the company’s solid distribution network by the first week of August this year. The Noida-based pharma giant entered into a non-exclusive Licensing Agreement with Gilead Sciences, Inc. in May 2020. The agreement granted the company right to register, manufacture and market Gilead's investigational drug Remdesivir across 127 countries including India. Remdesivir is currently approved in Japan as a treatment for patients infected with SARS-CoV-2, the virus responsible for the disease. Outside of Japan, it is an investigational drug and has not been approved by the FDA as whether it is safe and effective for the treatment of COVID-19 is still under investigation.