Jubilant Pharma Limited, a subsidiary of Jubilant Pharmova Limited, announces successful completion of safety and pharmacokinetic/absorption studies in animals and healthy human volunteers in India using a novel oral formulation of remdesivir against the commercially available injectable formulation of remdesivir.
Jubilant has sought authorization for additional studies for this novel oral formulation from the Drug Controller General of India (DCGI). Jubilant is hoping to provide an affordable, more convenient, easy-to-administer and potentially effective treatment option for COVID-19 patients. The proposed oral treatment is expected to be for 5 days, a duration similar to the injectable dosage form. Remdesivir is the first and the only anti-viral drug fully approved by the US FDA for the treatment of patients with COVID-19 requiring hospitalization.
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 remdesivir in 127 countries including India. On July 20, 2020, Jubilant received approval from the Drug Controller General of India (DCGI) to manufacture and market the antiviral drug remdesivir (“JUBI-R”) for 100 mg/vial (lyophilized injection) for restricted emergency use in India for the treatment of severe COVID-19.
“We are pleased to announce the ongoing development of a novel formulation of Remdesivir to address the pandemic at this critical juncture. Once approved, this will not only provide a more convenient and easy-toadminister formulation but also support an increasing demand of COVID-19 treatments.” stated Pramod Yadav, CEO, Jubilant Pharma Limited.