On Monday, Jubilant Pharma announced that it has developed a novel oral formulation of Remdesivir, which, the company said, is likely to ease the capacity constraint that injectable formulation faces and ensure wider and timely availability for covid-19 patients.
The development includes successful completion of safety and studies showing absorption of the oral formulation in bodies of animals and healthy human volunteers in India, the company said. Jubilant Pharma has sought authorization for additional studies for the oral formulation from the Drug Controller General of India (DCGI) V.G. Somani.
“Once approved, this will not only provide a more convenient and easy-to-administer formulation but also support an increasing demand of COVID-19 treatments.” chairman Shyam S. Bhartia and Hari S. Bhartia, co-chairman and managing director, of Jubilant Pharmova Ltd. Jubilant Pharma, is a subsidiary of Jubilant Pharmova.
Jubilant Pharm said it expects the proposed oral treatment to last for five days, similar to the duration of the injectable dosage.
Remdesivir is the first and the only anti-viral drug fully approved by the US Food and Drug Administration (FDA) for the treatment of patients with covid-19 requiring hospitalization.
Jubilant Pharma, and six other companies in India, manufacture the drug in India through a voluntary licensing agreement with US-based Gilead Sciences Inc, wherein the Indian firms can manufacture and sell the drug in India and 126 other low- and middle-income countries. The seven companies have recently scaled up capacity and reduced prices of the drug, which has been facing a shortage in India due to a sharp increase in demand during the second wave.