Remdesivir with NDDS: Jubilant seeks approval

Novel oral formulation of Remdesivir developed by Jubilant Pharma seeks DCGI’s approval

Jubilant Pharma has recently announced the development of the oral formulation of Remdesivir. The formulation is Remdesivir with NDDS (Novel Drug Delivery system)

Per the company, this move will help to ease the capacity constraints faced by the injectable formulation. It also added that this formulation will ensure wider and timely availability of the drug for COVID – 19 patients. ¹

Jubilient conducted safety studies in the bodies of humans and animals (for Remdesivir with NDDS). Apart from this, the drug firm has also performed the absorption studies of the oral formulation. These data were used to seek the DCGI’s^[1] approval for the oral formulation of Remdesivir.

Story background: Remdesivir with NDDS

The proposed duration of treatment using this oral formulation is about five days. This duration is similar to that observed when the injectable formulation is used in the patients.

Remdesivir is the first and only anti – viral drug that was fully approved by the USFDA^[2]. This drug was approved specifically for the treatment of patients with COVID – 19 requiring hospitalization.

Through voluntary licensing with Gilead Sciences Inc., seven pharma companies manufacture Remdesivir in India. These firms include Jubilant Pharma together with six other companies. Per this licensing, Indian firms can manufacture and sell Remdesivir in India and 126 other low – and middle–income countries.

Due to the second wave of COVID – 19 in India, these companies have ramped up their production recently. The rapid rise in demand is also due to the shortages faced throughout the country.

It was also revealed that the cost of this product was reduced due to the current situation. The pricing of the intravenous formulation from the seven companies has been reduced to a range of Rs. 899 to Rs. 3,490 per vial.

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