Lupin gets USFDA approval for Prasugrel Tablets

11 Jan 2023 , 10:13 AM

Global pharma major Lupin Limited announced that it has received United States Food and Drug Administration (USFDA) approval for its Abbreviated New Drug Application (ANDA), Prasugrel Tablets USP, 5 mg and 10 mg.

As per the filing, the Prasugrel Tablets is a generic equivalent of Effient Tablets, 5 mg and 10 mg of Cosette Pharmaceuticals, Inc. The product will be manufactured at Lupin’s facility in Goa, India.

Accordingly, Prasugrel Tablets USP, 5 mg and 10 mg, (RLD Effient) had estimated annual sales of USD 18 million in the U.S. (IQVIA MAT September 2022). 

On Wednesday, at around 10:22 AM, Lupin was trading at Rs755.45 per share lower by 0.45% on the BSE.

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