Lupin stated on Tuesday that the United States Food and Drug Administration (US FDA) has approved its abbreviated new drug application (ANDA), Prasugrel tablets for 5 mg and 10 mg, which is a generic counterpart of Cosette Pharmaceuticals Inc.’s Effient tablets, 5 mg and 10 mg.
According to a statement from Lupin, the product would be manufactured in the company’s Goa site.
According to IQVIA, prasugrel tablets of 5 mg and 10 mg have expected annual sales of USD 18 million in the United States.
A release said Lupin, headquartered in Mumbai, develops and commercialises a wide range of branded and generic formulations, biotechnology products, and APIs in over 100 markets in the US, India, South Africa, and across the Asia Pacific, Latin America, Europe, and Middle East regions.
Lupin said it has 15 manufacturing sites, seven research centres, more than 20,000 professionals working globally, and has been consistently recognised as a ‘Great Place to Work’ in the biotechnology and pharmaceuticals sector.