Lupin gets US regulator's nod for Prasugrel tablets used in heart ailments
Jan 10, 2023
Mumbai (Maharashtra) [India], Baltimore (Maryland) [US], January 11 : Global pharma major Lupin on Tuesday announced that it has received approval from the United States Food and Drug Administration (US FDA) for its abbreviated new drug application (ANDA), Prasugrel tablets for 5 mg and 10 mg, which 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, according to a statement from the pharma firm.
Prasugrel tablets of 5 mg and 10 mg had estimated annual sales of USD 18 million in the US, according to IQVIA.
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.
