Lupin has received approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA), Desvenlafaxine Extended-Release Tablets, 25 mg to market a generic equivalent of Pristiq Extended-Release Tablets, 25 mg of PF PRISM C.V. The product will be manufactured at Lupin’s facility in Goa, India.
Desvenlafaxine Extended-Release Tablets, 25 mg (RLD Pristiq) had estimated annual sales of USD 14 million in the U.S. (IQVIA MAT December 2021).
Lupin is an innovation-led transnational pharmaceutical company headquartered in Mumbai, India.