Lupin Receives Tentative Approval from U.S. FDA for Valbenazine Capsules

The American Food and Drug Administration (U.S. FDA) has tentatively approved the Valbenazine Capsules, 40 mg, 60 mg, and 80 mg, the generic version of Ingrezza® Capsules, 40 mg, 60 mg, and 80 mg from Neurocrine Biosciences, Inc., according to pharma giant Lupin Limited (Lupin). In the United States, it was estimated that Valbenazine Capsules sold for $1,235,000,000 annually. 

The global pharmaceutical business Lupin, with its headquarters in Mumbai, India, is innovation-driven. The company creates and promotes a wide variety of branded and generic formulations, biotechnology goods, and APIs in more than 100 markets throughout the Americas, Europe, the Middle East, India, and South Africa. 

The company has a strong presence in the anti-infective, gastro-intestinal (GI), central nervous system (CNS), and women's health sectors and holds a leadership position in the cardiovascular, anti-diabetic, and respiratory segments. By prescriptions, Lupin ranks as the third-largest pharmaceutical firm in the United States. In FY22, the company spent 8.7% of its revenue on research & development