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Lupin gets USFDA’s tentative approval for Valbenazine Capsules

27 Mar 2023 Evaluate

Lupin has received tentative approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA), Valbenazine Capsules, 40 mg, 60 mg, and 80 mg, to market a generic equivalent of Ingrezza Capsules, 40 mg, 60 mg, and 80 mg, of Neurocrine Biosciences, Inc.

Valbenazine Capsules (RLD Ingrezza) had estimated annual sales of $1,235 million in the U.S. (IQVIA MAT December 2022).

Lupin is an innovation led transnational pharmaceutical company producing, developing and marketing a wide range of branded and generic formulations, biotechnology products and active pharmaceutical ingredients (APIs) globally.

Peers
Company Name CMP
Sun Pharma. Inds. 1810.00
Dr. Reddys Labs. 1200.10
Cipla 1346.85
Lupin 2029.00
Zydus Lifesciences 1145.25
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