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Lupin gets USFDA’s nod for Rivaroxaban Tablets

15 May 2025 Evaluate

Lupin has received approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application for Rivaroxaban Tablets USP, 10 mg, 15 mg, and 20 mg. Rivaroxaban Tablets are bioequivalent to Xarelto Tablets, 10 mg, 15 mg, and 20 mg, of Janssen Pharmaceuticals. This product will be manufactured at Lupin’s Aurangabad facility in India. Rivaroxaban Tablets USP, 10 mg, 15 mg, and 20 mg (RLD Xarelto) had estimated annual sales of $8,052 million in the U.S. (IQVIA MAT March 2025). 

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.

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Company Name CMP
Sun Pharma. Inds. 1835.50
Dr. Reddys Labs. 1171.10
Cipla 1371.45
Lupin 2144.70
Zydus Lifesciences 1153.00
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