Lupin receives USFDA tentative nod for Siponimod tablets

Lupin announced that it has received tentative approval from the U.S. Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Siponimod Tablets in 0.25 mg, 1 mg and 2 mg.

The product is a generic equivalent of Novartis Pharmaceuticals Mayzent Tablets and is indicated for the treatment of relapsing forms of multiple sclerosis (MS), including clinically isolated syndrome, relapsing remitting disease, and active secondary progressive disease, in adults.

Lupin said the tablets will be manufactured at its Pithampur facility in India. According to IQVIA MAT October 2025 data, Siponimod Tablets (reference listed drug Mayzent) recorded annual U.S. sales of USD 195 million.

Lupin is a global pharmaceutical leader headquartered in Mumbai, India, with products distributed in over 100 markets. It specializes in pharmaceutical products, including branded and generic formulations, complex generics, biotechnology products, and active pharmaceutical ingredients.

Lupin reported a 73.33% surge in consolidated net profit to Rs 1,477.92 crore in Q2 FY26 as against Rs 852.63 crore posted in Q2 FY25. Revenue from operations jumped 24.27% year-on-year to Rs 6,831.43 crore in the quarter ended 30 September 2025.

The counter shed 0.21% to Rs 2,087.55 on the BSE.

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