Lupin Ltd Share Price – NSE  / BSE

Pharmaceuticals, Mid Cap

Lupin today announced that it has received tentative approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application for Siponimod Tablets, 0.25 mg, 1 mg and 2 mg. This product would be manufactured at Lupin's Pithampur facility in India.

Siponimod Tablets, 0.25 mg, 1 mg and 2 mg are bioequivalent to Mayzent? Tablets, 0.25 mg, 1 mg and 2 mg of Novartis Pharmaceuticals Corporation, and indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing remitting disease, and active secondary progressive disease, in adults.

Siponimod Tablets (RLD Mayzent?) had estimated annual sales of USD 195 million in the U.S. (IQVIA MAT October 2025).

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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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Lupin as entered into an Exclusive Licensing Agreement with Valorum Biologics (Valorum), a biosimilar specialist in the U.S., for its biosimilar Armlupeg? (pegfilgrastim-unne).

Under the terms of the agreement, Valorum will advance the commercialization and distribution of Armlupeg? (pegfilgrastim-unne) in the United States. Lupin will be responsible for manufacturing and supply of the product and will receive an upfront license fee and a royalty payment on net sales.

Pegfilgrastim-unne is indicated to reduce the duration of neutropenia and the incidence of febrile neutropenia in patients receiving chemotherapy.

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Under the terms of the agreement, Valorum will handle the commercialization and distribution of Armlupeg in the United States, while Lupin will be responsible for manufacturing and supplying the product. Lupin will receive an upfront license fee along with royalty payments on net sales.

Armlupeg (pegfilgrastim-unne) is indicated to reduce the duration of neutropenia and the incidence of febrile neutropenia in patients undergoing chemotherapy.

?We are pleased to collaborate with Valorum to expand access to affordable treatment options for patients undergoing chemotherapy. This partnership reflects our unwavering commitment to improving patient outcomes and aligns with our mission to make high-quality biosimilars more accessible. We look forward to strengthening our presence in the U.S. biosimilars market and building on our momentum as a global leader in developing and commercializing important biosimilar medicines,? said Spiro Gavaris, President ? U.S. Generics, Lupin.

Par S. Hyare, CEO of Valorum, said, ?We are excited to launch Armlupeg (pegfilgrastim-unne) in the U.S. Our team has a proven track record in specialty markets, and we expect to capture significant market share through our commercial expertise. Crucially, we also look forward to providing another option for healthcare providers and patients, increasing access to this important treatment in oncology supportive care.?

Valorum Biologics specializes in the U.S. commercialization of biosimilars, managing regulatory approval, product launch, and ongoing commercialization. The company focuses on optimizing patient access and delivering cost savings to the healthcare system.

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 rose 0.47% to Rs 2,090.45 on the BSE.

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