Lupin Ltd

The company is one of the first ANDA applicants and is eligible for 180 days of shared generic exclusivity. Eslicarbazepine Acetate Tablets, 200 mg, 400 mg, 600 mg, and 800 mg are bioequivalent to Aptiom Tablets, 200 mg, 400 mg, 600 mg, and 800 mg, of Sumitomo Pharma America, Inc., and indicated for the treatment of partial-onset seizures in patients 4 years of age and older. As per IQVIA MAT March 2025, Eslicarbazepine Acetate Tablets had estimated annual sales of $395 million in the U.S. 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. The company's consolidated net profit jumped 39.5% to Rs 855.16 crore in Q3 FY25 as compared with Rs 613.12 crore in Q4 FY24. Net sales increased 10.6% YoY to Rs 5618.56 crore during the quarter ended 31st March 2025. The scrip advanced 1.08% to end at Rs 2,070.95 on Wednesday, 7 May 2025.Powered by Capital Market - Live

Lupin will hold a meeting of the Board of Directors of the Company on 14 May 2025.Powered by Capital Market - Live

The drug is bioequivalent to Jynarque' Tablets by Otsuka Pharmaceutical Company. Lupin is the exclusive first-to-file applicant for this product, making it eligible for 180 days of generic market exclusivity in the U.S. market. The product will be manufactured at Lupin's Nagpur facility in India and is expected to launch soon. Tolvaptan is used to treat hyponatremia (low sodium levels in the blood) in patients with heart failure or syndrome of inappropriate antidiuretic hormone (SIADH). It is also approved to slow the progression of kidney function decline in adults at risk of rapidly advancing autosomal dominant polycystic kidney disease (ADPKD). The approved product has estimated annual sales of USD 1,467 million in the U.S. for the fiscal year ended 31 December 2024. Vinita Gupta, CEO of Lupin, said,''We are very pleased to have obtained approval for generic Tolvaptan from the U.S. FDA. This marks a significant entry into the nephrology segment and demonstrates our commitment to addressing the unmet needs of patients globally.' Mumbai-based Lupin is an innovation-led, transnational pharmaceutical company. It develops and commercializes a wide range of branded and generic formulations, biotechnology products, and APIs in over 100 markets in the US, India, South Africa, and across the Asia Pacific (APAC), Latin America (LATAM), Europe, and Middle East regions. Lupin's consolidated net profit jumped 38.81% to Rs 858.86 crore on a 10.60% increase in sales to Rs 5,618.6 crore in Q3 FY25 compared to Q3 FY24.Powered by Capital Market - Live

 Lupin has received approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application for Tolvaptan Tablets, 15 mg, 30 mg, 45 mg, 60 mg, and 90 mg. Tolvaptan Tablets are bioequivalent to Jynarque' Tablets, 15 mg, 30 mg, 45 mg, 60 mg, and 90 mg, of Otsuka Pharmaceutical Company. Lupin is the exclusive first-to-file for this product and is eligible for 180 days of generic drug exclusivity. This product will be manufactured at Lupin's Nagpur facility in India and will be launched soon. Tolvaptan is indicated to slow kidney function decline in adults at risk of rapidly progressing autosomal dominant polycystic kidney disease (ADPKD). Powered by Capital Market - Live

The EIR was issued following an inspection of the facility conducted from 10 June to 13 June 2024. Nilesh Gupta, Managing Director, Lupin, said, 'We are very pleased to have received the EIR from the US FDA for drug-device combination products at our Nagpur injectable facility. We remain committed to producing complex generic and essential products that address unmet needs. Mumbai-based Lupin is an innovation-led, transnational pharmaceutical company. It develops and commercializes a wide range of branded and generic formulations, biotechnology products, and APIs in over 100 markets in the US, India, South Africa, and across the Asia Pacific (APAC), Latin America (LATAM), Europe, and Middle East regions. Lupin's consolidated net profit jumped 38.81% to Rs 858.86 crore on a 10.60% increase in sales to Rs 5,618.6 crore in Q3 FY25 compared to Q3 FY24. Shares of Lupin rose 0.51% to Rs 1,945.65 on the BSE.Powered by Capital Market - Live

Nanomi B.V., a Dutch subsidiary of the global pharma major Lupin, today announced that it has won the prestigious CMO Award for Life Science Leadership in Drug Delivery, during the Drug, Chemical and Associated Technologies Association (DCAT) week at New York. Nanomi's pioneering approach in drug delivery has set new benchmarks in the industry, and this award serves as a motivation to continue its mission to revolutionize healthcare.Powered by Capital Market - Live

Lupin has allotted 24,101 equity shares under ESOP on 21 March 2025. In view of the above, the issued and paid-up share capital of the Company has increased to Rs 91,31,30,090 consisting of 45,65,65,045 equity shares of Rs 2/- each.Powered by Capital Market - Live

Lupin has received tentative approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application for Amifampridine Tablets, 10 mg. This product would be manufactured at Lupin's Goa facility in India. Amifampridine Tablets, 10 mg, are bioequivalent to Firdapse' Tablets, 10 mg of Catalyst Pharmaceuticals, Inc., and are indicated for the treatment of Lambert-Eaton myasthenic syndrome in adults and pediatric patients 6 years of age and older. Amifampridine Tablets, 10 mg (RLD Firdapse') had an estimated global net sale of USD 306 million for the fiscal year ended December 31, 2024.Powered by Capital Market - Live

Amifampridine Tablets, 10 mg, are bioequivalent to Firdapse Tablets, 10 mg, from Catalyst Pharmaceuticals, Inc., and are indicated for the treatment of Lambert-Eaton Myasthenic Syndrome in adults and pediatric patients 6 years of age and older. This product will be manufactured at Lupin's Goa facility in India. Amifampridine Tablets, 10 mg (RLD Firdapse), had an estimated global net sale of $306 million for the fiscal year ended 31 December 2024. Mumbai-based Lupin is an innovation-led, transnational pharmaceutical company. It develops and commercializes a wide range of branded and generic formulations, biotechnology products, and APIs in over 100 markets in the US, India, South Africa, and across the Asia Pacific (APAC), Latin America (LATAM), Europe, and Middle East regions. Lupin's consolidated net profit jumped 38.81% to Rs 858.86 crore on a 10.60% increase in sales to Rs 5,618.6 crore in Q3 FY25 compared to Q3 FY24.Powered by Capital Market - Live

The newly launched drug is bioequivalent to Xarelto 2.5 mg from Janssen Pharmaceuticals, Inc. Rivaroxaban is indicated for reducing the risk of major cardiovascular events in patients with coronary artery disease (CAD) and major thrombotic vascular events in patients with peripheral artery disease (PAD), including those who have undergone lower extremity revascularization due to symptomatic PAD. According to IQVIA MAT data for January 2025, rivaroxaban tablets USP, 2.5 mg, had estimated annual sales of $446 million in the US. Mumbai-based Lupin is an innovation-led, transnational pharmaceutical company. It develops and commercializes a wide range of branded and generic formulations, biotechnology products, and APIs in over 100 markets in the US, India, South Africa, and across the Asia Pacific (APAC), Latin America (LATAM), Europe, and Middle East regions. Lupin's consolidated net profit jumped 38.81% to Rs 858.86 crore on a 10.60% increase in sales to Rs 5,618.6 crore in Q3 FY25 compared to Q3 FY24. Shares of Lupin rose 0.69% to Rs 2,043 on the BSE.Powered by Capital Market - Live