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Lupin today announced the launch of Bosentan Tablets for Oral Suspension, 32 mg in the United States. This follows the approval received by Lupin's alliance partner, NATCO Pharma Limited (NATCO) for its Abbreviated New Drug Application from the United States Food and Drug Administration (U.S. FDA). NATCO holds the exclusive first-to-file status for this product and will have 180-day generic drug exclusivity.
Bosentan Tablets for Oral Suspension, 32 mg, are bioequivalent to Tracleer® Tablets for Oral Suspension of Actelion Pharmaceuticals US, Inc. They are indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) in pediatric patients aged 3 years and older with idiopathic or congenital PAH to improve pulmonary vascular resistance (PVR), which is expected to result in an improvement in exercise ability.
Bosentan Tablets (RLD Tracleer®) had estimated annual sales of USD 10 million in the U.S. (IQVIA MAT June 2025).
Bosentan is indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) in pediatric patients aged 3 years and older with idiopathic or congenital PAH to improve pulmonary vascular resistance (PVR), which is expected to result in an improvement in exercise ability.
As per IQVIA MAT data for June 2025, Bosentan Tablets (RLD Tracleer) had estimated annual sales of approximately $10 million in the US market.
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’s consolidated net profit jumped 52.13% to Rs 1,219.03 crore on 11.78% increase in income from operations to Rs 6,163.75 crore in Q1 FY26 over Q1 FY25.
Shares of Lupin declined 0.61% to Rs 1,956.50 on the BSE, while shares of Natco Pharma slipped 0.82% to Rs 885.95 on the BSE.
Lupin today announced that it has partnered with Sandoz Group AG (Sandoz), Switzerland, to market and commercialize Lupin's biosimilar ranibizumab across multiple regions.
Under the terms of the agreement, Sandoz will oversee commercialization of the product across the European Union (excluding Germany), Switzerland, Norway, Australia, Hong Kong, Vietnam, and Malaysia. Lupin will be responsible for manufacturing the product and for regulatory submissions. Sandoz will hold exclusive marketing rights in most of the designated markets, except for France, Australia, Vietnam, and Malaysia, where it will have semi-exclusive marketing rights. Pursuant to another agreement executed between the two companies, Sandoz will acquire sole rights for commercialization of Lupin's biosimilar ranibizumab in Canada, while Lupin will manage its manufacture and regulatory filings.
Ranibizumab is a recombinant humanized IgG1 monoclonal antibody fragment that binds to and inhibits vascular endothelial growth factor A (VEGF-A). Its indications encompass the treatment of patients with Neovascular (Wet) Age-Related Macular Degeneration (AMD), Macular Edema Following Retinal Vein Occlusion (RVO), Diabetic Macular Edema (DME), Proliferative Diabetic Retinopathy (PDR), and Choroidal Neovascularization (CNV).