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Drug maker Lupin on Friday said it has launched a generic medication to treat schizophrenia in the US with 180 days of exclusivity. The company has launched Risperidone for extended-release injectable suspension, 25 mg per vial, 37.5 mg per vial, and 50 mg per vial, single-dose vials, with 180-day CGT exclusivity in the US, the Mumbai-based drug maker said in a statement. This follows the recent approval received from the US Food and Drug Administration (USFDA). This is the company's first product using proprietary technology from PrecisionSphere, the Long-acting Injectable (LAI) platform developed by its subsidiary Nanomi BV. Risperidone for extended-release injectable suspension is bioequivalent and therapeutically equivalent to the reference listed drug Risperdal Consta LAI. It is indicated for the treatment of schizophrenia in adults and as monotherapy or as adjunctive therapy to lithium or valproate for the maintenance treatment of bipolar disorder in adults. As per IQVIA MA
Drug firm Lupin on Wednesday said it will set up a new manufacturing facility in Coral Springs, Florida, entailing an investment of USD 250 million. With a projected cumulative investment of USD 250 million, including research & development, infrastructure and capital expenditures over a five-year period, the new site will have the capacity to accommodate the production of more than 25 critical respiratory medicines, the Mumbai-based drug maker said in a regulatory filing. The Florida-based plant would produce products like albuterol inhalers for children with asthma, it added. By strengthening domestic manufacturing and enhancing supply chain diversification, this critical project will enhance medicine security and strengthen the company's position as a global respiratory leader, it said. Locally, the infrastructure will generate over 200 new long-term, skilled jobs by 2030 in Broward County. "The expansion of Lupin's footprint in Coral Springs is a core part of our growth ...
Drug maker Lupin on Monday said its subsidiary has inked a pact to fully acquire Amsterdam-headquartered VISUfarma BV at an enterprise value of 190 million euros. The company's wholly-owned subsidiary, Nanomi BV has signed a definitive agreement for the acquisition of VISUfarma BV, a portfolio company of global healthcare specialist investor GHO Capital Partners LLP, the Mumbai-based drug maker said in a statement. The acquisition of VISUfarma, with its broad portfolio of eye health products and established commercial infrastructure, aligns with the company's strategy to expand its European business and footprint and to advance the company's global specialty franchise, it added. By integrating VISUfarma's established commercial operations, Lupin will tap into the attractive ophthalmology market, which is experiencing significant global growth driven by an aging global population, the increasing incidence of diabetes-related eye complications, and growing awareness of preventive care
Pharma major Lupin Ltd on Wednesday said it has received tentative approval from the US health regulator for its generic version of Bictegravir, Emtricitabine, and Tenofovir Alafenamide tablets used to treat human immunodeficiency virus (HIV) infection. The approval by the US Food and Drug Administration (USFDA) is for the abbreviated new drug application for Bictegravir, Emtricitabine, and Tenofovir Alafenamide tablets of strength 50 mg/200 mg/25 mg, Lupin said in a regulatory filing. This product would be manufactured at Lupin's Nagpur facility, it added. Bictegravir, Emtricitabine, and Tenofovir Alafenamide tablets, 50 mg/200 mg/25 mg are bioequivalent to Biktarvy Tablets, 50 mg/200 mg/25 mg of Gilead Sciences, Inc., and indicated for the treatment of human immunodeficiency virus infection in adults and pediatric patients weighing at least 25 kg, it added. Citing IQVIA MAT July 2025 data, Lupin said the Bictegravir, Emtricitabine, and Tenofovir Alafenamide tablets (Biktarvy) had