Lupin wins USFDA nod for Risperidone for extended-release injectable suspension for schizophrenia
This is Lupin's first product using proprietary Nanomi B.V.'s technology and has a 180-day CGT exclusivity.;
Mumbai: Global pharma major Lupin Limited has announced that the company has received approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application (ANDA) for Risperidone for extended-release injectable suspension, 25 mg per vial, 37.5 mg per vial, and 50 mg per vial, Single-Dose Vials.
This is Lupin’s first product using proprietary Nanomi B.V.’s technology and has a 180-day CGT exclusivity.
Nanomi, a Lupin subsidiary, is focused on the development of innovative long-acting injectable (LAI) medicines to improve health outcomes for patients.
Vinita Gupta, CEO of Lupin, said, “We are very pleased with the approval of the first product from our Nanomi LAI platform. This first-cycle approval is a testament to the capabilities we have established for complex injectables across our teams in R&D, Operations and related functions. It validates our platform capabilities at Nanomi and underscores our commitment to expanding access to complex injectables for patients globally. As we execute on our strategy to evolve specialty/novel products, we plan to leverage the Nanomi platform for novel long-acting injectables that meet unmet patient needs.”
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