HOME > MARKETS > COMPANY NEWS
  COMPANY NEWS
COMPANY
Lupin gets USFDA’s nod for Risperidone injectable
Sep-03-2025

Lupin has received approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application 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 the company’s first product using proprietary Nanomi B.V.’s (Nanomi) technology and has a 180-day CGT exclusivity. Nanomi, a subsidiary of the company, is focused on the development of innovative long-acting injectable (LAI) medicines to improve health outcomes for patients.

Nanomi’s LAI platform has demonstrated efficacy and safety in drug delivery. Its proprietary particle control technology creates uniform microspheres that deliver extended-release profiles from weeks to months, superior injectability through smaller needles, and consistent drug concentrations. The technology can provide lifecycle extension opportunities for products in development or on the market that would benefit from longer-acting formulations.

Lupin is an innovation led transnational pharmaceutical company producing, developing and marketing a wide range of branded and generic formulations, biotechnology products and active pharmaceutical ingredients (APIs) globally.

  RELATED NEWS >>