Lupin receives USFDA nod for injectable used to treat Schizophrenia and bipolar disorder

Shares of Lupin Ltd. gained on Wednesday, September 3, said it has received approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Risperidone Injectable.It said it has received USFDA’s approval for Risperidone for extended-release injectable suspension, 25 mg per vial, 37.5 mg per vial, and 50 mg per vial, Single-Dose Vials.

Risperidone Injectable is the bioequivalent to the reference listed drug (RLD), Risperdal Consta Long-Acting Injection. It is used to treat Schizophrenia & bipolar disorder.

Lupin said this is its first product using proprietary Nanomi B.V.’s (Nanomi) technology and has a 180-day CGT exclusivity.
The drugmaker said its subsidiary Nanomi is focused on the development of innovative long-acting injectable (LAI) medicines to improve health outcomes for patients.”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,” Lupin CEO Vinita Gupta said.

Risperidone for extended-release injectable suspension (RLD Risperdal Consta®) had estimated annual sales of $190 million in the US, as per IQVIA MAT July 2025.

Lupin shares were trading 2.4% up at ₹1,935.1 apiece. The stock has declined 18.2% this year, so far.

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