Lupin Limited has informed the Exchange regarding a press release dated September 03, 2025, titled "Lupin Receives U.S. FDA Approval for Risperidone Long-Acting Injectable, with 180-Day CGT Exclusivity, the First Product from its Nanomi s Long-Acting Injectable Platform".
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Lupin has received U.S. FDA approval for its Risperidone Long-Acting Injectable, a generic version of the antipsychotic drug used to treat schizophrenia and bipolar disorder. The approval comes with 180-day Competitive Generic Therapy (CGT) exclusivity, meaning Lupin will be the sole generic supplier in the U.S. for six months before other generic competitors can enter. This is the first product to be commercialized from Lupin's Nanomi long-acting injectable technology platform, validating the company's investment in complex injectables.
Positive for shareholders — the 180-day exclusivity window allows Lupin to capture strong U.S. market share and pricing power in the near term, and successful approval of the first Nanomi platform product signals potential for more long-acting injectable launches from this pipeline.