Drug Approval | September 04, 2025
Lupin receives FDA approval for Risperidone LAI with 180-day CGT exclusivity
This is Lupin's first product using proprietary Nanomi's technology and has a 180-day CGT exclusivity
This is Lupin's first product using proprietary Nanomi's technology and has a 180-day CGT exclusivity
The US Generics market has been witnessing significant pricing pressure leading to significant losses at Jubilant Cadista since FY2022 onwards.
Funding round led by Sarissa Capital, includes Sun Pharma, Polaris Partners
Post this currently only Risperidone orally disintegrating tablets are allowed for import into the US from the Roorkee facility.
The company will engage with the agency to resolve the import alert at the earliest and ensure cGMP compliance.
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