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Global pharmaceutical major Lupin Limited has achieved a significant regulatory milestone with the United States Food and Drug Administration (US FDA) granting approval for its Abbreviated New Drug Application (ANDA) for Risperidone extended-release injectable suspension. This approval marks Lupin’s entry into the complex long-acting injectable (LAI) space, leveraging its proprietary Nanomi platform to deliver advanced drug formulations for mental health disorders.
Key Highlights of the Approval
The FDA has approved Lupin’s Risperidone injectable in three dosage strengths: 25 mg, 37.5 mg, and 50 mg per vial, all in single-dose formats.
This product is bioequivalent to Risperdal Consta, the reference listed drug used for treating schizophrenia and bipolar I disorder.
Lupin has been granted 180-day Competitive Generic Therapy (CGT) exclusivity, allowing it to be the sole generic supplier for a limited period in the US market.
Strategic Significance for Lupin
First Product from Nanomi’s LAI Platform
This is Lupin’s inaugural product developed using Nanomi B.V.’s proprietary LAI technology, a subsidiary focused on innovative drug delivery systems.
The platform utilizes particle control technology to create uniform microspheres that enable extended drug release over weeks or months.
Expansion into Complex Injectables
The approval validates Lupin’s capabilities in developing complex injectables, a segment with high entry barriers and significant growth potential.
It aligns with Lupin’s strategic pivot toward specialty and novel products, diversifying its portfolio beyond traditional generics.
Enhanced Patient Outcomes
Long-acting injectables like Risperidone reduce dosing frequency, improve medication adherence, and offer consistent therapeutic levels, especially critical in psychiatric care.
The product’s superior injectability and controlled release profile are expected to enhance patient comfort and clinical efficacy.
Market Potential and Competitive Landscape
Commercial Opportunity
According to IQVIA data, Risperdal Consta recorded annual US sales of approximately 190 million dollars as of July 2025.
Lupin’s entry with CGT exclusivity positions it to capture a significant share of this market, especially during the exclusivity window.
Competitive Advantage
The first-cycle approval from the FDA underscores Lupin’s regulatory and operational excellence.
With limited competition in the LAI generic space, Lupin stands to benefit from early mover advantage and pricing power.
Operational and R&D Excellence
Cross-Functional Collaboration
The successful approval reflects the coordinated efforts of Lupin’s R&D, manufacturing, and regulatory teams across global sites.
The company operates 15 manufacturing facilities and 7 R&D centers, supporting its innovation pipeline and global supply capabilities.
Future Pipeline Prospects
Lupin plans to leverage the Nanomi platform for additional LAI products across therapeutic areas, including central nervous system, oncology, and infectious diseases.
The platform’s lifecycle extension capabilities could also be applied to existing drugs nearing patent expiry.
Investor Sentiment and Stock Movement
Lupin’s shares rose 2.4 percent following the announcement, trading at ₹1,935.10 on the NSE.
Despite a year-to-date decline of 18.2 percent, the FDA approval has reignited investor optimism about Lupin’s growth trajectory.
Analysts view the development as a turning point in Lupin’s strategic evolution, potentially driving margin expansion and revenue diversification.
Conclusion
Lupin’s FDA approval for Risperidone long-acting injectable is more than a regulatory win—it’s a strategic leap into the future of drug delivery. With its Nanomi platform now validated, Lupin is poised to redefine its role in the specialty pharmaceutical space. As the company continues to innovate and expand its complex injectable portfolio, stakeholders can expect a new chapter of growth, impact, and global relevance.
Sources: Lupin Official Website, CNBC TV18, Business Upturn
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