Global pharmaceutical company Lupin Limited has announced that it has received approval from the United States Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Risperidone extended-release injectable suspension. The approval covers three different dosage levels: 25 mg, 37.5 mg, and 50 mg per vial, all in single-dose formats. This is the first time Lupin has received approval using the proprietary technology developed by its subsidiary, Nanomi B.V. The product has also been granted 180 days of Competitive Generic Therapy (CGT) exclusivity. Nanomi is a division of Lupin that focuses on researching and developing long-acting injectable medicines, aimed at improving clinical results.
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Vinita Gupta, the Chief Executive Officer at Lupin, expressed her satisfaction with the development and highlighted the importance of this approval as a significant milestone for the company’s long-acting injectable platform. She noted that receiving FDA clearance in the first review cycle shows the strong capabilities of Lupin’s research and development, manufacturing, and regulatory teams. According to Gupta, this achievement validates the technological foundation built at Nanomi and reinforces Lupin’s commitment to expanding access to complex and advanced injectable therapies around the world. She also mentioned that Lupin plans to continue using Nanomi’s platform as part of its strategy to grow its portfolio of specialty and novel therapeutics, especially those that address unmet medical needs.
Nanomi’s platform uses a unique particle engineering technology to create highly uniform microspheres, which are essential for delivering consistent and long-term drug release. These microspheres ensure that drug levels remain stable over extended periods, ranging from several weeks to a few months. The system is designed to improve injectability with finer needles and provides a more predictable release pattern compared to traditional methods. The technology also makes it possible to reformulate existing therapies into long-acting versions, which enhances both convenience and effectiveness.
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Dr. Shahin Fesharaki, the Chief Scientific Officer at Lupin, stated that the FDA approval of Risperidone is a strong validation of Nanomi’s long-acting injectable technology and confirms Lupin’s ability to bring technically complex injectable medicines to market. He emphasized that this success reflects the strength and dedication of Lupin’s cross-functional teams and represents a meaningful step forward in the company’s ongoing efforts to build a diverse pipeline of long-acting treatments across various therapeutic areas.
This FDA approval marks a major advancement not only for Lupin’s product portfolio but also for its technological capabilities. It underscores the company’s strategy to lead in the space of complex generics and innovative drug delivery systems, while strengthening its position in the U.S. and global markets.
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