Lupin Secures FDA Approval for Long-Acting Injectable Risperidone, Enhances Treatment Options for Patients

Lupin Secures FDA Approval for Long-Acting Injectable Risperidone

Lupin Limited, a leading pharmaceutical company, recently announced that the US Food and Drug Administration (FDA) has granted approval for its abbreviated new drug application (ANDA) for a long-acting injectable formulation of Risperidone. This product, available in 25 mg, 37.5 mg, and 50 mg single-dose vials, represents the initial release from Lupin's proprietary Nanomi platform, which specializes in long-acting injections (LAI). Importantly, this approval comes with a 180-day exclusivity period under the complex generics and therapies (CGT) classification, ensuring a unique market presence for a limited time.

The newly approved injectable Risperidone is bioequivalent to Risperdal Consta®, an existing treatment for schizophrenia and a maintenance therapy for Bipolar I disorder, either as monotherapy or when combined with lithium or valproate. The original market for Risperdal Consta® has shown impressive sales, generating an estimated annual revenue of $190 million in the US as of July 2025 (IQVIA MAT data) prior to this new approval.

Vinita Gupta, CEO of Lupin, expressed her enthusiasm regarding this significant milestone, stating, _“We are thrilled to have received the approval for the first product from our Nanomi LAI platform. This first-cycle approval confirms the expertise we have developed in the preparation of complex injectable products, showcasing the capabilities of our Nanomi platform in expanding access to such therapeutic options for patients globally.”_ Gupta noted that this advancement marks a crucial step in delivering specialized and novel products that cater to unmet patient needs.

The LAI platform by Nanomi has demonstrated its efficacy and safety profile for administering medications over extended periods. The proprietary particle control technology utilized in this platform generates uniform microspheres, offering extended release profiles that range from weeks to several months. Furthermore, this technology enhances injectability through the use of finer needles and achieves consistent drug concentrations over time. This capability not only supports the lifecycle extension of existing products but also proves beneficial for those therapies requiring long-acting formulations.

Dr. Shahin Fesharaki, Lupin's Chief Scientific Officer, emphasized the importance of this FDA approval, stating, _“The FDA's endorsement of Risperidone validates the capabilities of our LAI technology platform and marks a significant advancement in our journey towards curating innovative long-acting injectable medications across various therapeutic areas.”_ He further remarked that this is a pivotal milestone underscoring the collaborative efforts of Lupin’s cross-functional teams.

Lupin Limited itself is recognized as a global player in the pharmaceutical sector, headquartered in Mumbai, India, and its products are distributed in over 100 markets worldwide. The company specializes in a diversified range of products including generic formulations, complex generics, biotechnology products, and active pharmaceutical ingredients. Their robust presence in various therapeutic domains such as respiratory conditions, cardiology, diabetes, and infectious diseases commands respect from healthcare professionals and patients alike.

With 15 state-of-the-art manufacturing facilities and 7 research centers around the globe, Lupin boasts a team of over 24,000 dedicated employees. They continuously strive to enhance patient care through subsidiaries like Lupin Diagnostics and Lupin Digital Health, alongside focusing on innovative manufacturing solutions.

For additional information about Lupin, visit www.lupin.com or follow their updates on LinkedIn. To learn more about the Nanomi platform, check out www.nanomi.com.

In conclusion, the recent approval of Risperidone as a long-acting injectable reaffirms Lupin's commitment to improving patient outcomes while advancing its technological capabilities in the pharmaceutical landscape. As conditions such as schizophrenia and bipolar disorder continue to impact lives globally, innovative solutions such as this present promising advancements in treatment efficacy and patient adherence.