Lupin Gets USFDA Nod For Generic Schizophrenia Drug

has received approval from the US Food and Drug Administration (USFDA) to market its generic version of Risperidone Extended-Release Injectable Suspension, a treatment for schizophrenia. This approval marks a critical milestone for the Indian pharma major, as the US market remains one of the most lucrative for complex generics. The drug is a generic equivalent of Perseris®, developed by Indivior, and will allow Lupin to tap into the growing demand for affordable long-acting injectables in mental health. Such approvals not only expand patient access but also strengthen India’s reputation as a global hub for high-quality, cost-effective generics. From an industry perspective, the nod underscores the increasing role of Indian companies in specialized therapies. Long-acting injectables represent a niche but high-potential segment, with barriers to entry that favor firms capable of navigating complex formulations and regulatory requirements. While pricing pressure in the US generic market continues to challenge margins, approvals like this enable Indian players to differentiate themselves and move into higher-value therapies. For Lupin, it could open new revenue streams and improve its competitive positioning against peers like Sun Pharma, Dr. Reddy’s, and Aurobindo Pharma. In the broader context, this reflects how Indian pharmaceutical companies are evolving from volume-driven strategies to innovation-led growth in complex generics and specialty products. Source: NDTV Profit No Recommendations