Indian pharmaceutical giant Lupin has secured approval from the United States Food and Drug Administration (USFDA) for its generic Risperidone injection, a widely used treatment for schizophrenia and bipolar disorder. The approval allows Lupin to market the injectable formulation in the U.S., one of the world’s largest pharmaceutical markets. This regulatory milestone strengthens Lupin’s central nervous system (CNS) portfolio, expands its footprint in high-value generics, and demonstrates its capability to meet stringent international compliance standards.