A submission to the U.S. Food and Drug Administration (FDA) seeking approval to market a generic version of a previously approved branded drug. This application relies on the safety and efficacy findings of the original drug.
Meet Neuland at CPHI India 2026 | Hall 2, Booth 2D38 | Yashobhoomi Convention Centre, New Delhi | 24-26 November 2026 Schedule a Meeting

Explore how Neuland supports API programs from pre-IND through commercial manufacturing.