ABSTRACT
In this chapter, the evolution of the active pharmaceutical ingredient (API) manufacturing process for sunitinib malate will be described. The different routes evaluated to prepare the API, the factors that influenced the choice of the commercial process, salt selection, scale-up experience, and regulatory issues will be discussed in detail. The benefits and challenges of developing a “onepot” process will also be highlighted. It is hoped that this chapter will provide a sense of the spectrum of issues to be considered while designing a commercial process.
