Adventures in API synthesis

Jacob Rendell, Chemical R&D, API division, TEVA Pharmaceutical Industries, Beer Sheva, Israel

The development of safe, scalable and cost-effective processes for Active Pharmaceutical Ingredients (API) presents a variety of challenges for the organic chemist. Strict, and frequently diverse (depending on market), quality requirements imposed by health authorities and customers have to be carefully considered, sometimes already in early stages during design of synthesis. Patent constraints, raw material availability and short development timelines add additional limitations in an ever increasing competitive environment. Several of the challenges encountered during API process development and the solutions implemented will be illustrated by recent case studies from the R&D of TEVA’s API division.