When an existing European pharma customer decided to discontinue its in-house production of an anticholinergic API with a volume of several tonnes per year, we were asked to manufacture it exclusively within the boundaries of their existing registration.
Although only two synthesis steps had to be transferred for this niche product, the project demands were considerable. Challenges included stringent demands on raw materials, tight limits for particles sizes, exposure risks for our operators and commercial scale use of sodium; all within the constraints of an existing DMF.
The customer was especially satisfied with our quick response times in the development stage, our attention to detail and for our rigor and creativity in organic and analytical chemistry. We were also successful in finding and qualifying new sources for critical raw materials.