Custom Synthesis & API CMO
To offer both toll-manufacturing and exclusive synthesis of Active Pharmaceutical Ingredients or multi-step synthetic intermediates
We are a Contract Manufacturing Organization (CMO) in Chemistry and Biotechnology
We offer our customers and partners Sanofi’s experience and know-how from Process Development to industrial scale production.
We offer custom synthesis & API Contract Manufacturing under cGMP conditions for API and multistep intermediates.
- Toll manufacturing most often concerns molecules pending registration or those already marketed. Following transfer of your manufacturing process, it can be applied without modification for the production of the necessary quantities in accordance with the specifications provided. Any changes to the process are made with your agreement.
- Exclusive synthesis often concerns compounds that are still in the clinical development stage. According to customer's requirements, this involves working on process development to offer alternative synthetic route implementation via:
- Chemical and biotechnological development
- Analytical development
- Physical quality studies
- Clinical supplies
- Pilot plant production from technical /engineering runs to clinical supplies
- Process Engineering and scale-up
- Process safety
- Commercial supply at industrial scale
- Quality & regulatory support