Custom synthesis provides tailored chemical development and manufacturing solutions to support both generic APIs and new chemical entities (NCEs). This function delivers flexible, end-to-end capabilities—from route scouting and feasibility assessment to multi-kilogram scale production—ensuring rapid turnaround, cost-effectiveness, and strict quality and regulatory compliance. Custom synthesis teams collaborate with Analytical development, CDMOs, and supply-chain partners to meet diverse customer needs and accelerate market readiness.
Key Deliverables
- Custom route design and feasibility studies for generics and NCEs
- Small- to large-scale synthesis (gram to multi-kg) for development, validation, or commercial use
- Optimization of cost, yield, and purity for customer-specific requirements
- Analytical development and full characterization of synthesized materials
- Rapid turnaround for reference standards, intermediates, and building blocks
- Documentation and compliance packages, including method validation data and CMC-relevant support