Fine chemicals synthesis experience
With a deep understanding of organic synthesis in a cGMP environment, our team has the tenure and credentials needed to support your fine chemical project including product development, project management, and scale-up. Grace’s FCMS has decades of experience in organic chemical synthesis at our three fully integrated North American sites.
Our fine chemicals feature:
- Custom Active Pharmaceutical Ingredient (API) development and commercial manufacturing (~1kg – MTs) in fully compliant cGMP facilities
- Generic APIs – 15 DMFs currently
- Custom food / dietary supplement development and manufacturing, (~10’s kg’s – MTs)
- Regulatory starting materials (RSMs) and Registered Intermediates synthesized on scales up to 100’s MT/year per project
- Experience with chiral molecules, custom boronic acids, custom amino acids & protecting groups, solution phase peptide synthesis, aminations, alkylation, and homogeneous catalysis (i.e. Suzuki Coupling)
Premier Contract Development Manufacturing Capabilities and Services
Grace’s Fine Chemical Manufacturing Services (FCMS) is a North American contract development and manufacturing organization (CDMO) offering extensive capabilities for the pharmaceutical, nutraceutical, and fine chemical industries. Backed by more than 40 years of experience, we work closely with our customers every step of the way, from the lab to commercial-scale production. Plus, we assist in multinational compliance in both cGMP and non-cGMP industries.
Your integrated small molecule drug substance program
We have a deep understanding of organic synthesis in a cGMP environment and work collaboratively with our customers to design, develop, manufacture, and optimize proprietary, industry-leading synthesis technologies and novel molecules of importance to the pharmaceutical and nutraceutical industries. Grace forges strong relationships based upon transparency and communication.
From process development through the scale-up of RSMs to complex APIs, we work closely with you to understand your development goals and are with you every step of the way to help you achieve them using the most efficient methods.