Contract development and manufacturing

At FCC, your API project is in excellent hands. With our competencies we can add value to your project and collaborate with you to ensure success. We have a proud, half a century-long history in development, up-scaling and commercially manufacturing complex high potency APIs (HPAPIs), as well as narcotics and other established APIs.

Whether your project is for a New Chemical Entity (NCE), or a process for (re-)designing your (intermediate) API, we will be your partner from the development phase to the commercial implementation. FCC adds expertise, innovation, compliance, registration and partnership to your project. You will be working with a high-quality partner who offers skills and well-equipped pilot laboratories, pilot plants and cGMP facilities to enable development, efficient technology transfer and scale up of your API. 

Our facilities are successfully inspected and approved by regulatory authorities such as the US FDA, EDQM, PMDA, and others. On top of that we simply love molecules, and we are driven to guide you to effectively scale up from lab to plant.

Our experience with complex chemical reactions enables us to develop the most efficient processes. Supported by a robust quality system, we ensure that a high-quality product is manufactured in compliance with cGMP, ICH and SHE regulations. FCC assures you of flexibility and delivery reliability to meet your project needs.

Our services

• Direct contact with our Subject Matter Experts
• Professional project management 
• Route selection
• Process development and optimization
• Analytical development and validation 
• ICH stability studies
• Extensive sourcing network for raw materials
• Global regulatory expertise and support

Our API development capabilities includes

• Dedicated R&D Tech team with long standing expertise in synthesis & process development
• Supported by Lab & Pilot Plants with Containment capability of 50ng / m3 – 1 ug/m3
• Well established high expertise CRO & CAS partners
• Professional project management 
• Extensive sourcing network for raw materials
• Full analytical Development Services supported by ADD Lab
• Manufacturing under full cGMP
• Dedicated Regulatory expertise and support 
• Patent investigations, development and filing.
• HPLC, UPLC, LC-MS, 
• Access to university laboratories for high-resolution proton and carbon-13 spectrometry for state-of-the-art correlation spectroscopy such as COSY and HETCOR
• Access to university laboratories for SEM and X-ray powder diffraction studies
• Thermal analysis techniques, DSC, and TGA
• Kilo scale manufacturing and drying equipment