Custom API Manufacturing

API manufacturing is a long journey that requires a forward-looking, scientific approach to ensure smooth transitions as manufacturing requirements increase. The GMP process requires a comprehensive assessment of everything from the starting materials, premises, equipment and quality systems to the training of appropriate personnel. You need a trusted partner to help you navigate these challenges. Enhanced by an uncompromising commitment to cGMP standards and proven compliance track record, Cambrex is an expert partner you can trust across the lifecycle of your product.

Further enhanced by our acquisition of Snapdragon Chemistry and its brand new GMP facility offering multi-step, end-to-end continuous processing, our extensive drug substance manufacturing capabilities enable us to take your project from early-phase development and optimization to scale-up and commercial manufacture. We can provide lab-, kilo- and pilot-scale manufacturing support for preclinical studies through all phases of clinical trials, supplying milligram to kilogram quantities while continuing to improve the chemical process. We are equally proficient at supporting your commercial manufacturing needs for product launch and in-market supply, from kilogram to 100+ metric ton quantities.

Cambrex and Snapdragon offer a seamless, streamlined technology transfer process, and we provide full and consistent support throughout your molecule’s journey. Our team of scientists and project managers will ensure you have full visibility into your program, no matter where your product is in our network.