IND submission is a major milestone in the life of your drug. We can provide all supporting analytical data to help ensure a smooth application process.
We have the expertise, flexibility, and resources to provide a full range of pharmaceutical API custom development services at every stage of the lifecycle.
We can provide lab-, kilo- and pilot-scale manufacturing for preclinical studies and all phases of clinical trials, supplying milligram to kilogram quantities.
Cambrex brings more than 40 years of generic API manufacturing experience to its pharmaceutical partners. From our sites in Italy, Sweden, and the USA, we are a leading global supplier of generic APIs.
Drug substance tech transfer sounds so simple on the surface, but it’s a complex activity carrying a number of technical, regulatory, and quality risks.
At Cambrex, we provide a range of technologies equipped to solve your API manufacturing challenges, and we are flexible enough to handle the most complex molecules.
If you’re looking to outsource drug product development to a CDMO, you need a collaborative partner who will engage you deeply to understand the unique needs of your project.
From pre-formulation to commercial manufacturing and packaging, you can trust Cambrex to deliver your complex dosage forms with the perfect combination of technology, expertise, and collaboration.
At Cambrex, we offer a tried and trusted approach to technology transfer, for scale-up or when transitioning to a different facility.
We are equipped to take on projects at any size or scale, offering established pediatric formulation and development expertise and to-scale manufacturing capabilities.
Biopharma companies at all stages of development, rely on our expertise and broad capabilities to produce the clinical trial supply of drug products they need, when they need them.
We can support you, at any size or stage, with a range of primary and secondary packaging solutions.
You can rely on our extensive portfolio of analytical development solutions and testing services to rapidly advance your molecule for the greatest chance of success.
Cambrex offers a comprehensive suite of testing services for complex biopharmaceuticals including standalone analytical R&D, method validation, release testing, ICH stability, and routine QC testing.
We’re solid state chemistry experts who can deliver timely, phase-appropriate solutions to optimize the physical stability of your API, develop a more bioavailable formulation or overcome other challenges.
Cambrex’s experienced analysts are well-equipped to ensure microbial testing is of the highest quality for our customers and delivered with a quick and reliable turnaround.
Cambrex and Q1 Scientific’s stability storage and sample management capabilities provide a variety of pharmaceutical storage conditions, with walk-in and reach-in chambers that meet all ICH Q1A requirements.
Cambrex is here to support you in early-phase development. Our development experts apply their ingenuity and skill to address your unique challenges.
Our teams of creative problem-solvers work closely with you to accelerate drug development timelines, optimize processes, and meet regulatory requirements.
We understand that the commercial phase of drug development can be challenging, especially when it comes to manufacturing at scale and meeting changing market demands.
Cambrex is a leading global supplier of more than 70 generic APIs, as well as intermediates and derivatives.
Early-phase pharmaceutical development programs often experience challenges unique from those of later phase and commercial programs. Navigating the complex regulatory landscape requires experience to effectively design, develop and collect high-quality data prior to an IND submission, such as material characterization, solubility, product stability and safety. When you find the right development partner, you increase the likelihood of advancing your product.
Cambrex is here to support you in your early-phase program. Our development experts apply their ingenuity, technical skill, and experience to find creative solutions suitable to your needs. At every stage, our experts work closely with you in a collaborative partnership, while providing effective project management open communication and transparency.
Our state-of-the-art facilities support the following services for early-phase programs:
We love challenges, and we would like to learn more about yours. Contact us to discuss your early-phase program, and how we can help.
With Cambrex, you gain access to cutting-edge technologies combined with highly experienced industry professionals to support the needs of your IND filing.
We take a proactive approach to early-phase pharmaceutical process development and apply our expertise and creative problem-solving skills to optimize your chemical process.
Our dynamic formulation development services will adapt to your early-phase challenges as the needs arise. Our scientists have the experience and knowledge to help you advance.
Our veteran team of solid-state chemistry experts will work with you to address your unique early-phase development challenges and help you achieve your specific goals.
By offering a comprehensive suite of analytical testing services, we can support development, validation and testing for your program, whether it’s early-phase, late-phase or commercial, and ensure your materials meet the highest standards for safety and quality.
We offer extensive microbiology services at our FDA-registered facilities, which are fully compliant with all GMP and GLP testing services and standards.
We offer complete stability storage and testing services at all phases of development, including commercial programs.
We provide lab-scale and kilo-scale manufacturing for pilot API scale-up for pre-clinical material and for phase I clinical trial material, including all the analytical support required to reach early-phase regulatory milestones.
Our robust manufacturing and packaging services provide solutions to support the changing demands of your early-phase clinical program.