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.
Fixed-dose combination (FDC) drugs have become increasingly popular, mainly because they enable pharmaceutical companies to repurpose, repackage and expand indications for existing therapeutic agents. They also offer benefits to patients, including improved clinical performance and lower costs. But the promise of FDC drugs brings a number of pitfalls. Manufacturing these complex medicines requires specialized equipment and advanced methods and technologies across the formulation, analytical and manufacturing workflows.
Outsourcing FDC product formulation and manufacturing to an experienced CDMO like Cambrex has several advantages. We have the infrastructure, capital equipment, technology and skilled personnel to get your highly complex fixed-dose combination drugs to the market in a timely, cost-effective manner. You can rely on our expertise to produce safe and effective FDC drugs that have a high probability of regulatory approval. This requires thoughtful product design, state-of-the-art formulation and manufacturing technology and advanced analytical tools.
We have equipment to perform:
We can produce FDC drugs in several oral solid dosage forms and have experience manufacturing multi-API mini tablets, bi-layer tablets and multi-API coated tablets in both IR and ER formulations. Cambrex also offers a variety of polymer-coating options to enable controlled release of the different drug substances in an FDC product. In addition, we have hands-on experience in taste-masking that relies on our novel ion exchange technology.
Our scientists specialize in making connections. Start a conversation today and see how we can help you handle the complexities of producing fixed-dose combination drugs.