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.
Through innovative science and manufacturing excellence, we enable our customers to develop and deliver therapeutic solutions that improve the quality of life for patients around the world.
At Cambrex, we live and work by a set of values that help to make us refreshingly different:
Expertise, quality, regulatory excellence, responsiveness
Safe, inclusive, honest, transparent, and supportive
One Cambrex team, agile, always improving, celebrating success
Cambrex is a leading global contract development and manufacturing organization (CDMO) that provides drug substance, drug product, and analytical services across the entire drug life cycle.
We leverage our expertise to bring our customers’ products through the development, regulatory, and manufacturing process so that they are available for patients who need them.
Our capabilities in the areas of tech transfer, process and pharmaceutical product development, formulation development, production, scale-up and validation, and analytical method development allow us to partner with clients from development through commercialization or at any point along the way.
We serve a growing global customer base across multiple regulatory environments. These attributes allow us to be a partner of choice for many of today’s large pharma, generic pharma, and biotech pharma companies.
Along with our scientific and manufacturing expertise, we strive to be excellent partners and creative problem-solvers. We work with customers to find effective and expedient solutions to their pharmaceutical development and manufacturing challenges. We are engaged and always exploring new ideas and approaches. We are agile and flexible and can accommodate changes that may arise in the needs of a customer’s project, at any point in a product’s lifecycle.
Cambrex embraces the unique backgrounds and perspectives of all colleagues to serve the needs of our customers, and to generate a vibrant Cambrex community. We strive to create a deep sense of inclusion and fully embrace the remarkable diversity of perspectives, backgrounds, and talents of our 2,400 + colleagues around the world.
Advance our culture through inclusion
Build a diverse workforce to serve the needs of our global customer community
Leverage our breadth of experience and expertise to enhance our way of doing business
Together, we can build a healthier, happier, inclusive community where each person can thrive.
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