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.
Some CDMOs offer niche capabilities characterized by discrete and transactional services. Others provide integrated services but lack a commitment to build collaborative partnerships. Cambrex is a different kind of CDMO. We offer end-to-end development and manufacturing services and strive to become an extension of your in-house team. We have specialized expertise — and a dedicated team of experts — to address challenges during any phase of development and beyond.
If you have a molecule in early-phase drug development, you need a versatile CDMO with experience in a variety of chemical development, analytical development and formulation technologies that can help to accelerate your candidate through the drug development lifecycle. Cambrex can help you navigate early-phase challenges, from manufacture of toxicology batches to IND application, to completion of your critical first-in-human trials.
Partnering with a CDMO for late-phase drug development in support of clinical trials can accelerate the overall development trajectory and increase your chances of success. Cambrex is an ideal partner because we have the ability and expertise to develop chemical processes and analytical methods that provide a strong CMC package in preparation for late-stage clinical trials, registration batches, commercial validation and commercial launch.
When choosing a CDMO for commercial manufacturing, it is vital to choose a partner who can properly scale with your API and drug product demands. Whether you plan to support commercial launch with a relatively small annual volume (widow-orphan indication or HiPo), or whether you will immediately need metric ton quantities, Cambrex has you covered. We have the skill and capacity to grow with your increasing demands as indications or markets are added, making us the ideal commercial manufacturing partner.
Manufacturing generics takes a science-driven approach balanced with robust production capabilities. Cambrex is a leading global supplier of generic APIs. We deliver end-to-end pharmaceutical production, including drying, finishing and purification, as well as custom development and analytical testing through manufacture of metric tons of generic APIs.
Our streamlined IND data collection and submission strategy, based on our decades of experience, helps accelerate your filing process without sacrificing quality.
We offer comprehensive analytical testing services to provide the data you need for critical early-phase drug development decisions. At our state-of-the-art facilities, Cambrex experts ensure regulatory compliance and the highest standards for safety and efficacy.
Our development experts specialize in using creative problem-solving to handle early-phase challenges while maintaining validation rigor to avoid late-stage process changes. This helps you advance more rapidly to late-stage manufacturing.
With decades of experience and broad capabilities, our flexible manufacturing and packaging solutions can support changing demands to meet your late-phase clinical trial needs.
Our facilities in Whippany, NJ, USA, and Mirabel, Québec, Canada, are equipped to produce the late-stage clinical trial supply of drug products you need, when you need them. We offer a wide variety of sterile and non-sterile packaging solutions for a range of dosage forms.
By offering a comprehensive suite of analytical testing services, we can support your late-phase development and ensure your clinical trial materials meet the highest standards for safety and quality.
At Cambrex, our experts specialize in API manufacturing and scale-up from preclinical to commercial phases. We offer extensive manufacturing capabilities, streamlined technology transfer, and consistent support across all sites.
Our facilities are designed to be flexible so we can meet your commercial manufacturing needs, ranging from small-scale for orphan drugs to large-scale commercial production.
Although every technology transfer process is different, our experts apply their skills and knowledge to make the transition to commercial manufacturing as smooth as possible.
Cambrex is a leading global supplier of generic APIs with sites in Italy, Sweden, and the US. We collaborate with generic drug firms before patent expiration and offer comprehensive services and manufacturing capabilities.
Our global manufacturing facilities reliably supply high-quality advanced pharmaceutical intermediates and raw starting materials. We maintain a large catalog of APIs and have a proven track record for meeting cGMP standards.
Our scientists specialize in making connections. Start a conversation today and see what it’s like to work with a collaborative CDMO.