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.
Biopharma companies at all stages of development rely on our expertise and broad capabilities to produce the clinical trial drug product supply they need, when they need them. Many of our clinical stage customers start with us in Phase I and progress through Phase III and beyond, as Cambrex provides agile end-to-end clinical supply manufacturing services through commercialization, simplifying the regulatory path for our customers.
Count on Cambrex for:
Our experts and facilities are equipped to manufacture clinical supplies as small as 1 kg for oral solid dosage forms with a variety of technologies, including:
Dedicated Formulation Support
Our formulation experts are your technical resource during every step of your clinical development program. This close partnership and support ensure you receive the best possible advice based on scientific and technical guidance. From the bench to our pilot plant, up to production-size equipment, a designated formulator stays committed to your project to ensure continuity and that the knowledge gained through development is maintained for registration and commercial launch.
Throughout clinical development, we support all your analytical development programs. Our analytical laboratories are equipped with both UPLC and HPLC capabilities, as well as a full range of dissolution equipment. We also provide analytical method validation services for Phase I through commercial. Our stability services cover the entire range of ICH conditions, as well as specialized conditions.
From solids to liquids to creams and ointments, our facilities in Whippany, NJ and Mirabel, Québec are equipped to meet your clinical study’s unique packaging requirements. We offer a wide variety of sterile and non-sterile packaging solutions for a range of dosage forms.
We love challenges, and we would like to learn more about yours. Contact us with your clinical trial supply questions or problems.
Thank you for subscribing up to our newsletter.