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.
Our drug product formulation development experts are passionate about problem-solving and helping customers find the right formulation strategy to advance their products efficiently without sacrificing quality. As we work through this critical phase of your drug’s formulation, we draw on proven skills and a unique approach:
We have the technology and expertise to handle a broad range of complex oral solid dosage forms, topicals and oral liquids. We handle pediatric dosages, DEA controlled substances (schedule I to IV) and complex modified-release formulations, pellets and micro-dose tablets.
Our formulation scientists and analytical chemists will work with you to design and execute all excipient interaction, pre-formulation, formulation, Design of Experiment (DoE) and Quality by Design (QbD) studies to ensure your product meets your clinical objectives and milestones. We aim to accelerate the process of bringing your projects to registration by efficiently and successfully identifying a lead formulation.
We can provide small-scale proof-of-concept prototype batches, manufacture clinical trial materials, perform scale-up manufacturing and registration batch manufacturing and conduct technology transfer and validation services in preparation for commercial manufacturing.
A dedicated project manager will oversee your project’s activities and progress, serving as your primary point of contact from beginning to end.
Our scientists specialize in making connections. Start a conversation today with one of our drug product formulation development experts and see what it’s like to work with a collaborative CDMO.
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