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.
Scaling up liquid formulations can present a number of challenges related to mixing, solubility, viscosity and filtration. With complex solutions, suspensions and emulsions, these issues can become even more magnified as the liquid formulation transitions from feasibility to commercialization.
At Cambrex, our technicians are here to address your unique manufacturing and packaging challenges as you advance your liquid product to market efficiently and confidently. With fully integrated pharmaceutical development and liquid manufacturing services for oral solutions and suspensions, including pediatric liquid dose forms, we work with you to help you meet your goals.
As our development facilities are co-located within our commercial manufacturing operations, we can seamlessly transition from pre-formulation and formulation development throughout clinical studies and into commercial manufacturing.
Our liquids expertise is supported by in-house quality and microbiology labs, robust quality systems and a team of highly skilled technicians to support your manufacturing needs. We currently supply liquid dosage forms commercially to the US, Canada and throughout Europe.
Our manufacturing capabilities cover a wide variety of technologies:
We can help with all monophasic and biphasic formulations, including complex solutions, suspensions and emulsions:
Our liquid packaging lines are versatile enough to accommodate a wide range of formulations:
Our liquid, cream, and ointment (LCO) capabilities cover a wide variety of manufacturing and packaging technologies from small- to large-scale dosage forms.
Looking for a partner that balances passion with painstaking attention to detail? Speak to one of our experts about how we can help you succeed.
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