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.
When you partner with Cambrex, you gain fully integrated development, manufacturing and packaging services for liquids, creams and sterile and non-sterile ointments. You also enjoy direct access to our technical experts, who are here to help you advance your drug product successfully.
Our development facilities are co-located within our commercial manufacturing operations, facilitating the seamless transition of your project from pre-formulation and formulation development to clinical and commercial supply. Furthermore, you can rely on support from our in-house quality and microbiology labs, robust quality systems and expert technicians every step of the way.
We are equipped to manufacture and package a wide variety of complex semi-solid and liquid dosage forms in small- to large-scale volumes, including:
Using our state-of-the-art Ekato Unimix vacuum processing mixer equipment, we can offer cGMP batches from 40 L to 150 L, ideal for development and registration batches. With multiple specialized teams and full-service facilities approved by the FDA, EMA, Health Canada and DEA (CI-CV), Cambrex can help you advance your project and make sure it meets the highest standards for product quality and regulatory compliance.
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With fully integrated pharmaceutical development and manufacturing services for liquid dosage forms, including oral solutions and suspensions, Cambrex can help accelerate your liquid product to market.
We are a leading provider of semi-solid dose products. We offer both sterile and non-sterile manufacturing suites, as well as fully scalable suppository filling, with a capacity of 100 million units annually.
Cambrex provides the full range of support and services needed to create topical formulations, both prescription dermatological drugs and over-the-counter products, and produce them at large scale for the global market.
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.