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.
East Rutherford, NJ – November 14, 2019 (GLOBE NEWSWIRE) — Cambrex Corporation (NYSE: CBM), the leading small molecule company providing drug substance, drug product and analytical services across the entire drug lifecycle, has won the ‘Excellence in Pharma: API Development’ category at the annual CPhI Pharma Awards, which took place at a Gala Dinner at CPhI Worldwide in Frankfurt on November 5th. This marks the third time that Cambrex has won the category in the past 4 years, having previously won in 2016 and 2017. The Company was also judged ‘highly commended’ in the same category in 2018.
The winning entry, for the company’s crystallization screening and process development service, highlighted a peptide crystallization project bridging the gap between the laboratory and manufacturing plant, providing a controlled, robust and scalable crystallization process.
Cambrex’s advanced expertise and innovative approach to peptide crystallization allowed for the delivery of a robust, scalable and transferable process affording effective isolation and batch-to-batch consistency and reducing the cost of the purification and manufacturing process. The development also resulted in a crystalline solid form of the peptide, which showed enhanced physical properties and allowed for improvements to be made in downstream processing.
“We thank the judges and our industry peers for this unprecedented third API Development award,” commented Hayley Reece, Executive Director, Technical Services at Cambrex Edinburgh. She added, “This project was undertaken at our Edinburgh site, which is a world-leader in providing solid form development services for drug substance and drug product and where we recently announced a strategic expansion, to enable us to serve more customers in the solid-state screening and crystallization process development market.”
Established in 2004, the CPhI Pharma Awards are among the most prestigious recognitions within the pharmaceutical industry. The awards celebrate thinkers and creators breaking new ground and strongly advocate companies committed to driving the industry forward.
Cambrex is the leading small molecule company that provides drug substance, drug product and analytical services across the entire drug lifecycle. The company provides customers with an end-to-end partnership for the research, development and manufacture of small molecule therapeutics. With over 35 years’ experience and a growing team of over 2,000 experts servicing global clients from sites in North America and Europe, Cambrex is a trusted partner in branded and generic markets for API and dosage form development and manufacturing.
Cambrex offers a range of specialist drug substance technologies and capabilities including biocatalysis, continuous flow, controlled substances, solid state science, material characterization and highly potent APIs. In addition, Cambrex can support conventional dosage forms including oral solids, semi-solids and liquids and has the expertise to manufacture specialist dosage forms such as modified-release, fixed dose combination, pediatric, bi-layer tablets, stick packs, topicals, controlled substances, sterile and non-sterile ointments.