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 – May 26, 2021 – Cambrex today announced the completion of an investment project at its facility in Tallinn, Estonia to upgrade its kilogram-scale laboratory to undertake the manufacture of pharmaceutical intermediates under current good manufacturing practice (CGMP) conditions.
The project includes the installation of a new 160-liter reactor train in the laboratory which will expand the site’s capabilities to manufacture material for clinical trials and allow early phase projects to be developed further at the site prior to tech transfer and scale up. Building work and installation of the new reactor and supporting equipment is now complete, and preparation for GMP qualification is underway.
The facility also houses 150-liter glass and stainless-steel reactors, which will continue to offer kilogram-scale manufacturing of materials for pre-clinical toxicological study applications.
“Our team of experts in Tallinn work closely with the Cambrex manufacturing site at Karlskoga in Sweden, and this expansion will accelerate the progression and tech transfer of projects within the early clinical development phases,” commented Joe Nettleton, President of Cambrex’s Drug Substance Business Unit. He added, “Cambrex has a commitment to investing in the capacity, capabilities and expertise within our global network of facilities, to reinforce our position as a market-leading CDMO in small molecule development, and ensure we can serve the needs of the growing market.
The site in Tallinn provides custom organic synthesis and contract research, analytical and development services, working on process development and scale-up synthesis to kilogram quantities. The facility is located adjacent to Tallinn University of Technology’s campus, allowing for strong collaborative links with the University’s analytical and chemistry departments.
In 2019, Cambrex was acquired by funds advised by Permira, a global investment firm, to continue to build upon Cambrex’s market leading position in API development and manufacturing and support the growth of its end-to-end integrated service offerings across the pharmaceutical value chain.
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 40 years’ experience and a growing team of over 2,100 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.
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