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 – Cambrex Corporation (NYSE: CBM, “Cambrex”), a leading provider of products and services to the life sciences industry, is celebrating 30 years of service and operations. With production sites in the US, Europe and India, and sales throughout the world, Cambrex specializes in the development and manufacture of small molecule Active Pharmaceutical Ingredients (APIs) and intermediates to support the clinical and commercial needs of the pharmaceutical and biotechnology industries.
Founded in 1981 by Cyril C. Baldwin, Jr. and Arthur Mendolia, the Company began operations as CasChem, manufacturing specialty and fine chemicals for niche market segments. The Company changed its name to Cambrex Corporation in 1987.
In 1991, Cambrex entered the life sciences and pharmaceutical industries with the acquisition of Salsbury Chemicals, now Cambrex Charles City, specialists in the manufacture of intermediates and APIs for the pharmaceutical industry. Cambrex significantly expanded its operations internationally in 1994, with the acquisition of Nobel Chemicals AB in Karlskoga, Sweden, and Profarmaco S.r.l. in Milan, Italy, now Cambrex Karlskoga and Cambrex Profarmaco Milano, respectively, both leaders in the manufacture of generic and branded APIs and intermediates.
Cambrex continues to actively invest to strengthen its life sciences offerings. With the 2008 acquisition of Estonia-based Prosyntest, Cambrex added a group of world class R&D chemists to their already strong custom development group. In 2010, Cambrex acquired IEP GmbH in Wiesbaden, Germany, a leader in biocatalytic transformations, to broaden its existing enzymatic biocatalysis capabilities. Most recently, Cambrex acquired a 51% share in Zenara Pharma, a Hyderabad, India-based pharmaceutical company focused on final dosage form products and Nicotine Replacement Therapies (NRT).
“We are extremely proud to celebrate Cambrex’s 30 years of success and reputation as a world leader in providing products and services for small molecule therapeutics,” said Cambrex President and CEO, Steven M. Klosk, “Moving forward, we remain committed to meeting our customers’ needs for quality, reliability and innovation.”