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 – 9 November, 2017 – Cambrex Corporation (NYSE: CBM) the leading manufacturer of small molecule innovator and generic Active Pharmaceutical Ingredients (APIs), has won the ‘API Development’ category at the annual CPhI Pharma Awards, which took place at a Gala Dinner at CPhI Worldwide in Frankfurt on October 24th. This marks the second successive year that Cambrex has been successful in this category.
The winning entry presented a case study which examined an alternative route developed by Cambrex towards the drug ospemifene, used for the treatment of dyspareunia.
The original published synthetic route was a seven-step process which involved multiple purification and recrystallization steps. Cambrex developed a robust, commercially scalable process using standard plant equipment, and needing only two synthetic steps and one recrystallization. Waste was minimized, and the use of solvents dramatically reduced with recycling and reuse where possible.
The resulting, final API is of an extremely high purity, and this, along with a three-fold increase in yield offers a considerable reduction of the cost of goods.
“We are very pleased to have won this prestigious award in two consecutive years, having been recognized for our approach to the synthesis of dronedarone in 2016,” commented Jonathan Knight, Vice President, New Product Development at Cambrex. He added, “We thank our industry peers and editors on the judging panel for acknowledging the innovative approach that Cambrex’s technical team applied in this novel route for the production of ospemifene.”
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 Corporation is an innovative life sciences company that provides products, services and technologies to accelerate the development and commercialization of small molecule therapeutics. The company offers Active Pharmaceutical Ingredients (APIs), advanced intermediates and enhanced drug delivery products for branded and generic pharmaceuticals. Development and manufacturing capabilities include enzymatic biotransformations, high potency APIs, high energy chemical synthesis and controlled substances. For more information, please visit www.cambrex.com
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