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”) announced today that it won the Silver Innovation Award at the 2009 CPhI Event for its Continuous-Flow Microwave-Assisted Organic Synthesis (CFMAOS) technology. The award was accepted by Dr. Jayne E. Muir (Market Research & New Technologies – Europe), who presented the technology to a panel of judges at this important pharmaceutical ingredients exhibition in Madrid, Spain on October 13, 2009.
The CPhI Innovation Awards give companies the chance to showcase the best of their R&D efforts and are widely recognized as premier awards in the field of international pharmaceutical manufacturing. This year had a particularly strong number and quality of entries and the six shortlisted companies spanned a wide range of subjects, from biopolymers to colors and coatings. On accepting the award, Dr. Muir said, “The area of flow chemistry is very exciting at the moment, and we were pleased with the interest and number of questions about the CaMWave(TM) technology following the presentation and throughout CPhI.”
The CF-MAOS technology represents a dual technological breakthrough, allowing both the scale-up of microwave-assisted chemistry and the handling of heterogeneous mixtures in continuous-flow. This new technology will finally bring the benefits of both technologies out of the laboratory and into production. The CaMWave(TM) KiloLAB flow reactor is capable of manufacturing in excess of 20 kilograms of product per day, and larger reactors will generate more than one hundred metric tons of product per year. This versatile technology facilitates faster, cleaner, more reliable reactions, leading to improved productivity and lower manufacturing costs.
If you would like to inquire further about this technology, please contact Dr. Jayne E. Muir at +44 (0)1223 237527 or firstname.lastname@example.org.