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.
07.12.2016
East Rutherford, NJ – July 12, 2016 – Cambrex Corporation (NYSE: CBM, “Cambrex”), the leading manufacturer of small molecule innovator and generic Active Pharmaceutical Ingredients (APIs), today announced the completion and validation of a $50 million state-of-the-art production and warehousing expansion at its cGMP Charles City, Iowa site. The investment in capacity and capabilities was made in reflection of strong market demand for small molecule APIs and high utilization of Cambrex’s existing large scale assets.
The new 7,500 sq. ft. multi-purpose manufacturing facility will initially add a total of 70m3 of glass lined and Hastelloy reactors ranging in size from 7m3 to 16m3, along with 6m2 Hastelloy agitated filter dryers to provide a flexible, multi-purpose configuration, and will be capable of handling potent APIs at an Occupational Exposure Limit (OEL) of down to 1μg/m3. The facility complements the three existing large scale manufacturing facilities at the Charles City site.
The 36,000 sq. ft. cGMP warehouse provides general cGMP storage for 2,720 pallets and segregated 2-8°C refrigerated storage for 360 pallet spaces and features Distributed Control System monitoring and control for temperature and humidity. The facility employs a barcode system for automated bin location and has a dedicated sampling room with appropriate extraction and handling for flammable materials.
Additionally, a further 7,500 sq. ft. manufacturing shell has been constructed which will be fitted out to customer specification.
“There is high demand for US based suppliers with large scale cGMP contract manufacturing capacity and world class quality systems,” commented Steve Klosk, CEO of Cambrex. He added, “We have invested over $125 million at the Charles City site since we acquired it in 1991 and believe that this expansion, combined with a very talented and experienced team, provides an ongoing foundation for our customers’ small molecule product manufacturing needs while supporting our goal of bringing our customers’ products to market quickly.”
Cambrex’s Charles City, Iowa facility sits on a 45-acre site and manufactures a wide range of APIs and pharmaceutical intermediates, including highly potent molecules and controlled substances. The facility is one of a limited number authorized by the US DEA to import narcotic raw materials at commercial scale.