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”) is pleased to announce that it has initiated the second significant expansion of its Charles City, Iowa facility in less than three years. Strong continued growth in demand for the Company’s active pharmaceutical ingredient (API) contract manufacturing capabilities is driving the need for more capacity. The Company expects to invest between $45 and $50 million during 2015, including a state of the art cGMP production facility and related supporting infrastructure. This project is expected to be completed in early 2016 and is designed to allow Cambrex to quickly and efficiently further expand cGMP capacity, as future growth requires.
The new manufacturing facility will initially add a total of 70 cubic meters of glass lined and hastelloy reactors ranging in size from 7m3 to 16m3 along with 6m2 hastelloy filter dryers to provide a flexible, multi-purpose configuration. The facility will be designed to the highest regulatory and safety standards, capable of handling potent APIs at an OEL down to 1µg/m3 and will significantly increase the Company’s cGMP manufacturing capabilities. The facility is also expandable with the ability to add additional capacity on a short timeline. The capacity is being added along with 45,000 square feet of new fully cGMP, temperature and humidity controlled warehouse space.
Joe Nettleton, VP of Operations of Cambrex Charles City said, “We are pleased to be expanding again so quickly in this competitive global pharmaceutical landscape. The need for increased API capacity comes on the back of strong market demand and high capacity utilization of our current large scale assets. There is high demand for US-based suppliers with large scale cGMP contract manufacturing capacity and world-class quality systems, and we have demonstrated that we are quite capable of meeting that demand.”
Shawn Cavanagh, Chief Operating Officer of Cambrex agreed, “In recent years, we have seen significantly stronger demand for the assets and capabilities that our Charles City facility has. We believe this expansion, combined with a very talented and experienced team, provides an ongoing foundation for our customers’ small molecule product manufacturing needs and supports our goal of bringing our customers’ products to market quickly.”