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.
05.14.2013
East Rutherford, NJ – Cambrex Corporation (NYSE: CBM, “Cambrex”) celebrated the completion of its facility expansion in Cambrex Charles City (Iowa, USA) with a ribbon cutting ceremony for employees and invited guests on Thursday, May 9, 2013. The major facility expansion was completed in just over 10 months from initial ground breaking, employing more than 180 contractors and creating over 60 new positions at Cambrex Charles City.
The state-of-the-art, temperature controlled, 7,000 sq.ft. facility will be used to increase cGMP Active Pharmaceutical Ingredients (API) manufacturing capabilities for both existing products and a new product currently going through the later stages of FDA clinical review that is expected to be commercialized in the near term. The facility expansion adds an additional 40,000 gallons of reactor capacity, which equates to the potential for tens of metric tons of API production on an annual basis.
“We are pleased to be expanding in a competitive global pharmaceutical landscape. It’s been a labor-intensive and carefully executed project that has led to significant job creation,” said Joe Nettleton, VP of Operations of Cambrex Charles City. The site continues to fill additional positions to meet staffing requirements.
“There is strong demand for flexible large-scale cGMP assets in the U.S., and we believe these assets, combined with our world-class quality systems, provide an ongoing foundation for growth,” said Shawn Cavanagh, Chief Operation Officer of Cambrex. “We are extremely pleased to have the facility completed so quickly. This is a testament to the level of determination, talent and leadership we have at Cambrex Charles City.”
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