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 Snapdragon Chemistry, now part of Cambrex, our chemists specialize in creating custom solutions and technologies to take on your toughest process development and production challenges. This includes expertise in designing and building reactors that enable seamless technology transfer as a process scales up for commercial manufacturing.
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.
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 offers extensive development services tailored to meet your drug product needs in early development. From pre-formulation to Phase II, we ensure your products are developed with speed, flexibility, and quality in mind.
Whether you need rapid development, flexible manufacturing solutions, or high-quality production, Cambrex is your trusted partner for advancing your drug product from concept to the clinic.
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.
11.17.2020
East Rutherford, NJ – November 17, 2020 – Cambrex today announced that it is expanding its mid-scale and large-scale API manufacturing capacity in Charles City, Iowa. The $50+ million investment is designed to meet the continually growing demand for small molecule drug substance development and manufacturing. It will be the sixth major investment that Cambrex has made at the site in the past eight years to support customers in mid-scale, large-scale and highly potent small molecule API manufacturing.
The expansion, which will be operational in early 2022, will add 3 large-scale manufacturing work centers and 1 mid-scale work center to the facility in Iowa, increasing the site’s capacity by 30 percent. When completed, the Charles City site will employ more than 400 people.
“Small molecule manufacturing demand has been growing consistently over recent years, and this investment will enable Cambrex to continue to capitalize on this growth, further strengthening our position as a market-leading CDMO,” commented Joe Nettleton, President of Cambrex’s Drug Substance Business Unit. He added, “This expansion in the U.S. for API manufacturing capacity comes at a time when our customers increasingly require high-quality partners to ensure reliable supply chains within the pharmaceutical sector.”
Cambrex’s Charles City facility is located on a 45-acre site, and as part of the company’s Drug Substance business unit, manufactures a wide range of APIs and pharmaceutical intermediates, including highly potent molecules and controlled substances.
In 2019, Cambrex was acquired by funds advised by Permira, a global investment firm, to continue to build upon Cambrex’s market leading position in API development and manufacturing and support the growth of its integrated service offering across the pharmaceutical value chain.
About Cambrex Cambrex is the leading small molecule company that provides drug substance, drug product, and analytical services across the entire drug lifecycle. The company provides customers with an end-to-end partnership for the research, development, and manufacture of small molecule therapeutics. With over 35 years’ experience and a growing team of over 2,100 experts servicing global clients from sites in North America and Europe, Cambrex is a trusted partner in branded and generic markets for API and dosage form development and manufacturing.
Cambrex offers a range of specialist drug substance technologies and capabilities, including biocatalysis, continuous flow, controlled substances, solid state science, material characterization, and highly potent APIs. Cambrex can also support conventional dosage forms, including oral solids, semi-solids, and liquids, and has the expertise to manufacture specialist dosage forms such as modified-release, fixed-dose combination, pediatric, bi-layer tablets, stick packs, topicals, controlled substances, sterile and non-sterile ointments.