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.
04.12.2022
East Rutherford, NJ – April 12, 2022 – Cambrex announced today the completion of a $50 million expansion of its large-scale active pharmaceutical ingredient (API) manufacturing capabilities at its Charles City, Iowa facility. The startup of the new manufacturing space is the culmination of a two-year project, originally announced in 2020, to increase the capacity of Cambrex’s flagship API facility by 30%. The expansion positions Cambrex with the largest and most advanced API facility in the United States and ensures the long-term capacity to support Cambrex’s existing customer base and future growth supported by robust market demand.
“The opening of our Charles City facility expansion is a significant milestone for Cambrex, solidifying our position as the leading U.S.-based provider of small molecule APIs,” said Thomas Loewald, CEO of Cambrex. “We continue to see strong demand for high quality, U.S.-based development, and manufacturing of new APIs, and we are excited to offer our existing and potential new customers access to the best-in-class capabilities of our Charles City facility.”
Following the expansion, Cambrex’s Charles City facility has approximately 400 employees and an installed reactor capacity of over 25,000 gallons (approximately 100 cubic meters). With multiple large-scale manufacturing areas, the facility is able to reduce production timelines by manufacturing multiple products with complex chemical syntheses in parallel. The facility is located on a 45-acre property and produces a wide range of APIs and pharmaceutical intermediates, including highly potent molecules and controlled substances.
In addition to its expansion in Iowa, Cambrex continues to invest in additional small- and mid-scale API manufacturing capacity at its Karlskoga, Sweden, and High Point, North Carolina facilities. New capacity at those facilities is expected to come online in late 2022 and mid-2023, respectively.
About Cambrex
Cambrex is a leading global contract development and manufacturing organization (CDMO) that provides drug substance, drug product, and analytical services across the entire drug lifecycle. With over 40 years of experience and a growing team of over 2,200 experts servicing global clients from North America and Europe, Cambrex is a trusted partner in branded and generic markets for API and finished dosage form development and manufacturing.
Cambrex offers a range of specialized drug substance technologies and capabilities, including biocatalysis, continuous flow, controlled substances, solid-state science, material characterization, and highly potent APIs. In addition, Cambrex can support conventional dosage forms, including oral solids, semi-solids, and liquids, and has the expertise to manufacture speciality dosage forms such as modified-release, fixed-dose combination, pediatric, bi-layer tablets, stick packs, topicals, controlled substances, sterile, and non-sterile ointments.