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.
05.30.2017
East Rutherford, NJ – May 30, 2017 – Cambrex Corporation (NYSE: CBM), the leading manufacturer of small molecule innovator and generic Active Pharmaceutical Ingredients (APIs), today announced that it has expanded large scale manufacturing capacity at its cGMP facility in Karlskoga, Sweden and has introduced additional continuous flow manufacturing for the production of high purity intermediates.
The expansion includes the installation of new multi-purpose reactors ranging from 4m 3 to 12m 3 and upgrading of the control room within an existing plant on site. This extra capacity increases the large scale manufacturing capabilities of the Karlskoga facility, which supports clients’ development projects from R&D through to large scale commercial manufacturing. Installation of all new equipment, including a 9m³ hydrogenation reactor, is expected to be completed by Q3 2017.
In addition to the capacity investment at the Karlskoga site, Cambrex has introduced a dedicated continuous flow production unit, capable of producing multiple metric tons of high purity intermediates per annum.
“The additional capacity at the site, within our current infrastructure, will enable us to service our existing and future customers more efficiently,” commented Bjarne Sandberg, Managing Director, Cambrex Karlskoga. He added, “The continuous flow unit builds on our long experience with continuous flow and high energy chemistry and allows for greater production efficiency and flexibility.”
The expansion at Cambrex’s Swedish site is part of an ongoing strategic campaign to invest in small molecule API manufacturing across its global network of facilities.
Cambrex Corporation is an innovative life sciences company that provides products, services and technologies to accelerate the development and commercialization of small molecule therapeutics. The Company offers Active Pharmaceutical Ingredients (APIs), advanced intermediates and enhanced drug delivery products for branded and generic pharmaceuticals.
Development and manufacturing capabilities include enzymatic biotransformations, high potency APIs, high energy chemical synthesis and controlled substances. For more information, please visit www.cambrex.com