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.
01.16.2018
East Rutherford, NJ – January 16, 2018 – Cambrex Corporation (NYSE: CBM), the leading manufacturer of small molecule innovator and generic Active Pharmaceutical Ingredients (APIs), today held an opening ceremony with AstraZeneca, at its Karlskoga, Sweden site to mark the commencement of a long-term manufacturing agreement between the two companies for a key intermediate.
The announcement follows the completion, in 2017, of both a large-scale, multi-purpose capacity expansion which also includes hydrogenation capabilities and a dedicated continuous flow production unit capable of producing multiple metric tons of high purity advanced intermediates per annum at the Karlskoga facility.
Speaking at the ceremony, Juliette White, VP Global External Sourcing, AstraZeneca, commented, “Cambrex was selected as our manufacturing partner on this long-term intermediate supply agreement as they clearly demonstrated a robust technically and commercially attractive solution, as well as having a good track record in terms of performance and delivery.” She added “We look forward to a successful collaboration with Cambrex.”
Shawn Cavanagh, COO of Cambrex, stated, “We have an excellent relationship with AstraZeneca dating back to the 1950s and are excited to partner with them on the long-term production of several important products.” He added, “We will continue to invest in capabilities, technology and appropriate capacity at the Karlskoga site in line with AstraZeneca’s ambitious targets and on-going customer demand.”
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.
Cambrex’s Karlskoga, site develops and manufactures small molecule APIs, new chemical entities (NCEs) and intermediates from grams to tons, through all phases of the drug lifecycle.
Home to a team of more than 400 employees, the site is comprised of a combination of GMP and non-GMP work, providing classic and advanced chemistry capabilities, continuous processes and high energy chemistry expertise.
The site also features a wide range of flexible manufacturing facilities including kilo scale, pilot scale and large scale commercial production plants.
For more information, please visit www.cambrex.com
AstraZeneca is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of diseases in three therapy areas – Oncology, Cardiovascular & Metabolic Diseases and Respiratory. The Company also is selectively active in the areas of autoimmunity, neuroscience and infection. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide.
For more information, please visit www.astrazeneca.com and follow us on Twitter @AstraZeneca.