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.
East Rutherford, NJ – August 8, 2017 – Cambrex Corporation (NYSE: CBM), the leading manufacturer of small molecule innovator and generic Active Pharmaceutical Ingredients (APIs), today announced that it is to invest $24 million in a new facility to manufacture highly potent APIs (HPAPIs) at its Charles City, Iowa plant.
The 4,500 sq. ft. production area will operate to an occupational exposure limit (OEL) down to 0.1µg/m3 and have a total reactor capacity of 2,200 gallons, which will be made up from a range of 200, 500 and 1,000 gallon glass and Hastelloy vessels to manufacture batches from 50 to 300kg.
The project will also reconfigure the existing small scale manufacturing area providing a single high containment building to support early stage development and manufacturing, providing flexibility across a broad range of scale. Construction and installation of all new equipment is expected to be completed by Q1 2019.
“This expansion is in line with Cambrex’s commitment to ongoing investment in small molecule manufacturing, as well as responding to the rising number of APIs that require specialized handling due to potency and toxicity,” commented Shawn Cavanagh, COO of Cambrex. He added, “Cambrex has built a strong reputation in the clinical-scale supply of potent, and extremely potent molecules, and the flexibility that this facility will give allows us to effectively handle projects throughout their development and commercial life-cycle.”
This latest expansion is part of an ongoing strategic campaign to invest in small molecule API development and manufacturing across Cambrex’s global network of facilities, and follows the opening of a $50 million, 7,500 sq. ft. multi-purpose manufacturing facility at Charles City in 2016, which added a total of 70m3 of manufacturing capacity to the site.
Cambrex’s Charles City, Iowa facility is located on a 45-acre site and manufactures a wide range of APIs and pharmaceutical intermediates, including highly potent molecules and controlled substances. The facility is one of a limited number authorized by the US DEA to import narcotic raw materials at commercial scale.
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
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