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.
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.
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.
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.
Over the last decade, the FDA’s initiative to improve product safety through principles of Quality by Design (QbD) has spurred a transformation in manufacturing processes. The concept of using a control strategy to ensure product quality was originally devised to increase consumer safety, but following these guidelines also offers benefits to drug producers. The application of QbD methods to process design yields better understanding of each step in product synthesis. With a complete picture of the parameters that control each step during manufacturing, chemists can monitor and control individual reactions to optimize the overall production process. A robust GMP manufacturing process can pay dividends in both time and cost efficiency, all while aligning the process to fulfil regulatory filing requirements.
In part one of our case study, learn how Cambrex applies exceptional analytical methods to ensure that quality of the end product is designed at the front end of the process. Our combination of our world-class facilities and the experience of our pharma-trained scientists gives us a competitive edge in demonstrating complete control of a manufacturing process during regulatory filing.
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Cambrex and Q1 Scientific’s stability storage and sample management capabilities serve the Pharmaceutical, Medical Device and Life Sciences industries, with locations across North America and Europe. We offer long-term storage and analysis of reference standards to ensure a consistent, high-quality supply for your needs.
Extractables and leachables (“E&L”) studies are an essential component of regulatory filing to demonstrate product safety. Depending on the container-closure system or medical device being evaluated, E&L studies can be very complex. Choosing a CDMO with expertise is critical to successful delivery of robust E&L data that you can trust.
Rigorous, effective analytical testing is key in the drug development lifecycle. Because this testing is used to verify control of drug chemistry, it can help identify barriers that prevent movement to the next phase in the development process. That’s why it’s critical to have efficient, accurate and high-quality analytical support for your testing requirements.