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.
Stick packs offer several advantages for patients, including convenience and portability, and allow easy pediatric dosing in a powder that can be mixed with food or beverages to improve compliance, reduce confusion and decrease risk. They are also attractive solutions for pharmaceutical manufacturing because they eliminate the need for encapsulation and tableting processes, simplifying packaging.
Still, stick packs present unique challenges. Protecting product integrity in stick packs is one of the greatest concerns. Specialized equipment and processes are required to ensure that the product is formed, filled, and sealed in an environment with carefully controlled temperature, humidity and residual oxygen. A CDMO should be able to accommodate a range of foil capabilities, dosing solutions and opening features. It should also be able to offer comprehensive support throughout the entire product life cycle, from pre-formulation to manufacturing.
Cambrex supports customers with dedicated stick pack manufacturing operations at our drug product facility in Whippany, NJ. Our state-of-the-art technology and equipment can handle common stick pack solutions as we strive to meet the highest standards for quality and regulatory compliance. Plus, when you partner with Cambrex, you gain access to a high level of expertise. Our experts work closely with you from pharmaceutical development and registration to commercial manufacturing. We are with you every step of the way to help you bring your drug product to market as efficiently as possible.
We love challenges, and we would like to learn more about yours. Contact us to learn more about our capabilities for manufacturing stick packs and other specialized dosage forms.