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.
Our specialists and facilities are equipped to take on pediatric dosage forms (PDFs) projects at any size or scale. We offer established pediatric formulation and development expertise and to-scale manufacturing capabilities. Our infrastructure and expertise cover the sweet spot for producing the small-to-medium-sized batches needed to meet market demands for pediatric dosage forms and orphan drugs, and our capabilities extend to large-scale manufacturing.
When a pharmaceutical company partners with Cambrex for pediatric dosage form development, it provides guidance on the patient population and the dosing targets based on age or weight groupings and clinical endpoints. Our formulation scientists and manufacturing teams process this data to identify the best options for reformulating a drug for the targeted pediatric patient population. When the first clinical supplies are available and dose-ranging studies are complete, Cambrex works side-by-side with the customer to establish the final dosage strengths and formulations based on clinical efficacy and safety information obtained from the trials. With in-house formulation scientists and a dedicated development group, we offer pilot and commercial-scale manufacturing in one location to complete projects faster with more reliable turnaround and delivery times.
Not only are there many ways to develop pediatric dosage forms, but there are also multiple ways to package them. Cambrex can package pediatric drugs in various formats optimized for ease of administration. These include various types of bottles for dispensing liquids or suspensions, capsules containing powders that can be opened and poured out into water or apple juice and Cambrex’s unique stick packs for packaging granules, powders, beads or mini tablets, which have been successfully used in several commercially approved PDFs.
Rising demand for pediatric dosage forms requires reformulation and development expertise but also to-scale manufacturing capabilities.
Our flexible approach led to multiple pediatric formulation projects and a collaborative partnership in our client’s ongoing efforts to bring pediatric formulations to market.
Looking for a partner that balances passion with painstaking attention to detail? Speak to one of our pediatric dosage form experts about how we can help you succeed.
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