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.
Oral solid dosage (OSD) forms account for the majority of pharmaceutical therapies. Despite their ubiquity and proven manufacturing pedigree, OSDs can still present significant challenges. With an increase in complex molecules, it’s critical to provide diverse formulation and OSD solutions.
If you’re searching for a CDMO partner that is completely focused on the success of your OSD project, look no further than Cambrex. Whatever your project size or stage, we welcome your solid dose manufacturing challenges and have the expertise to deliver a wide range of oral solid dosage forms. They include:
Your manufacturing objectives are our priority, and we are equipped to help you meet them. Our development facilities are located alongside our commercial manufacturing setup, allowing seamless transition from pre-formulation and formulation development to clinical supplies and commercial supply. These capabilities are supported by Cambrex’s in-house chemistry and microbiology laboratories, robust quality systems and expert technicians.
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Our experts have extensive experience developing and manufacturing fixed-dose combination drugs, and our facilities have specialized equipment to produce multiple dosage forms and coating options.
Although bi-layer tablets pose unique manufacturing challenges, our experts and facilities are prepared with the experience and infrastructure to help you bring these drug products to market.
Cambrex facilities are fully equipped to support stick pack manufacturing while meeting the highest standards for quality and regulatory compliance and protecting product integrity.
From development through to commercial manufacturing, we support customers bringing mini tablets to market and offer varied coatings and taste-masking excipients.
Cambrex is a leading global contract development and manufacturing organization (CDMO) that provides drug substance, drug product, and analytical services across the entire drug lifecycle.
We love challenges, and we would like to learn more about yours. Contact us to speak with a solid dose manufacturing expert.