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.
When it comes to commercial API manufacturing, not all CDMOs are created equal. Manufacturing capacity is important, but so is the mission of the team working on your project. Are they completely invested in your success? Are they prepared to do whatever it takes to address the challenges that will inevitably arise?
At Cambrex, small molecule API manufacturing — at all phases, from preclinical to commercial — has been our specialty for more than 40 years. With our “expect-the-unexpected” mindset and collaborative approach, we are uniquely qualified to help you deliver a reliable supply of API built on safe and robust processes. This is only enhanced by our uncompromising commitment to cGMP standards and proven compliance track record.
Our extensive commercial API manufacturing capabilities allow us to take your project from development to scale-up and commercial production. Cambrex offers a seamless, streamlined technology transfer process with full and consistent support throughout the manufacturing journey, across all the sites below:
High Point, NC, USA
Support for API development, flow chemistry, and manufacturing of small-scale commercial volumes with capacity up to 2000 L.
Charles City, IA, USA
Support for large-scale API development and commercial manufacturing with capacity up to 16,000 L.
Support for large-scale API development and commercial manufacturing with capacity up to 12,000 L.
Paullo (Milan), Italy
Support for large-scale API development and commercial manufacturing with capacity up to 14,000 L.
Our cGMP commercial-scale capacity totals 964,000 liters / 254,700 gallons.
As more novel therapies and orphan drugs fill the drug development pipeline, small-scale CDMO capabilities have become an increasingly common need for sponsors developing and commercializing new drug entities.
Solid state properties of active pharmaceutical ingredients (API) are a critical attribute of any drug product and significantly impact the drug’s efficacy, safety, and stability. The selection, development and scaling-up of a solid-state form with desirable properties is therefore critical for the success of drug development programs.
Partner with a CDMO who can deliver right-sized solutions for your small-volume program at each stage and grow with you from early development through commercialization.
Looking for a partner that balances passion with painstaking attention to detail. Speak to one of our experts about your commercial API manufacturing challenges.