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 Drug Substance services are designed to help you advance your API with confidence, from early process development to commercial readiness. We have a stellar team of chemists and process engineers, a unique, science-led project management approach and a network of tightly coordinated sites to oversee all of your API development and manufacturing needs. Our greatest strength is the ability to take especially challenging processes — either because of safety issues, poor yields, or scalability concerns — and make them commercially viable.
The investigational new drug (IND) application is a major milestone in the life of your drug. Before submitting an IND application, you must develop — often in a fit-for-purpose manner — your medicinal chemistry process route so that it’s ready for larger-scale manufacturing. This involves accounting for all impurities and reducing steps that are impractical for scale-up in terms of timing and cost. Cambrex can help you meet strict regulatory requirements while balancing speed to filing.
Cambrex has the expertise, flexibility and resources to deliver your custom small molecule API development projects on time, within budget and to the highest quality standards. We provide a full range of pharmaceutical custom development services, from IND support and pre-clinical to Phase III clinical trials and technology transfer for commercial supply. You can count on our development experts to support your products at every stage of the development lifecycle.
Every pharmaceutical manufacturing process is unique. We listen to understand your challenges before identifying solutions to meet your custom manufacturing needs. Throughout the process, we remain relentlessly focused on delivering superior results every time. Customers appreciate our uncompromising commitment to cGMP standards and proven compliance track record, which mitigate risk as you scale up for commercial manufacture.
At Cambrex, we work with generic drug companies well in advance of drug patent expiration, offering a robust library of APIs, commercial-scale cGMP manufacturing and strong regulatory performance with agencies around the world. It’s this approach, combined with our teams in Italy, Sweden and the US, that makes us a leading global supplier of generic APIs.
At Cambrex, we offer a tried and trusted approach to technology transfer — for scale-up, second source supply or when transitioning to a different facility. We combine deep expertise and unrivaled agility to offer a seamless, streamlined technology transfer process for your API with full and consistent support across all phases.
Our number-one priority is to develop a robust process that will eventually bring your API to market safely, effectively and as quickly as possible. Often this work requires the use of innovative science and cutting-edge tools, techniques and processes. We offer a deep bench of experienced scientists and a range of specialized technologies to solve even your most demanding API manufacturing challenges.
Our streamlined IND data collection and submission strategy, based on our decades of experience, helps accelerate your filing process without sacrificing quality.
We offer comprehensive analytical testing services to provide the data you need for critical early-phase drug development decisions. At our state-of-the-art facilities, Cambrex experts ensure regulatory compliance and the highest standards for safety and efficacy.
Our development experts specialize in using creative problem-solving to handle early-phase challenges while maintaining validation rigor to avoid late-stage process changes. This helps you advance more rapidly to late-stage manufacturing.
With decades of experience and broad capabilities, our flexible manufacturing and packaging solutions can support changing demands to meet your late-phase clinical trial needs.
Our facilities in Whippany, NJ, USA, and Mirabel, Québec, Canada, are equipped to produce the late-stage clinical trial supply of drug products you need, when you need them. We offer a wide variety of sterile and non-sterile packaging solutions for a range of dosage forms.
By offering a comprehensive suite of analytical testing services, we can support your late-phase development and ensure your clinical trial materials meet the highest standards for safety and quality.
At Cambrex, our experts specialize in API manufacturing and scale-up from preclinical to commercial phases. We offer extensive manufacturing capabilities, streamlined technology transfer, and consistent support across all sites.
Our facilities are designed to be flexible so we can meet your commercial manufacturing needs, ranging from small-scale for orphan drugs to large-scale commercial production.
Although every technology transfer process is different, our experts apply their skills and knowledge to make the transition to commercial manufacturing as smooth as possible.
Cambrex is a leading global supplier of generic APIs with sites in Italy, Sweden, and the US. We collaborate with generic drug firms before patent expiration and offer comprehensive services and manufacturing capabilities.
Our global manufacturing facilities reliably supply high-quality advanced pharmaceutical intermediates and raw starting materials. We maintain a large catalog of APIs and have a proven track record for meeting cGMP standards.
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.
For drug developers commercializing orphan drugs, the search to find small-scale commercial partners presents a unique challenge – one that we are prepared to solve for you.
Our scientists specialize in making connections. Start a conversation today and see what it’s like to work with a collaborative CDMO.
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