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.
East Rutherford, NJ – February 08, 2022 – Cambrex, a leading global contract development and manufacturing organization (CDMO), announced today that it has been recognized by the annual CMO (Contract Manufacturing Organization) Leadership Awards in the categories of Quality and Service. This marks the eighth consecutive year Cambrex has been acknowledged with an award.
“Cambrex is honored to be identified once again by our customers and industry peers as a leading supplier to the pharmaceutical industry. To be recognized in the categories of quality and service delivery reflects our technical expertise and our approach to delivering customized solutions focused on our customers’ needs,” said Thomas Loewald, Chief Executive Officer at Cambrex. He added, “Demand for outsourced pharmaceutical development and manufacturing is growing steadily. At Cambrex, we are committed to investing in the capacity, capabilities, and expertise needed to strengthen our position as a leading global CDMO.”
CMO Leadership Awards results are based on primary market research from Industry Standard Research’s Contract Manufacturing Quality Benchmarking annual online surveys. For the 2022 CMO Leadership Awards, 86 CMOs were evaluated on 23 performance metrics. Research participants were recruited from biopharmaceutical companies of all sizes and were screened for decision-making influence and authority when it comes to working with CMOs. Respondents only evaluated companies with which they had worked on an outsourced project within the past 18 months. This level of qualification ensures that ratings come from actual involvement with a business and that companies identified as leaders are backed by experiential data. CMOs must meet the minimum threshold of customer survey responses to be eligible for an award.
“Congratulations to all the Life Science Leader and Outsourced Pharma 2022 CMO Leadership Award winners,” announced Louis Garguilo, Chief Editor and Conference Chair, Outsourced Pharma. “You are the biopharma industry’s top service providers – those who have excelled for your customers through pandemic hurdles, supply-chain challenges, and advancing demands of new platforms and technologies.”
Cambrex recently celebrated the 40th anniversary of its founding in 1981. Following 40 years of growth and transformation into a leading global contract development and manufacturing organization, Cambrex continues its commitment to leadership in pharmaceutical drug substance manufacturing with over $100 million of investments in progress across its global manufacturing network.
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. With over 40 years of experience and a growing team of over 2,200 experts servicing global clients from North America and Europe, Cambrex is a trusted partner in branded and generic markets for API and finished dosage form development and manufacturing.
Cambrex offers a range of specialized drug substance technologies and capabilities, including biocatalysis. Continuous flow, controlled substances, solid-state science, material characterization, and highly potent APIs. In addition, Cambrex can support conventional dosage forms, including oral solids, semi-solids, and liquids, and has the expertise to manufacture specialty dosage forms such as modified-release, fixed-dose combination, pediatric, bi-layer tablets, stick packs, topicals, controlled substances, sterile, and non-sterile ointments.
About the CMO Leadership Awards
Now in its 11th year, Outsourced Pharma and Life Science Leader’s CMO Leadership Awards provide readers with accurate and reliable customer feedback to assist them in choosing a reputable partner for their development and manufacturing needs. For the 2022 CMO Leadership Awards, Industry Standard Research (ISR) determined the award recipients through their evaluation of more than 86 contract manufacturers. These CMOs were assessed by 23 performance metrics in ISR’s annual Contract Manufacturing Quality Benchmarking survey.
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