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 Snapdragon Chemistry, now part of Cambrex, our chemists specialize in creating custom solutions and technologies to take on your toughest process development and production challenges. This includes expertise in designing and building reactors that enable seamless technology transfer as a process scales up for commercial manufacturing.
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.
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 offers extensive development services tailored to meet your drug product needs in early development. From pre-formulation to Phase II, we ensure your products are developed with speed, flexibility, and quality in mind.
Whether you need rapid development, flexible manufacturing solutions, or high-quality production, Cambrex is your trusted partner for advancing your drug product from concept to the clinic.
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.
10.02.2023
East Rutherford, NJ – October 2, 2023 – Cambrex today announced the completion of its $38 million capacity expansion at its small molecule active pharmaceutical ingredient (API) manufacturing facility in High Point, North Carolina. This expansion doubles the facility’s manufacturing capacity, with new state-of-the-art analytical and chemical development laboratories, two new clinical manufacturing suites, and a small-scale commercial manufacturing operation with three work centers and 2,000 Liter reactors.
“When we began this project in 2021, our vision extended far beyond capacity,” said Tom Loewald, CEO, Cambrex. “We designed a facility that can continue to deliver on client needs as the industry evolves, with state-of-the-art technology and laboratory equipment, an energy-efficient infrastructure, and clinical to commercial manufacturing scale.”
The High Point capabilities complement those of previously acquired Snapdragon Chemistry, which specializes in R&D for API batch and continuous flow process development. The combination of Snapdragon Chemistry and the expansion in High Point allows clients to utilize one vendor for flow chemistry scale-up from R&D through commercialization.
In addition to the new infrastructure, more than 70 new jobs have been created as Cambrex continues to recruit expert pharmaceutical R&D scientists and staff to the region. Dan Bowles, Vice President and General Manager, Cambrex High Point added, “We are extremely excited about this expansion in North Carolina, which would not have been possible without the support of the State’s leadership and economic development programs, and their focus on nurturing the region’s skilled and diverse workforce.”
Cambrex continues to expand its capabilities and capacity across its North American and European network to meet the growing demand for outsourced product development and manufacturing services.
For a behind-the-scenes preview of the new manufacturing suites, please join our webinar on Thursday, October 5, 2023.
About Cambrex 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 2,400 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, stability storage, 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.