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 – Cambrex Corporation (NYSE: CBM, “Cambrex”) is pleased to announce that Cambrex Charles City (Iowa, USA) has furthered its commitment to environmental, health, safety and security excellence by becoming recertified in the ChemStewards® performance improvement program of the Society of Chemical Manufacturers and Affiliates (SOCMA). ChemStewards represents a commitment to improve environmental, health, safety and security (EHS&S) performance for the batch chemical manufacturing industry through a system of reviews and independent audits.
Cambrex Charles City’s recertification to ChemStewards demonstrates a focus and commitment to continuous improvement of regulatory compliance and product management, and further instills confidence and trust in our customers and community. Over the past few years, Cambrex Charles City has expanded on its EHS&S core programs with several continuous improvement directives aimed at coworker training, process hazard analysis and incident investigation programs.
“I continue to be extremely proud of our hard work and dedication to EHS&S programs. This recertification further demonstrates our commitment to continuous improvement to our coworkers, our neighbors in the community and our products,” said Joe Nettleton, Vice President of Operations & Site Director, Cambrex Charles City.
“Recertification of ChemStewards is a major step for Cambrex Charles City’s employees, customers and community,” said Lawrence D. Sloan, SOCMA President and CEO. “Cambrex Charles City has shown a consistent commitment to making their process management system the best it can be. SOCMA’s ChemStewards program is designed to help batch, custom and specialty chemical companies prioritize environmental, health, safety and security improvement. Cambrex Charles City’s successful completion of the program should serve as proof for their customers of their superior performance.”
SOCMA is the only U.S.-based trade association dedicated solely to the batch, custom and specialty chemical industry. SOCMA has a global membership of more than 220 companies. For more information on our services and products, please visit www.socma.com.
ChemStewards is SOCMA’s flagship EHS&S continuous performance improvement program. . As a mandatory requirement for SOCMA members engaged in the manufacturing or handling of chemicals, ChemStewards is helping participants reach for superior EHS&S performance. To learn more visit www.chemstewards.com.