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”), a leading life sciences company, announced today that the Board of Directors appointed Steven M. Klosk, President and Chief Executive Officer and a member of the Cambrex Corporation Board of Directors effective May 14, 2008. James A. Mack, President and Chief Executive Officer since 1995 and Chairman since 1999, has announced he will step down. The Company will separate the positions of Board Chairman and CEO and John R. Miller, currently lead director, will assume the position of Non-Executive Chairman of the Board. Mr. Mack will remain a Board member and advisor until his retirement on June 30, 2008.
Mr. Klosk, 51, joined Cambrex in October 1992 as Vice President-Administration. He was appointed Executive Vice President, Administration in October 1996, and was promoted to the position of Executive Vice President and Chief Operating Officer for Cambrex Pharma and BioPharmaceutical Business Unit in October 2003. In January 2005 Mr. Klosk assumed direct responsibility for the BioPharmaceutical Business Unit as Chief Operating Officer. In January 2007 he was appointed Executive Vice President and Chief Operating Officer for the Corporation. He holds a Bachelor of Science degree from Cornell University and a J. D. degree from New York Law School.
“I have enjoyed my many years with Cambrex and now is the right time to turn the Company over to new leadership. I am confident that with his many years with Cambrex, Steve will ably continue the pattern of growth that is so much a part of the Company,” commented Mr. Mack.
“I am excited about the opportunity to lead the Cambrex team as we focus on our growth initiatives in proprietary products and polymeric drug delivery, highly potent compounds, controlled substances and our growing pipeline of new custom development products. In addition, we are well positioned to leverage our recently completed facility near Milan, Italy to support our leading position in generic active pharmaceutical ingredients,” said Mr. Klosk. “I am extremely grateful to Jim for his many years of outstanding service to Cambrex and for his personal mentorship.”