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 – June 2, 2020 – Cambrex, the leading small molecule company providing drug substance, drug product and analytical services across the entire drug lifecycle, today announced that Steven Klosk will retire as Chief Executive Officer and member of the Board of Directors on June 30, 2020, after 28 years with the company. The company’s Board is currently in the advanced stages of a comprehensive search for Mr. Klosk’s successor. In the interim, the company will be led by an Office of the CEO comprised of Wayne Hewett, Chairman of the Board, Robert Green, Executive Vice President and Chief Financial Officer, and Samantha Hanley, Senior Vice President and General Counsel.
“The Cambrex team has been like family to me, and it has been an honor to contribute to the tremendous growth of such a special company,” said Mr. Klosk. “I am so proud of our employees whose technical expertise, dedication and integrity have enabled us to earn and maintain trusted relationships with our global clients at every stage of the drug lifecycle. I am confident the company is on a path towards continued success well into the future.”
Wayne Hewett, Chairman of the Board of Directors, said, “Cambrex’s sterling reputation is due in very large part to Steve and his commitment to making Cambrex the most valuable partner to its global customer base. He has been an outstanding leader whose legacy will have an indelible impact on the company, and the Board is grateful for all his contributions.”
In addition to Mr. Klosk’s retirement, Shawn Cavanagh will step down as President, Chief Operating Officer and member of the Board of Directors, but will take on the new role of strategic advisor to the incoming CEO and Board of Directors for an initial twelve-month period.
“It has been a privilege to work alongside Steve and our 2,100 + employees to make Cambrex the premier CDMO in our space, distinguishing ourselves for our commitment to quality, innovation and end-to-end partnerships with our clients,” said Mr. Cavanagh. “I look forward to working closely with our new CEO and the Board over the coming months to ensure the company is well positioned for this next phase in its journey.”
John Coyle and Henry Minello, members of Cambrex’s Board of Directors and Permira Partners, added, “Shawn’s dedication and passion have been critical to building Cambrex into the company it is today. We are very glad that he is staying on as an advisor in support of a seamless transition and we look forward to continuing to benefit from his insights and expertise. We are highly confident that Cambrex will build on its strong performance thanks to the excellent team Steve and Shawn have built, and won’t miss a beat during this interim period due to the Office of the CEO leadership of Wayne, Robert and Samantha.”
Cambrex is the leading small molecule company that provides drug substance, drug product and analytical services across the entire drug lifecycle. The company provides customers with an end-to-end partnership for the research, development and manufacture of small molecule therapeutics. With over 35 years’ experience and a growing team of over 2,000 experts servicing global clients from sites in North America and Europe, Cambrex is a trusted partner in branded and generic markets for API and dosage form development and manufacturing.
Cambrex offers a range of specialist 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 specialist dosage forms such as modified-release, fixed dose combination, pediatric, bi-layer tablets, stick packs, topicals, controlled substances, sterile and non-sterile ointments.
Permira is a global investment firm. Founded in 1985, the firm advises funds with a total committed capital of approximately US$48bn (€44bn) and makes long-term investments, including majority control investments as well as strategic minority investments, in companies with the objective of transforming their performance and driving sustainable growth. The Permira funds have made over 250 private equity investments in four key sectors: Technology, Consumer, Services, and Healthcare. Permira employs over 250 people in 14 offices across Europe, North America, and Asia.