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.
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”) announced today that James F. Winschel, Jr., age 64, was appointed to the Company’s Board of Directors for a term expiring on the date of its 2015 annual meeting and will serve on the Board’s Audit Committee and Regulatory Affairs Committee. Mr. Winschel’s appointment maintains the size of the Board at nine members following John Miller’s retirement in April.
Chairman of the Board, Shlomo Yanai, commented, “Jim has enjoyed a distinguished business career and his appointment further strengthens our functional expertise and life sciences experience on the Board. I am confident that he will make significant contributions to our company.”
Following thirteen years as Senior Vice President and Chief Financial Officer of PAREXEL International Corporation (NASDAQ: PRXL), a leading biopharmaceutical services organization providing comprehensive drug development, consulting, medical communications, and technology services and solutions to the biopharmaceutical industry in over 100 countries, Mr. Winschel was named Executive Vice President of PAREXEL in September 2013.
As CFO of PAREXEL, Mr. Winschel was responsible for directing all worldwide financial and related matters. Since joining PAREXEL in June 2000, PAREXEL’s revenue has grown by more than $1.5 billion, backlog has increased by $4.5 billion, and PAREXEL’s market capitalization went from $225 million to $2.8 billion.
Prior to joining PAREXEL, Mr. Winschel served as President of U.B. Vehicle Leasing, Inc., a division of BTM Capital Corporation, a subsidiary of The Bank of Tokyo-Mitsubishi, Ltd. Prior to assuming the presidency of this division, he served as Executive Vice President and CFO of BTM Capital. Previously, Mr. Winschel held leadership positions at Caremark International, Inc., Whirlpool Financial Corporation, and the General Electric Company.