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.
01.27.2012
East Rutherford, NJ – Cambrex Corporation (NYSE: CBM, “Cambrex”) is pleased to announce that the development and validation of Sufentanil and Sufentanil Citrate have been completed and beginning in February 2012, Cambrex will begin supplying commercial quantities of each product to the marketplace. Further, Cambrex has the capability to supply micronized Sufentanil Citrate. Cambrex’s Charles City (Iowa) facility validated the production for Sufentanil base and completed the validation production of Sufentanil Citrate in late 2011.
“The development and validation of Sufentanil and Sufentanil Citrate was a natural extension of Cambrex’s high potency and controlled substance manufacturing capabilities at our Charles City facility,” commented Dr. Kurt Kiewel, Director of Chemical Development at Cambrex Charles City. “The process was based on our patented technology which allows straightforward access to all of the Fentanyl derivatives.” Cambrex has been manufacturing Fentanyl for the worldwide pharmaceutical market since 2006.
The process development and validation were performed in the High Potency Development Center at Cambrex Charles City. As Sufentanil has approximately 1000 times the potency of morphine and 5 to 10 times the potency of Fentanyl, containment and isolation were extremely critical for workers’ safety. The High Potency Development Center is a dedicated, controlled-access chemical and analytical lab suite with barrier isolation technology capable of safely manufacturing materials classified as Exposure Control Band (ECB) 4, the most potent materials. Validated cleaning methods were developed to detect very low levels of Sufentanil, ensuring the prevention of cross contamination with other products.
Sufentanil and Sufentanil Citrate meet the specifications of the US and European Pharmacopeias. Cambrex has the capacity to produce the total aggregate quota of Sufentanil and Sufentanil Citrate for the US market. Cambrex has US Drug Enforcement Agency (DEA) licensure for the research, development and manufacture of Schedule I-IV Controlled Substances.