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.
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 offers extensive development services tailored to meet your drug product needs in early development. From pre-formulation to Phase II, we ensure your products are developed with speed, flexibility, and quality in mind.
Whether you need rapid development, flexible manufacturing solutions, or high-quality production, Cambrex is your trusted partner for advancing your drug product from concept to the clinic.
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.
12.16.2013
East Rutherford, NJ – Cambrex Corporation (NYSE: CBM, “Cambrex”) announced that the US Food and Drug Administration (FDA) completed an inspection of Cambrex’s active pharmaceutical ingredient (API) manufacturing facility in Charles City, Iowa. The inspection found the site to be compliant with the principles and guidelines of Good Manufacturing Practice (GMP) and no Form 483 observations were issued. The US FDA authorities inspected the facility from July 31 to August 2, 2013.
Joe Nettleton, Vice President Operations and Charles City Site Director commented, “We are very pleased with the results of this latest FDA inspection, which further strengthens our track record of outstanding regulatory compliance. We commit significant resources and work diligently to maintain high quality standards and continuously improve quality platforms within Cambrex.”
The entire facility and the quality systems used for the manufacture and release of APIs and food grade products were subject to a detailed compliance inspection. This follows successful inspections at Charles City made previously by the US FDA in March 2010 and February 2012, neither of which resulted in any issued 483 observations, the Korean FDA in January 2012 and the Medicines and Healthcare Products Regulatory Agency (MHRA) of the UK October 2011, after which a GMP certificate for a drug product intermediate was issued.