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.
This Policy also describes how we collect, use, disclose, store, and otherwise process information through our Website, and how that information may be used or disclosed by us.
This Policy does not apply to information we collect through any other means, or to information collected on any third-party site or by any third-party application that may link to or be accessible from the Website.
The Company complies with the General Data Protection Regulation (GDPR) as set forth by the European Parliament. GDPR mandates that We protect the personal data and privacy of individuals within the EU and EEA. If there is any conflict between the policies in this Policy and the GDPR, the GDPR shall govern.
Please read the following carefully to understand our policies and practices regarding your personal information and how we will treat it. By using or accessing our Website, you agree to this Policy. This Policy may change from time to time and your continued use of the Website is deemed to be acceptance of such changes, so please check the Policy periodically for updates.
We collect several types of information from and about users of our Website, including:
Usage Details and IP Addresses – As you navigate through the Website, we may also collect details of your visits to our Website, including, but not limited to, traffic data, location data, logs and other communication data, and the resources that you access, as well as information about your computer and internet connection, including your IP address, operating system and browser type, for system administration and to report aggregate information as needed. This is statistical data about our users’ equipment, browsing actions and patterns, and does not identify any individual.
Web Beacons – Pages of the Website may contain electronic images known as web beacons (also referred to as single-pixel gifs) that permit the Company to count users who have visited those pages and for other related website statistics (for example, recording the popularity of certain website content and verifying system and server integrity). Web beacons are not used to access your personal information on the Website and are only used to compile aggregated statistics concerning use of the Website.
We may use information that we collect about you or that you provide to us, including any personal information, in the following ways:
We are an international business, and at times may need to transfer your information within the Company or to third parties in connection with the purposes set forth in this Policy. We may disclose personal information that you provide via this Website to the following third parties:
Consultants, contractors and service providers we use to support our business
In the event of merger, acquisition, or any form of sale of some or all of Cambrex’s assets, in which case personal information held by Cambrex about its customers will be among the assets transferred to the buyer.
We may also disclose your personal information to third parties to:
We have implemented measures designed to secure your personal information from accidental loss and from unauthorized access, use, alteration and disclosure. All information you provide to us is stored on our secure servers behind firewalls.
Unfortunately, the transmission of information via the internet is not completely secure. Although we do our best to protect your personal information, we cannot guarantee the security of your personal information transmitted to our Website. Any transmission of personal information is at your own risk, and to the fullest extent permitted by law, we will not be responsible for any damages or liabilities relating to any such instances. In case of such a data breach, we will notify you of any loss, misuse or alteration of personal information affecting you.
Except as otherwise permitted or required by applicable law or regulation, We will only will retain your information for legitimate business purposes, for as long as is reasonably necessary to fulfill the purposes for which we collected it, as required to satisfy any legal, accounting, or reporting obligations, or as necessary to resolve any dispute or enforce our agreements or any other legal right. To determine the appropriate retention period, we consider our legal obligations, the amount, nature, and sensitivity of the information, the reasons for retaining the information, and whether we can achieve these purposes by other means. Any information that is no longer needed is securely destroyed.
All persons with whom we interact may request additional information about how we collect, use, disclose, store, and otherwise process information by writing to us at firstname.lastname@example.org.
You should review this Policy carefully, because if you do not agree with our practices, your ultimate choice is not to use the Website. Remember, by using any part of the Website, you accept and agree to our privacy practices.
We welcome your comments and questions regarding this Policy. If you have any questions about this Policy, please contact us at email@example.com.
We love challenges, and we would like to learn more about yours. Contact us to discuss your project.