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.
2620 Trade Centre Ave Longmont, CO 80503, USA
Tel: +1 866-459-4600 Fax: +1 303-772-2856
Our Longmont location specializes in the early development of small molecule pharmaceutical products in a fully integrated drug substance and drug product facility. We offer development and manufacturing services to enable IND submissions. Frequently working on molecules right out of discovery, we have process chemistry expertise to design and develop synthetic routes for scale-up into two non-GMP production suites with a capacity of up to 200 L. Four cGMP drug substance production suites with capacity up to 200 L are available to produce drug substance to support clinical trials. Drug product pre-formulation and formulation development is performed on the bench or within our walk-in, non-GMP manufacturing hood. Four fully cGMP compliant drug product manufacturing suites with unidirectional personnel/material flow and supplied by single pass air are available for clinical trial manufacturing and packaging. Dosage forms include powder in capsule, powder in bottle, formulated capsule, and formulated tablet with associated packaging and labeling.
Our site is also equipped to handle potent compounds up to SafeBridge 3A for both drug substances and drug products. The facility also has a research license for the handling of controlled substances.
In addition, we offer both comprehensive analytical support for product development projects as well as standalone analytical services to our clients. This includes method development, validation, and cGMP/non-GMP testing and stability. We are proud to offer a fully equipped materials characterization lab capable of providing testing of elemental impurities by ICP-MS, XRPD, particle size, LC/MS/MS, DSC, TGA, and TGA-GCMS.
For our Longmont site’s registration certifications see our forms and certifications.
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