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.
10.03.2016
East Rutherford, NJ – 3rd October, 2016 – Cambrex Corporation (NYSE: CBM) the leading manufacturer of small molecule innovator and generic Active Pharmaceutical Ingredients (APIs), today announced the validation and ISO certification of a new pilot plant at its state-of-the-art manufacturing and R&D site in Paullo (MI), Italy.
The cGMP plant, which can produce batch sizes from 1kg to 15kg, was constructed in order to meet customer demand for small-scale API volumes, both for validation to support a DMF filing for Abbreviated New Drug Applications or generic registrations, and for API supply to niche markets, including ophthalmic drugs. The new facility will also provide custom manufacturing of NCEs and intermediates for early stage drug development and clinical trials.
“We currently have a product portfolio comprising over 70 generic APIs, which are manufactured under cGMP, for the global generic pharmaceutical industry,” commented Aldo Magnini, Managing Director, Cambrex Milan. “We have invested in the pilot plant to expand our small-scale volume offering for customers worldwide and to give us greater speed, flexibility and capacity in this market space.”
The new facility is equipped with a hydrogenator that can operate at 30 Bar and two separate lines of 150 liter glass lined and stainless steel reactors. ISO 8 classified, the plant is also equipped with a static dryer, milling and micronization capabilities.
Cambrex plans a further upgrade of the pilot plant in 2017 to support production of Class 3/4 high potency products.