Our capabilities and expertise include pre-formulation and clinical supply, tech transfer, process and pharmaceutical product development, formulation development, scale-up and validation, analytical method development, commercial manufacturing and packaging. Find out more about our drug product expertise below.
Cambrex handles complex oral solid dosage forms, topicals and oral liquids with ease and specialize in controlled substances, pediatric dosage and modified release dosage forms.
In fulfilling all aspects of the CMC dosage form section of the NDA, our laboratories, pilot facilities and experts arewith you at every stage of the development process. We take products through excipient iterations, pre-formulation and formulation activities, through to the manufacture of clinical trial materials to exacting standards. Our integrated analytical services provide the method development and validation support you need for your registration package – flexibly, efficiently and with an excellent EMEA, HPFBI and FDA inspection record.
Many of our clinical stage customers start in Phase I and progress through Phase III and beyond, as Cambrex has the ability to manufacture all the way through commercialization to simplify the regulatory path.
Our experts can manufacture clinical supplies as small as 1kg for oral solid dosage forms with a variety of unit operation equipment such as wet granulation, dry granulation, fluid bed technology, including the use of solvents, encapsulation, tablet compression and film coating. We also support stick pack filling – tablets and granules – for pediatric trials, liquid/suspension clinical supplies and Powder in Bottle (PiB) dosage forms.
With specialized teams and full service EMEA, HPFBI, FDA and DEA (CI-CV) approved facilities, Cambrex is equipped for manufacturing excellence to the highest standards of product quality and regulatory compliance.
Both of our drug product sites have a variety of equipment and a high likelihood of completing the transfer in a train of equipment that is like-for-like of existing SUPAC category or sub category equipment. Should a supply chain need changing to manufacture an existing product, our experts can manage all aspects of the technology transfer process – seamlessly.
Cambrex offers final packaging for solid, liquid, and semi-solid, non-sterile and sterile dosage forms – customer-ready or in custom forms. Primary packaging is conducted in enclosed rooms isolated by air pressure differential from secondary packaging operations. Units of sale are serialized per current regulations. From blister packs and child resistant closures, to blister hospital unit dose and physician samples, we specialize in every shape and form
Solid state science
Understanding the physical properties of an active pharmaceutical ingredient (API) is integral to obtaining a developable solid form. By discovering the most suitable form, API stability, solubility, bioavailability and processability may be improved and solid form risks mitigated. As a world leader in solid form screening studies, Cambrex delivers unrivalled solid form work programs designed to identify the most suitable form of active pharmaceutical ingredients for further development.
We offer material characterization to measure and determine the properties of materials. Analysis of materials often extends beyond chromatographic or infrared techniques. That’s why our team at Cambrex have the expertise to evaluate materials using a variety of techniques. Characterization of materials is performed using Polarizing Light Miscroscopy (PLM), Differential Scanning Calorimetry (DSC), Thermogravimetric Analysis (TGA), Laser Particle Size (LPS), and X-Ray Powder Diffraction (XRPD).
Our drug product expertise
At Cambrex we leverage our finished dosage expertise to bring your product through the development, regulatory, and manufacturing process to ensure they are available for the patients who need them.
Our expertise spans many dosage forms, including the following:
- Complex oral solids
- Pediatric dosage forms
- Fixed-dose combinations
- Oral solutions & suspensions
- Controlled substances
We’re happy to help, get in touch
Don’t hesitate to get in touch if you require more information about our drug product services. Our experts are always available to help.