Fixed-dose combination (FDC) products offer significant advantages for the pharmaceutical industry, including the potential to extend protection of patents and market share, reduce overall manufacturing costs, and add new NDAs to a company’s drug development portfolio with shorter and less costly paths to regulatory approval.
The many advantages of FDC drug products have made them an increasingly attractive option for patients, pharmaceutical companies, physicians, and regulatory agencies. These potential benefits include, but are not limited to, better patient compliance, more convenient dosing associated with improved clinical performance, cost savings for both patients (fewer co-pays) and drug manufacturers (reduced production costs), and extended patent protection and market positioning in the face of competition from generics. These advantages cannot be taken for granted, however. Producing safe and effective FDC products that are also cost-effective and have a high probability of a regulatory approval requires thoughtful product design, access to state-of-the-art formulation and manufacturing technology, and advanced analytical tools.
Explore a recent case study describing specific projects that Cambrex completed for two large pharmaceutical customers demonstrates the broad-ranging technological capabilities and expertise Cambrex can offer.