Fixed-Dose Combinations

Fixed-dose combination (FDC) drugs have become increasingly popular, mainly because they enable pharmaceutical companies to repurpose, repackage and expand indications for existing therapeutic agents. They also offer benefits to patients, including improved clinical performance and lower costs. But the promise of FDC drugs brings a number of pitfalls. Manufacturing these complex medicines requires specialized equipment and advanced methods and technologies across the formulation, analytical and manufacturing workflows.

Outsourcing FDC product formulation and manufacturing to an experienced CDMO like Cambrex has several advantages. We have the infrastructure, capital equipment, technology and skilled personnel to get your highly complex fixed-dose combination drugs to the market in a timely, cost-effective manner. You can rely on our expertise to produce safe and effective FDC drugs that have a high probability of regulatory approval. This requires thoughtful product design, state-of-the-art formulation and manufacturing technology and advanced analytical tools.

We have equipment to perform:

  • Wet granulation/roller compaction
  • Extrusion-spheronization
  • Fluid bed technology

We can produce FDC drugs in several oral solid dosage forms and have experience manufacturing multi-API mini tablets, bi-layer tablets and multi-API coated tablets in both IR and ER formulations. Cambrex also offers a variety of polymer-coating options to enable controlled release of the different drug substances in an FDC product. In addition, we have hands-on experience in taste-masking that relies on our novel ion exchange technology.

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