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Fixed-dose combination: Considerations for design, formulation, manufacturing and analysis

Pharmaceutical Technology

Pharmaceutical companies – and the FDA – are embracing FDCs. Between 2010 and the end of 2015, of the 655 New Drug Applications (NDAs) approved by the FDA, 63 were for FDCs. The potential to extend the patent life and market exclusivity of a company’s APIs is a potent financial incentive. The numbers tell the story.

Dosage 52