A finished dosage form (FDF) is the final, fully manufactured medicinal product that contains the drug substance and all required excipients, and is processed into a specific delivery format, such as a tablet, capsule, injection, suspension, or topical preparation.
At this stage, the product has completed all necessary manufacturing and processing steps, including formulation, blending, sterilization or granulation (as applicable), filling, packaging, and labelling, and is suitable for patient use without further modification. Although FDF and drug product (DP) are synonymous for regulatory purposes, DP is the preferred term in scientific and regulatory documents, as it emphasises the entity as a legally approved medicine. In contrast, FDF is more commonly used in pharmaceutical manufacturing and in discussions of the commercial supply chain.
FDFs are defined in regulatory guidance from agencies such as the FDA and EMA, which require that they meet established quality, safety, and performance specifications before approval. Unlike the drug substance or active pharmaceutical ingredient (API), which provides the pharmacologically active component, the FDF determines how the API is delivered, absorbed, and administered in practice.