📘 Difference Between API and Finished Dosage Forms
📘 Difference Between API and Finished Dosage Forms A Deep, Insightful Guide for Pharmaceutical Professionals In the world of pharmaceuticals, two terms are used constantly: API and Finished Dosage Form (FDF) . At first glance they might seem similar — both are part of medicine manufacturing — but their roles, complexity, regulatory significance, and impact on patient outcomes are fundamentally different. Understanding this distinction is essential for anyone involved in pharmaceutical quality, manufacturing, regulatory affairs, or supply chain operations. 🧬 What Is an API (Active Pharmaceutical Ingredient)? 📌 The Active Pharmaceutical Ingredient (API) is the biologically active substance in a medicine that produces the intended therapeutic effect. The API is: The main chemical or biological molecule that fights disease or alters biological function. The reason the medicine works. Manufactured with precision to meet extremely high ...