API – Active Pharmaceutical Ingredient

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The U.S. Food and Drug Administration (FDA) is the government agency that regulates marketed drug products and approves marketing of new drug products. The FDA defines a drug product as a finished dosage form (e.g., tablet, capsule, or solution) that contains the drug (called the drug substance or active ingredient) in a particular strength, generally in association with one or more other ingredients. The FDA considers the different strengths and dosage forms of a drug as separate and distinct drug products.

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The process of new drug development and discovery is long, complex, and risky. Typically, it takes an average of 10 years for a drug to make it to pharmacy shelves after its first discovery. The major steps in this discovery, development, and approval process are summarized in the following figure

New Drugs  Developed and Approved  for Marketing

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