API, or Active Pharmaceutical Ingredient, is a substance intended to be used in the manufacture of a drug product and that, when used in the production of a drug, becomes an active ingredient in the drug product. As defined by the FDA (Food and Drug Administration), an API is "the part of any drug that produces its intended effects". In other words, an API is the biologically active component of a drug that is responsible for its therapeutic effect.
API manufacturers must comply with FDA's current Good Manufacturing Practice (cGMP) regulations and they need to submit certain information to FDA as part of their drug applications, such as information on the API's identity, purity, quality, strength, and composition. The FDA also evaluates the safety and efficacy of an API, through the drug application process and inspections of the API manufacturing facilities.
FDA also plays an important role in ensuring the quality and integrity of the API supply chain. This includes promoting transparency, traceability, and security of the API manufacturing process, with the goal of preventing the entry of counterfeit, adulterated, or substandard API into the drug supply chain.
In summary, API (Active Pharmaceutical Ingredient) is a substance that is intended to be used in the manufacture of a drug product, which when used in the production of a drug becomes the active ingredient in the drug product. API is defined by FDA as the part of any drug that produces its intended effects, and API manufacturers must comply with FDA's cGMP regulations and FDA evaluate their safety and efficacy. The FDA also plays an important role in ensuring the quality and integrity of the API supply chain, promoting transparency, traceability, and security of the API manufacturing process.
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