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Active Pharmaceutical Ingredient

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Active pharmaceutical ingredients (APIs) are part of any drug that produces the desired effect. Some drugs, such as combination therapy, have a variety of active ingredients that can treat different symptoms or work in different ways.

All drugs consist of two core components: the API (which is the main component) and the excipient (a substance other than the drug that helps deliver the drug to the system). An excipient is a chemically inert substance, such as lactose or mineral oil in a pill.

Manufacturers use certain criteria to determine the strength of the API in each drug. However, standards vary widely from brand to brand. Each brand may use a different test method, which may result in different effects.

In all cases, the FDA requires manufacturers to demonstrate the effectiveness of their products in real life and under laboratory conditions.

The quality of the API has a significant impact on the efficacy of the drug (producing the desired results) and the safety of the drug. Poor-quality APIs or mismanufactured products have been linked to serious problems, such as illness or death.

Even in the case of outsourcing, APIs are subject to strict regulations and supervision from their shipping countries. For example, API plants overseas are still subject to inspection by the U.S. Food and Drug Administration.

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