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What is an Active Pharmaceutical Ingredient?According to the World Health Organization (WHO) the definition of an API is established as any substance used in a finished pharmaceutical product (FPP), whose ultimate goal is to develop a pharmacological activity or generate some direct effect in the diagnosis, treatment or prevention of a disease in a patient.

What is the difference between an Active Pharmaceutical Ingredient and a finished pharmaceutical product?

It is relevant to consider that when there is a mixture of an API with an excipient (inactive substance) or with some other API, it will remove the API title for the product and now it will be considered as the first stage of production of a finished pharmaceutical product.

 

 

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