The main differences between API and pharmaceutical intermediates can be summarized as follows:
Definition: APIs are the active substances in pharmaceutical products, directly interacting with the body for therapeutic effects. Pharmaceutical intermediates are synthesized compounds used during API production at different stages.
Function: APIs have direct therapeutic function, treating medical conditions. In contrast, pharmaceutical intermediates facilitate API synthesis as building blocks or precursors without direct therapeutic function.
Use and Application: APIs are final products used in pharmaceutical formulations for patient use, providing therapeutic effects. Pharmaceutical intermediates are used solely in API manufacturing and not administered to patients directly.
Regulatory Approval: APIs undergo rigorous testing and regulatory approval for quality, safety, and efficacy in pharmaceutical products. In contrast, pharmaceutical intermediates have fewer regulatory requirements as they are used within the manufacturing process.
Chemical Structure and Complexity: APIs are fully formed compounds that produce therapeutic effects, while pharmaceutical intermediates are partially formed compounds undergoing further modifications.