The core difference between pharmaceutical intermediates and active pharmaceutical ingredients (APIs) is: intermediates are intermediate products in the synthesis process of APIs and require further processing; APIs are active ingredients that can be directly formulated and require drug production licenses and quality certification.

　　Differences in Definition and Function

　　Pharmaceutical Intermediates:

　　They are transitional chemical products in the API synthesis process that require molecular changes or purification to become APIs.

　　They do not have direct therapeutic effects and may contain unpurified impurities.

　　Active Pharmaceutical Ingredients (API):

　　They are active ingredients with completed synthesis pathways that can be directly used to produce tablets, injections, and other drugs.

　　They have clear pharmacological activity and must meet pharmacopoeia standards (e.g., purity ≥ 99%).

　　Production and Regulatory Requirements

　　Production License:

　　Intermediates can be produced in ordinary chemical plants without a drug production license.

　　APIs must be produced in GMP-certified facilities and legally obtain drug approval numbers.

　　Quality Standards:

　　Intermediate purity is usually above 95% (adjusted according to subsequent reaction requirements).

　　APIs require testing for active ingredient content, impurity limits, microbiological indicators, etc., complying with pharmacopoeia standards of various countries.

　　Industry Characteristics and Applications

　　Intermediates:

　　The market is highly competitive; the core competitiveness of enterprises depends on quality control and cost management.

　　No registration with drug regulatory authorities is required (FDA requires key intermediates to be filed).

　　APIs:

　　Directly determine drug efficacy and require submission of complete pharmaceutical data to regulatory agencies (such as NMPA, FDA).

　　The production process must comply with international drug production quality management standards such as ICH Q7.