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  • What is the difference between an intermediate and an API?
    Nov 08, 2018

    From the perspective of new drug development, the drug substance is a compound that can be safely used in the human body for therapeutic diagnosis after sufficient pharmaceutical research; and the intermediate is a compound in the process of synthesizing a drug substance, which does not necessarily have therapeutic effects or toxicity. Note that what I said is not necessarily the case. Some intermediates in the synthesis of APIs are also APIs. From the perspective of pharmacy management, the drug substance should be applied to the drug regulatory authority (in the case of China, the State Food and Drug Administration, the FDA in the United States, and the EMEA in Europe), and obtain the approval number in the GMP-compliant factory. Intermediate synthesis; and the intermediate is only an intermediate product in the process of synthesizing the bulk drug, and no need to obtain the symbol. It should be noted that the same compound as the drug substance is not obtained as a drug substance or is not produced in a GMP plant. From the perspective of new drug development, the drug substance is a compound that can be safely used in the human body for therapeutic diagnosis after sufficient pharmaceutical research; and the intermediate is a compound in the process of synthesizing a drug substance, which does not necessarily have therapeutic effects or toxicity. Note that what I said is not necessarily the case. Some intermediates in the synthesis of APIs are also APIs. 


    From the perspective of pharmacy management, the drug substance should be applied to the drug regulatory authority (in the case of China, the State Food and Drug Administration, the FDA in the United States, and the EMEA in Europe), and obtain the approval number in the GMP-compliant factory. Intermediate synthesis; and the intermediate is only an intermediate product in the process of synthesizing the bulk drug, and no need to obtain the symbol. It should be noted that the same compound as the drug substance is not obtained as a drug substance or is not produced in a GMP plant.