How many batch files of drug products are required for an ANDA?

刊登日期:2019-11-13  |  點閱次數 : 1689 次 

For an ANDA, at least one representative batch file of drug product in pilot scale is required. Also, the representative batch of drug product must be produced within two years before the date of application. Please refer to ICH Q1A for the definition of pilot scale batch. In addition, for imported products, a process validation report including the information on three consecutive batches in commercial scale should be submitted.



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