For ANDA registration, which section of CTD format should the batch analyses of the drug product be provided in? Should the analyzed batch be manufactured within 2 years?

刊登日期:2019-11-13  |  點閱次數 : 1095 次 

Batch analyses of the drug product could be provided in 3.2.P.5.4 or 3.2.R.1. According to the current Regulations for Registration of Medicinal Products, the applicant should submit the manufacturing records of any batch produced within 2 years before the date of application, including the corresponding CoAs of the API, excipients and finished product.



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