ABSTRACT
INTRODUCTION Manufacture of the finished product (also known as the drug product) is one topic that will be required to be addressed for all applications for Marketing Authorization Applications (MAAs) whether the application concerned is for a new drug or is abridged (abbreviated). Thus the information will be required for all application types and procedures-New Drug Applications (NDA),AbbreviatedNewDrugApplication (ANDA), full application, or abridged application. The information submitted to regulatory agencies on the method of manufacture of the pharmaceutical product will also need to be kept up to date and will therefore be subject to various types of updating process (which might include variations, supplements and annual reports as applicable in the jurisdiction where the product is licensed).
