Filing of Irbesartan Tablet 75 MG Module 3 ANDA Submission

Abstract

Generic drug applications are termed ―abbreviated‖ because they are generally not required to include preclinical (animal) and clinical (human) data to establish safety and efficacy. This thesis deals with the filing of generic drug product through ANDA. The thesis focuses on Quality Module (Module 3 or CMC). This Quality Module in the eCTD format serves as the backbone of any regulatory submission, an IND or NDA. One of the main cause of refusal to file/receive actions by the USFDA is due to inadequate Chemistry, Manufacturing and Control (CMC) data. This missing data relates to formulation issue, incomplete stability data and inactive ingredients without supportive data. So it is mandatory to properly review and understand the documents. As the major pharmaceutical market in the world is United States, its reviewal process is stringent and the Indian pharmaceutical company should follow the requirements for commercialization of product in US. As the final submission is accepted by USFDA in only electronic form the quality of submission should be built in long before the data and information are gathered, assembled and submitted to the agency.