Filing of "X" Injection: Module 3 ANDA Submission

Abstract

Generic drug applications are termed “abbreviated’’ as they did not require preclinical and clinical data to establish the safety and efficacy of the drug product. This thesis mainly deals with the filing of the drug product through ANDA. This thesis mainly focuses on the Quality Module or Chemistry Manufacturing and Control Section (Module 3) of the generic drug submission. The Quality Module serves as a backbone in any of the regulatory submissions for the marketing authorization of drugs. One of the major reasons for refusal to receive / file issued by the USFDA is due to the deficiency of the data in the Chemistry, Manufacturing and Control (CMC) section. So, it is mandatory to properly review and then submit the documents to the regulatory authorities. As one of the major pharmaceutical markets in the world is the United States of America (USA), its review process is very stringent and the pharmaceutical industry should follow the requirements for the commercialization of the drug product in the USA