ANDA Dossier Filing in US Market for "X" Drug

Abstract

The availability of generic medication is an important issue in the regions like USA at low cost. This thesis deals with the registration process of generic medicinal products in the USA. The thesis focuses on chemical active ingredient, X administered as solid oral dosage forms i.e Tablet of strength 60 mg and 80 mg packed in HDPE bottle. The time frame under examination is from submission until approval of the generic product, including a presubmission period for the ANDA dossier submission. The dossier is prepared as per ICH eCTD format which includes 5 modules. Module 1 includes administrative information which is different for different country. Module 2 contain summary, in FDA quality over all summary is on Question Based Review. Module 3 contains information about drug product, drug substance and regional information. Module 4 is not applicable as animal studies are not performed. Module 5 contains clinical data to prove bio equivalence as per RLD. The dossier prepared is submitted through eCTD using software which compile, validate and review it. It is forward to FDA either CD or electronic submission gateway. The FDA ESG is the central transmission point for sending information electronically to the FDA. Within that context, the FDA ESG is a conduit along which submissions travel to reach their final destination. It does not open or review submissions; it automatically routes them to the proper FDA Center or Office. FDA review the dossier in different section in CDER .If dossier is complete, FDA give substantial approval to market the drug in US market otherwise give refuse to receive letter.