Marketing Authorization Application (MAA) representation for preparation of DMF’s in European for active pharmaceutical ingredient
Journal Title: Indian Journal of Research in Pharmacy and Biotechnology - Year 2014, Vol 2, Issue 6
Abstract
In this type of work a comparative study on marketing authorization application (MAA) representation for Preparation of Drug master files (DMF) in Europe for Active pharmaceutical ingredient (API) was reviewed thoroughly. The MAA representation DMF is required. This document provides the regulatory authority with confidential information regarding facilities, processes in a manufacturing unit. In this work all types in a DMF is included. The work focused on the preparation of DMF’s for API. The dossier required for the CTD also included. The data required for DMF with their serial classes are mentioned. The study on EDMF and the particulars are listed.
Authors and Affiliations
M. Phani Kumar, Rajesh Akki, Munagala Gayatri Ramya, M. V. Nagabhushanam, D. Nagarjuna Reddy
Keywords
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