Drug Master File (DMF) - EDMF/ASMF, US DMF
Drug Master File (DMF) is a master document containing complete information on a API. It is known as European Drug Master File (EDMF) or Active Substance Master File (ASMF) and US-Drug Master file (US-DMF) in Europe and United States respectively.
It is a submission to FDA covering factual and complete information on its chemistry, stability,purity,impurity profile,packaging and cGMP status of any API.
The Main Objective of DMF is to meet regulatory requirements and for Market Authorization (MA).
The content and the format for drug master file used in United States differs from that used in European Countries for market authorization (MA).In United States there are 5 types of Drug Master file.
We add value to your product by:
- Consulting on Preparation of European Drug Master Files (EDMF), United States Drug Master File (US-DMF) and for any other country.
- Complete support for preparation of necessary document and registration of products with FDA and answering post submission queries.
- Reformatting DMF to meet requirements of different countries.
We also perform the following:
Structural Elucidation Studies (Elemental Analysis, IR, Mass, NMR C & H, XRD, DSC), Analytical Method Validation, Process Validation and Stability Data for API,Determination & Validation of Potential Impurities & Solvent Impurities (All the data supported by necessary Chromatograms & Spectrums).
Our services are tailored to meet clients requirements, and add value to their company by minimizing both time and money spent.
DMF Resources
- List of products for which we prepared Drug Master File
- CTD DMF Index (Sample)
- List of some of our clients
- Different types of US-DMF
- DCGI India Registration procedure