Skip to main content

Drug Master File

Drug Master File or DMF is a document prepared by a pharmaceutical manufacturer and submitted solely at its discretion to the appropriate regulatory authority in the intended drug market. There is no regulatory requirement to file a DMF. However, the document provides the regulatory authority with confidential, detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of one or more human drugs.
Drug Master File (DMF) is a document containing complete information on an Active Pharmaceutical Ingredient (API) or finished drug dosage form. 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.
The DMF contains factual and complete information on a drug product's chemistry, manufacture, stability, purity, impurity profile, packaging, and the cGMP status of any human drug product.

Source: Wikipedia


Popular posts from this blog

An Introduction to Spectroscopy Techniques and Their Applications in Analysis

 Spectroscopy is the study of the interaction between matter and electromagnetic radiation. It is a technique used to analyze the composition and structure of matter by examining how light or other electromagnetic radiation is absorbed, emitted, or scattered by that matter. A spectrometer is an instrument used to measure spectra. It can split light into its constituent wavelengths and measure the intensity at each wavelength.  A spectrophotometer is a specific type of spectrometer that measures the intensity of light as a function of wavelength. It can be used to measure the absorption, transmission, or reflection of light. A spectroscope is a simple spectrometer used to observe spectral lines and bands. It usually consists of a prism or diffraction grating to disperse light and view a spectrum. A spectrograph is a spectroscope that can record the spectrum onto a photographic plate or detector. It produces a spectral graph or spectrogram. Spectra refers to the characteristic pattern