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

Comments

Popular posts from this blog

How to Use Shortened URLs Safely

URL shorteners like bit.ly and TinyURL make long web addresses compact and easy to share. However, shortened URLs can also be used for phishing attacks and malware distribution if you don't take precautions. Here are some tips on how to use shortened URLs safely. Check the Full URL Before Clicking Never blindly click on a shortened URL. Many popular URL shorteners have a preview feature to show you the full destination URL: - For bit.ly links, add a "+" to the end of the shortened URL. For example: http://bit.ly/2mXQFlG+ - For TinyURL links, add "preview." before the URL. For example: http://preview.tinyurl.com/yckmx7n8  - You can also use online tools like GetLinkInfo.com to reveal the full URL. Checking the full URL gives you visibility into the actual website you'll be directed to before clicking. Be Wary of Suspicious Short Links Shortened URLs are commonly used for phishing, spam, and malware distribution. Some signs a shortened URL may be suspicious: -