Drug Master Files: All You Need to Know

• By: Staff Editor
• Date: July 20, 2017

Drug Master Files: All You Need to Know

Drug Master File (DMF) is a package of confidential, proprietary assets, detailing the formulae, processes, materials, test methods, and other information relevant to the manufacture of product used in the composition, packaging, and/or processing of pharmaceuticals and/or biologics. Though there are no regulatory requirements to file a DMF, the benefit of its use is overwhelming. A DMF filing help firms maintain confidentiality of proprietary information and yet ensure compliance with regulatory requirements for disclosure of product details.