Certificate of Drug Master File (DMF) for Symetal’s lacquered blister foil
In an effort to continuously meet customer requirements, Symetal set out on a project to have its lacquered blister foil products (20 - 30 microns) registered with the U.S. Food and Drug Administration (FDA) under a Drug Master File (DMF) number.
A Drug Master File (DMF) is a submission to the Food and Drug Administration (FDA) that may be used to provide confidential detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of one or more human drugs. The submission of a DMF is not required by law or FDA regulation.
There are five types of DMF's:
- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel
- Type II Drug Substance, Drug Substance Intermediate, and Material Used in Their Preparation, or Drug Product
- Type III Packaging Material
- Type IV Excipient, Colorant, Flavor, Essence, or Material Used in Their Preparation
- Type V FDA Accepted Reference Information
For the purposes of this application, the DMF for our lacquered blister foil (20 - 30 microns) is classified as Type III Packaging Material. In this context, a DMF is a useful mechanism to market our products to the U.S. Drug Industry.
About FDA:
The Food and Drug Administration (FDA) is an agency within the U.S. Department of Health and Human Services. It consists of the Office of the Commissioner and four directorates overseeing the core functions of the agency: Medical Products and Tobacco, Foods and Veterinary Medicine, Global Regulatory Operations and Policy, and Operations. For more information, please visit the website: www.fda.gov.
