We are pleased to announce that our dehumidifying bags "Propasil" in Tyvek have recently been registered with the U.S. agency Food and Drug Administration (FDA) by submitting a Drug Master File (DMF) type III.
What is a Drug Master File?
The Drug Master File is a document submitted to the FDA used to provide confidential and detailed information about structures, processes, or articles used in the production, processing, packaging, and storage of pharmaceutical products for human use.
A Drug Master File type III, specifically, provides essential information for the evaluation of materials used to package pharmaceutical products in order to assess any negative interactions that may adversely affect the integrity of the drug itself.