PharmaCyte Biotech submits Drug Master File to USFDA for Pancreatic Cancer Therapy

Austrianova's Chief Technical Officer, Walter H. Gunzburg stated, "The DMF filing is a key event for both PharmaCyte and Austrianova since it will provide the basis for many Cell-in-a-Box® products in addition to CypCaps™. The DMF is by its nature a comprehensive document compiled from many months of in-house work and past historical data and was compiled with the support and advice of an external consultant."

A DMF is submitted to the FDA to provide detailed information about facilities, processes and materials used in the manufacturing, processing and packaging of human drugs and biologics. It is a prerequisite to securing approval and commercialization and ensures confidentiality of proprietary information related to the Active Pharmaceutical Ingredient (API). The information contained in a DMF is used to support, among other applications, an IND.

The DMF requirements are complex and specific, encompassing every detail involved with the manufacture of the API – from raw materials to analytical methods, process development and optimization. The scrutiny goes all the way back to the starting materials used in the API.

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