Business Wire

ANP’s Polymeric Drug Excipient Drug Master File (DMF) Accepted and Published by the U.S. Food and Drug Administration (FDA)

NEWARK, Del.--(BUSINESS WIRE)--ANP Technologies, Inc. (ANP) announced that its drug master file (DMF) on its novel, nano-encapsulating polymer-based drug excipient, ANP001B has been accepted and ...
Morningstar

Akadeum Life Sciences Announces Drug Master File Submission to the US FDA for GMP Microbubble Cell Separation

Akadeum has been successfully customer-audited per US and EU GMP standards, and the products meet endotoxin, sterility, and viral requirements per USP and ICH standards. As expected for raw materials ...
Nasdaq

BWXT Medical Submits Drug Master File for Actinium-225 API to U.S. Food and Drug Administration

OTTAWA, Ontario--(BUSINESS WIRE)-- BWXT Medical Ltd. has submitted a Drug Master File (DMF) to the U.S. Drug and Food Administration (FDA) for No Carrier Added (n.c.a.) Actinium-225 (Ac-225) Active ...
JD Supra

FDA Issues a Final Rule on Biologics License Applications, Investigational New Drug Applications and Master Files

On February 12, the FDA issued a final rule regarding the use of Drug Master Files (“DMF”) in Biologics License Applications. DMFs are submissions to the FDA “used to provide confidential, detailed ...