Gannet BioChem Files Type II Drug Master File for mPEG Propionaldehyde 20K to Support Pegfilgrastim Biosimilars

Gannet BioChem, a leading life sciences manufacturing company, today announced that it has filed a Type II Drug Master File under its Arab, AL facility (FEI 3006223361) for its PEG propionaldehyde 20K ...
JD Supra

Another step forward in digital health: FDA issues draft guidance for drug master files (DMFs) for electronics and software components of combination products regulated ...

On Monday, the FDA published the draft guidance, “Type V DMFs for CDER-Led Combination Products Using Device Constituent Parts With Electronics or Software,” which could facilitate drug manufacturers’ ...
Nasdaq

FDA Formally Accepts PharmaCyte Biotech’s Drug Master File for Company’s Pancreatic Cancer Therapy

LAGUNA HILLS, Calif.--(BUSINESS WIRE)-- PharmaCyte Biotech, Inc. (OTCQB: PMCB), a biotechnology company focused on developing cellular therapies for cancer and diabetes using its signature live-cell ...
Business Wire

Noramco Announces Submission of Drug Master File for Lisdexamfetamine Dimesylate ─ Active Pharmaceutical Ingredient

WILMINGTON, Del.--(BUSINESS WIRE)--Noramco, LLC, a leading North American producer of controlled substance bulk Active Pharmaceutical Ingredients (APIs) for the pharmaceutical industry, today ...
Nasdaq

PharmaCyte Biotech Announces Submission of Drug Master File to FDA for Company’s Pancreatic Cancer Therapy

LAGUNA HILLS, Calif.--(BUSINESS WIRE)-- PharmaCyte Biotech, Inc. (OTCQB: PMCB), a biotechnology company focused on developing cellular therapies for cancer and diabetes using its signature live-cell ...