C-Ray Therapeutics Receives FDA Acceptance of Type II Drug Master File for Copper-64 (Cu-64)

Co., Ltd., today announced that its Type II Drug Master File (DMF) for COPPER [64Cu] CHLORIDE FOR RADIOLABELLING has been listed as active by the U.S. Food and Drug Administration (FDA) under DMF No.
RAPS

FDA Drafts Guidance on Type V DMFs for Combination Products

The US Food and Drug Administration (FDA) on Monday issued draft guidance detailing when a Type V drug master file (DMF) can be used to provide information about Center for Drug Evaluation and ...
La Grande Observer

GeminiBio Submits Drug Master File (DMF) to FDA

WEST SACRAMENTO, Calif., March 13, 2025 /PRNewswire/ — Gemini Bioproducts, LLC (“GeminiBio”), a biopharma and advanced therapy raw materials supplier, and a portfolio company of BelHealth Investment ...
Nasdaq

MediPharm Labs Enters United States Pharmaceutical Market with Submission of FDA DMF

DMFs are regulatory submissions filed with the FDA containing confidential, detailed information about manufacturing, processes, packaging, and stability of APIs to be used in medicinal products for ...

NorthStar Secures FDA Acceptance of Drug Master File for No-Carrier-Added Actinium-225

NorthStar Medical Radioisotopes, LLC (NorthStar), a leading radiopharmaceutical company, today announced that it received notice of the U.S. Food & Drug Administration’s (FDA) acceptance of its Type ...
Business Insider

FDA Accepts GMP Plasmid DMF of OBiO Technology

SHANGHAI, Jan. 16, 2023 /PRNewswire/ -- OBiO Technology (Shanghai) Corp., Ltd. ('OBiO', 688238.SH), a gene and cell therapy-focused contract research organization (CRO) and contract development and ...
RAPS

GDUFA IV: Negotiations address DMFs, internal consultations, imminent actions

Officials from the US Food and Drug Administration (FDA) and representatives from the generic drug industry met on 19 February as part of the negotiations for the fourth iteration of the Generic Drug ...