Nasdaq

BIO-TECHNE ANNOUNCES SUBMISSION OF FDA DRUG MASTER FILE FOR EXCELLERATE GMP IPSC EXPANSION MEDIUM SUPPORTING STEM CELL THERAPY

MINNEAPOLIS, Dec. 20, 2023 /PRNewswire/ -- Bio-Techne Corporation (NASDAQ: TECH) today announced that it has filed a Drug Master File (DMF) with the U.S. Food and Drug Administration (FDA) for its ...
Yahoo Finance

VANTAGE FILES FDA DRUG MASTER FILE FOR VYCERIN™ API GLYCERIN, USP DESIGNED SPECIFICALLY TO MEET PHARMACEUTICAL FORMULATION NEEDS

Deerfield, Illinois, Feb. 27, 2025 (GLOBE NEWSWIRE) -- DEERFIELD, IL. February 27, 2025 – Vantage Specialty Chemicals, Inc., (Vantage) today announced that its VYCERIN™ API Glycerin, USP is listed on ...
Yahoo Finance

Purisys Activates Drug Master File for Nalmefene, Introducing New Solution for Acute Opioid Overdose Treatment

Athens, Georgia--(Newsfile Corp. - September 10, 2024) - Purisys LLC, a leading supplier of active pharmaceutical ingredients (APIs), contract development and manufacturing (CDMO) services, and ...

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 ...
Business Wire

ARTMS Inc. Submits Drug Master File for the First Ever Multi-Curie Production of Gallium-68 with ARTMS’ Solid Target Solution on Medical Cyclotrons

BURNABY, British Columbia--(BUSINESS WIRE)--ARTMS Inc. (ARTMS) is pleased to announce the submission of a Drug Master File (DMF) to the FDA for the high-volume production of Gallium-68 (68 Ga) with ...
MarketWatch

Carrington Labs unit files drug master file with FDA

SAN FRANCISCO (MarketWatch) -- Carrington Laboratories Inc. said on Tuesday that its subsidiary, DelSite Biotechnologies Inc., has filed a drug master file with the Food and Drug Administration. The ...
Business Wire

FDA has issued Drug Master File for ITM’s Gallium Generator GeGant

GARCHING, Germany & HOUSTON--(BUSINESS WIRE)--ITM Isotopen Technologien München AG (ITM), a biotechnology and radiopharmaceutical group of companies, and RadioMedix Inc., a clinical stage ...
manilatimes

ARTMS Drug Master File for Gallium Production Technology Referenced with Telix's Gozellix®

BURNABY, British Columbia, April 01, 2025 (GLOBE NEWSWIRE) -- Telix ARTMS, Inc. (ARTMS), a global leader in radioisotope production technologies, is pleased to announce that the drug master file (DMF) ...
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 ...
Morningstar

Applied StemCell Announces Drug Master File Submission to the US FDA for their GMP-Grade iPSC Cell Line

Applied StemCell, an advanced therapeutics CRO/CDMO specializing in iPSCs, gene editing, and small animal models, announced today that it has submitted a Type II Drug Master File (DMF) to the U.S.
Royal Society of Chemistry

Drug Master Files (DMFs) - Understanding and Meeting Your Global Regulatory and Processing Responsibilities By compliance2go

This DMFs (Drug Master Files) training will discuss the current review and enforcement climate within FDA and the manner in which drug master files (DMFs) are reviewed by FDA personnel. Besides the US ...
The Bakersfield Californian

VANTAGE FILES FDA DRUG MASTER FILE FOR VYCERIN™ API GLYCERIN, USP DESIGNED SPECIFICALLY TO MEET ...

Deerfield, Illinois, Feb. 27, 2025 (GLOBE NEWSWIRE) -- DEERFIELD, IL. February 27, 2025 – Vantage Specialty Chemicals, Inc., (Vantage) today announced that its VYCERIN™ API Glycerin, USP is listed on ...