The issuer is solely responsible for the content of this announcement. Berlin, 3 March 2023. Eckert & Ziegler (ISIN DE0005659700, SDAX) has successfully submitted a Type II Drug Master File (DMF) with ...

The guidance document discusses the preparation and submitting of drug master files as well as FDA’s review process. FDA announced the publication of draft guidance on drug master files on October 18, ...

DUBLIN--(BUSINESS WIRE)--The "6-Hour Virtual Seminar on The Use of Drug Master Files & Quality Agreements: Understanding and Meeting your Regulatory and Processing Responsibilities" webinar has been ...

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) ...

On July 9, 2012, the Generic Drug User Fee Act (GDUFA) was passed by the US Congress. The Act, to be implemented from Oct. 1, 2012, is designed to streamline the generic-drug review process and has ...

This webinar will cover a step-by-step process to construct and submit the European Drug Master File (EDMF), recordkeeping requirements and manufacturer responsibilities.

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 ...

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

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 ...

St. Louis, MO, June 09, 2020 (GLOBE NEWSWIRE) -- Curium announced today that it has filed the first stand-alone Drug Master File (DMF) with the U.S. Food and Drug Administration (FDA) and has also ...

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 ...

VANCOUVER, British Columbia--(BUSINESS WIRE)--STEMCELL Technologies announced it has filed a Type II Drug Master File (DMF) to the Food and Drug Administration (FDA) for the Cellular Therapy Ancillary ...