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 ...
NORTH BILLERICA, Mass.--(BUSINESS WIRE)--Lantheus Holdings, Inc. (NASDAQ: LNTH) (Lantheus), the parent company of Lantheus Medical Imaging, Inc. and Progenics Pharmaceuticals, Inc., and a global ...
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 ...
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.
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 ...
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 ...
WILMINGTON, Del.--(BUSINESS WIRE)--Noramco, LLC, a leading North American producer of controlled substance bulk Active Pharmaceutical Ingredients (APIs) for the pharmaceutical industry, today ...
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