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On Monday, the FDA published the draft guidance, “Type V DMFs for CDER-Led Combination Products Using Device Constituent Parts With Electronics or Software,” which could facilitate drug manufacturers’ ...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