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 ...
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 ...
On Monday, the FDA published the draft guidance, “Type V DMFs for CDER-Led Combination Products Using Device Constituent Parts With Electronics or Software,” which could facilitate drug manufacturers’ ...
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 ...
(RTTNews) - Bio-Techne Corp. (TECH) announced Wednesday that it has filed a Drug Master File (DMF) with the U.S. Food and Drug Administration (FDA) for its ExCellerate GMP iPSC Expansion Medium, ...
ANN ARBOR, Mich., Nov. 18, 2025 /PRNewswire/ -- Akadeum Life Sciences, the leader in buoyant cell separation, announced today that it has submitted a Type II Drug Master File (DMF) to the U.S. Food ...
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