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 ...
HSINCHU, Dec. 2, 2025 /PRNewswire/ -- Amaran Biotech, a next-generation Contract Development and Manufacturing Organization (CDMO), announced that its self-developed, GMP-grade high-purity vaccine ...
On Monday, the FDA published the draft guidance, “Type V DMFs for CDER-Led Combination Products Using Device Constituent Parts With Electronics or Software,” which could facilitate drug manufacturers’ ...
SEATTLE--(BUSINESS WIRE)--Pluristyx, a leading provider of innovative, unmodified, and gene-edited induced pluripotent stem cell (iPSC) lines, submitted a Type II Drug Master File (DMF) to the U.S.
Indian companies filed 184 Type II DMFs with the US FDA in Q1 2026 against China's 149, reinforcing the country's leadership ...
The author describes several issues in creating drug master files and active substance files for active pharmaceutical ingredients and intermediates. This article covers the submission requirements ...
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