JD Supra

Another step forward in digital health: FDA issues draft guidance for drug master files (DMFs) for electronics and software components of combination products regulated ...

On Monday, the FDA published the draft guidance, “Type V DMFs for CDER-Led Combination Products Using Device Constituent Parts With Electronics or Software,” which could facilitate drug manufacturers’ ...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

GeminiBio Submits Drug Master File (DMF) to FDA

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 ...
Yahoo Finance

Amaran Biotech's Vaccine Adjuvant AB-801 Receives FDA Drug Master File (DMF) Filing Acknowledgement

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 ...
PharmiWeb

Cellbox Solutions Submits Device Master File (DMF) to the U.S. FDA

Submission represents an important step towards establishing the Cellbox Live Shipment Technology as a new standard for warm chain logistic in the cell therapy sector Cellbox customers can now ...
Nasdaq

22nd Century Group (XXII) Announces Filing of U.S. DMF (Drug Master File) for CBD API; New Global Sales, Marketing and Distribution Agreement with Transo-Pharm for Cannabinoid APIs

BUFFALO, N.Y., Jan. 23, 2023 (GLOBE NEWSWIRE) -- 22nd Century Group, Inc. (Nasdaq: XXII), a leading biotechnology company dedicated to improving health with reduced nicotine tobacco, hemp/cannabis and ...