Drug Master File (DMF) holders provide a hazard assessment for impurity classification to comply with International Council for Harmonisation (ICH) M7 (R2) Assessment and Control of DNA Reactive ...

VANCOUVER, British Columbia--(BUSINESS WIRE)--STEMCELL Technologies announced it has filed a Type II Drug Master File (DMF) to the Food and Drug Administration (FDA) for the Cellular Therapy Ancillary ...

With the evolution of pharmaceutical industry over the past decades, compliance remains a key factor in bringing novel drugs to market. Proregulations, as a product safety and regulatory consulting ...

Deerfield, Illinois, Feb. 27, 2025 (GLOBE NEWSWIRE) -- DEERFIELD, IL. February 27, 2025 – Vantage Specialty Chemicals, Inc., (Vantage) today announced that its VYCERIN™ API Glycerin, USP is listed on ...

NEWARK, Del.--(BUSINESS WIRE)--ANP Technologies, Inc. (ANP) announced that its drug master file (DMF) on its novel, nano-encapsulating polymer-based drug excipient, ANP001B has been accepted and ...

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 ...

Athens, Georgia--(Newsfile Corp. - September 10, 2024) - Purisys LLC, a leading supplier of active pharmaceutical ingredients (APIs), contract development and manufacturing (CDMO) services, and ...

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 ...

BURNABY, British Columbia, April 01, 2025 (GLOBE NEWSWIRE) -- Telix ARTMS, Inc. (ARTMS), a global leader in radioisotope production technologies, is pleased to announce that the drug master file (DMF) ...

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 ...