DMFs are regulatory submissions filed with the FDA containing confidential, detailed information about manufacturing, processes, packaging, and stability of APIs to be used in medicinal products for ...
MediPharm Labs Corp. MEDIF LABS MLZ has made its first delivery to the United States, and has completed the US FDA drug API manufacturer inspection at the company's Barrie, Ontario facility. On July ...
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 ...
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 ...
Leading Producer of Controlled Substance APIs Now Supplying Lisdex API to Generic Drug Manufacturers Preparing for the 2023 Patent Expiry of Top-Selling Branded ADHD Therapy WILMINGTON, ...
What not to do with active pharmaceutical ingredient (API) batch records? Tear them out of a company logbook ahead of an FDA inspection, for one. Earlier this month, Indian drugmaker Indiana Chem-Port ...
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