The revised draft guidance from the US Food and Drug Administration (FDA) on drug master files (DMFs) deals with submissions on confidential information about facilities, manufacturing, processing, ...
WILMINGTON, Del.--(BUSINESS WIRE)--Noramco, LLC, a leading North American producer of controlled substance bulk Active Pharmaceutical Ingredients (APIs) for the pharmaceutical industry, today ...
The US Food and Drug Administration (FDA) has released new draft guidance on how it assesses the completeness of drug master files submitted to it under generic drug applications, aiming to streamline ...
FDA acceptance enables pharmaceutical development partners to directly reference NorthStar no-carrier-added (n.c.a.) Ac-225 DMF in IND and NDA submissions NorthStar’s regulatory and cGMP manufacturing ...
HUNTSVILLE, Ala., March 10, 2026 (GLOBE NEWSWIRE) -- Gannet BioChem, a leading life sciences manufacturing company, today announced that it has filed a Type II Drug Master File under its Arab, AL ...
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