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Last Updated: December 28, 2025

Drug Master Files for: melphalan hydrochloride

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melphalan hydrochloride Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
20073	A	II	12/20/2006	CHEMPACIFIC CORP	MELPHALAN DRUG SUBSTANCE
20883	A	II	9/24/2007	OLON SPA	MELPHALAN HYDROCHLORIDE
23667	I	II	4/1/2010	XIAN LIBANG PHARMACEUTICAL CO LTD	MELPHALAN HYDROCHLORIDE (NON STERILE BULK DRUG SUBSTANCE)
25040	A	II	7/1/2011	EMCURE PHARMACEUTICALS LTD	MELPHALAN HYDROCHLORIDE
25644	A	II	12/29/2011	CHEMWERTH INC	MELPHALAN HCL, NON-STERILE, BULK DRUG SUBSTANCE
25791	A	II	2/14/2012	FARMABIOS SPA	MELPHALAN HYDROCHLORIDE
27306	A	II	7/10/2013	NERPHARMA SRL	MELPHALAN HYDROCHLORIDE DRUG SUBSTANCE
>DMF No.	>Status	>Type	>Submission Date	>Holder	>Subject

Drug Master File Glossary

STATUS OF DMFS

A = Active. This means that the DMF was found acceptable for filing, administratively, and is up-to-date.
I = Inactive
N = Not an assigned number
P = DMF Pending Filing Review

TYPES OF DMFs

Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)
Type II Drug Substance, Drug Substance Intermediate, and Material Used in Their Preparation, or Drug Product
Type III Packaging Material
Type IV Excipient, Colorant, Flavor, Essence, or Material Used in Their Preparation
Type V FDA Accepted Reference Information

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