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Last Updated: April 19, 2024

Drug Master Files for: glatiramer acetate

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glatiramer acetate Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
25855	A	II	3/24/2012	DR REDDYS LABORATORIES LTD	GLATIRAMER ACETATE
26489	A	II	9/27/2012	AMBIOPHARM INC	GLATIRAMER NON-STERILE, BULK DRUG SUBSTANCE
27723	A	II	12/12/2013	CORDEN PHARMA COLORADO INC	GLATIRAMER ACETATE
28989	A	II	12/25/2014	HYBIO PHARMACEUTICAL CO LTD	GLATIRAMER ACETATE, NON-STERILE BULK DRUG SUBSTANCE
33092	A	II	9/12/2018	GLAND PHARMA LTD	GLATIRAMER ACETATE
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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