Drug Master Files for: RUFINAMIDE

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RUFINAMIDE Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
25676	A	II	1/4/2012	DIPHARMA FRANCIS SRL	RUFINAMIDE USP
26209	A	II	10/23/2012	GLENMARK PHARMACEUTICALS LTD	RUFINAMIDE
26316	A	II	10/9/2012	LUPIN LTD	RUFINAMIDE USP
26385	A	II	9/29/2012	MSN LABORATORIES PRIVATE LTD	RUFINAMIDE USP [ROUTE CODE RU]
28284	I	II	5/9/2014	ZHEJIANG JIUZHOU PHARMACEUTICAL CO LTD	RUFINAMIDE
29034	A	II	3/27/2015	APOTEX PHARMACHEM INC	RUFINAMIDE USP
32713	A	II	4/30/2018	MSN LIFE SCIENCES PRIVATE LTD	RUFINAMIDE USP
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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