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Last Updated: September 26, 2023

Drug Master Files for: Sun Pharm

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Sun Pharm Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
12133	A	II	9/17/1996	ZHEJIANG HISUN PHARMACEUTICAL CO LTD	LOVASTATIN USP
12207	I	II	11/6/1996	SUN PHARMACEUTICAL INDUSTRIES LTD	RANITIDINE HYDROCHLORIDE USP
12814	I	II	1/6/1998	ZHEJIANG HISUN PHARMACEUTICAL CO LTD	BLEOMYCIN A2 AND B2/COPPER COMPLEX, NON-STERILE BULK DRUG SUBSTANCE
12895	I	II	3/11/1998	SUN PHARMACEUTICAL INDUSTRIES LTD	AMOXICILLIN USP, TRIHYDRATE, (NON-STERILE BULK)
12962	A	II	4/24/1998	ZHEJIANG HISUN PHARMACEUTICAL CO LTD	BLEOMYCIN SULFATE USP
12986	I	II	5/11/1998	ZHEJIANG HISUN PHARMACEUTICAL CO LTD	CLONAZEPAM, 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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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