Drug Master Files for: LIRAGLUTIDE

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LIRAGLUTIDE Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
27215	A	II	6/12/2013	AMBIOPHARM INC	LIRAGLUTIDE, NON-STERILE, BULK DRUG SUBSTANCE
28513	I	II	6/23/2014	CHENGDU SHENGNUO BIOPHARM CO LTD	LIRAGLUTIDE
29302	A	II	10/7/2015	CHENGDU SHENGNUO BIOPHARM CO LTD	LIRAGLUTIDE
29711	A	II	9/10/2015	ALP PHARM BEIJING CO LTD	LIRAGLUTIDE
30095	A	II	12/7/2015	HYBIO PHARMACEUTICAL CO LTD	LIRAGLUTIDE NON-STERILE BULK 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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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