Drug Master Files for: PIMECROLIMUS

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PIMECROLIMUS Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
29390	A	II	9/30/2015	BIOCON LTD	PIMECROLIMUS
29433	A	II	5/28/2015	BRIGHTGENE BIOMEDICAL TECHNOLOGY CO LTD	PIMECROLIMUS INTERMEDIATE ASCOMYCIN
29658	A	II	9/15/2015	CONCORD BIOTECH LTD	PIMECROLIMUS
30090	A	II	12/30/2015	BRIGHTGENE BIOMEDICAL TECHNOLOGY CO LTD	PIMECROLIMUS (NON-STERILE, API)
32348	A	II	12/14/2017	EUTICALS SPA	PIMECROLIMUS
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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