Drug Master Files for: SIROLIMUS

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SIROLIMUS Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
16890	A	II	10/1/2003	CHEMWERTH INC	SIROLIMUS
19813	A	II	9/28/2006	LONZA AG	SIROLIMUS
21037	A	II	11/13/2007	EUTICALS SPA	Sirolimus
21425	I	II	3/8/2008	WORLD JIANGSU INDUSTRY CO LTD	RAPAMYCIN/SIROLIMUS (NON-STERILE, A INGREDIENT)
21571	A	II	4/16/2008	BIOCON LTD	SIROLIMUS DRUG SUBSTANCE
23109	I	II	9/14/2009	HANGZHOU ZHONGMEI HUADONG PHARMACEUTICAL CO LTD	SIROLIMUS
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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