Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Serving hundreds of leading biopharmaceutical companies globally:

Chinese Patent Office
Daiichi Sankyo
Farmers Insurance
US Department of Justice
Cipla
Johnson and Johnson

Generated: July 22, 2019

DrugPatentWatch Database Preview

Drug Master Files for: TACROLIMUS

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TACROLIMUS Drug Master Files

DMF No. Status Type Submission Date Holder Subject
11137 I II 10/13/1994 KLINGE PHARMA GMBH MANUFACTURING SITE, FACILITIES, PERSONNEL AND GENERAL OPERATING PROCEDURES FOR FK506 (TACROLIMUS) OINTMENT FOR CLINICAL SAMPLES IN MUNCHEN, GERMANY
16833 A II 9/12/2003 ASTELLAS PHARMA INC TACROLIMUS (FK506) DRUG SUBSTANCE
18442 A II 6/21/2005 BIOCON LTD TACROLIMUS USP
18908 A II 10/24/2005 CONCORD BIOTECH LTD TACROLIMUS USP
DMF No. Status Type Submission Date Holder Subject

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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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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Serving hundreds of leading biopharmaceutical companies globally:

QuintilesIMS
Farmers Insurance
Fuji
Johnson and Johnson
Colorcon
Argus Health

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