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Serving leading biopharmaceutical companies globally:

Teva
Medtronic
McKesson
AstraZeneca
Covington
Fish and Richardson
McKinsey
Cipla
UBS
US Department of Justice

Generated: October 23, 2017

DrugPatentWatch Database Preview

Drug Master Files for: tacrolimus

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DMF No. Status Type Submission Date Holder Subject
11137III10/13/1994KLINGE PHARMA GMBHMANUFACTURING SITE, FACILITIES, PERSONNEL AND GENERAL OPERATING PROCEDURES FOR FK506 (TACROLIMUS) OINTMENT FOR CLINICAL SAMPLES IN MUNCHEN, GERMANY
16833AII9/12/2003ASTELLAS PHARMA INCTACROLIMUS (FK506) DRUG SUBSTANCE
18442AII6/21/2005BIOCON LTDTACROLIMUS USP
18908AII10/24/2005CONCORD BIOTECH LTDTACROLIMUS USP
18985AII11/28/2005CHUNGHWA CHEMICAL SYNTHESIS AND BIOTECH CO LTDTACROLIMUS
19072III12/22/2005ZHEJIANG HISUN PHARMACEUTICAL CO LTDTACROLIMUS (NON-STERILE A PHARMACEUTICAL INGREDIENT)
19979AII11/20/2006LEK PHARMACEUTICALS DDTACROLIMUS
20390III3/26/2007HANGZHOU HUADONG MEDICINE GROUP BIOTECHNOLOGY INSTITUTE CO LTDTACROLIMUS
21332AII2/12/2008DR REDDYS LABORATORIES LTDDILUTED TACROLIMUS 20%
21808III7/16/2008CHEMWERTH INCTACROLIMUS, NON-STERILE, BULK DRUG SUBSTANCE
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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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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 leading biopharmaceutical companies globally:

Express Scripts
AstraZeneca
Johnson and Johnson
Accenture
Fish and Richardson
Queensland Health
Boehringer Ingelheim
Citi
Cerilliant
Cantor Fitzgerald

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