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Serving hundreds of leading biopharmaceutical companies globally:

Cerilliant
Mallinckrodt
Colorcon
Dow
Daiichi Sankyo
Accenture
Johnson and Johnson
Deloitte
McKesson

Generated: July 19, 2018

DrugPatentWatch Database Preview

Drug Master Files for: BIVALIRUDIN

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BIVALIRUDIN Drug Master Files

DMF No. Status Type Submission Date Holder Subject
12797 A II 12/22/1997 POLYPEPTIDE SA HIRULOG (BIVALIRUDIN)- A PHARMACEUTICAL INGREDIENT
20853 A II 9/14/2007 AMBIOPHARM INC BIVALIRUDIN, NON-STERILE BULK DRUG SUBSTANCE
20863 A II 9/18/2007 TEVA PHARMACEUTICAL INDUSTRIES LTD BIVALIRUDIN
23656 A II 3/23/2010 DR REDDYS LABORATORIES LTD BIVALIRUDIN
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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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:

Chinese Patent Office
McKesson
Dow
Mallinckrodt
Fuji
Moodys
Fish and Richardson
AstraZeneca
UBS

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