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Generated: November 20, 2018

DrugPatentWatch Database Preview

Drug Master Files for: rifaximin

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rifaximin Drug Master Files

DMF No. Status Type Submission Date Holder Subject
12352 I II 2/6/1997 PHARMACEUTICAL FINE CHEMICALS PFC BAHAMAS LTD RIFAXIMIN
15635 A II 9/20/2001 FIS FABBRICA ITALIANA SINTETICI SPA RIFAXIMIN
17150 A II 2/10/2004 SANOFI SPA RIFAXIMIN
17974 A II 12/14/2004 OLON SPA RIFAXIMIN
20436 A II 3/31/2007 LUPIN LTD RIFAXIMIN
28096 A II 3/28/2014 MSN LABORATORIES PRIVATE LTD RIFAXIMIN [ROUTE CODE RX]
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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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:

Teva
Chubb
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US Army
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Accenture
Covington
Cipla

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