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Serving hundreds of leading biopharmaceutical companies globally:

US Army
Colorcon
Deloitte
Moodys
Harvard Business School
Boehringer Ingelheim
Merck
Accenture
Teva

Generated: July 18, 2018

DrugPatentWatch Database Preview

Drug Master Files for: simvastatin

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simvastatin Drug Master Files

DMF No. Status Type Submission Date Holder Subject
14599 A II 11/29/1999 TEVA PHARMACEUTICAL INDUSTRIES LTD SIMVASTATIN
15722 I II 11/7/2001 SUN PHARMACEUTICAL INDUSTRIES LTD SIMVASTATIN USP
16094 A II 8/12/2002 BIOCON LTD SIMVASTATIN USP
16305 A II 12/11/2002 ZHEJIANG HISUN PHARMACEUTICAL CO LTD SIMVASTATIN 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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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:

Merck
US Department of Justice
Mallinckrodt
Teva
Cerilliant
US Army
Boehringer Ingelheim
Medtronic
Daiichi Sankyo

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