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Harvard Business School
Medtronic
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Moodys
Fish and Richardson
Federal Trade Commission
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Generated: November 20, 2018

DrugPatentWatch Database Preview

Drug Master Files for: enzalutamide

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enzalutamide Drug Master Files

DMF No. Status Type Submission Date Holder Subject
29062 A II 3/23/2015 SAI LIFE SCIENCES LTD 4-((2-CYANOPROPAN-2-YL)AMINO)-2-FLUORO-N-METHYLBENZAMIDE (ENZALUTAMIDE INTERMEDIATE)
29117 A II 3/31/2015 DR REDDYS LABORATORIES LTD ENZALUTAMIDE
29872 A II 5/24/2016 TEVA PHARMACEUTICAL INDUSTRIES LTD ENZALUTAMIDE
30010 A II 11/28/2015 MYLAN LABORATORIES LTD ENZALUTAMIDE
30260 A II 3/17/2016 SHILPA MEDICARE LTD ENZALUTAMIDE
30279 A II 2/29/2016 MSN LABORATORIES PRIVATE LTD ENZALUTAMIDE [ROUTE CODE EI]
30304 A II 3/29/2016 CADILA HEALTHCARE LTD ENZALUTAMIDE
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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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:

McKesson
McKinsey
Harvard Business School
Daiichi Sankyo
Julphar
US Department of Justice
Fuji
Argus Health
Dow

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