Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Serving hundreds of leading biopharmaceutical companies globally:

Boehringer Ingelheim
Merck
Farmers Insurance
Chubb
US Department of Justice
Fish and Richardson

Generated: September 16, 2019

DrugPatentWatch Database Preview

Drug Master Files for: aprepitant

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aprepitant Drug Master Files

DMF No. Status Type Submission Date Holder Subject
20381 A II 3/28/2007 GLENMARK PHARMACEUTICALS LTD APREPITANT USP
21345 A II 2/18/2008 DR REDDYS LABORATORIES LTD APREPITANT USP
24829 A II 3/31/2011 DR REDDYS LABORATORIES LTD FOSAPREPITANT DIMEGLUMINE
24835 A II 4/7/2011 MSN PHARMACHEM PRIVATE LTD APREPITANT USP (ROUTE CODE - AP)
25572 A II 12/12/2011 HETERO DRUGS LTD APREPITANT
>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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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:

QuintilesIMS
Harvard Business School
Johnson and Johnson
Farmers Insurance
McKesson
US Department of Justice

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