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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Last Updated: November 13, 2019

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Drug Master Files for: fosaprepitant

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fosaprepitant Drug Master Files

DMF No. Status Type Submission Date Holder Subject
24829 A II 3/31/2011 DR REDDYS LABORATORIES LTD FOSAPREPITANT DIMEGLUMINE
25614 A II 12/21/2011 HETERO DRUGS LTD FOSAPREPITANT DIMEGLUMINE
25682 A II 1/6/2012 MSN LABORATORIES PRIVATE LTD FOSAPREPITANT DIMEGLUMINE [ROUTE CODE - FD]
28288 A II 11/26/2014 LIANYUNGANG RUNZHONG PHARMACEUTICAL CO LTD FOSAPREPITANT DIMEGLUMINE
28992 A II 3/18/2015 GLENMARK PHARMACEUTICALS LTD FOSAPREPITANT DIMEGLUMINE
30137 A II 12/31/2015 WOCKHARDT BIO AG FOSAPREPITANT DIMEGLUMINE
30973 A II 7/17/2017 SCINOPHARM TAIWAN LTD FOSAPREPITANT DIMEGLUMINE
>DMF No. >Status >Type >Submission Date >Holder >Subject

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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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 leading biopharmaceutical companies globally:

Express Scripts
Medtronic
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McKinsey
Boehringer Ingelheim
Colorcon

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