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:

UBS
Cantor Fitzgerald
QuintilesIMS
AstraZeneca
Covington
Mallinckrodt

Generated: September 17, 2019

DrugPatentWatch Database Preview

Drug Master Files for: apixaban

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apixaban Drug Master Files

DMF No. Status Type Submission Date Holder Subject
28009 A II 2/26/2014 MSN LABORATORIES PRIVATE LTD APIXABAN [ROUTE CODE AX]
29660 A II 9/30/2015 ALEMBIC PHARMACEUTICALS LTD APIXABAN
29667 A II 9/2/2015 ZHEJIANG HUAHAI PHARMACEUTICAL CO LTD APIXABAN
29707 A II 9/22/2015 DR REDDYS LABORATORIES LTD APIXABAN
30060 A II 12/31/2015 GLENMARK PHARMACEUTICALS LTD APIXABAN
30336 A II 3/14/2016 DELMAR CHEMICALS INC APIXABAN
>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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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:

Mallinckrodt
Citi
Merck
US Army
Cantor Fitzgerald
Boehringer Ingelheim

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