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:

Chinese Patent Office
Queensland Health
Fish and Richardson
Farmers Insurance
Mallinckrodt
QuintilesIMS

Generated: September 22, 2019

DrugPatentWatch Database Preview

Drug Master Files for: vortioxetine

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vortioxetine Drug Master Files

DMF No. Status Type Submission Date Holder Subject
29849 A II 8/15/2016 ALP PHARM BEIJING CO LTD VORTIOXETINE HYDROBROMIDE
30309 A II 3/10/2016 MSN PHARMACHEM PRIVATE LTD VORTIOXETINE HYDROBROMIDE [ROUTE CODE VX]
31281 A II 12/30/2016 ALEMBIC PHARMACEUTICALS LTD VORTIOXETINE HYDROBROMIDE
31314 A II 3/1/2017 LEK PHARMACEUTICALS DD VORTIOXETINE HYDROBROMIDE
31389 A II 3/4/2017 CIPLA LTD VORTIOXETINE HYDROBROMIDE
31411 A II 2/28/2017 MSN PHARMACHEM PRIVATE LTD VORTIOXETINE HYDROBROMIDE (FORM-H)
>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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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 hundreds of leading biopharmaceutical companies globally:

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Covington
Medtronic
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Citi

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