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:

McKesson
Boehringer Ingelheim
Citi
QuintilesIMS
Cantor Fitzgerald
US Department of Justice

Generated: July 23, 2019

DrugPatentWatch Database Preview

Drug Master Files for: vardenafil

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vardenafil Drug Master Files

DMF No. Status Type Submission Date Holder Subject
20780 A II 8/17/2007 DR REDDYS LABORATORIES LTD VARDENAFIL HYDROCHLORIDE TRIHYDRATE
25174 A II 8/2/2011 ZAKLADY FARMACEUTYCZNE POLPHARMA SA VARDENAFIL HYDROCHLORIDE TRIHYDRATE
25795 A II 4/9/2012 MACLEODS PHARMACEUTICALS LTD VARDENAFIL HYDROCHLORIDE TRIHYDRATE
28900 A II 12/31/2014 ALEMBIC PHARMACEUTICALS LTD VARDENAFIL HYDROCHLORIDE USP
30804 A II 10/27/2016 RAKS PHARMA PVT LTD VARDENAFIL HYDROCHLORIDE TRIHYDRATE USP
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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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:

Chinese Patent Office
QuintilesIMS
Fuji
Cipla
US Army
Merck

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