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:

Fuji
Citi
Boehringer Ingelheim
Harvard Business School
Express Scripts
Daiichi Sankyo

Generated: August 22, 2019

DrugPatentWatch Database Preview

Drug Master Files for: GLYCOPYRROLATE

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GLYCOPYRROLATE Drug Master Files

DMF No. Status Type Submission Date Holder Subject
16972 A II 11/13/2003 AMSA ANONIMA MATERIE SINTETICHE AND AFFINI SPA GLYCOPYRROLATE
18106 A II 2/22/2005 PCAS GLYCOPYRROLATE
18727 A II 8/31/2005 HIKMA PHARMACEUTICALS GLYCOPYRROLATE USP
19026 A II 12/10/2005 AKSHAT PHARMA PRIVATE LTD GLYCOPYRROLATE USP
19710 A II 8/28/2006 HARMAN FINOCHEM LTD GLYCOPYRROLATE 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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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:

McKinsey
Colorcon
Moodys
Johnson and Johnson
Federal Trade Commission
Baxter

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