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 leading biopharmaceutical companies globally:

Moodys
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Colorcon
Johnson and Johnson
AstraZeneca
Express Scripts

Last Updated: November 20, 2019

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Drug Master Files for: Daiichi Sankyo

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Daiichi Sankyo Drug Master Files

DMF No. Status Type Submission Date Holder Subject
10102 A II 2/26/1993 DAIICHI SANKYO CO LTD LEVOFLOXACIN DRUG SUBSTANCE
14321 I II 7/29/1999 DAIICHI SANKYO CO LTD CS-011 DRUG PRODUCT
14884 A II 5/15/2000 DAIICHI SANKYO EUROPE GMBH CS-866(5 10 20 & 40MG) TABLETS
14953 A II 7/14/2000 DAIICHI SANKYO CO LTD OLMESARTAN MEDOXOMIL DRUG SUBSTANCE
15780 I II 12/20/2001 DAIICHI SANKYO CO LTD DATICHI PHARMACEUTICAL CO LTD DU-6859A
15906 I II 3/19/2002 DAIICHI SANKYO CO LTD CS-758 DRUG PRODUCT
>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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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:

Harvard Business School
Boehringer Ingelheim
Dow
AstraZeneca
Colorcon
Baxter

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