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:

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Dow
AstraZeneca

Last Updated: December 5, 2019

DrugPatentWatch Database Preview

Drug Master Files for: exemestane

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exemestane Drug Master Files

DMF No. Status Type Submission Date Holder Subject
17813 A II 11/4/2004 CEDARBURG PHARMACEUTICALS EXEMESTANE
20219 I II 1/30/2007 PERRIGO API LTD EXEMESTANE
21441 I II 12/8/2007 YANCHENG XINYI PHARM AND CHEM CO LTD EXEMESTANE (NON-STERILE, BULK FORM)
22099 A II 11/13/2008 CIPLA LTD EXEMESTANE USP
22365 A II 12/29/2008 TRIFARMA SPA EXEMESTANE
22439 A II 1/21/2009 STERLING SPA EXEMESTANE
>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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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