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:

Express Scripts
Cipla
Merck
AstraZeneca
Julphar
Covington

Generated: September 19, 2019

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Drug Master Files for: docetaxel

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docetaxel Drug Master Files

DMF No. Status Type Submission Date Holder Subject
20021 A II 12/8/2006 SCINOPHARM TAIWAN LTD DOCETAXEL USP
20608 I II 6/11/2007 ACCORD HEALTHCARE INC ANHYDROUS DOCETAXEL
20722 I II 6/20/2007 SAI PHYTOCEUTICALS PVT LTD DOCETAXEL TRIHYDRATE
20942 A II 10/12/2007 SCINOPHARM TAIWAN LTD DOCETAXEL TRIHYDRATE USP
20961 A II 10/22/2007 POLYMED THERAPEUTICS INC DOCETAXEL ANHYDROUS, NON-STERILE BULK DRUG SUBSTANCE
21040 A II 11/15/2007 POLYMED THERAPEUTICS INC DOCETAXEL TRIHYDRATE DRUG SUBSTANCE
>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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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:

Medtronic
Daiichi Sankyo
Chubb
Cipla
McKinsey
AstraZeneca

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