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:

Colorcon
Baxter
McKesson
Merck
Johnson and Johnson
Medtronic

Last Updated: October 22, 2019

DrugPatentWatch Database Preview

Drug Master Files for: Dow Pharm

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Dow Pharm Drug Master Files

DMF No. Status Type Submission Date Holder Subject
1256 I II 12/5/1968 MERRELL DOW RESEARCH INSTITUTE DIV MERRELL DOW PHARMACEUTICAL INC MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES.
26891 A II 4/17/2013 SHENZHEN TECHDOW PHARMACEUTICAL CO LTD ENOXAPARIN SODIUM USP
32744 A II 7/2/2018 SHENZHEN TECHDOW PHARMACEUTICAL CO LTD ENOXAPARIN SODIUM USP
604 I 7/5/1963 MERRELL DOW PHARMS INC SUB MARION MERRELL DOW INC MFG & PROCESS DATA; MONITORS RESPONS. FOR CLIN. & PHARMACOLOG. DATA
8358 I I 12/22/1989 MERRELL DOW PHARMS CANADA INC FACILITIES AND OPERATING PROCEDURES IN ONTARIO, CANADA
8982 I I 2/18/1991 GRUPPO LEPETIT SPA SUB MERRELL DOW PHARMACEUTICALS INC FACILITIES AND OPERATING PROCEDURES IN BRINDISI, ITALY
>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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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:

Mallinckrodt
Harvard Business School
Colorcon
Medtronic
McKesson
Merck

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