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:

Daiichi Sankyo
Harvard Business School
Mallinckrodt
Cipla
UBS
Queensland Health

Generated: July 22, 2019

DrugPatentWatch Database Preview

Drug Master Files for: diltiazem

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diltiazem Drug Master Files

DMF No. Status Type Submission Date Holder Subject
10381 I II 7/9/1993 MITSUBISHI TANABE PHARMA CORP DILTIAZEM HYDROCHLORIDE (PROCESS C)
10466 I II 6/2/1993 SUMITRA PHARMACEUTICALS AND CHEMICALS LTD DILTIAZEM HYDROCHLORIDE
11077 I II 9/9/1994 TANABE SEIYAKU CO LTD DILTIAZEM MALATE
11161 I II 10/24/1994 MERCK RESEARCH LABORATORIES DIV MERCK AND CO INC DILTIAZEM ER TABLETS
11170 I II 10/28/1994 MERCK RESEARCH LABORATORIES DIV MERCK AND CO INC ENALAPRIL MALEATE & DILTIAZEM ER TABLETS
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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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:

Cipla
US Army
Argus Health
Merck
Julphar
Colorcon

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