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:

Federal Trade Commission
Queensland Health
Fuji
Mallinckrodt
Boehringer Ingelheim
UBS

Generated: July 18, 2019

DrugPatentWatch Database Preview

Drug Master Files for: Lax

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Lax Drug Master Files

DMF No. Status Type Submission Date Holder Subject
10055 I II 1/25/1993 GLAXO WELLCOME INC MANUFACTURING PRODUCTION FACILITY IN TORONTO, CANADA
10179 I II 6/8/1989 GLAXOCHEM LTD PENICILLIN G INTERMEDIATES
10661 I II 1/5/1994 GLAXO WELLCOME INC MANUFACTURING FACILITY AT VERONA, ITALY.
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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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:

QuintilesIMS
Argus Health
Merck
Healthtrust
Baxter
Chinese Patent Office

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