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Serving hundreds of leading biopharmaceutical companies globally:

Argus Health
Moodys
Baxter
Cerilliant
McKinsey
US Department of Justice
Queensland Health
Express Scripts
Cantor Fitzgerald

Generated: May 27, 2018

DrugPatentWatch Database Preview

Drug Master Files for: bepotastine

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bepotastine Drug Master Files

DMF No. Status Type Submission Date Holder Subject
19966 A II 11/15/2006 UBE INDUSTRIES LTD BEPOTASTINE BESILATE
27170 I II 7/3/2013 MEDICHEM MANUFACTURING MALTA LTD BEPOTASTINE BESILATE
27350 A II 8/14/2013 BAL PHARMA LTD BEPOTASTINE BESILATE
27386 A II 8/16/2013 BAL PHARMA LTD BEPOTASTINE BESILATE
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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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:

Cerilliant
Express Scripts
Argus Health
Harvard Business School
Teva
US Department of Justice
Deloitte
Dow
Daiichi Sankyo

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