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Serving leading biopharmaceutical companies globally:

Chinese Patent Office
Harvard Business School
Medtronic
AstraZeneca
US Department of Justice
Fish and Richardson
McKinsey
Baxter
Teva
Accenture

Generated: December 16, 2017

DrugPatentWatch Database Preview

Drug Master Files for: bepotastine

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DMF No. Status Type Submission Date Holder Subject
19966AII11/15/2006UBE INDUSTRIES LTDBEPOTASTINE BESILATE
27170III7/3/2013MEDICHEM MANUFACTURING MALTA LTDBEPOTASTINE BESILATE
27350AII8/14/2013BAL PHARMA LTDBEPOTASTINE BESILATE
27386AII8/16/2013BAL PHARMA LTDBEPOTASTINE BESILATE
27465AII8/27/2013ICROM SPABEPOTASTINE BESILATE
28012AII3/3/2014MSN LABORATORIES PRIVATE LTDBEPOTASTINE BESILATE [ROUTE CODE - BB]
28901AII12/10/2014MEDICHEM MANUFACTURING MALTA LTDBEPOTASTINE BESILATE
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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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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 leading biopharmaceutical companies globally:

Federal Trade Commission
McKinsey
US Army
Harvard Business School
Chubb
Cerilliant
Moodys
Fish and Richardson
UBS
Queensland Health

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