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Serving leading biopharmaceutical companies globally:

Queensland Health
Julphar
UBS
McKinsey
Merck
Colorcon
US Department of Justice
Dow
Deloitte
Federal Trade Commission

Generated: December 12, 2017

DrugPatentWatch Database Preview

Drug Master Files for: entecavir

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DMF No. Status Type Submission Date Holder Subject
23663AII5/21/2010CIPLA LTDENTECAVIR MONOHYDRATE USP
24305AII10/19/2010APOTEX PHARMACHEM INDIA PVT LTDENTECAVIR USP
24601AII1/28/2011CHONGQING CARELIFE PHARMACEUTICAL CO LTDENTECAVIR HYDRATE, NON-STERILE BULK DRUG SUBSTANCE
25200AII8/5/2011ZHEJIANG AUSUN PHARMACEUTICAL CO LTDENTECAVIR MONOHYDRATE BULK DRUG SUBSTANCE
25549AII11/30/2011SCINOPHARM TAIWAN LTDENTECAVIR MONOHYDRATE
26307AII8/14/2012HETERO DRUGS LTDENTECAVIR MONOHYDRATE
27066III4/5/2013KYONGBO PHARMACEUTICAL CO LTDENTECAVIR
27401AII8/31/2013AUROBINDO PHARMA LTDENTECAVIR
27444AII11/20/2013WISDOM PHARMACEUTICAL CO LTDENTECAVIR
27767AII12/26/2013CADILA HEALTHCARE LTDENTECAVIR
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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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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:

Medtronic
AstraZeneca
Moodys
Baxter
Dow
QuintilesIMS
Johnson and Johnson
Queensland Health
Colorcon
Argus Health

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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