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Serving 500+ biopharmaceutical companies globally:

Boehringer Ingelheim
Citi
Julphar
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Express Scripts
QuintilesIMS
Argus Health
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Cantor Fitzgerald
Healthtrust

Generated: September 20, 2017

DrugPatentWatch Database Preview

Drug Master Files for: dofetilide

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DMF No. Status Type Submission Date Holder Subject
27816AII2/25/2014JOHNSON MATTHEY PHARMA SERVICES4245.C (MILLED) [DOFETILIDE]
28301AII6/5/2014SIGMAPHARM LABORATORIES LLCAMORPHOUS DOFETILIDE
29722AII10/7/2015APICORE US LLCDOFETILIDE USP, POLYMORPH P162B
30042AII12/17/2015INDUSTRIALE CHIMICA SRLDOFETILIDE USP
30560AII6/1/2016AUROBINDO PHARMA LTDDOFETILIDE USP
30508AII6/29/2016BIDDLE SAWYER PHARMA LLCDOFETILIDE USP
31026AII11/19/2016SUN PHARMACEUTICAL INDUSTRIES LTDDOFETILIDE USP
31158AII12/30/2016MSN LIFE SCIENCES PRIVATE LTDDOFETILIDE USP
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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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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 500+ biopharmaceutical companies globally:

Deloitte
Fish and Richardson
US Army
Medtronic
Farmers Insurance
Colorcon
Chinese Patent Office
Mallinckrodt
Fuji
QuintilesIMS

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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