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Serving leading biopharmaceutical companies globally:

UBS
Cipla
US Department of Justice
QuintilesIMS
Citi
Farmers Insurance
Boehringer Ingelheim
Cerilliant
Harvard Business School
Merck

Generated: October 23, 2017

DrugPatentWatch Database Preview

Drug Master Files for: modafinil

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DMF No. Status Type Submission Date Holder Subject
11806III1/15/1996ORSYMONDEMANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES OF MODAFINIL DRUG SUBSTANCE IN MITRY-MORY MITRY-MORY CEDEX FRANCE.
11970AII5/15/1996CEPHALON INCMODAFINIL DRUG SUBSTANCE
16140AII9/19/2002PERRIGO API LTDMODAFINIL
16250AII11/19/2002DIPHARMA FRANCIS SRLMODAFINIL USP
16306AII12/12/2002MYLAN LABORATORIES LTDMODAFINIL USP
16310AII12/13/2002TEVA PHARMACEUTICAL INDUSTRIES LTDMODAFINIL
16477AII3/21/2003ALEMBIC PHARMACEUTICALS LTDMODAFINIL USP
17545III7/19/2004UNION QUIMICO FARMACEUTICA SA (UQUIFA SA)MODAFINIL
17815AII11/10/2004HELSINN ADVANCED SYNTHESIS SAMODAFINIL
18062AII2/3/2005FLAMMA SPAMODAFINIL
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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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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:

AstraZeneca
McKesson
UBS
Boehringer Ingelheim
Dow
US Army
QuintilesIMS
Express Scripts
McKinsey
Cantor Fitzgerald

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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