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US Department of Justice
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Generated: February 23, 2018

DrugPatentWatch Database Preview

Drug Master Files for: pirfenidone

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DMF No. Status Type Submission Date Holder Subject
5170III11/24/1983SOCIETA ITALIANA MEDICINALI SCANDICCI SIMS SRLPIRFENIDONE
15168AII11/30/2000SIGNA SA DE CVPIRFENIDONE EP
29700AII11/4/2015HONOUR LAB LTDPIRFENIDONE
30351AII4/13/2016LUPIN LTDPIRFENIDONE
30922AII9/30/2016GRANULES INDIA LTDPIRFENIDONE
30952AII9/20/2016SHILPA MEDICARE LTDPIRFENIDONE
31072AII11/30/2016GLENMARK PHARMACEUTICALS LTDPIRFENIDONE
31264AII12/31/2016MSN LIFE SCIENCES PRIVATE LTDPIRFENIDONE
31274AII12/31/2016MYLAN LABORATORIES LTDPIRFENIDONE
31815AII7/31/2017PROCOS SPAPIRFENIDONE
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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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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:

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Cipla
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Harvard Business School
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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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