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Serving leading biopharmaceutical companies globally:

AstraZeneca
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Cantor Fitzgerald
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Generated: December 16, 2017

DrugPatentWatch Database Preview

Drug Master Files for: sulindac

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DMF No. Status Type Submission Date Holder Subject
6187AII2/11/1986FIS FABBRICA ITALIANA SINTETICI SPASULINDAC
6439III6/23/1986DINAMITE DIPHARMA SPASULINDAC USP
7005III5/29/1987SIBEFAT SPASULINDAC USP XXI
7064III6/22/1987NIPPON KAYAKU CO LTDSULINDAC
8472III3/12/1990SUMIKA FINE CHEMICALS CO LTDSULINDAC
8934III10/31/1990SIBEFAT SRLSULINDAC
12224AII11/15/1996OLON SPASULINDAC
13018III6/10/1998ZACH SYSTEM SPASULINDAC SULFONE
13089III7/21/1998DIPHARMA SPASULINDAC, MANFACTURED IN MERETO DI TOMBA (UD), ITALY
16180AII10/8/2002DR REDDYS LABORATORIES LTDSULINDAC 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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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 leading biopharmaceutical companies globally:

Mallinckrodt
Covington
Chubb
Moodys
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Deloitte
QuintilesIMS
Dow
Harvard Business School

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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