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Serving 500+ biopharmaceutical companies globally:

Accenture
Federal Trade Commission
Cipla
Chubb
UBS
Johnson and Johnson
Moodys
Colorcon
Cerilliant
Dow

Generated: September 21, 2017

DrugPatentWatch Database Preview

Drug Master Files for: rivaroxaban

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DMF No. Status Type Submission Date Holder Subject
28922AII12/31/2014APOTEX PHARMACHEM INDIA PVT LTDRIVAROXABAN
21580AII7/23/2008BAYER AGRIVAROXABAN COATED TABLETS, 10 MG
21581AII7/23/2008BAYER AGRIVAROXABAN (MICRONIZED) DRUG SUBSTANCE
21592AII7/24/2008JANSSEN ORTHO LLCRIVAROXABAN 10 MG FILM COATED TABLETS
28864AII1/16/2015GLENMARK PHARMACEUTICALS LTDRIVAROXABAN
28816AII3/6/2015TARO PHARMACEUTICAL INDUSTRIES LTDRIVAROXABAN MICRONIZED
28786AII1/8/2015HEC PHARM CO LTDRIVAROXABAN, NON-STERILE BULK DRUG SUBSTANCE
29439AII5/18/2015ZHEJIANG SUPOR PHARMACEUTICALS CO LTDRIVAROXABAN USP
27661AII10/21/2013ZAKLADY FARMACEUTYCZNE POLPHARMA SARIVAROXABAN
27807AII12/31/2013MSN LABORATORIES PRIVATE LTDRIVAROXABAN [ROUTE CODE - 'RR']
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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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
Novartis
McKinsey
Express Scripts
Chubb
Harvard Business School
US Army
Accenture
Covington
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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