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Serving leading biopharmaceutical companies globally:

Mallinckrodt
Deloitte
Cerilliant
Express Scripts
Healthtrust
McKinsey
Harvard Business School
US Army
Colorcon
Johnson and Johnson

Generated: December 17, 2017

DrugPatentWatch Database Preview

Drug Master Files for: risedronate

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DMF No. Status Type Submission Date Holder Subject
16604AII5/22/2003TEVA PHARMACEUTICAL INDUSTRIES LTDRISEDRONATE SODIUM
18807III9/25/2005DIVIS LABORATORIES LTDRISEDRONATE SODIUM
19968AII11/3/2006JUBILANT GENERICS LTDRISEDRONATE SODIUM HEMIPENTAHYDRATE-USP
20162AII3/16/2007CIPLA LTDRISEDRONATE SODIUM HEMI PENTAHYDRATE USP
20384AII3/26/2007ZAKLADY FARMACEUTYCZNE POLPHARMA SASODIUM RISEDRONATE HEMI-PENTAHYDRATE
20398AII4/2/2007MYLAN LABORATORIES LTDRISEDRONATE SODIUM USP (HEMI-PENTAHYDRATE)
21033AII10/24/2007IND SWIFT LABORATORIES LTD RISEDRONATE SODIUM HEMIPENTAHYDRATE USP
21121AII12/6/2007AUROBINDO PHARMA LTDRisedronate Sodium Hemipentahydrate USP (Non-Sterile Drug Substance)
21172AII12/21/2007ITF CHEMICAL LTDASODIUM RISEDRONATE AMORPHOUS
21447III3/21/2008DR REDDYS LABORATORIES LTDRISEDRONATE SODIUM HEMIPENTAHYDRATE
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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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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:

Moodys
Farmers Insurance
Accenture
McKesson
Dow
Chubb
Fuji
Medtronic
Chinese Patent Office
Citi

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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