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Serving hundreds of leading biopharmaceutical companies globally:

Harvard Business School
Argus Health
Citi
Medtronic
Covington
Deloitte
Merck
Johnson and Johnson
Federal Trade Commission

Generated: July 18, 2018

DrugPatentWatch Database Preview

Drug Master Files for: ibandronate

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ibandronate Drug Master Files

DMF No. Status Type Submission Date Holder Subject
15429 I II 5/15/2001 ROCHE DIAGNOSTICS GMBH IBANDRONATE, EDITION I
20391 A II 3/31/2007 CHONGQING SHENGHUAXI PHARMACEUTICAL CO LTD SODIUM IBANDRONATE
20393 A II 3/29/2007 AUROBINDO PHARMA LTD IBANDRONATE SODIUM (NON-STERILE DRUG SUBSTANCE)
20411 A II 4/5/2007 NATCO PHARMA LTD IBANDRONATE SODIUM MONOHYDRATE
DMF No. Status Type Submission Date Holder Subject

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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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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 hundreds of leading biopharmaceutical companies globally:

Citi
Merck
Healthtrust
Julphar
Farmers Insurance
Chinese Patent Office
Boehringer Ingelheim
Fish and Richardson
US Army

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