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Serving hundreds of leading biopharmaceutical companies globally:

UBS
McKesson
Chubb
Mallinckrodt
Federal Trade Commission
McKinsey
Accenture
Argus Health
Boehringer Ingelheim

Generated: May 23, 2018

DrugPatentWatch Database Preview

Drug Master Files for: RANITIDINE HYDROCHLORIDE

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RANITIDINE HYDROCHLORIDE Drug Master Files

DMF No. Status Type Submission Date Holder Subject
7528 I II 6/14/1988 SHANGHAI NO 6 PHARMACEUTICAL FACTORY RANITIDINE HYDROCHLORIDE
8288 A II 11/17/1989 UNION QUIMICO FARMACEUTICA SA (UQUIFA SA) RANITIDINE HCL
8494 I II 3/27/1990 QUIMICA SINTETICA SA RANITIDINE HYDROCHLORIDE
8953 I II 1/29/1991 PHARMAGLOBE LABORATORIES LTD RANITIDINE HYDROCHLORIDE
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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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:

Harvard Business School
Medtronic
QuintilesIMS
Citi
Colorcon
Argus Health
Julphar
Johnson and Johnson
Cipla

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