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Cerilliant
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Fuji
Baxter
Colorcon
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Citi
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Harvard Business School

Generated: September 22, 2018

DrugPatentWatch Database Preview

Drug Master Files for: STERILE WATER FOR INJECTION

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STERILE WATER FOR INJECTION Drug Master Files

DMF No. Status Type Submission Date Holder Subject
10003 A II 11/25/1992 ACS DOBFAR SPA SODIUM CARBONATE STERILE
10009 I V 7/30/1990 ASTELLAS PHARMA INC STERILE PROCESSING FACILITIES FOR CEFTIZOXIME SODIUM, STERILE (BULK) LOCATED IN TAKAOKA, JAPAN
10076 I V 12/18/1986 ACS DOBFAR SPA STERILE FINISHED PRODUCTS AND STERILE PROCESSING OPERATIONS AT THE VIALE ADDETTA PLANT IN MILANO, ITALY
10077 A V 8/27/1991 ACS DOBFAR SPA STERILE FINISHED PRODUCTS AND STERILE PROCESSING OPERATIONS
10120 I II 12/4/1989 BIOCHIMICA OPOS 2 SPA ACT, BULK, NON-STERILE
10152 I V 8/7/1972 ASTELLAS PHARMA INC STERILE PROCESSING FACILITIES FOR CEFAZOLIN SODIUM STERILE, (BULK) AS LOCATED IN FUJI, JAPAN
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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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:

US Department of Justice
Cerilliant
Federal Trade Commission
Citi
Chubb
US Army
Mallinckrodt
Johnson and Johnson
Teva

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