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Serving hundreds of leading biopharmaceutical companies globally:

Farmers Insurance
Merck
Fish and Richardson
US Army
Deloitte
Federal Trade Commission
Julphar
AstraZeneca
McKesson

Generated: August 19, 2018

DrugPatentWatch Database Preview

Drug Master Files for: Janssen Pharma

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Janssen Pharma Drug Master Files

DMF No. Status Type Submission Date Holder Subject
2695 I I 6/14/1976 JANSSEN PHARMACEUTICA INC FACILS & COMTRLS-JANSSEN PHARMA. N.V.-BELL TELEFOONLAAN, GEEL, BELGIUM
2932 I I 5/4/1977 JANSSEN PHARMACEUTICA INC MANUFACTURING SITE, FACILITIES, PERSONNEL AND GENERAL OPERATING PROCEDURES IN BEERSE, BELGIUM.
3217 I II 6/23/1978 JANSSEN PHARMACEUTICA NV FACILS. & CONTROLS FOR PRODUCTION UNIT II AT GEEL, BELGIUM
3384 I II 12/1/1978 JANSSEN PHARMACEUTICA NV CHEMICAL PRODUCTION & CONTROL OF BPC'S FOR INVESTIGATIONAL USE IN BEERSE, BELGIUM.
4890 I II 3/31/1983 JANSSEN PHARMACEUTICA NV DROPERIDOL,CODE#R4749,MNFG IN BELGIUM AND PUERTO RICO FACILITIES
5108 I II 9/9/1983 JANSSEN PHARMACEUTICA NV OXATOMIDE-R 35443 AS PROCESSED IN THE BELGIUM FACILITY
5172 I II 11/25/1983 JANSSEN PHARMACEUTICA NV ASTEMIZOLE-R 43512
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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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:

Queensland Health
Farmers Insurance
Covington
Cerilliant
Medtronic
AstraZeneca
Boehringer Ingelheim
Chubb
Julphar

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