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Serving hundreds of leading biopharmaceutical companies globally:

Medtronic
Dow
Cantor Fitzgerald
McKinsey
Merck
Mallinckrodt
Moodys
Express Scripts
Covington

Generated: June 21, 2018

DrugPatentWatch Database Preview

Drug Master Files for: Able

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Able Drug Master Files

DMF No. Status Type Submission Date Holder Subject
31636 A II 10/11/2017 RELIABLE BIOPHARMACEUTICAL LLC PENTAMIDINE ISETHIONATE USP
4116 I II 3/18/1981 CRISPEN LABORATORIES AND ASCOT INJECTABLES MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN MELROSE PARK, ILL
5989 I II 9/9/1985 ABLE LABORATORIES INC FACILITY IN SOUTH PLAINFIELD, NEW JERSEY
6636 I II 10/22/1986 RELIABLE CHEMICAL CO PROTAMINE SULFATE (BULK)
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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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:

QuintilesIMS
Cipla
Express Scripts
Fish and Richardson
Federal Trade Commission
Merck
Teva
Baxter
Mallinckrodt

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