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Last Updated: December 12, 2019

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Drug Master Files for: Genzyme Corp

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Genzyme Corp Drug Master Files

DMF No. Status Type Submission Date Holder Subject
10101 I II 2/25/1993 GENZYME CORP CERAMIDETRIHEXOSIDASE
10375 I II 7/26/1993 GENZYME CORP MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN LIESTAL, SWITZERLAND.
10556 I II 9/30/1993 GENZYME CORP SODIUM CHOLESTERYL SULPHATE
10923 I II 5/25/1994 GENZYME CORP SN-1-PALMITOYL-2-OLEOYLPHOSPHATIDYLGLYCEROL SODIUM SALT (POPG.NA)
10996 I II 7/21/1994 GENZYME CORP 5-METHYLSULFONAMIDOINDOLE-2-CARBOXYLIC ACID
>DMF No. >Status >Type >Submission Date >Holder >Subject

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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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

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Express Scripts
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Colorcon
Medtronic

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