Genzyme Corporation
Overview
Genzyme Corporation is a biotechnology company dedicated to discovering and delivering transformative therapies for patients with rare and ultra-rare diseases. As a subsidiary of Sanofi, Genzyme focuses on developing therapies that can address unmet medical needs in several therapeutic areas.
Therapeutic areas
API / Drug Master Files
Genzyme Corporation holds 0 active (8 total) FDA Type II Drug Master Files — identifying it as an active-substance / API supplier. Type II DMFs are filed with the FDA to support the use of an active pharmaceutical ingredient in drug applications.
- LEUPROLIDE ACETATEInactive1999-10-08
- CLINDAMYCIN PHOSPHATEInactive1998-09-01
- 5-METHYLSULFONAMIDOINDOLE-2-CARBOXYLIC ACIDInactive1994-07-21
- SN-1-PALMITOYL-2-OLEOYLPHOSPHATIDYLGLYCEROL SODIUM SALT (POPG.NA)Inactive1994-05-25
- SODIUM CHOLESTERYL SULPHATEInactive1993-09-30
- MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN LIESTAL, SWITZERLAND.Inactive1993-07-26
- CERAMIDETRIHEXOSIDASEInactive1993-02-25
- ACEBUTOLOL HYDROCHLORIDEInactive1992-11-10
FDA compliance signals
13 FDA enforcement records linked to this company.
- 4832025-02-14
No written record of investigation
- 4832025-02-14
Procedures are written, and followed
- 4832025-02-14
Examination of packaging and labeling
- warning_letter2025-01-15
FDA Warning Letter (drug product)
- recall — Class III2017-11-22
Labeling: Incorrect or Missing Package Insert.
- 4832016-08-18
No written record of investigation
- 4832016-08-18
Calibration/Inspection/Checking not done
- 4832016-08-18
Deviations from laboratory control requirements
- recall — Class III2016-04-06
Labeling: Incorrect or Missing Lot and/or Exp Date
- recall — Class II2016-03-09
Presence of Particulate Matter: Glass particles found in the product after reconstitution.
- recall — Class II2016-03-09
Presence of Particulate Matter: Glass particles found in the product after reconstitution.
- 4832014-11-21
Contract drug products--lack of responsibility
- 4832014-11-21
Contamination, chemical or physical change, deterioration
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