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
Active pharmaceutical ingredients supplied
Substances Genzyme Corporation is evidenced to supply (US FDA Drug Master File or EU CEP). Open any ingredient to see its full supplier landscape, CAS number and patent status.
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
Examination of packaging and labeling
- 4832025-02-14
Procedures are written, and followed
- 4832025-02-14
No written record of investigation
- warning_letter2025-01-15
FDA Warning Letter (drug product)
- recall — Class III2017-11-22
Labeling: Incorrect or Missing Package Insert.
- 4832016-08-18
Deviations from laboratory control requirements
- 4832016-08-18
No written record of investigation
- 4832016-08-18
Calibration/Inspection/Checking not done
- 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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