Manufacturing Establishments5
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Genzyme Ireland Limited
Genzyme Corporation
985127419
Bionique Testing Laboratories, Inc.
Genzyme Corporation
108684523
Genzyme Corporation
Genzyme Corporation
050424395
Bioreliance Corporation
Genzyme Corporation
147227730
Eurofins Biopharma Product Testing Ireland Limited
Genzyme Corporation
238239933
Products2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
XENPOZYME
Product Details
NDC Product Code
58468-0050Application Number
BLA761261Marketing Category
BLA (C73585)Route of Administration
INTRAVENOUSEffective Date
December 12, 2023SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATEInactive
Code: 593YOG76RNClass: IACTQuantity: 8.17 mg in 5.1 mL
Olipudase alfaActive
Code: 6D5766Q4OPClass: ACTIBQuantity: 20 mg in 5.1 mL
SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATEInactive
Code: 70WT22SF4BClass: IACTQuantity: 4.47 mg in 5.1 mL
METHIONINEInactive
Code: AE28F7PNPLClass: IACTQuantity: 74.6 mg in 5.1 mL
SUCROSEInactive
Code: C151H8M554Class: IACTQuantity: 250 mg in 5.1 mL
XENPOZYME
Product Details
NDC Product Code
58468-0051Application Number
BLA761261Marketing Category
BLA (C73585)Route of Administration
INTRAVENOUSEffective Date
December 12, 2023SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATEInactive
Code: 70WT22SF4BClass: IACTQuantity: 0.89 mg in 1.1 mL
Olipudase alfaActive
Code: 6D5766Q4OPClass: ACTIBQuantity: 4 mg in 1.1 mL
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATEInactive
Code: 593YOG76RNClass: IACTQuantity: 1.63 mg in 1.1 mL
SUCROSEInactive
Code: C151H8M554Class: IACTQuantity: 50 mg in 1.1 mL
METHIONINEInactive
Code: AE28F7PNPLClass: IACTQuantity: 14.92 mg in 1.1 mL