Labeler · US market

Genzyme Corporation

Genzyme Corporation is a US drug labeler with US FDA registrations covering 26 drug concepts (26 currently active) across 40 packages. It is currently the only active US supplier of 22 drugs.

ACTIVE — US

openFDA · updated weekly

Labeler codes58468

Active drugs26

Registrations33 active / 33

Packages40

Sole supplier of22 drugs

Portfolio26 drugs · US

Every drug concept this labeler has US registrations for, by package count.

Drug	Type	NDCs	Packages	Status
Teriflunomide tablet, film coated	rx	2	6	SUPPLYING
Vandetanib tablet, film coated	rx	2	2	SUPPLYING
Fitusiran injection, solution	rx	2	2	SUPPLYING
Alemtuzumab injection	rx	1	2	SUPPLYING
Agalsidase Beta injection, powder, lyophilized, for solution	rx	2	2	SUPPLYING
Eliglustat capsule	rx	1	2	SUPPLYING
Rilzabrutinib tablet, film coated	rx	1	2	SUPPLYING
Sevelamer Carbonate powder, for suspension	rx	2	2	SUPPLYING
Olipudase Alfa-Rpcp injection, powder, lyophilized, for solution	rx	2	2	SUPPLYING
Dupilumab solution	other	2	2	SUPPLYING
Avalglucosidase Alfa solution	other	1	1	SUPPLYING
Lapine T-Lymphocyte Immune Globulin injection, powder, for solution	other	1	1	SUPPLYING
Thyrotropin Alfa injection, powder, lyophilized, for solution	other	1	1	SUPPLYING
Laronidase injection, solution, concentrate	rx	1	1	SUPPLYING
Alglucosidase Alfa solution	other	1	1	SUPPLYING
Sevelamer Carbonate tablet, film coated	rx	1	1	SUPPLYING
Agalsidase Beta injection, powder, lyophilized, for solution	other	1	1	SUPPLYING
Avalglucosidase Alfa injection, powder, lyophilized, for solution	other	1	1	SUPPLYING
Avalglucosidase Alfa-Ngpt injection, powder, lyophilized, for solution	rx	1	1	SUPPLYING
Alemtuzumab injection, solution, concentrate	rx	1	1	SUPPLYING
Caplacizumab kit	rx	1	1	SUPPLYING
Alglucosidase Alfa injection, powder, for solution	rx	1	1	SUPPLYING
Imiglucerase injection, powder, lyophilized, for solution	rx	1	1	SUPPLYING
Thyrotropin Alfa injection, powder, lyophilized, for solution	rx	1	1	SUPPLYING
Anti-Thymocyte Globulin (Rabbit) injection, powder, lyophilized, for solution	rx	1	1	SUPPLYING
Imiglucerase injection, powder, lyophilized, for solution	other	1	1	SUPPLYING

Sole US supplier

Drugs where this labeler is currently the only active US supplier — a single point of failure if it exits.

+12 more

At a glance

TypeLabeler
Labeler codes58468
Filing names1
Drugs (active)26
Drugs (all time)26
US registrations33
Packages40

Recent events

Shortages, recalls, and registration changes across all filing names.

Oct 12, 2017
RECALLRecall (Class III): Clolar (clofarabine) 20 mg/20 mL (1 mg/mL) Injection, for intravenous use, Rx Only, Mfd. by: Teva Pharmachemie Swenswe…
Feb 16, 2016
RECALLRecall (Class II): Thyrogen (thyrotropin alfa for injection), 0.9 mg/mL after reconstitution, For intramuscular injection only, Rx Only, T…
Feb 16, 2016
RECALLRecall (Class II): Thyrogen (thyrotropin alfa for injection), 0.9 mg/mL after reconstitution, For intramuscular injection only, Rx Only, …
Dec 8, 2015
RECALLRecall (Class III): Lumizyme (alglucosidase alpha), 50 mg/vial, For Intravenous Infusion Only, Rx Only, Manufactured by Genzyme Corportatio…

Watch this company

Alerts for recalls, exits, and new registrations.

Facility locations, FDA inspections, and parent-company mapping are on the roadmap. Name variants reported to FDA under different spellings are merged into this profile; figures cover the entity across all its filing names.