Labeler · US market

GRIFOLS USA, LLC

GRIFOLS USA, LLC is a US drug labeler with US FDA registrations covering 21 drug concepts (20 currently active) across 96 packages. It is currently the only active US supplier of 16 drugs.

ACTIVE — US

openFDA · updated weekly

Labeler codes13533 · 61953 · 68516

Active drugs20

Registrations50 active / 53

Packages96

Sole supplier of16 drugs

Portfolio21 drugs · US

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

Drug	Type	NDCs	Packages	Status
Albumin (Human) injection, solution	other	5	16	SUPPLYING
Immune Globulin (Human) injection	other	2	10	SUPPLYING
Antihemophilic Factor/Von Willebrand Factor Complex (Human) kit	other	10	10	SUPPLYING
Albumin (Human) solution	rx	4	9	SUPPLYING
Coagulation Factor Ix (Human) kit	other	6	6	SUPPLYING
Immune Globulin Subcutaneous, Human-Klhw solution	other	1	4	SUPPLYING
Hepatitis B Immune Globulin (Human) injection	other	1	4	SUPPLYING
Human Fibrinogen, Human Thrombin solution	other	1	4	SUPPLYING
Immune Globulin (Human) injection, solution	other	2	4	SUPPLYING
Rabies Immune Globulin (Human) injection, solution	other	1	3	SUPPLYING
Antithrombin Iii (Human) kit	other	3	3	SUPPLYING
Rho(d) Immune Globulin (Human) solution	other	2	3	SUPPLYING
Factor Ix Complex kit	other	3	3	SUPPLYING
Alpha-1-Proteinase Inhibitor (Human) kit	other	3	3	SUPPLYING
Immune Globulin (Human) injection, solution	other	1	3	SUPPLYING
Alpha1-Proteinase Inhibitor (Human) injection, solution	other	1	3	SUPPLYING
Rabies Immune Globulin (Human) injection	other	1	2	SUPPLYING
Fibrinogen, Human-Chmt kit	other	1	1	SUPPLYING
Plasma Protein Fraction (Human) solution	other	1	1	SUPPLYING
Tetanus Immune Globulin (Human) injection	other	1	1	SUPPLYING
Human Fibrinogen, Human Thrombin kit	other	3	3	DISCONTINUED

Sole US supplier

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

Alpha1-Proteinase Inhibitor (Human)other
Antihemophilic Factor/Von Willebrand Factor Complex (Human)other
Antithrombin Iii (Human)other
Coagulation Factor Ix (Human)other
Factor Ix Complexother
Fibrinogen, Human-Chmtother
Hepatitis B Immune Globulin (Human)other
Human Fibrinogen, Human Thrombinother
Immune Globulin (Human)other
Immune Globulin (Human)other

+6 more

At a glance

TypeLabeler
Labeler codes13533, 61953, 68516
Filing names1
Drugs (active)20
Drugs (all time)21
US registrations53
Packages96

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.