Labeler · US market

EMD Serono, Inc.

EMD Serono, Inc. is a US drug labeler with US FDA registrations covering 10 drug concepts (10 currently active) across 25 packages. It is currently the only active US supplier of 6 drugs.

ACTIVE — US

openFDA · updated weekly

Labeler codes44087

Active drugs10

Registrations18 active / 18

Packages25

Sole supplier of6 drugs

Portfolio10 drugs · US

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

Drug	Type	NDCs	Packages	Status
Cladribine tablet	rx	1	7	SUPPLYING
Interferon Beta-1a injection, solution	rx	4	4	SUPPLYING
Somatropin kit	rx	3	3	SUPPLYING
Follitropin injection, solution	rx	3	3	SUPPLYING
Interferon Beta-1a kit	rx	2	2	SUPPLYING
Tepotinib Hydrochloride tablet	rx	1	2	SUPPLYING
Cetrorelix Acetate kit	rx	1	1	SUPPLYING
Avelumab injection, solution, concentrate	rx	1	1	SUPPLYING
Follitropin Alfa kit	rx	1	1	SUPPLYING
Choriogonadotropin Alfa injection, solution	rx	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.

At a glance

TypeLabeler
Labeler codes44087
Filing names1
Drugs (active)10
Drugs (all time)10
US registrations18
Packages25

Recent events

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

Jun 29, 2020
RECALLRecall (Class II): Cetrotide (cetrorelix acetate for Injection) 0.25 mg, Sterile - for subcutaneous use only, Rx Only, Manufactured for: E…
Sep 10, 2015
RECALLRecall (Class III): ClomiPHENE CITRATE Tablets, USP, 50 mg, 10-count (2 foil sealed plastic trays of 5 tablets each) per carton, Rx only, M…

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.