NDC 71104-978

Altuviiio 250 [iU] per 3 mL kit

On the label: Bioverativ Therapeutics Inc..

United States: 2Belgium: 1Ireland: 1Germany: 1

Where it's made

FactoryWhereRoleLast FDA inspection
Biogen MA Inc.Morrisville, NC, United StatesMakes the active ingredient No problems foundJun 13, 2018 · 9 inspections
Biogen U.S. CorporationMorrisville, NC, United StatesMakes it and tests it Problems found, fixed voluntarilyAug 26, 2022 · 3 inspections
Genzyme FlandersGeel, BelgiumMakes the active ingredient and tests it Problems found, fixed voluntarilySep 25, 2024 · 9 inspections
Genzyme Ireland LimitedWaterford, IrelandMakes it and tests it Problems found, fixed voluntarilyFeb 25, 2022 · 7 inspections
Vetter Pharma Fertigung GmbH & Co. KG (Langenargen Eisenbahnstrasse)Langenargen, GermanyMakes it and tests it Problems found, fixed voluntarilyMar 20, 2024 · 8 inspections
Eurofins Lancaster Laboratories, LLCLancaster, PA, United StatesTests it Problems found, fixed voluntarilyAug 26, 2025 · 8 inspections
Genzyme CorporationNorthborough, MA, United StatesPackages it and labels it No problems foundAug 14, 2025 · 6 inspections
PPD Development Ireland Ltd.Athlone, IrelandTests it Problems found, fixed voluntarilyMar 9, 2023 · 4 inspections
Rechon Life Science ABLimhamn, SwedenPackages it and labels it Serious problems, FDA actionSep 6, 2024 · 6 inspections, 1 with FDA action
Vetter Pharma Fertigung GmbH & Co. KG (Ravensburg Mooswiesen)Ravensburg, GermanyTests it and packages it Problems found, fixed voluntarilyJul 21, 2023 · 8 inspections
Vetter Pharma Fertigung GmbH & Co. KG (Ravensburg Schuetzenstrasse)Ravensburg, GermanyTests it Problems found, fixed voluntarilyJul 13, 2022 · 10 inspections

Product details

Generic drug
Efanesoctocog Alfa: every company that makes it
Form
kit
Strength
250 [iU] per 3 mL
Approval
BLA BLA125771
On the market since
Feb 22, 2023
Package NDCs
71104-035-01 71104-978-01 71104-985-08
Official label
DailyMed (National Library of Medicine), updated Oct 20, 2026

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