NDC 71104-922

Alprolix 1000 [iU] per 5 mL kit

On the label: Bioverativ Therapeutics Inc..

United States: 3Germany: 2

Where it's made

FactoryWhereRoleLast FDA inspection
Biogen MA Inc.Morrisville, NC, United StatesMakes the active ingredient and tests it 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
Lonza Biologics, Inc.Portsmouth, NH, United StatesMakes the active ingredient and tests it Problems found, fixed voluntarilyFeb 6, 2026 · 8 inspections
Vetter Pharma Fertigung GmbH & Co. KG (Langenargen Eisenbahnstrasse)Langenargen, GermanyMakes it and tests it Problems found, fixed voluntarilyMar 20, 2024 · 8 inspections
Vetter Pharma Fertigung GmbH & Co. KG (Ravensburg Schuetzenstrasse)Ravensburg, GermanyMakes it and tests it Problems found, fixed voluntarilyJul 13, 2022 · 10 inspections
Avista Pharma Solutions, Inc. dba CambrexAgawam, MA, United StatesTests it Problems found, fixed voluntarilyJul 25, 2025 · 6 inspections
Eurofins Biopharma Product Testing Ireland LimitedIrelandTests it Problems found, fixed voluntarilyMay 26, 2023 · 5 inspections
Eurofins Biopharma Product Testing Munich GmbHPlanegg, GermanyTests it Problems found, fixed voluntarilyJun 23, 2023 · 3 inspections
PPD Development Ireland Ltd.Athlone, IrelandTests it Problems found, fixed voluntarilyMar 9, 2023 · 4 inspections
Packaging Coordinators, LLCPhiladelphia, PA, United StatesPackages it and labels it Problems found, fixed voluntarilyJan 31, 2025 · 6 inspections
Rechon Life Science ABLimhamn, SwedenPackages it and labels it Serious problems, FDA actionSep 6, 2024 · 6 inspections, 1 with FDA action
Sharp Packaging Services, LLCAllentown, PA, United StatesPackages it and labels it No problems foundNov 21, 2025 · 7 inspections
Vetter Pharma Fertigung GmbH & Co. KG (Ravensburg Mooswiesen)Ravensburg, GermanyTests it, packages it and labels it Problems found, fixed voluntarilyJul 21, 2023 · 8 inspections

Product details

Generic drug
Eftrenonacog Alfa: every company that makes it
Form
kit
Strength
1000 [iU] per 5 mL
Approval
BLA BLA125444
On the market since
May 5, 2014
Package NDCs
71104-045-01 71104-922-01 71104-954-09
Official label
DailyMed (National Library of Medicine), updated May 16, 2024

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