NDC 70437-240

Nerlynx 40 mg tablet

On the label: Puma Biotechnology, Inc..

Spain: 2Germany: 1

Where it's made

FactoryWhereRoleLast FDA inspection
Esteve Quimica, S.A.Celra, SpainMakes the active ingredient and tests it Problems found, fixed voluntarilySep 18, 2025 · 6 inspections
Esteve Quimica, S.A.Banyeres del Penedes, SpainMakes the active ingredient and tests it Problems found, fixed voluntarilyOct 24, 2025 · 7 inspections
Excella GmbH & Co. KGFeucht, GermanyMakes it, tests it, packages it and labels it Problems found, fixed voluntarilyOct 19, 2022 · 7 inspections
AndersonBrecon (UK) LimitedHereford, United KingdomPackages it and labels it Problems found, fixed voluntarilyApr 5, 2024 · 5 inspections
AndersonBrecon Inc.Rockford, IL, United StatesPackages it and labels it No problems foundAug 19, 2026 · 11 inspections
Esteve Quimica, S.A.Barcelona, SpainTests it Problems found, fixed voluntarilyJun 22, 2018 · 3 inspections
Labor LS SE & Co. KGBad Bocklet, GermanyTests it Problems found, fixed voluntarilyDec 14, 2022 · 6 inspections, 1 with FDA action

Product details

Generic drug
Neratinib: every company that makes it
Form
tablet, oral
Strength
40 mg
Approval
NDA NDA208051
On the market since
Jul 17, 2017
Package NDCs
70437-240-18 70437-240-26 70437-240-33
Official label
DailyMed (National Library of Medicine), updated Jul 2, 2026

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