NDC 63539-927

Lorbrena 25 mg tablet, film coated

On the label: U.S. Pharmaceuticals.

Ireland: 1Germany: 1

Where it's made

FactoryWhereRoleLast FDA inspection
Pfizer Ireland Pharmaceuticals Unlimited CompanyRingaskiddy, IrelandMakes the active ingredient and tests it Problems found, fixed voluntarilyOct 25, 2024 · 6 inspections
Pfizer Manufacturing Deutschland GmbHFreiburg im Breisgau, GermanyMakes it, tests it, packages it and labels it Problems found, fixed voluntarilyJul 2, 2025 · 8 inspections
Pharmacia & Upjohn Company LLCKalamazoo, MI, United StatesPackages it and labels it Problems found, fixed voluntarilyJun 16, 2023 · 9 inspections
Viatris Pharmaceuticals LLCVega Baja, PR, United StatesPackages it and labels it Problems found, fixed voluntarilyMay 18, 2026 · 11 inspections

Product details

Generic drug
Lorlatinib: every company that makes it
Form
tablet, film coated, oral
Strength
25 mg
Approval
NDA NDA210868
On the market since
Jan 3, 2023
Package NDCs
63539-927-01
Official label
DailyMed (National Library of Medicine), updated Feb 13, 2026

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