Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Catalent Pharma Solutions, LLC | Winchester, KY, United States | Makes it | Problems found, fixed voluntarilyApr 22, 2025 · 10 inspections |
| Janssen Ortho LLC | Gurabo, PR, United States | Makes it and tests it | Problems found, fixed voluntarilyMar 28, 2023 · 7 inspections |
| Janssen Pharmaceutica NV | Geel, Belgium | Makes it and tests it | Problems found, fixed voluntarilyMar 26, 2024 · 7 inspections |
| Janssen Pharmaceuticals, Inc. | Athens, GA, United States | Makes the active ingredient, tests it and packages it | Problems found, fixed voluntarilyJan 24, 2025 · 5 inspections |
| Janssen Cilag SpA | Borgo San Michele, Italy | Tests it and packages it | Problems found, fixed voluntarilySep 27, 2024 · 6 inspections |
| Johnson & Johnson Private Limited | Mumbai, India | Tests it | No problems foundApr 30, 2025 · 4 inspections |
Product details
- Generic drug
- Apalutamide: every company that makes it
- Form
- tablet, film coated, oral
- Strength
- 60 mg
- Approval
- NDA NDA210951
- On the market since
- Feb 14, 2018
- Package NDCs
59676-600-1259676-600-5659676-600-99- Official label
- DailyMed (National Library of Medicine), updated Jul 2, 2026
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