Azole Antifungal
Where is Itraconazole made?
12 companies sell it under their own name and 3 repackagers rebottle it. Their labels name 13 factories in India, the United States, Belgium, Ireland and Australia.
India 7United States 2Belgium 2Ireland 1Australia 1
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Janssen Pharmaceuticals, Inc. Sporanox100 mg · NDC 50458-290 | Janssen Ortho LLCMakes it | Gurabo, PR, United States | Problems found, fixed voluntarilyMar 2023 |
| Janssen Pharmaceutica NVMakes the active ingredient | Geel, Belgium | Problems found, fixed voluntarilyMar 2024 | |
| Janssen Pharmaceutica NVMakes it | Olen, Belgium | Problems found, fixed voluntarilyOct 2025 | |
| Janssen Pharmaceutical Sciences Unlimited CompanyMakes the active ingredient | Co Cork, Ireland | Problems found, fixed voluntarilyOct 2023 | |
| Patriot Pharmaceuticals100 mg · NDC 10147-1700 | Janssen Ortho LLCMakes it | Gurabo, PR, United States | Problems found, fixed voluntarilyMar 2023 |
| Janssen Pharmaceutica NVMakes the active ingredient | Geel, Belgium | Problems found, fixed voluntarilyMar 2024 | |
| Janssen Pharmaceutica NVMakes it | Olen, Belgium | Problems found, fixed voluntarilyOct 2025 | |
| Janssen Pharmaceutical Sciences Unlimited CompanyMakes the active ingredient | Co Cork, Ireland | Problems found, fixed voluntarilyOct 2023 | |
| Amneal Pharmaceuticals10 mg per 1 mL, 100 mg · NDC 65162-087, 65162-630 | Amneal Pharmaceuticals Private LimitedMakes it, tests it, packages it and labels it | Ahmedabad, India | Problems found, fixed voluntarilyJan 2025 |
| Amneal Pharmaceuticals, LLCMakes it, tests it, packages it and labels it | Branchburg, NJ, United States | No problems foundAug 2026 | |
| Torrent Pharma, Inc.100 mg · NDC 13668-463 | Torrent Pharmaceuticals LimitedMakes it | Indrad, India | Problems found, fixed voluntarilyJun 2024 |
| Torrent Pharmaceuticals LimitedMakes it | Bharuch, India | No problems foundJan 2026 | |
| Alembic Pharmaceuticals Inc.100 mg · NDC 62332-204 | Alembic Pharmaceuticals LimitedMakes it | Panchmahal, India | No problems foundJul 2024 |
| Alembic Pharmaceuticals Limited100 mg · NDC 46708-204 | Alembic Pharmaceuticals LimitedMakes it | Panchmahal, India | No problems foundJul 2024 |
| Ascend Laboratories, LLC100 mg · NDC 67877-454 | Alkem Laboratories LimitedMakes it, tests it and packages it | Amaliya Daman, India | No problems foundAug 2019 |
| Camber Pharmaceuticals Inc.10 mg per 1 mL · NDC 31722-006 | Annora Pharma Private LimitedMakes it | Sangareddy, India | Problems found, fixed voluntarilyMar 2025 |
| Mayne Pharma Inc. Tolsura65 mg · NDC 51862-462 | Mayne Pharma International Pty Ltd.Makes it and tests it | Salisbury South, Australia | Problems found, fixed voluntarilyMar 2025 |
| Natco Pharma USA LLC10 mg per 1 mL · NDC 69339-159 | Annora Pharma Private LimitedMakes it | Sangareddy, India | Problems found, fixed voluntarilyMar 2025 |
| Northstar Rx LLC.100 mg · NDC 16714-743 | Alkem Laboratories LimitedMakes it | Amaliya Daman, India | No problems foundAug 2019 |
| Rising Pharma Holdings, Inc.100 mg · NDC 16571-245 | Cohance Lifesciences LimitedMakes it | Medchal-Malkajgiri, India | Problems found, fixed voluntarilyAug 2019 |
Repackaged by
These companies buy Itraconazole in bulk and rebottle it, often for mail-order, clinic or hospital pharmacies. If your bottle shows one of these names, open its NDC to see who made the pills inside.
- American Health Packaging:
60687-299 - AvPAK:
50268-450 - Carilion Materials Management:
68151-2718