Antimetabolite
Where is Hydroxyurea made?
11 companies sell it under their own name and 6 repackagers rebottle it. Their labels name 5 factories in the United States, the United Kingdom, China and Italy.
United States 2United Kingdom 1China 1Italy 1
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Leading Pharma, LLC500 mg · NDC 69315-164 | Halo Pharmaceutical IncMakes it | Whippany, NJ, United States | No problems foundDec 2025 |
| Nova Laboratories, Ltd. Xromi100 mg per 1 mL · NDC 62484-0015 | Nova Laboratories LtdMakes it | Wigston, United Kingdom | Problems found, fixed voluntarilyFeb 2019 |
| Qilu Pharmaceutical Co., Ltd.500 mg · NDC 67184-0607 | Qilu Pharmaceutical Co., Ltd. (Biological Industrial Park)Makes it, tests it and packages it | Jinan, China | Problems found, fixed voluntarilyMay 2026 |
| Somerset Therapeutics, LLC500 mg · NDC 70069-820 | Qilu Pharmaceutical Co., Ltd. (Biological Industrial Park)Makes it, tests it and packages it | Jinan, China | Problems found, fixed voluntarilyMay 2026 |
| Waylis Therapeutics LLC Droxia, Hydrea200 mg, 300 mg, 400 mg, 500 mg · NDC 80725-820, 80725-830, 80725-840 +1 | Latina Pharma S.P.AMakes it | Sermoneta, Italy | Problems found, fixed voluntarilyJan 2024 |
| Yunigen, Inc.100 mg, 500 mg · NDC 87500-100, 87500-101 | Yunigen, Inc.Makes it, tests it, packages it and labels it | Morgantown, WV, United States | Not inspected on record |
| ENDO USA, Inc.500 mg · NDC 49884-724 | The label doesn't name the factory. Plants this company names for other drugs | ||
| H2-Pharma LLC Droxia, Hydrea200 mg, 300 mg, 400 mg, 500 mg · NDC 61269-402, 61269-403, 61269-404 +1 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Marlex Pharmaceuticals, Inc.500 mg · NDC 10135-702 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Medunik Siklos100 mg, 1000 mg · NDC 71770-105, 71770-120 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Teva Pharmaceuticals USA, Inc.500 mg · NDC 0555-0882 | The label doesn't name the factory. Plants this company names for other drugs | ||
Repackaged by
These companies buy Hydroxyurea 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:
68084-284 - AvKARE, Inc.:
42291-321 - Coupler LLC:
67046-1619 - Golden State Medical Supply, Inc.:
51407-909 - Major Pharmaceuticals:
0904-6939 - Physicians Total Care, Inc.:
54868-4773