Factor Xa Inhibitor
Where is Fondaparinux made?
6 companies sell it under their own name and 1 repackager rebottle it. Their labels name 5 factories in India, Italy, Taiwan and China.
India 2Italy 1Taiwan 1China 1
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Italfarmaco S.p.A2.5 mg per 0.5 mL, 5 mg per 0.4 mL, 7.5 mg per 0.6 mL, 10 mg per 0.8 mL · NDC 11797-157, 11797-154, 11797-155 +1 | Italfarmaco SPAMakes it, tests it, packages it and labels it | Milan, Italy | Problems found, fixed voluntarilyJun 2023 |
| ScinoPharm Taiwan, Ltd.Makes the active ingredient | Tainan, Taiwan | Serious problems, FDA actionJun 2026 | |
| AuroMedics Pharma LLC2.5 mg per 0.5 mL, 5 mg per 0.4 mL, 7.5 mg per 0.6 mL, 10 mg per 0.8 mL · NDC 55150-233, 55150-230, 55150-231 +1 | Eugia Pharma Specialities LimitedMakes it, tests it and packages it | Sangareddy, India | Serious problems, FDA actionFeb 2026 |
| Dr.Reddy's Laboratories Ltd.2.5 mg per 0.5 mL, 5 mg per 0.4 mL, 7.5 mg per 0.6 mL, 10 mg per 0.8 mL · NDC 55111-681, 55111-678, 55111-679 +1 | Gland Pharma LimitedMakes it and tests it | Hyderabad, India | Problems found, fixed voluntarilyJul 2024 |
| Sandoz Inc.2.5 mg per 0.5 mL, 5 mg per 0.4 mL, 7.5 mg per 0.6 mL, 10 mg per 0.8 mL · NDC 0781-3476, 0781-3443, 0781-3454 +1 | Jiangsu Hengrui Pharmaceuticals Co., Ltd. (Dongjin Road Site)Makes it, tests it, packages it, labels it and sterilizes it | Lianyungang, China | Problems found, fixed voluntarilyAug 2023 |
| Zydus Pharmaceuticals (USA) Inc.2.5 mg per 0.5 mL, 5 mg per 0.4 mL, 7.5 mg per 0.6 mL, 10 mg per 0.8 mL · NDC 70710-1517, 70710-1514, 70710-1515 +1 | ScinoPharm Taiwan, Ltd.Makes the active ingredient | Tainan, Taiwan | Serious problems, FDA actionJun 2026 |
| Mylan Institutional LLC Arixtra2.5 mg per 0.5 mL, 5 mg per 0.4 mL, 7.5 mg per 0.6 mL, 10 mg per 0.8 mL · NDC 67457-595, 67457-585, 67457-592 +5 | The label doesn't name the factory. Plants this company names for other drugs | ||
Repackaged by
These companies buy Fondaparinux 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.
- Physicians Total Care, Inc.:
54868-5652,54868-5501
Recalls
- Sep 30, 2022 · Class II · AuroMedics Pharma LLC
Subpotent Drug: Out of specification for assay
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.