Low Molecular Weight Heparin
Where is Enoxaparin made?
15 companies sell it under their own name and 3 repackagers rebottle it. Their labels name 12 factories in India, China, the United States, France, Germany, Singapore and 1 other.
India 3China 3United States 2France 1Germany 1Singapore 1Italy 1
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Fresenius Kabi, LLC30 mg per 0.3 mL, 40 mg per 0.4 mL, 60 mg per 0.6 mL, 80 mg per 0.8 mL, 100 mg per 1 mL, 120 mg per 0.8 mL · NDC 63323-605, 63323-586, 63323-609 +12 | Gland Pharma LimitedMakes it, makes the active ingredient, tests it and packages it | Hyderabad, India | Problems found, fixed voluntarilyJul 2024 |
| Gland Pharma LimitedMakes it, tests it and packages it | Hyderabad, India | Problems found, fixed voluntarilyJun 2023 | |
| Patheon Manufacturing Services LLCMakes it, tests it, packages it and labels it | Ridgefield, NJ, United States | Problems found, fixed voluntarilyMar 2024 | |
| Sanofi Winthrop IndustrieMakes it, tests it, packages it and labels it | Le Trait, France | Problems found, fixed voluntarilyApr 2023 | |
| Sanofi-Aventis Deutschland GmbHMakes it, tests it, packages it and labels it | Frankfurt am Main, Germany | Problems found, fixed voluntarilyMar 2022 | |
| Sanofi-Aventis Singapore Pte. Ltd.Makes the active ingredient and tests it | Singapore, Singapore | Problems found, fixed voluntarilyJun 2025 | |
| Sanofi-Aventis U.S. LLC Lovenox30 mg per 0.3 mL, 40 mg per 0.4 mL, 60 mg per 0.6 mL, 80 mg per 0.8 mL, 100 mg per 1 mL, 120 mg per 0.8 mL · NDC 0075-8020, 0075-0623, 0955-1010 +21 | Patheon Manufacturing Services LLCMakes it, tests it, packages it and labels it | Ridgefield, NJ, United States | Problems found, fixed voluntarilyMar 2024 |
| Sanofi Winthrop IndustrieMakes it, tests it, packages it and labels it | Le Trait, France | Problems found, fixed voluntarilyApr 2023 | |
| Sanofi-Aventis Deutschland GmbHMakes it, tests it, packages it and labels it | Frankfurt am Main, Germany | Problems found, fixed voluntarilyMar 2022 | |
| Sanofi-Aventis Singapore Pte. Ltd.Makes the active ingredient and tests it | Singapore, Singapore | Problems found, fixed voluntarilyJun 2025 | |
| BluePoint Laboratories.100 mg per 1 mL, 150 mg per 1 mL, 300 mg per 3 mL · NDC 68001-633, 68001-634, 68001-635 +13 | Amphastar Pharmaceuticals, Inc.Makes it and tests it | Rancho Cucamonga, CA, United States | Problems found, fixed voluntarilyNov 2025 |
| Nanjing King-Friend Biochemical Pharmaceutical Co., Ltd (API and FDF Site)Makes it, tests it and packages it | Nanjing, China | Problems found, fixed voluntarilyNov 2023 | |
| Gland Pharma Limited30 mg per 0.3 mL, 40 mg per 0.4 mL, 60 mg per 0.6 mL, 80 mg per 0.8 mL, 100 mg per 1 mL, 120 mg per 0.8 mL · NDC 68083-638, 68083-639, 68083-640 +4 | Gland Pharma LimitedMakes it, tests it, packages it and labels it | Hyderabad, India | Problems found, fixed voluntarilyJul 2024 |
| Gland Pharma LimitedMakes it, tests it, packages it and labels it | Hyderabad, India | Problems found, fixed voluntarilyJun 2023 | |
| Amphastar Pharmaceuticals, Inc.100 mg per 1 mL, 150 mg per 1 mL, 300 mg per 3 mL · NDC 0548-5601, 0548-5602, 0548-5603 +5 | Amphastar Pharmaceuticals, Inc.Makes it, tests it, packages it and labels it | Rancho Cucamonga, CA, United States | Problems found, fixed voluntarilyNov 2025 |
| BE Pharmaceuticals Inc.30 mg per 0.3 mL, 40 mg per 0.4 mL, 60 mg per 0.6 mL, 80 mg per 0.8 mL, 100 mg per 1 mL, 120 mg per 0.8 mL · NDC 71839-113, 71839-115, 71839-116 +4 | Be Biosol Private LimitedMakes it and tests it | Medchal-Malkajgiri, India | Problems found, fixed voluntarilyNov 2024 |
| Hebei Changshan Biochemical Pharmaceutical Co., Ltd.30 mg per 0.3 mL, 40 mg per 0.4 mL, 60 mg per 0.6 mL, 80 mg per 0.8 mL, 100 mg per 1 mL, 120 mg per 0.8 mL · NDC 28955-105, 28955-106, 28955-107 +4 | Hebei Changshan Biochemical Pharmaceutical Co.,ltd.Makes it and tests it | Shijiazhuang, China | No problems foundApr 2024 |
| Hepalink USA Inc.30 mg per 0.3 mL, 40 mg per 0.4 mL, 60 mg per 0.6 mL, 80 mg per 0.8 mL, 100 mg per 1 mL, 120 mg per 0.8 mL · NDC 81952-130, 81952-132, 81952-135 +4 | Shenzhen Techdow Pharmaceutical Co., Ltd.Makes it and tests it | Shenzhen, China | Problems found, fixed voluntarilySep 2019 |
| Italfarmaco S.p.A30 mg per 0.3 mL, 40 mg per 0.4 mL, 60 mg per 0.6 mL, 80 mg per 0.8 mL, 100 mg per 1 mL, 120 mg per 0.8 mL · NDC 11797-761, 11797-762, 11797-763 +4 | Italfarmaco SPAMakes it | Milan, Italy | Problems found, fixed voluntarilyJun 2023 |
| Meitheal Pharmaceuticals Inc.100 mg per 1 mL, 150 mg per 1 mL, 300 mg per 3 mL · NDC 71288-432, 71288-433, 71288-434 +5 | Nanjing King-Friend Biochemical Pharmaceutical Co., Ltd (API and FDF Site)Makes it | Nanjing, China | Problems found, fixed voluntarilyNov 2023 |
| Northstar Rx LLC.30 mg per 0.3 mL, 40 mg per 0.4 mL, 60 mg per 0.6 mL, 80 mg per 0.8 mL, 100 mg per 1 mL, 120 mg per 0.8 mL · NDC 72603-205, 16714-006, 16714-016 +11 | Shenzhen Techdow Pharmaceutical Co., Ltd.Makes it and tests it | Shenzhen, China | Problems found, fixed voluntarilySep 2019 |
| Sandoz Inc.30 mg per 0.3 mL, 40 mg per 0.4 mL, 60 mg per 0.6 mL, 80 mg per 0.8 mL, 100 mg per 1 mL, 120 mg per 0.8 mL · NDC 0781-3238, 0781-3246, 0781-3256 +11 | Shenzhen Techdow Pharmaceutical Co., Ltd.Makes it and tests it | Shenzhen, China | Problems found, fixed voluntarilySep 2019 |
| Zydus Pharmaceuticals (USA) Inc.30 mg per 0.3 mL, 40 mg per 0.4 mL, 60 mg per 0.6 mL, 80 mg per 0.8 mL, 100 mg per 1 mL, 120 mg per 0.8 mL · NDC 70710-1761, 70710-1762, 70710-1763 +4 | Italfarmaco SPAMakes it | Milan, Italy | Problems found, fixed voluntarilyJun 2023 |
| Civica, Inc.100 mg per 1 mL · NDC 72572-280 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Sagent Pharmaceuticals100 mg per 1 mL, 150 mg per 1 mL · NDC 25021-410, 25021-411 | The label doesn't name the factory. Plants this company names for other drugs | ||
Repackaged by
These companies buy Enoxaparin 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.
- A-S Medication Solutions:
50090-3445 - Cardinal Health 107, LLC:
55154-3540,55154-3541,55154-3542,55154-3543+3 - Physicians Total Care, Inc.:
54868-5835,54868-5837,54868-5440,54868-5587+1
Recalls
- Aug 5, 2025 · Class II · Cardinal Health Inc.
Correct Labeled Product Mispack: Bags labeled for Enoxaparin Sodium Injection, 80 mg/0.8 mL, contained Enoxaparin Sodium Injection, 30 mg/0.3 mL - Jan 26, 2022 · Class II · Cardinal Healthcare
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. - Dec 5, 2017 · Class III · Sanofi-Aventis U.S. LLC
Labeling: Label Error on Declared Strength. A single syringe labeled as 150 mg/1.0 mL was found packaged in a blister labeled as 120 mg/mL
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.