Anti-coagulant, Direct Thrombin Inhibitor
Where is Bivalirudin made?
13 companies sell it under their own name. Their labels name 10 factories in India, China, Switzerland, the United States and Israel.
India 4China 3Switzerland 1United States 1Israel 1
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Accord Healthcare Inc.250 mg per 5 mL · NDC 16729-275 | Intas Pharmaceuticals LimitedMakes it and tests it | Ahmedabad, India | No problems foundJul 2024 |
| Intas Pharmaceuticals LimitedMakes it and tests it | Ahmedabad, India | Serious problems, FDA actionDec 2022 | |
| AuroMedics Pharma LLC250 mg · NDC 55150-210 | Eugia Pharma Specialities LimitedMakes it, tests it and packages it | Sangareddy, India | Serious problems, FDA actionFeb 2026 |
| Dr.Reddy's Laboratories Ltd.250 mg · NDC 55111-652 | Gland Pharma LimitedMakes it and tests it | Hyderabad, India | Problems found, fixed voluntarilyJul 2024 |
| ENDO USA, Inc.250 mg · NDC 42023-622 | Bachem AGMakes the active ingredient | Bubendorf, Switzerland | Problems found, fixed voluntarilyAug 2024 |
| Fresenius Kabi, LLC250 mg · NDC 63323-562 | Fresenius Kabi USA, LLCMakes it and tests it | Melrose Park, IL, United States | Problems found, fixed voluntarilyAug 2023 |
| Hainan Shuangcheng Pharmaceuticals Co., Ltd.250 mg · NDC 52958-034 | Hainan Shuangcheng Pharmaceuticals Co., Ltd.Makes it, makes the active ingredient, tests it, packages it, labels it and sterilizes it | Haikou City, China | Problems found, fixed voluntarilyJan 2024 |
| MAIA Pharmaceuticals, Inc.250 mg · NDC 70511-142 | Gland Pharma LimitedMakes it | Hyderabad, India | Problems found, fixed voluntarilyJul 2024 |
| Meitheal Pharmaceuticals Inc.250 mg per 5 mL · NDC 71288-427 | Nanjing King-Friend Biochemical Pharmaceutical Co., Ltd (API and FDF Site)Makes it | Nanjing, China | Problems found, fixed voluntarilyNov 2023 |
| Sandoz Inc.250 mg · NDC 0781-3158 | Novetide Ltd.Makes the active ingredient | Netanya, Israel | No problems foundNov 2019 |
| Slate Run Pharmaceuticals, LLC.250 mg · NDC 70436-025 | Hainan Poly Pharm. Co., Ltd.Makes it | Haikou, China | Problems found, fixed voluntarilyJun 2023 |
| Avenacy Inc.250 mg · NDC 83634-400 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Civica, Inc.250 mg · NDC 72572-035 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Mylan Institutional LLC250 mg per 5 mL · NDC 67457-256 | The label doesn't name the factory. Plants this company names for other drugs | ||
Recalls
- Jul 3, 2023 · Class II · Accord Healthcare, Inc.
Presence of Particulate Matter: Particulate matter identified as fiber.
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.