Anti-coagulant, Direct Thrombin Inhibitor
Where is Argatroban made?
13 companies sell it under their own name. Their labels name 5 factories in India.
India 5
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Accord Healthcare Inc.1 mg per 1 mL · NDC 16729-430 | Intas Pharmaceuticals LimitedMakes it and tests it | Ahmedabad, India | No problems foundJul 2024 |
| Amneal Pharmaceuticals LLC100 mg per 1 mL · NDC 70121-1037 | Amneal Pharmaceuticals Private LimitedMakes it, tests it, packages it and sterilizes it | Ahmedabad, India | No problems foundJun 2024 |
| AuroMedics Pharma LLC50 mg per 50 mL · NDC 55150-241 | Eugia Pharma Specialities LimitedMakes it, tests it and packages it | Sangareddy, India | Serious problems, FDA actionFeb 2026 |
| Caplin Steriles Limited50 mg per 50 mL · NDC 65145-126 | Caplin Steriles LimitedMakes it, tests it and packages it | Gummidipoondi, India | No problems foundAug 2024 |
| Fresenius Kabi USA, LLC50 mg per 50 mL · NDC 65219-429 | Caplin Steriles LimitedMakes it, tests it and packages it | Gummidipoondi, India | No problems foundAug 2024 |
| Gland Pharma Limited50 mg per 50 mL, 125 mg per 125 mL · NDC 68083-141, 68083-568 | Gland Pharma LimitedMakes it, tests it, packages it and labels it | Hyderabad, India | Problems found, fixed voluntarilyJul 2024 |
| Hospira, Inc.100 mg per 1 mL · NDC 0409-1140 | Gland Pharma LimitedMakes it, makes the active ingredient, tests it and packages it | Hyderabad, India | Problems found, fixed voluntarilyJul 2024 |
| Mullan Pharmaceutical Inc.50 mg per 50 mL · NDC 83301-0062, 83301-0500 | Gland Pharma LimitedMakes it | Hyderabad, India | Problems found, fixed voluntarilyJul 2024 |
| Hikma Pharmaceuticals USA Inc.50 mg per 50 mL, 250 mg per 2.5 mL · NDC 0143-9288, 0143-9674, 0143-9377 +1 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Mylan Institutional LLC250 mg per 2.5 mL · NDC 67457-212 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Par Health USA, LLC250 mg per 2.5 mL · NDC 42023-182 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Plano Pharmaceuticals Inc.125 mg per 125 mL · NDC 87188-104 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Sagent Pharmaceuticals1 mg per 1 mL · NDC 25021-414 | The label doesn't name the factory. Plants this company names for other drugs | ||
Recalls
- Oct 13, 2026 · Class I · Par Health USA, LLC · 2 recall notices
Particulate matter: particulate matter identified as cellulose, polystyrene, polyethylene teraphalate, stainless steel, or stopper material in the product solution. - Aug 28, 2018 · Class III · Pfizer Inc.
Failed Impurities/Degradation Specifications; Out of specification stability testing results at the 18 month time point - Jul 6, 2017 · Class III · Hospira Inc., A Pfizer Company
Failed Impurities/Degradation Specifications; out of specification result for denitroquinoline-related impurity during three month time point
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.