Drug
Who makes argatroban?
12 companies list argatroban as a human prescription drug. Forms: injection; injection, solution; solution. Routes: intravenous.
Labellers from the openFDA NDC Directory. A labeller is the firm named on the label, not necessarily the site that made the product, and a listing is not an FDA approval. Data as of 24 Sept 2026. Methodology
Companies listing argatroban
| Company | Forms | Application | NDCs | Registered sites |
|---|---|---|---|---|
| Hikma Pharmaceuticals USA Inc.United States | injection | NDANDA203049 | 4 | 4 |
| GLAND PHARMA LIMITEDIndia | injection, solution; solution | ANDAANDA205570, ANDA217848 | 2 | 4 |
| Mullan Pharmaceutical Inc. | injection | ANDAANDA217848 | 2 | 0 |
| Fresenius Kabi USA, LLCUnited States | injection | ANDAANDA214235 | 1 | 6 |
| Par Health USA, LLCIndia | injection | ANDAANDA091665 | 1 | 5 |
| ACCORD HEALTHCARE LIMITEDUnited Kingdom | injection | NDANDA212035 | 1 | 2 |
| Amneal Ireland LimitedIreland | injection, solution | ANDAANDA206698 | 1 | 1 |
| CAPLIN STERILES LIMITEDIndia | injection | ANDAANDA214235 | 1 | 1 |
| Eugia US LLC | injection, solution | NDANDA209552 | 1 | 0 |
| Mylan Institutional Inc. | injection, solution | ANDAANDA202626 | 1 | 0 |
| Plano Pharmaceuticals Inc. | solution | NDANDA022485 | 1 | 0 |
| Sagent Pharmaceuticals | injection, solution | ANDAANDA214235 | 1 | 0 |
Bulk ingredient listings
- APOTHECON PHARMACEUTICALS PRIVATE LIMITEDIndia · 1 NDC
- BrightGene Bio-Medical Technology Co., Ltd.China · 1 NDC
- Curia India Private LimitedItaly · 1 NDC
Orange Book patents
2 unexpired patents list argatroban as the active ingredient, expiring between Sept 2027 and Sept 2027. Application holder: CIPLA LTD.
Enquiry
Common questions
- Who makes argatroban?
- 12 companies list argatroban as a human prescription drug in the openFDA NDC Directory, led by Hikma Pharmaceuticals USA Inc., GLAND PHARMA LIMITED, Mullan Pharmaceutical Inc., Fresenius Kabi USA, LLC, Par Health USA, LLC. Each is the labeller, the firm named on the label; the product may be made at a site registered to another company.
- Is there a generic argatroban?
- 8 companies list argatroban under an abbreviated new drug application (ANDA), the application type used for generics, and 4 under an NDA or BLA. Listing status is from the NDC Directory; it is not a statement of availability.
- Who supplies argatroban active ingredient?
- 3 companies list argatroban as a bulk ingredient, including APOTHECON PHARMACEUTICALS PRIVATE LIMITED, BrightGene Bio-Medical Technology Co., Ltd., Curia India Private Limited.