Factor Xa Inhibitor
Where is Rivaroxaban made?
21 companies sell it under their own name and 3 repackagers rebottle it. Their labels name 18 factories in India, the United States, Germany, Israel, China and Portugal.
India 10United States 3Germany 2Israel 1China 1Portugal 1
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Janssen Pharmaceuticals, Inc. Xarelto2.5 mg, 10 mg, 15 mg, 15 mg / 20 mg, 20 mg, 155 mg · NDC 50458-580, 50458-578, 50458-584 +3 | Bayer AGMakes it, makes the active ingredient, tests it and mills it | Leverkusen, Germany | Problems found, fixed voluntarilyMar 2025 |
| Bayer AGMakes the active ingredient | Wuppertal, Germany | Problems found, fixed voluntarilyJan 2023 | |
| Janssen Ortho LLCMakes it and tests it | Gurabo, PR, United States | Problems found, fixed voluntarilyMar 2023 | |
| Lusomedicamenta - Sociedade Tecnica Farmaceutica, S.a.Makes it | Queluz de Baixo, Portugal | Problems found, fixed voluntarilyOct 2024 | |
| Alembic Pharmaceuticals Inc.2.5 mg, 10 mg, 15 mg, 15 mg / 20 mg, 20 mg · NDC 62332-346, 62332-347, 62332-240 +2 | Alembic Pharmaceuticals LimitedMakes it | Panchmahal, India | No problems foundJul 2024 |
| Alembic Pharmaceuticals Limited2.5 mg, 10 mg, 15 mg, 15 mg / 20 mg, 20 mg · NDC 46708-346, 46708-347, 46708-240 +2 | Alembic Pharmaceuticals LimitedMakes it | Panchmahal, India | No problems foundJul 2024 |
| Ascend Laboratories, LLC155 mg · NDC 67877-882 | Alkem Laboratories LimitedMakes it, tests it and packages it | Amaliya Daman, India | No problems foundAug 2019 |
| Aurobindo Pharma Limited2.5 mg · NDC 59651-849 | Aurobindo Pharma LimitedMakes it and tests it | Mahabubnagar, India | Problems found, fixed voluntarilyMay 2022 |
| Camber Pharmaceuticals Inc.2.5 mg · NDC 31722-496 | Ascent Pharmaceuticals IncMakes it, tests it and packages it | Central Islip, NY, United States | Problems found, fixed voluntarilyAug 2024 |
| Caraco Pharmaceutical Laboratories, Ltd.2.5 mg · NDC 51672-4228 | Taro Pharmaceutical Industries Ltd.Makes it | Haifa Bay, Israel | No problems foundDec 2022 |
| Changzhou Pharmaceutical Factory10 mg, 15 mg, 20 mg · NDC 55488-0540, 55488-0541, 55488-0542 | Changzhou Pharmaceutical FactoryMakes it | Changzhou, China | Problems found, fixed voluntarilyJan 2024 |
| Dr. Reddy's Laboratories Inc.2.5 mg · NDC 43598-981 | Dr. Reddy's Laboratories LimitedMakes it and tests it | Srikakulam, India | Problems found, fixed voluntarilyMay 2022 |
| Exelan Pharmaceuticals, Inc.2.5 mg · NDC 76282-774 | ScieGen Pharmaceuticals, INC.Makes it, tests it and packages it | Hauppauge, NY, United States | Problems found, fixed voluntarilyMay 2026 |
| Florida Pharmaceutical Products, LLC.2.5 mg · NDC 71921-405 | Indoco Remedies LimitedMakes it and tests it | Goa, India | Problems found, fixed voluntarilyJan 2023 |
| Indoco Remedies Limited2.5 mg, 10 mg, 15 mg, 20 mg · NDC 14445-148, 14445-183, 14445-147 +1 | Indoco Remedies LimitedMakes it, tests it, packages it and labels it | Goa, India | Problems found, fixed voluntarilyJan 2023 |
| Lifestar Pharma LLC.2.5 mg · NDC 70756-006 | Mankind Pharma LimitedMakes it, tests it and packages it | Sirmaur, India | Problems found, fixed voluntarilyFeb 2022 |
| Lupin Pharmaceuticals, Inc.2.5 mg, 155 mg · NDC 70748-355, 68180-709 | Lupin LimitedMakes it and packages it | Chhatrapati Sambhajinagar, India | Problems found, fixed voluntarilyMar 2024 |
| Macleods Pharmaceuticals Limited2.5 mg · NDC 33342-488 | Macleods Pharmaceuticals LimitedMakes it, tests it, packages it and labels it | District Solan, India | Problems found, fixed voluntarilyOct 2023 |
| Micro Labs Limited2.5 mg · NDC 42571-345 | Micro Labs LimitedMakes it, tests it, packages it and labels it | Verna, India | Problems found, fixed voluntarilyMay 2025 |
| Northstar Rx LLC.2.5 mg · NDC 72603-890 | Macleods Pharmaceuticals LimitedMakes it, tests it, packages it and labels it | District Solan, India | Problems found, fixed voluntarilyOct 2023 |
| Novadoz Pharmaceuticals LLC2.5 mg · NDC 72205-416 | MSN Laboratories Private LimitedMakes it and tests it | Rangareddy District, India | Problems found, fixed voluntarilyDec 2023 |
| ScieGen Pharmaceuticals, Inc.2.5 mg · NDC 50228-513 | ScieGen Pharmaceuticals, INC.Makes it, tests it and packages it | Hauppauge, NY, United States | Problems found, fixed voluntarilyMay 2026 |
| XLCare Pharmaceuticals, Inc.2.5 mg · NDC 72865-321 | Ascent Pharmaceuticals IncMakes it, tests it and packages it | Central Islip, NY, United States | Problems found, fixed voluntarilyAug 2024 |
| Apotex Corp.2.5 mg · NDC 60505-6256 | The label doesn't name the factory. Plants this company names for other drugs | ||
Repackaged by
These companies buy Rivaroxaban 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:
50090-3625,50090-4469,50090-3639,50090-4468 - Aphena Pharma Solutions - Tennessee, Inc.:
71610-690 - Cardinal Health 107, LLC:
55154-1422,55154-1424,55154-1423
Recalls
- Sep 17, 2014 · Class II · Janssen Ortho L.L.C.
Microbial Contamination of Non-Sterile Products: Consumer complaint confirmed microbial contamination in sales sample.
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.