Direct Thrombin Inhibitor
Where is Dabigatran made?
14 companies sell it under their own name and 3 repackagers rebottle it. Their labels name 11 factories in India, the United States, Canada, Italy and Germany.
India 6United States 2Canada 1Italy 1Germany 1
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Boehringer Ingelheim Pharmaceuticals, Inc. Pradaxa20 mg, 30 mg, 40 mg, 50 mg, 75 mg, 110 mg · NDC 0597-0108, 0597-0445, 0597-0360 +6 | Bidachem S.p.a.Makes the active ingredient and tests it | Fornovo S. Giovanni (BG), Italy | Problems found, fixed voluntarilyMay 2024 |
| Boehringer Ingelheim Pharma GmbH and Co. KGMakes it, makes the active ingredient, tests it, packages it and labels it | Ingelheim am Rhein, Germany | Problems found, fixed voluntarilyMay 2025 | |
| Novadoz Pharmaceuticals LLC75 mg, 110 mg, 150 mg · NDC 72205-203, 72205-204, 72205-202 | MSN Laboratories Private LimitedMakes it and tests it | Rangareddy District, India | Problems found, fixed voluntarilyDec 2023 |
| MSN Pharmaceuticals IncMakes it and tests it | Piscataway, NJ, United States | No problems foundMar 2026 | |
| Alembic Pharmaceuticals Inc.75 mg, 110 mg, 150 mg · NDC 62332-635, 62332-636, 62332-634 | Alembic Pharmaceuticals LimitedMakes it | Panchmahal, India | No problems foundJul 2024 |
| Alembic Pharmaceuticals Limited75 mg, 110 mg, 150 mg · NDC 46708-635, 46708-636, 46708-634 | Alembic Pharmaceuticals LimitedMakes it | Panchmahal, India | No problems foundJul 2024 |
| Apotex Corp.75 mg, 110 mg, 150 mg · NDC 60505-4349, 60505-4348, 60505-4347 | Apotex Inc.Makes it and tests it | Etobicoke, Canada | No problems foundSep 2024 |
| Ascend Laboratories, LLC75 mg, 110 mg, 150 mg · NDC 67877-624, 67877-475, 67877-474 | Alkem Laboratories LimitedMakes it | Amaliya Daman, India | No problems foundAug 2019 |
| Aurobindo Pharma Limited75 mg, 110 mg, 150 mg · NDC 59651-974, 59651-975, 59651-973 | Aurobindo Pharma LimitedMakes it and tests it | Mahabubnagar, India | Problems found, fixed voluntarilyMay 2022 |
| Camber Pharmaceuticals Inc.75 mg, 110 mg, 150 mg · NDC 31722-666, 31722-622, 31722-621 | Hetero Labs LimitedMakes it | Hyderabad, India | Problems found, fixed voluntarilyJul 2023 |
| Dr. Reddy's Laboratories Inc.75 mg, 110 mg, 150 mg · NDC 43598-453, 43598-641, 43598-642 | Dr. Reddy's Laboratories LimitedMakes it and tests it | Srikakulam, India | Problems found, fixed voluntarilyMay 2022 |
| Major Pharmaceuticals75 mg, 110 mg, 150 mg · NDC 0904-7254, 0904-7255, 0904-7253 | Alkem Laboratories LimitedMakes it, tests it and packages it | Amaliya Daman, India | No problems foundAug 2019 |
| Northstar Rx LLC.150 mg · NDC 72603-239 | Hetero Labs LimitedMakes it | Hyderabad, India | Problems found, fixed voluntarilyJul 2023 |
| XLCare Pharmaceuticals, Inc.75 mg, 150 mg · NDC 72865-273, 72865-272 | Ascent Pharmaceuticals IncMakes it, tests it and packages it | Central Islip, NY, United States | Problems found, fixed voluntarilyAug 2024 |
| AvKARE, Inc.75 mg, 150 mg · NDC 42291-034, 42291-033 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Mylan Pharmaceuticals Inc.75 mg, 150 mg · NDC 0378-0266, 0378-0265 | The label doesn't name the factory. Plants this company names for other drugs | ||
Repackaged by
These companies buy Dabigatran 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:
50090-3617,50090-7657,50090-8158,50090-7530+2 - American Health Packaging:
60687-974,60687-963 - AvPAK:
50268-200
Recalls
- Jul 16, 2026 · Class III · Ascend Laboratories, LLC · 3 recall notices
Failed impurity/degradation specification: an OOS result observed in Related substance test analysis w.r.t Impurity II, Impurity III and Total impurities for 12-month stability - Jun 30, 2026 · Class III · Ascend Laboratories, LLC · 2 recall notices
Failed Impurities/Degradation Specifications: OOS result was observed during the related substance test analysis with respect to Impurity II, Impurity III and Total impurity testing for 12 Month Long-Term Stability. - Dec 12, 2024 · Class II · Ascend Laboratories, LLC · 2 recall notices
CGMP Deviations: Presence of N-nitroso-Dabigatran impurity above recommended interim limit - Mar 14, 2023 · Class II · Ascend Laboratories, LLC · 2 recall notices
CGMP Deviations: Detection of N-nitroso-dabigatran (NDAB) impurity levels above the Acceptable Daily Intake Limit.
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.