Drug
Who makes dabigatran etexilate?
16 companies list dabigatran etexilate as a human prescription drug, including under the names Pradaxa. Forms: capsule; capsule, coated pellets; pellet. Routes: oral.
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 dabigatran etexilate
| Company | Forms | Application | NDCs | Registered sites |
|---|---|---|---|---|
| Alembic Pharmaceuticals LimitedIndia | capsule | ANDAANDA215233 | 6 | 7 |
| Boehringer Ingelheim Biopharmaceuticals China LtdGermany | pellet | NDANDA214358 | 6 | 3 |
| International Medication Systems, Ltd.United States | capsule; capsule, coated pellets | ANDAANDA208040, ANDA213879 | 4 | 3 |
| Apotex Inc.Canada | capsule | ANDAANDA208070 | 3 | 6 |
| Aurobindo Pharma LimitedIndia | capsule | ANDAANDA208039 | 3 | 6 |
| Camber Pharmaceuticals, Inc.United States | capsule | ANDAANDA207961 | 3 | 1 |
| ASCEND Therapeutics US, LLC | capsule, coated pellets | ANDAANDA208040 | 3 | 0 |
| Dr. Reddys Laboratories Limited | capsule | ANDAANDA208048 | 3 | 0 |
| MAJOR Pharmaceuticals Inc. | capsule, coated pellets | ANDAANDA208040 | 3 | 0 |
| Novadoz Pharmaceuticals LLC | capsule | ANDAANDA213879 | 3 | 0 |
| Pharma Packaging Solutions, LLC dba Tjoapack, LLCUnited States | capsule | ANDAANDA213879 | 2 | 5 |
| XLCare Pharmaceuticals Inc.United States | capsule | ANDAANDA207961 | 2 | 1 |
| AvKARE | capsule | ANDAANDA213879 | 2 | 0 |
| Mylan Pharmaceuticals, Inc. | capsule | ANDAANDA208067 | 2 | 0 |
| AvPAK | capsule | ANDAANDA213879 | 1 | 0 |
| NorthStar RxLLC | capsule | ANDAANDA207961 | 1 | 0 |
Bulk ingredient listings
- Boehringer Ingelheim Biopharmaceuticals China LtdGermany · 1 NDC
Enquiry
Common questions
- Who makes dabigatran etexilate?
- 16 companies list dabigatran etexilate as a human prescription drug in the openFDA NDC Directory, led by Alembic Pharmaceuticals Limited, Boehringer Ingelheim Biopharmaceuticals China Ltd, International Medication Systems, Ltd., Apotex Inc., Aurobindo Pharma Limited. 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 Pradaxa?
- 15 companies list dabigatran etexilate under an abbreviated new drug application (ANDA), the application type used for generics, and 1 under an NDA or BLA. Listing status is from the NDC Directory; it is not a statement of availability.
- Who supplies dabigatran etexilate active ingredient?
- 1 company lists dabigatran etexilate as a bulk ingredient, including Boehringer Ingelheim Biopharmaceuticals China Ltd.