Drug
Who makes carbamazepine?
44 companies list carbamazepine as a human prescription drug, including under the names Carbatrol, EQUETRO, Tegretol, Tegretol XR, Carbamazepin. Forms: capsule, extended release; suspension; tablet; tablet, chewable; tablet, extended release; tablet, film coated, extended release. 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 carbamazepine
| Company | Forms | Application | NDCs | Registered sites |
|---|---|---|---|---|
| Bryant Ranch PrepackUnited States | capsule, extended release; tablet; tablet, chewable; tablet, extended release | ANDAANDA070541, ANDA074649, ANDA075712 | 14 | 1 |
| RemedyRepack, IncUnited States | capsule, extended release; tablet; tablet, chewable; tablet, extended release | ANDAANDA074649, ANDA075687, ANDA075948 | 11 | 1 |
| Alembic Pharmaceuticals LimitedIndia | tablet; tablet, film coated, extended release | ANDAANDA216623, ANDA219939 | 8 | 7 |
| Sun Pharmaceutical Industries LimitedIndia | suspension; tablet; tablet, chewable; tablet, extended release | ANDAANDA074649, ANDA075687, ANDA076729 | 7 | 13 |
| Coupler LLCUnited States | capsule, extended release; tablet; tablet, chewable; tablet, extended release | ANDAANDA075712, ANDA076697, ANDA078115 | 6 | 1 |
| Golden State Medical Supply Inc.United States | tablet; tablet, chewable; tablet, extended release | ANDAANDA074649, ANDA075687, ANDA075948 | 6 | 1 |
| Northstar Rx, LLC, | tablet, extended release | ANDAANDA205571, ANDA216594 | 6 | 0 |
| Novartis Pharmaceuticals CorporationSwitzerland | suspension; tablet; tablet, extended release | NDANDA016608, NDA018927, NDA020234 | 5 | 20 |
| Pharma Packaging Solutions, LLC dba Tjoapack, LLCUnited States | tablet; tablet, chewable; tablet, extended release | ANDAANDA075712, ANDA075948, ANDA211623 | 5 | 5 |
| Torrent Pharma, Inc.India | tablet; tablet, chewable; tablet, extended release | ANDAANDA075712, ANDA077272, ANDA212524 | 5 | 5 |
| UMEDICA LABORATORIES PRIVATE LIMITEDIndia | tablet; tablet, extended release | ANDAANDA207798, ANDA216594 | 5 | 1 |
| Apotex Inc.Canada | capsule, extended release; tablet | ANDAANDA075948, ANDA078986 | 4 | 6 |
| ANI Pharmaceuticals, Inc.United States | capsule, extended release; suspension | ANDAANDA076697, ANDA214277 | 4 | 1 |
| AvPAK | capsule, extended release; tablet | ANDAANDA078986, ANDA218221 | 4 | 0 |
| Zydus Lifesciences LimitedIndia | tablet, extended release | ANDAANDA205571 | 3 | 12 |
| Takeda Pharmaceuticals U.S.A., Inc.Germany | capsule, extended release | NDANDA020712 | 3 | 7 |
| Epic Laboratories, LLCUnited States | tablet, extended release | ANDAANDA216235 | 3 | 3 |
| Ajanta Pharma LimitedIndia | tablet, extended release | ANDAANDA216193 | 3 | 2 |
| Bostal LLCUnited States | tablet, extended release | ANDAANDA215591 | 3 | 1 |
| Rising Pharma Holdings, Inc.United States | tablet, extended release | ANDAANDA211623 | 3 | 1 |
| Zydus Pharmaceuticals USA Inc.India | tablet, extended release | ANDAANDA205571 | 3 | 1 |
| ASCEND Therapeutics US, LLC | tablet, extended release | ANDAANDA217277 | 3 | 0 |
| Ingenus Pharmaceuticals, LLC | tablet, extended release | ANDAANDA216404 | 3 | 0 |
| Jubilant Cadista Pharmaceuticals Inc. | tablet, extended release | ANDAANDA216594 | 3 | 0 |
| MAJOR Pharmaceuticals Inc. | capsule, extended release; tablet; tablet, chewable | ANDAANDA075712, ANDA077272, ANDA078986 | 3 | 0 |
| Novartis Pharma Produktions GmbH | tablet, extended release | DRUG FOR FURTHER PROCESSING | 3 | 0 |
| Upsher-Smith Laboratories, Inc. | tablet, extended release | ANDAANDA213311 | 3 | 0 |
| Validus Pharmaceuticals LLC | capsule, extended release | NDANDA021710 | 3 | 0 |
| International Medication Systems, Ltd.United States | tablet | ANDAANDA074649, ANDA207798 | 2 | 3 |
| Nivagen Pharmaceuticals LLCUnited States | tablet | ANDAANDA207798 | 2 | 2 |
| NCS HealthCare of KY, LLC dba Vangard LabsUnited States | tablet; tablet, chewable | ANDAANDA074649, ANDA075687 | 2 | 1 |
| Preferred Pharmaceuticals Inc.United States | tablet | ANDAANDA075948, ANDA207798 | 2 | 1 |
| Aphena Pharma Solutions - Tennessee, LLC | tablet | ANDAANDA074649, ANDA075948 | 2 | 0 |
| Chartwell Governmental & Specialty RX, LLC. | suspension | ANDAANDA075714 | 2 | 0 |
| Chartwell RX, LLC. | suspension | ANDAANDA075714 | 2 | 0 |
| Oryza Pharmaceuticals, Inc. | tablet, extended release | ANDAANDA212948 | 2 | 0 |
| Cardinal Health 418, Inc.United States | tablet | ANDAANDA077272 | 1 | 34 |
| Unichem Laboratories Limited, IndiaIndia | tablet | ANDAANDA213284 | 1 | 5 |
| Bionpharma Inc.India | tablet | ANDAANDA218221 | 1 | 1 |
| Direct RxUnited States | tablet | ANDAANDA207798 | 1 | 1 |
| NuCare Pharmaceuticals,Inc.United States | tablet | ANDAANDA213284 | 1 | 1 |
| PD-Rx Pharmaceuticals Inc.United States | tablet | ANDAANDA074649 | 1 | 1 |
| Proficient Rx LPUnited States | tablet | ANDAANDA075948 | 1 | 1 |
| Atlantic Biologicals Corps. | suspension | ANDAANDA076729 | 1 | 0 |
Bulk ingredient listings
- FIS FABBRICA ITALIANA SINTETICI SPAItaly · 2 NDC
- Jubilant Biosys LimitedIndia · 2 NDC
- Zhejiang Jiuzhou Pharmaceutical Co., Ltd.China · 2 NDC
- Amoli Organics (A Division of Umedica Laboratories Pvt. Ltd.)India · 1 NDC
- Arene Life Sciences Private LimitedIndia · 1 NDC
- Bajaj Healthcare LtdIndia · 1 NDC
- CTX Lifesciences Pvt. Ltd.India · 1 NDC
- Dasami Lab Private LimitedIndia · 1 NDC
- LETCO MEDICAL, LLCUnited States · 1 NDC
- MEDISCA Inc.United States · 1 NDC
- Professional Compounding Centers of America dba PCCAUnited States · 1 NDC
- Spectrum Pharmaceuticals, Inc.United States · 1 NDC
Orange Book patents
7 unexpired patents list carbamazepine as the active ingredient, expiring between Nov 2028 and Jan 2040. Application holder: LUNDBECK PHARMACEUTICALS LLC.
Enquiry
Common questions
- Who makes carbamazepine?
- 44 companies list carbamazepine as a human prescription drug in the openFDA NDC Directory, led by Bryant Ranch Prepack, RemedyRepack, Inc, Alembic Pharmaceuticals Limited, Sun Pharmaceutical Industries Limited, Coupler 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 Carbatrol?
- 40 companies list carbamazepine under an abbreviated new drug application (ANDA), the application type used for generics, and 3 under an NDA or BLA. Listing status is from the NDC Directory; it is not a statement of availability.
- Who supplies carbamazepine active ingredient?
- 12 companies list carbamazepine as a bulk ingredient, including FIS FABBRICA ITALIANA SINTETICI SPA, Jubilant Biosys Limited, Zhejiang Jiuzhou Pharmaceutical Co., Ltd., Amoli Organics (A Division of Umedica Laboratories Pvt. Ltd.).