Drug
Who makes dapagliflozin?
23 companies list dapagliflozin as a human prescription drug, including under the names FARXIGA. Forms: tablet; tablet, film coated. 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 dapagliflozin
| Company | Forms | Application | NDCs | Registered sites |
|---|---|---|---|---|
| International Medication Systems, Ltd.United States | tablet, film coated | ANDA, NDA, NDA AUTHORIZED GENERICANDA211468, NDA202293 | 6 | 3 |
| Alembic Pharmaceuticals LimitedIndia | tablet, film coated | ANDAANDA211560 | 4 | 7 |
| AstraZeneca PLCUnited States | tablet, film coated | NDANDA202293 | 2 | 15 |
| Lupin LimitedIndia | tablet | ANDAANDA211531 | 2 | 14 |
| Zydus Lifesciences LimitedIndia | tablet | ANDAANDA211582 | 2 | 12 |
| Biocon Biologics LimitedIndia | tablet, film coated | ANDAANDA211470 | 2 | 9 |
| CIPLA PHARMACEUTICALS LIMITEDIndia | tablet, film coated | ANDAANDA211535 | 2 | 7 |
| Apotex Inc.Canada | tablet, film coated | ANDAANDA211523 | 2 | 6 |
| Aurobindo Pharma LimitedIndia | tablet, film coated | ANDAANDA211468 | 2 | 6 |
| Teva Pharmaceutical Industries Ltd.Canada | tablet, film coated | ANDAANDA211541 | 2 | 6 |
| Macleods Pharmaceuticals LimitedIndia | tablet | ANDAANDA211506 | 2 | 5 |
| Sandoz Industrial Products S.AAustria | tablet, film coated | ANDAANDA211312 | 2 | 5 |
| Ajanta Pharma LimitedIndia | tablet | ANDAANDA211482 | 2 | 2 |
| ANI Pharmaceuticals, Inc.United States | tablet, film coated | ANDAANDA211156 | 2 | 1 |
| Bryant Ranch PrepackUnited States | tablet, film coated | ANDA, NDA AUTHORIZED GENERICANDA211541, NDA202293 | 2 | 1 |
| Florida Pharmaceutical Products LLCUnited States | tablet | ANDAANDA211156 | 2 | 1 |
| Zydus Pharmaceuticals USA Inc.India | tablet | ANDAANDA211582 | 2 | 1 |
| ASCEND Therapeutics US, LLC | tablet, film coated | ANDAANDA211545 | 2 | 0 |
| AvKARE | tablet, film coated | ANDAANDA211478 | 2 | 0 |
| Novadoz Pharmaceuticals LLC | tablet, film coated | ANDAANDA211478 | 2 | 0 |
| Prasco Laboratories | tablet, film coated | NDA AUTHORIZED GENERICNDA202293 | 2 | 0 |
| RedPharm DrugUnited States | tablet | ANDAANDA211506 | 1 | 1 |
| RemedyRepack, IncUnited States | tablet, film coated | NDANDA202293 | 1 | 1 |
Bulk ingredient listings
- Dr. Reddy's Laboratories LimitedIndia · 2 NDC
- Zhejiang Ausun Pharmaceutical Co., Ltd.China · 2 NDC
- Alivus Life Sciences Limited · 1 NDC
- Aurobindo Pharma LimitedIndia · 1 NDC
- Biocon Biologics LimitedIndia · 1 NDC
- HARMAN FINOCHEM LIMITEDIndia · 1 NDC
- Honour Lab LimitedIndia · 1 NDC
- Jiangsu Hansoh Pharmaceutical Group Co., Ltd.China · 1 NDC
- M/s. Lee Pharma Limited · 1 NDC
- MSN Laboratories Private Limited,India · 1 NDC
- Optimus Drugs Private LimitedIndia · 1 NDC
- SK BIOTEKIreland · 1 NDC
- SUN PHARMACEUTICAL IND LTD, MUMBAI · 1 NDC
Orange Book patents
29 unexpired patents list dapagliflozin as the active ingredient, expiring between Feb 2027 and Oct 2041. Application holder: ASTRAZENECA AB.
Enquiry
Common questions
- Who makes dapagliflozin?
- 23 companies list dapagliflozin as a human prescription drug in the openFDA NDC Directory, led by International Medication Systems, Ltd., Alembic Pharmaceuticals Limited, AstraZeneca PLC, Lupin Limited, Zydus Lifesciences 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 FARXIGA?
- 20 companies list dapagliflozin 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 dapagliflozin active ingredient?
- 13 companies list dapagliflozin as a bulk ingredient, including Dr. Reddy's Laboratories Limited, Zhejiang Ausun Pharmaceutical Co., Ltd., Alivus Life Sciences Limited, Aurobindo Pharma Limited.