Drug
Who makes ambrisentan?
12 companies list ambrisentan as a human prescription drug, including under the names Letairis. Forms: 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 ambrisentan
| Company | Forms | Application | NDCs | Registered sites |
|---|---|---|---|---|
| Sun Pharmaceutical Industries LimitedIndia | tablet, film coated | ANDAANDA210784 | 2 | 13 |
| Zydus Lifesciences LimitedIndia | tablet, film coated | ANDAANDA210058 | 2 | 12 |
| CIPLA PHARMACEUTICALS LIMITEDIndia | tablet, film coated | ANDAANDA210715 | 2 | 7 |
| Apotex Inc.Canada | tablet, film coated | ANDAANDA210701 | 2 | 6 |
| Aurobindo Pharma LimitedIndia | tablet, film coated | ANDAANDA216531 | 2 | 6 |
| Gilead Sciences, Inc.United States | tablet, film coated | NDANDA022081 | 2 | 4 |
| International Medication Systems, Ltd.United States | tablet, film coated | ANDAANDA216531 | 2 | 3 |
| Golden State Medical Supply Inc.United States | tablet, film coated | ANDAANDA210701 | 2 | 1 |
| Sigmapharm Laboratories, LLCUnited States | tablet, film coated | ANDAANDA208354 | 2 | 1 |
| Zydus Pharmaceuticals USA Inc.India | tablet, film coated | ANDAANDA210058 | 2 | 1 |
| Mylan Pharmaceuticals, Inc. | tablet, film coated | ANDAANDA208441 | 2 | 0 |
| Quallent Pharmaceuticals Health, LLC | tablet, film coated | ANDAANDA210058 | 2 | 0 |
Bulk ingredient listings
- CIPLA PHARMACEUTICALS LIMITEDIndia · 1 NDC
- MSN Laboratories Private Limited,India · 1 NDC
- Matrix Pharmacorp Private LimitedIndia · 1 NDC
- Medichem Manufacturing (Malta) Ltd. · 1 NDC
- Veranova, L.P.United States · 1 NDC
- Zhejiang Huahai Pharmaceutical Technology Co LtdChina · 1 NDC
Orange Book patents
3 unexpired patents list ambrisentan as the active ingredient, expiring between Dec 2027 and Oct 2031. Application holder: GILEAD SCIENCES INC.
Enquiry
Common questions
- Who makes ambrisentan?
- 12 companies list ambrisentan as a human prescription drug in the openFDA NDC Directory, led by Sun Pharmaceutical Industries Limited, Zydus Lifesciences Limited, CIPLA PHARMACEUTICALS LIMITED, 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 Letairis?
- 11 companies list ambrisentan 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 ambrisentan active ingredient?
- 6 companies list ambrisentan as a bulk ingredient, including CIPLA PHARMACEUTICALS LIMITED, MSN Laboratories Private Limited,, Matrix Pharmacorp Private Limited, Medichem Manufacturing (Malta) Ltd..