Drug
Who makes macitentan?
14 companies list macitentan as a human prescription drug, including under the names OPSUMIT. 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 macitentan
| Company | Forms | Application | NDCs | Registered sites |
|---|---|---|---|---|
| Alembic Pharmaceuticals LimitedIndia | tablet, film coated | ANDAANDA211128 | 2 | 7 |
| Sun Pharmaceutical Industries LimitedIndia | tablet, film coated | ANDAANDA211123 | 1 | 13 |
| Apotex Inc.Canada | tablet, film coated | ANDAANDA211195 | 1 | 6 |
| Aurobindo Pharma LimitedIndia | tablet, film coated | ANDAANDA211198 | 1 | 6 |
| Teva Pharmaceutical Industries Ltd.Canada | tablet, film coated | ANDAANDA211187 | 1 | 6 |
| LAURUS LABS LIMITEDIndia | tablet, film coated | ANDAANDA211120 | 1 | 5 |
| Sandoz Industrial Products S.AAustria | tablet, film coated | ANDAANDA211136 | 1 | 5 |
| Torrent Pharma, Inc.India | tablet | ANDAANDA211107 | 1 | 5 |
| Excella GmbH & Co. KGGermany | tablet, film coated | DRUG FOR FURTHER PROCESSING | 1 | 1 |
| Novugen Pharma Sdn. Bhd.Malaysia | tablet, film coated | ANDAANDA211026 | 1 | 1 |
| Zydus Pharmaceuticals USA Inc.India | tablet, film coated | ANDAANDA211224 | 1 | 1 |
| Actelion Pharmaceuticals US, Inc. | tablet, film coated | NDANDA204410 | 1 | 0 |
| Amneal Pharmaceuticals NY LLC | tablet, film coated | ANDAANDA211000 | 1 | 0 |
| Mylan Pharmaceuticals, Inc. | tablet, film coated | ANDAANDA211161 | 1 | 0 |
Bulk ingredient listings
- Zhejiang Ausun Pharmaceutical Co., Ltd.China · 2 NDC
- Aurobindo Pharma LimitedIndia · 1 NDC
- Honour Lab LimitedIndia · 1 NDC
- MSN Life Sciences Private LimitedIndia · 1 NDC
- Mylan Pharmaceuticals, Inc. · 1 NDC
- TAPI Croatia industries d.o.o.Croatia · 1 NDC
- Viyash Life Sciences Private Limited · 1 NDC
- ZHEJIANG LEPU PHARMACEUTICAL CO., LTD.China · 1 NDC
Orange Book patents
7 unexpired patents list macitentan as the active ingredient, expiring between Mar 2027 and Oct 2029. Application holder: ACTELION PHARMACEUTICALS US INC.
Enquiry
Common questions
- Who makes macitentan?
- 14 companies list macitentan as a human prescription drug in the openFDA NDC Directory, led by Alembic Pharmaceuticals Limited, Sun Pharmaceutical Industries Limited, Apotex Inc., Aurobindo Pharma Limited, Teva Pharmaceutical Industries Ltd.. 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 OPSUMIT?
- 12 companies list macitentan 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 macitentan active ingredient?
- 8 companies list macitentan as a bulk ingredient, including Zhejiang Ausun Pharmaceutical Co., Ltd., Aurobindo Pharma Limited, Honour Lab Limited, MSN Life Sciences Private Limited.