Medicine
Opsumit 10 mg tablet
Opsumit 10 mg tablet is a prescription medicine containing Macitentan for oral use, marketed by Actelion Pharmaceuticals, with its source record on the US FDA register. It is available on request for export supply from India to licensed hospitals, importers and physicians.
Availability
Export supply from India to licensed buyers
Typical lead time
On request
Counted from payment and complete documents
Shipping
Ambient
Store at 20 ºC to 25 ºC (68 ºF to 77 ºF). Excursions are permitted between 15…
Key facts
- Active ingredient (INN)
- Macitentan
- Brand
- Opsumit
- Strength
- 10 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 1 blister pack, 1 bottle
- Marketing authorisation holder
- Actelion Pharmaceuticals
- Manufacturer
- Actelion Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Store at 20 ºC to 25 ºC (68 ºF to 77 ºF). Excursions are permitted between 15 °C and 30 °C (59 °F and 86 °F).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- C02KX04 Macitentan
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 4 November 2013
- Identifiers
- RxCUI 1442137, 1442143DailyMed set ID 1e484a50-55db-4b85-8c57-6cd1b0353abdNDC 66215-501Application NDA204410
Record updated 12 November 2026
Documents available
Documents that can be provided with this medicine. Your regulator may ask for more, and the quote lists the full set.
No document list is recorded for this medicine yet. Tell us which documents your regulator needs (for example a CoA, COPP or GMP certificate) when you request a quote.
Packs
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 1 blister pack in 1 carton / 15 tablet, film coated in 1 blister pack | 66215-501-15 | Actelion Pharmaceuticals | 4 November 2013 |
| 1 bottle in 1 carton / 30 tablet, film coated in 1 bottle | 66215-501-30 | Actelion Pharmaceuticals | 4 November 2013 |
Status by register
Where this medicine is registered, from the source record and the regulator data we hold. Ask us about a country that is not listed.
Import route
Pick the destination country to see the legal import route, who applies and typical timelines, from our import guide for that country.
Import guides are available for 25 countries. Pick one to see its route summary.
BrazilColombiaEgyptEthiopiaGhanaIraqKazakhstanKenyaAll import guides
Alternatives
Other makers and brands of Macitentan 10 mg tablet.
Clinical summary
Macitentan is an endothelin receptor antagonist. It is available as tablets for oral use. MedsAcross supplies Macitentan for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
Read about MacitentanFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- OPSUMIT prescribing information (Actelion Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
- Opsumit: European public assessment report (EPAR) · European Medicines Agency
- Macitentan Accord: European public assessment report (EPAR) · European Medicines Agency
Need Opsumit 10 mg tablet for your hospital or patient?
Send one request with the destination country and quantity. We confirm availability, lead time and the documents your regulator needs.