Medicine
Tracleer 125 mg tablet
Tracleer 125 mg tablet is a prescription medicine containing Bosentan 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)
- Bosentan
- Brand
- Tracleer
- Strength
- 125 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 10 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). These storage temperatures apply to both film-coated and dispersible tablets. Divided dispersible tablets should be stored under the same conditions and used within 7 days. Tablet pieces may be returned to the opened blister and stored there out of reach of children for up to 7 days.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- C02KX01 Bosentan
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 20 November 2001
- Identifiers
- RxCUI 349253, 352066, 656659 +3DailyMed set ID 749e42fb-2fe0-45dd-9268-b43bb3f4081cNDC 66215-102Application NDA021290
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 |
|---|---|---|---|
| 10 blister pack in 1 carton / 3 tablet, film coated in 1 blister pack | 66215-102-03 | Actelion Pharmaceuticals | 2 October 2012 |
| 1 bottle, plastic in 1 carton / 60 tablet, film coated in 1 bottle, plastic | 66215-102-06 | Actelion Pharmaceuticals | 20 November 2001 |
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 Bosentan 125 mg tablet.
Other strengths and forms of Bosentan
Clinical summary
Bosentan is an endothelin receptor antagonist indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1). It is available as tablets and tablet for oral suspension. MedsAcross supplies Bosentan 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 BosentanFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Tracleer prescribing information (Actelion Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
- Stayveer: European public assessment report (EPAR) · European Medicines Agency
- Tracleer: European public assessment report (EPAR) · European Medicines Agency
Need Tracleer 125 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.