Macitentan 10 mg Suppliers & Bulk Manufacturers

Available Forms: Tablets

Available Strengths: 10 mg

Reference Brands: Opsumit (USA)

Category: Heart Disorder

Macitentan 10 mg film-coated tablets, a once-daily endothelin receptor antagonist for pulmonary arterial hypertension, for hospital pharmacies, specialist distributors and tender buyers in registered markets.

Product Description:

Macitentan is an oral endothelin receptor antagonist for pulmonary arterial hypertension (PAH). It blocks both ETA and ETB receptors, more strongly at ETA, countering the vessel narrowing and wall thickening that endothelin drives in the lungs. This page lists 10 mg film-coated tablets, the standard adult dose taken once a day with or without food. A single strength keeps the regimen simple for this long-term specialist medicine.

It is licensed for long-term use in adults with PAH in WHO functional class II to III, alone or with a phosphodiesterase-5 inhibitor and other PAH therapies. Embryo-fetal toxicity is the key risk: it is contraindicated in pregnancy, and women who could conceive need a negative test before starting, reliable contraception and monthly testing. Liver tests and haemoglobin are checked before and during use. Strong CYP3A4 inducers such as rifampicin should be avoided.

Sourcing notes. Macitentan is prescription-only and bought mainly by hospital pharmacies and national PAH programmes. Registration normally needs a full CTD or ACTD dossier with bioequivalence data against the reference product. Patent status still varies by market, so confirm it before quoting. Tablets come in blisters or bottles with desiccant; request zone IVb data where the climate is hot and humid. Ask for the patient card or prescriber guide the regulator requires, plus a batch CoA, GMP certificate and CoPP. Specify pack size, pack type and shelf life on arrival.