Opsumit (macitentan) is an oral endothelin receptor antagonist for pulmonary arterial hypertension, supplied as a 10 mg film-coated tablet taken once daily, with a US boxed warning on embryo-fetal toxicity and no cold chain.
M Care Exports supplies Opsumit (macitentan) and Indian-made macitentan tablets to hospital pharmacies, importers and tender desks in the GCC, Africa and the UK. If you are looking for the 10 mg tablet, send the destination, the pack and the quantity, and we quote per destination.
Macitentan exporter and bulk supplier from India.
"We need a partner for Opsumit 10 mg" is a typical enquiry from a hospital pharmacy that serves a pulmonary hypertension clinic, or from a tender desk. M Care is a merchant-exporter: we supply originator or regulator-registered brands and Indian-made lines, and we confirm which one your destination's registration route accepts before quoting. Our catalogue lists an Indian-made line, Macitent 10 mg tablets. We do not state that it is registered in any destination. The originator film-coated tablet is one strength, 10 mg, so the quote turns on the pack format (the US label lists 15-count blisters in a carton and 30-count bottles, the UK SmPC lists blisters in cartons of 30 film-coated tablets), the quantity, the destination's registration route and Incoterms. The label texts we read set no refrigeration requirement. A macitentan and tadalafil tablet, Opsynvi, has its own DailyMed label and is a separate product that this page does not cover.
Source
WHO-GMP-certified Indian manufacturing line, named on every quote.
Minimum order
No blanket MOQ. Set by the source manufacturer's minimum batch-release quantity for the strength and pack ordered.
Pricing
On request. Indicative FOB or CIF quote, formal proforma on confirmation.
Incoterms
EXW, FOB, CIF, CIP or DAP.
Payment
Letter of credit (sight or usance) and telegraphic transfer.
Documentation
WHO-GMP certificate of the source line, product-specific CoPP, batch CoA, method of analysis, Free Sale Certificate, Certificate of Origin, CTD or eCTD dossier. On request.
Shelf-life
Minimum remaining shelf-life agreed per order and confirmed on the proforma.
Response
Availability and CoPP status within two working days; pre-alert documents before dispatch.
Endothelin receptor antagonist, sourced and documented for export.
Opsumit is an endothelin receptor antagonist (ERA). The UK SmPC states that macitentan is active on both ET A and ET B receptors and is approximately 100-fold more selective for ET A in vitro. The US label (Actelion Pharmaceuticals US, Inc., revised 4/2025) lists one strength, a 10 mg bi-convex, round, white film-coated tablet, and indicates it in adults for pulmonary arterial hypertension (PAH, WHO Group I) to reduce the risks of disease progression and hospitalization for PAH. The dose is 10 mg once daily, and the label states that doses higher than 10 mg once daily have not been studied in PAH and are not recommended. The UK SmPC (Janssen-Cilag Limited) covers long-term treatment of PAH in adults of WHO Functional Class II to III, and in paediatric patients aged less than 18 years with bodyweight of at least 40 kg and WHO Functional Class II to III. The UK SmPC says the 10 mg film-coated tablets are only recommended in paediatric patients weighing at least 40 kg, and a 2.5 mg dispersible tablet is available for those under 40 kg. The EMA page for Opsumit, authorised in the EU on 20 December 2013, lists paediatric indications both for patients under 18 years weighing at least 40 kg and for patients aged 2 years to less than 18 years, and notes that dispersible tablets are available for children. The US label states that safety and effectiveness in paediatric patients have not been established for the treatment of PAH.
Active ingredient
Macitentan. Endothelin receptor antagonist.
Forms and strengths
10 mg film-coated tablet; 2.5 mg dispersible tablet (paediatric, UK SmPC).
Indications
Macitentan is an oral endothelin receptor antagonist indicated for pulmonary arterial hypertension, with each market's indication and age limits worded by its own label. Supplied by M Care Exports as originator Opsumit and as Indian-made lines.
Administration
Oral. Film-coated tablet.
Documentation
Batch-specific CoA, CoPP, manufacturing-site WHO-GMP certificate and stability data compiled per consignment, in the format the destination regulator expects.
Hospital pharmacies, licensed importers and tender desks across our export markets.
India is our origin. We do not sell into the Indian market.
Buyers are hospital pharmacists, MoH and hospital tender desks, and licensed importers and distributors in the GCC, Africa and the UK. Typical enquiries read "I'm looking for Opsumit 10 mg for a PAH clinic" or "We need a partner for macitentan tablets for a tender". The UK SmPC says treatment should only be initiated and monitored by a physician experienced in the treatment of PAH, so most demand comes through specialist centres. Each destination has its own route, for example the Emirates Drug Establishment (EDE) in the UAE and the MHRA in the UK. Whether a given destination has registered the product, or needs an unlicensed or named-patient import, depends on that regulator, and M Care Exports confirms the route per enquiry.
GCC registration routes
Supply against MoH registration held by your local licensed importer, or via the GCC central registration pathway.
UK unlicensed routes
Where no UK licence exists, the MHRA Specials and named-patient import routes cover clinically justified demand.
Tender desks
Bid-pack documentation assembled to the tender's specification, from CoPP to batch records.
Dossier support
CTD documentation from the sourcing manufacturer, compiled for your regulator's format.
What the dispensing pharmacist checks on macitentan.
Start with pregnancy and the liver. The US label carries a boxed warning on embryo-fetal toxicity: exclude pregnancy before treatment in females of reproductive potential, and use effective contraception before starting, during treatment and for one month after stopping. The UK SmPC adds that monthly pregnancy tests are recommended, and it contraindicates use in pregnancy, in women of childbearing potential not using reliable contraception, and during breastfeeding. For the liver, the US label says to obtain baseline liver enzymes and monitor as clinically indicated, while the UK SmPC recommends monthly ALT and AST monitoring. Both texts ask for haemoglobin before starting and repeat testing as clinically indicated, and advise against starting in severe anaemia. On interactions, the US label says to avoid co-administration with strong CYP3A4 inducers such as rifampin and with strong CYP3A4 inhibitors such as ketoconazole and ritonavir. The UK SmPC reports that rifampicin 600 mg daily reduced steady-state macitentan exposure by 79%. Storage is ambient: the US label gives 20 to 25 °C, and the UK SmPC says not above 30 °C.
The documentation pack a regulator actually asks for.
Opsumit is an ambient-temperature tablet. The US label gives 20 °C to 25 °C with excursions permitted between 15 °C and 30 °C. The UK SmPC says do not store above 30 °C and gives a shelf life of 5 years. Holders as the labels name them: Actelion Pharmaceuticals US, Inc. on the US label and Janssen-Cilag Limited on the UK SmPC. The EMA page we read does not name the EU holder. M Care documentation covers batch certificates of analysis, export documents and destination-aligned dossier support where the regulator asks for it. We state the source and status of each line before quoting, and we make no claim of WHO-GMP or WHO prequalification for ourselves.
CoA and MoA, per batch
Batch-specific certificate and method of analysis from the sourcing manufacturer's QC release.
CoPP, WHO-GMP, MFG licence
Certificate of pharmaceutical product and site GMP certification issued via CDSCO channels, naming the actual manufacturing site.
CTD Module 3
Chemistry, manufacturing and controls documentation available from the sourcing manufacturer for registration filings.
Pack insert, labels, artwork
Destination-language patient information and labelling to the local regulator's standard, locked before shipment.
Pharmacovigilance
A named PV contact arranged in the destination market where the registration requires one.
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The full category listing for procurement desks.
Molecule · strength · volume · destination. One working day to a quote.
- Send us the specifics. Form and strength, pack preference, destination market and indicative volume for macitentan.
- We route to the right line. The enquiry goes to the WHO-GMP certified manufacturing partner whose certificates fit your regulator.
- Commercial and regulatory offer. FOB or CIF price with the documentation list, named manufacturing site and current certificate validity.
- Order, produce, release, ship. QC release on the Indian side, batch documents compiled, despatch on the agreed incoterm.
- After delivery. Batch records and certificates archived and retrievable for the life of the product on your shelf.
Macitentan supply, the specific questions.
What does Opsumit 10 mg come in, and is there a cold chain?
Opsumit has one film-coated tablet strength on the US and UK labels, 10 mg. The US label lists 15-count blisters in a carton and 30-count bottles. The UK SmPC lists blisters in cartons of 30 film-coated tablets. Neither text requires refrigeration. The US label gives 20 °C to 25 °C, and the UK SmPC says not above 30 °C. For paediatric patients under 40 kg the UK SmPC refers to a separate 2.5 mg dispersible tablet. Tell us the pack you need and the destination, and we quote that line.
What sets the landed price of Opsumit 10 mg?
We do not publish prices. For an importer, the landed price turns on whether you want the originator or another macitentan line, the pack format, the quantity, the registration route in the destination, and the Incoterms. There is no cold-chain cost because the labels set ambient storage, but freight, documentation and shelf life at dispatch still matter. M Care Exports quotes per destination once we have the strength, pack, volume and country.
Is there an Opsumit generic?
In the US, DailyMed lists macitentan tablet labels from several labelers other than Actelion, including Teva, Sandoz, Sun Pharmaceutical and Zydus. In the UK, the emc search we ran for macitentan returned only Opsumit products from Janssen-Cilag, the 10 mg film-coated tablet and the 2.5 mg dispersible tablet. The EMA Opsumit page we read does not discuss generics, so we make no statement on EU generic status. Separately, M Care supplies Indian-made lines such as Macitent 10 mg, and does not claim any is registered in a given destination.
What is Opsumit used for?
Opsumit is indicated for pulmonary arterial hypertension. The US label words it as PAH (WHO Group I) in adults, to reduce the risks of disease progression and hospitalization for PAH. The UK SmPC words it as long-term treatment of PAH in adults of WHO Functional Class II to III, as monotherapy or in combination, and in paediatric patients aged less than 18 years weighing at least 40 kg. Each market's label governs, so check the wording for your destination.
Does Opsumit have a REMS?
The current US label we read (revised 4/2025) carries a boxed warning on embryo-fetal toxicity and does not describe a REMS. The boxed warning requires excluding pregnancy before treatment, effective contraception, and continuing contraception for one month after stopping. The UK SmPC separately recommends monthly pregnancy tests. A destination regulator may set its own risk-management requirements, which we confirm per enquiry.
What is the mechanism of action of Opsumit?
Macitentan is an orally active endothelin receptor antagonist. The UK SmPC explains that endothelin-1 and its receptors, ET A and ET B, mediate effects including vasoconstriction, fibrosis and proliferation, and that the local endothelin system is upregulated in PAH. Macitentan acts on both receptors and is approximately 100-fold more selective for ET A than ET B in vitro. The SmPC states that this prevents endothelin-mediated activation of second messenger systems that result in vasoconstriction and smooth muscle cell proliferation.
Who stands behind this page, and where its statements come from.
Reviewed by Dr. Rajat Bhatt, PharmD, Managing Director, M Care Exports. Last reviewed 2026-11-09.
This page is sourcing information for licensed importers, hospital procurement and tender desks. It is not medical, pharmaceutical or prescribing advice, and it is not a substitute for the approved product information of the line on your order. See our full disclaimer.
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