Inspra (eplerenone) is licensed in the UK for post-myocardial-infarction and chronic heart failure, with an additional hypertension indication on the US label, and FDA and MHRA-approved generic eplerenone tablets sit alongside the originator brand.
M Care Exports supplies Inspra (eplerenone), a selective aldosterone (mineralocorticoid) receptor antagonist taken once daily for heart failure and, on the US label, hypertension. M Care is a merchant exporter: we source the Viatris-marketed originator brand and FDA and MHRA-approved generic eplerenone tablets through licensed Indian distribution and manufacturing channels and dispatch on quote, not from our own manufacturing.
Eplerenone exporter and bulk supplier from India.
For hospital cardiology, wholesaler and tender-desk orders, M Care quotes eplerenone tablets against buyer specification: brand (Inspra) or generic, strength (25 mg or 50 mg) and destination-market regulatory documentation, drawn from licensed WHO-GMP manufacturer lines on the M Care roster. Because the UK indication set (post-MI and NYHA II chronic heart failure) is narrower than the US label, which also carries a standalone hypertension indication, we confirm the buyer's destination-country labelling and intended indication before dispatch, then align CTD/eCTD or country-specific dossier paperwork to the destination regulator's requirements.
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.
Selective aldosterone (mineralocorticoid) receptor antagonist, sourced and documented for export.
Eplerenone is a selective aldosterone (mineralocorticoid) receptor antagonist: it blocks aldosterone binding more selectively than spironolactone, which is why it carries a lower rate of gynaecomastia and other antiandrogenic effects on its label. It is dosed orally, not injected, and needs no reconstitution. The UK SmPC licenses eplerenone to reduce cardiovascular mortality and morbidity in stable patients with left ventricular dysfunction (LVEF ≤40%) and clinical heart failure after recent myocardial infarction, plus NYHA class II chronic heart failure with LVEF ≤30%, both on top of standard therapy; the FDA label additionally licenses eplerenone for hypertension in adults, an indication the UK label does not carry. Destination-country labelling should be checked against this before a quote is finalised. Inspra is supplied as 25 mg and 50 mg film-coated tablets, initiated at 25 mg once daily and titrated to a 50 mg maximum.
Active ingredient
Eplerenone. Selective aldosterone (mineralocorticoid) receptor antagonist.
Forms and strengths
25 mg film-coated tablet; 50 mg film-coated tablet.
Indications
Eplerenone, a selective aldosterone receptor antagonist licensed in the UK for post-myocardial-infarction and chronic (NYHA II) heart failure, with an additional hypertension indication on the US label. Supplied as originator Inspra and licensed generic tablets from Indian WHO-GMP facilities to regulated and semi-regulated markets outside India.
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 for eplerenone are mainly hospital cardiology pharmacies managing post-MI and chronic heart-failure patients on guideline-directed medical therapy, national and regional MoH tender desks running cardiovascular and NCD formulary lists, licensed pharmaceutical wholesalers and importers, and NGO or foundation procurement programmes supporting heart-failure treatment access in markets where local registration is in place.
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 eplerenone.
Eplerenone is started at 25 mg once daily and titrated to the 50 mg target dose within four weeks, guided by serum potassium rather than a fixed schedule. Potassium should be checked before initiation, within the first week, and at one month after starting or adjusting the dose, since eplerenone is contraindicated at a baseline potassium above 5.0 mmol/L and treatment is withheld once levels reach 6.0 mmol/L or higher. Renal function matters as much as potassium: eplerenone is contraindicated in severe renal impairment (eGFR below 30) and severe hepatic impairment (Child-Pugh C), and the triple combination of an ACE inhibitor, an ARB and eplerenone together is specifically contraindicated. Strong CYP3A4 inhibitors (ketoconazole, itraconazole, ritonavir, clarithromycin) are also contraindicated, since they raise eplerenone exposure substantially; moderate CYP3A4 inhibitors instead cap the dose at 25 mg daily. No cold-chain handling or reconstitution is required; tablets travel on ambient-temperature logistics.
The documentation pack a regulator actually asks for.
As an oral solid dosage form, eplerenone travels on standard ambient-temperature logistics rather than the cold-chain lanes M Care validates for biologics and insulins. What buyers need instead is batch-level certificate of analysis, CDSCO export documentation and, where the destination market requires it, CTD or eCTD-format dossier support so the buyer's own regulator can register the product. Eplerenone does not appear on the current WHO Model List of Essential Medicines; spironolactone is the potassium-sparing aldosterone antagonist WHO lists as the essential-medicines reference agent for this mechanism, so tender desks weighing eplerenone against spironolactone are typically choosing eplerenone's more selective receptor binding and lower antiandrogenic side-effect rate against spironolactone's WHO EML status and lower unit cost. On the brand-versus-generic question, Inspra remains the originator product, currently marketed in the UK by Viatris; FDA-approved generic eplerenone tablets from multiple manufacturers are separately registered in the US, and generic eplerenone entries are also registered in the UK, so buyers genuinely have a brand-or-generic choice, subject to destination-market approval status, which M Care confirms before quoting.
The paperwork above is the molecule-specific part; the general pathway a destination regulator expects is set out in our licensed import route guide.
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.
Adjacent lines procurement desks order alongside eplerenone.
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 eplerenone.
- 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.
Eplerenone supply, the specific questions.
Does a generic version of Inspra exist?
Yes. FDA-approved generic eplerenone tablets are registered and marketed in the US alongside the originator brand Inspra, and generic eplerenone tablets are separately registered in the UK. Registration status for generic eplerenone varies by destination country, so M Care checks local approval before quoting brand or generic against a specific tender.
Can M Care supply Inspra to our market?
Yes, on an import basis. We source Inspra through Viatris's licensed Indian distribution channels and dispatch against your import authorisation and any local registration your pharmacy, hospital or wholesaler holds.
What strengths of eplerenone tablets are available?
25 mg and 50 mg film-coated tablets, matching the Inspra strengths. Treatment is initiated at 25 mg once daily and titrated to the 50 mg target dose within four weeks, guided by the patient's serum potassium level.
Is eplerenone licensed for hypertension?
It depends on the destination label. The FDA label licenses eplerenone for hypertension in adults in addition to heart failure, but the UK SmPC licenses it only for the two heart-failure indications, post-MI left ventricular dysfunction and NYHA class II chronic heart failure. We confirm the buyer's destination-country labelling before quoting against a hypertension-specific tender line.
Why would a formulary choose eplerenone over spironolactone?
Eplerenone binds the aldosterone receptor more selectively than spironolactone, which is associated with a lower rate of gynaecomastia and other antiandrogenic effects on its label. Spironolactone, by contrast, sits on the WHO Essential Medicines List and typically costs less, so the choice is a clinical and formulary-cost trade-off rather than a straightforward substitution.
What monitoring does eplerenone require before and during supply-chain planning?
Serum potassium is checked before initiation, within the first week, and at one month after starting or adjusting the dose, because eplerenone is contraindicated at a baseline potassium above 5.0 mmol/L. It is also contraindicated in severe renal impairment (eGFR below 30), severe hepatic impairment, and alongside strong CYP3A4 inhibitors, which is worth flagging to a buyer's clinical team even though it does not change how M Care packs or ships the product.
Who stands behind this page, and where its statements come from.
Reviewed by Dr. Rajat Bhatt, PharmD, Managing Director, M Care Exports. Last reviewed 2026-09-14.
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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