Spironolactone Tablets Exporter and Supplier from India
M Care Exports supplies spironolactone tablets in 25mg, 50mg and 100mg strengths from Indian WHO GMP and EU GMP sites to hospital pharmacies, MoH tender authorities and NGO heart failure programmes across the UK, GCC, African, LATAM and Southeast Asian markets. Spironolactone is on the 23rd WHO Model List of Essential Medicines (2023) and is recommended by NICE NG106 as third-line therapy in heart failure with reduced ejection fraction and by NICE NG136 as fourth-line therapy in resistant hypertension.
Spironolactone at a glance
Molecule
Spironolactone, synthetic steroidal aldosterone antagonist. INN spironolactone. CAS 52-01-7. ATC C03DA01. Competitive blockade of the mineralocorticoid receptor in the distal tubule and in cardiac and vascular tissue.
Strengths supplied
25mg, 50mg and 100mg film-coated or uncoated tablets. 5 mg per mL oral suspension on a project basis for paediatric and tube feed indications, subject to importer market authorisation.
Pack formats
PVC-PVdC and aluminium blister of 10 tablets in cartons of 30, 60 and 100. HDPE bottles of 30, 60, 100 and 500 tablets with desiccant. Hospital bulk packs of 10 by 10 blister cartons available for tender.
Regulatory dossiers
CTD format dossier available. Each shipment carries CoA per batch, CPP from Indian competent authority, BMR summary on request, ICH zone IVa stability and a 36 to 60 month shelf life on validated formulations.
Clinical role
RALES trial mortality benefit in HFrEF on top of ACE inhibitor and beta-blocker. PATHWAY-2 trial evidence for resistant hypertension. First-line diuretic in cirrhotic ascites per AASLD and EASL. Routine potassium and creatinine monitoring required.
Procurement profile
Generic and off patent. Tender unit pricing in single digit cents per tablet at MoH volume. Largest tender volumes in African and Southeast Asian heart failure, ascites and hypertension programmes.
Spironolactone tender and contract supply by region
M Care Exports holds active supply lanes for spironolactone tablets into five regional buyer groups, each with its own dossier expectations, language requirements and pack convention.
United Kingdom NHS
Supply into UK wholesalers and NHS hospital groups under MHRA licensed importer arrangements. NICE NG106 establishes third-line role in HFrEF and NG136 establishes fourth-line role in resistant hypertension. Reimbursed on the NHS Category M generic tariff and on Commercial Medicines Unit frameworks for hospital supply.
GCC and MENA tenders
Tender response for SFDA, MOHAP, NUPCO, SEHA and SCH frameworks. Spironolactone is on Saudi MoH formulary as the preferred mineralocorticoid receptor antagonist for HFrEF, with cost leadership against eplerenone. Arabic English bilingual artwork, halal sourced excipients where required and SFDA legalised CPP.
African public-sector and NGO
Supply into Kenya KEMSA, Nigeria FMOH, Ghana NHIA, South Africa NDoH essential drugs list, Ethiopia EPSS and Uganda NMS. WHO EML core list status supports Global Fund and Unitaid co-financing where HIV associated cardiomyopathy is part of the country grant. French and Portuguese leaflets for Francophone and Lusophone Africa.
EU mainland tenders
Generic competition is mature and tender margins thin. EU MAH partnered supply from Indian sites holding active EU GMP certification with QP release in the Netherlands, Germany or Cyprus. Dossier alignment with Germany G-BA AMNOG, France HAS and Italy AIFA hospital frameworks.
LATAM and Southeast Asia
Mexico COFEPRIS, Brazil ANVISA SUS formulary, Philippines FDA, Indonesia BPOM JKN national health insurance and Thailand FDA UC scheme. Brazil SUS dispenses around 3.5 million units per year through primary care HFrEF and cirrhotic ascites pathways, with serialised cartons aligned to country scheme.
Pharmacist procurement note on spironolactone
Spironolactone is the RALES-grade mineralocorticoid receptor antagonist and the third-line therapy in heart failure with reduced ejection fraction on top of an ACE inhibitor or ARB and a beta-blocker. Procurement should expect a clinician audience monitoring serum potassium and creatinine at week 1, week 4, week 8 and week 12, then every 4 to 6 months for the duration of therapy. Initiation is contraindicated where baseline serum potassium exceeds 5.0 mmol per litre or where eGFR is below 30 mL per minute per 1.73 m squared. Gynaecomastia affects around 10 percent of male patients at the 50 mg dose, is dose related and reversible on stopping, and is the most common reason for switching to eplerenone. Hyperkalaemia risk is amplified by ACE inhibitors, ARBs, the ARNI sacubitril valsartan as observed in the PIONEER-HF and PARADIGM-HF substudies, and NSAIDs. PATHWAY-2 established spironolactone as superior to bisoprolol and doxazosin for systolic blood pressure reduction in resistant hypertension. In cirrhotic ascites it remains first-line at 100 to 400 mg daily with a loop diuretic per AASLD and EASL guidelines.
Spironolactone regulatory and quality dossier
Spironolactone tenders are won on dossier completeness as much as on price. Every consignment from M Care Exports ships with a numbered documentation pack matched to the importer country requirement.
Manufacturing GMP
Indian manufacturing sites hold WHO GMP from the State Licensing Authority and CDSCO oversight, with EU GMP and PIC/S inspection records available for premium markets. Site master files, plant layout and validation summaries are shared under NDA.
Product specification
Finished product specification aligned to BP, EP or USP monograph per buyer preference. Specification covers assay 95 to 105 percent of label, related substances per Ph Eur 2.2.29, dissolution per USP 711 and microbial limits per Ph Eur 2.6.12.
Stability and shelf life
ICH zone IVa accelerated and long term stability on validated formulations supports a 36 to 60 month shelf life at 30 degrees Celsius and 65 percent relative humidity, suitable for tropical climate distribution. Stability data is available in tabular and graphical form for dossier filing.
CoA and CPP
Certificate of Analysis issued per batch by the manufacturer QC and counter signed by exporter QA where required. CPP issued by Indian competent authority CDSCO in WHO format with apostille or embassy legalisation as required.
Pharmacovigilance
Pharmacovigilance system master file summary, qualified person contact, ICSR reporting workflow and PSUR submission schedule are documented and shared with the importer MAH or distributor, with importer country potassium monitoring leaflet text where required.
Serialisation and artwork
2D Datamatrix serialisation per importer country scheme including KSA SFDA Tatmeen, UAE Tatmeen, EU FMD legacy where applicable, and country specific blister and carton artwork with Braille on UK packs, leaflet languages and barcode placement.
Related cardiovascular molecules and services
Procurement teams typically co-tender spironolactone with the rest of the guideline directed heart failure cocktail and the resistant hypertension stack. Common companion molecules and supporting services are below.
Bisoprolol fumarate tablets
Cardioselective beta-blocker for HFrEF on top of an ACE inhibitor or ARB. 1.25mg, 2.5mg, 5mg and 10mg strengths. Co-prescribed with spironolactone in NICE NG106 guideline directed therapy.
Losartan potassium tablets
Angiotensin II receptor blocker for hypertension and renal protection. 25mg, 50mg and 100mg strengths. Frequently co-prescribed with spironolactone in HFrEF and resistant hypertension, with combined hyperkalaemia monitoring.
Amlodipine besylate tablets
Calcium channel blocker for hypertension and stable angina. 5mg and 10mg tablets. Third-line in NICE NG136 hypertension before spironolactone is added as the fourth-line agent in resistant disease.
Metoprolol tartrate and succinate
Beta-blocker for rate control in atrial fibrillation, heart failure and post myocardial infarction. Tartrate 25/50/100mg IR and succinate XR 25/50/100/200mg. Alternative to bisoprolol in HFrEF triple therapy with spironolactone.
GCC tender response service
End to end tender response for SFDA, NUPCO, MOHAP, MOH Kuwait and Bahrain SQH frameworks. Dossier translation, CPP legalisation, sample shipment, financial bid preparation and post award supply.
EU GMP import service
EU MAH partnered supply from EU GMP sites with QP release, artwork management, FMD legacy serialisation, leaflet translation and importer compliance across EU 27 markets.
From enquiry to landed shipment in five steps
- Buyer brief and qualification. Share country, indication, target strengths, monthly demand, target landed price and tender deadline. We confirm exporter eligibility for your destination and route the enquiry to the matched manufacturing partner.
- Dossier and sample dispatch. CoA, CPP, GMP certificate, finished product specification, stability summary and pack artwork are shared within 48 hours. Physical samples are couriered against pro forma sample invoice for regulatory submission and bioequivalence reference.
- Commercial offer and contract. Firm price on CIP, CIF or DDP per INCOTERMS 2020, payment via 100 percent LC at sight or DA 90 days for vetted MoH buyers. Contract signed with split delivery schedule for tender awards above 6 months.
- Production, QC release and pre-shipment. Batch manufactured to importer artwork, serialised per country scheme, QC release against BP, EP or USP monograph. Pre-shipment inspection by importer or third party where required.
- Shipment and post-award support. Sea LCL, sea FCL or air per buyer choice. Documentation pack couriered ahead of vessel. Pharmacovigilance reporting, batch recall protocol and re-tender support continue for the contract duration.
Spironolactone procurement questions
Which strengths and pack sizes do you supply for spironolactone?
Standard supply is 25mg, 50mg and 100mg film-coated or uncoated tablets. Pack formats are PVC-PVdC and aluminium blister of 10 tablets in cartons of 30, 60 or 100, HDPE bottles of 30, 60, 100 and 500 tablets with desiccant, and hospital bulk packs of 10 by 10 blister cartons. A 5 mg per mL oral suspension is available on a project basis for paediatric and tube feed indications, subject to importer market authorisation. Other configurations including unit dose strips can be supplied against tender award with a minimum order quantity confirmed at brief stage.
Is spironolactone on the NHS Category M tariff and the WHO Model List of Essential Medicines?
Yes on both counts. Spironolactone 25mg, 50mg and 100mg tablets reimburse on the NHS Category M generic tariff under the PSNC drug tariff and are commonly supplied to NHS hospital groups through Commercial Medicines Unit frameworks. Spironolactone is on the 23rd WHO Model List of Essential Medicines (2023), listed in section 16 Diuretics and in section 12 Cardiovascular medicines for heart failure with reduced ejection fraction. WHO EML core list status supports inclusion in national essential medicines lists across African, Southeast Asian and LATAM public-sector procurement programmes.
How is spironolactone differentiated from eplerenone for tender procurement?
Spironolactone is the original RALES-grade mineralocorticoid receptor antagonist and is off patent, with tender unit prices in single digit cents per tablet. Eplerenone is the selective MRA with a lower gynaecomastia incidence, supported by EPHESUS in post-MI LV dysfunction and EMPHASIS-HF in mild HFrEF. For HFrEF tender procurement in cost sensitive public-sector frameworks, spironolactone is the default choice on cost leadership grounds, with eplerenone reserved for patients who develop dose limiting gynaecomastia on spironolactone. M Care can supply both molecules and align dossier and pack convention for switch protocols within the same tender.
What batch documentation accompanies each shipment of spironolactone?
Each consignment carries a numbered documentation pack covering Certificate of Analysis per batch, Certificate of Pharmaceutical Product in WHO format issued by CDSCO, manufacturer GMP certificate, finished product specification aligned to BP, EP or USP, stability summary on ICH zone IVa conditions, packing list, commercial invoice, bill of lading or air waybill, and country specific legalisation including apostille, embassy attestation or Chamber of Commerce certification per importer requirement. BMR summary, validation reports and method transfer protocols are available on request under NDA.
Can M Care supply spironolactone for African ministry tenders including KEMSA and FMOH Nigeria?
Yes. M Care holds active supply lanes into Kenya KEMSA, Nigeria FMOH, Ghana NHIA, South Africa NDoH essential drugs list, Ethiopia EPSS, Zambia ZAMMSA and Uganda NMS for spironolactone and the wider cardiovascular range. Documentation is prepared to WHO PQ standard equivalence for evaluator review, with French and Portuguese leaflets for Francophone and Lusophone Africa. CIF Mombasa, Lagos, Tema, Durban and Dar es Salaam are routine. WHO EML core list status supports inclusion in country essential medicines lists and in Global Fund or Unitaid co-financed grants where HIV associated cardiomyopathy is part of the programme scope.
What is the shelf life and storage requirement for tropical climate shipping?
Validated finished generic spironolactone tablets carry a 36 to 60 month shelf life supported by ICH zone IVa long term stability data at 30 degrees Celsius and 65 percent relative humidity. Storage requirement is below 25 degrees Celsius in the original blister or HDPE bottle pack, protected from light. Packaging is specified for tropical climate distribution with desiccant in bottle packs and PVC-PVdC and aluminium foil blister for high humidity destinations. Shipment is via reefer where the importer requires controlled temperature transit, otherwise ambient sea or air with temperature mapping documentation on request.
Does spironolactone require WHO Prequalification status for Global Fund or Unitaid procurement?
No. WHO Prequalification of Finished Pharmaceutical Products covers HIV, TB, malaria, reproductive health and selected neglected tropical disease products. Spironolactone is outside the WHO PQ scope. Global Fund and Unitaid procurement of spironolactone is supported through alternative pathways including SRA approval, WHO EML core list status, recipient country regulatory authority approval and Expert Review Panel listing. M Care prepares the equivalent documentation package, including stringent regulatory authority approval letters where available, for Global Fund and Unitaid evaluator review.
Request a spironolactone tender quotation
Share your destination country, indication, strengths and monthly demand. Our cardiovascular desk returns a costed offer with CoA, CPP, GMP certificate and stability summary within 48 working hours.