Losartan tablet — Indian WHO-GMP supply for the NICE NG136 first-line antihypertensive in adults under 55.
First-in-class angiotensin receptor blocker (ARB) — the global reference AT1-selective antagonist for hypertension, heart failure, diabetic nephropathy and stroke risk reduction in LVH. NICE NG136 first-line monotherapy for adults aged <55 not of Black African or Caribbean family origin (Step 1B). Standard ACE-intolerance switch where cough or angioedema preclude ACE inhibitors. RENAAL trial evidence for diabetic nephropathy, LIFE trial evidence for stroke reduction in LVH. 25mg, 50mg and 100mg losartan potassium film-coated tablets from Indian WHO-GMP facilities. NHS Drug Tariff Category M generic dispensing scale. Multiple partner lines under WHO Prequalification.
Multiple WHO-GMP partner lines · 25mg / 50mg / 100mg losartan potassium film-coated tablets · CTD dossier on file · NHS NG136 Step 1B first-line · First-in-class ARB with the deepest renal-protective evidence base.
Active ingredient
Losartan potassium — first-in-class AT1-selective angiotensin receptor blocker. Mechanism: competitive inhibition at the AT1 receptor blocks angiotensin II-mediated vasoconstriction, aldosterone release, sodium retention and sympathetic activation. Active metabolite EXP-3174 (carboxylic acid) is 10-40× more potent than the parent drug and gives extended pharmacological half-life of 6-9 hours despite the parent's 2-hour half-life. AT2 receptor function is preserved (unlike ACE inhibitors which lower angiotensin II generation overall) — this preserves the AT2 cardio-protective signalling. M Care does not hold FDA or TGA registrations for this molecule.
Strengths stocked
25mg film-coated tablet — paediatric and titration-start dose; recommended for elderly >75 years, hepatic-impaired adults, and patients with intravascular volume depletion. 50mg film-coated tablet — standard adult monotherapy starting dose for hypertension; the highest-volume tender-line dose. 100mg film-coated tablet — maximum monotherapy dose, heart-failure target, and diabetic-nephropathy target per the RENAAL trial protocol. All three strengths supplied as scored or unscored film-coated tablets per market specification, in HDPE bottles or destination-language blister packaging. Combination product context: losartan is also widely tendered in fixed-dose combinations with hydrochlorothiazide (Hyzaar generic) — M Care can quote the FDC supply lines on a separate workflow.
Indications scope
Essential hypertension as NICE NG136 Step 1B first-line for adults <55 not of Black African or Caribbean family origin (alternate to ACE inhibitor, switched on ACE-intolerance), then Step 2 combination with amlodipine, then Step 3 with thiazide-like diuretic. Heart failure with reduced ejection fraction (HFrEF) second-line per NICE NG106 / ESC HF guidelines on ACE-intolerance. Diabetic nephropathy with proteinuria per RENAAL trial. Hypertension with left ventricular hypertrophy for stroke risk reduction per LIFE trial. Hypertensive nephropathy in non-diabetic CKD per NICE NG203. Paediatric hypertension at age-adjusted dosing. ACE-intolerance pathway as the standard ARB switch.
Buyer fit
UK NHS community pharmacy at NHS Drug Tariff Category M reimbursement scale — high-volume primary-care antihypertensive line. GCC hypertension tender desks — Saudi Arabia (NUPCO, SFDA-registered), UAE (MoHAP, DHA), Kuwait (CMSPS), Qatar (Hamad Medical Corporation, MoPH), Oman (MoH, OFDA), Bahrain (NHRA). African public-sector procurement — Nigeria (NAFDAC, FHC), Kenya (KEMSA, PPB), Ghana (FDA, GHS), South Africa (SAHPRA, NDoH), Ethiopia (EFDA), Tanzania (MSD, TMDA). EU EU-GMP-route community pharmacy and tender chains. NGO and humanitarian procurement — Global Fund cardiovascular comorbidity programmes, MSF essential medicines, especially diabetic nephropathy LMIC initiatives.
What we file with the quote
Indian manufacturer's CDSCO Form 26 export licence and EU-GMP / WHO-GMP certificate, Certificate of Pharmaceutical Product (CoPP) per WHO format for the destination regulator, batch Certificate of Analysis (CoA) against the manufacturer's BP/USP/EP-aligned monograph, Summary of Product Characteristics (SmPC) per destination regulator's format, Patient Information Leaflet (PIL) with destination-language translation where required, full CTD Module 1-5 dossier for new-market registration submission, and NHS Drug Tariff line confirmation for UK community-pharmacy buyers.
Lead times
Stock items 50mg and 100mg ship in 10-14 working days from PO ex-Mumbai. 25mg titration-start strength typically 14-21 working days due to lower campaign frequency. Tender quantities (>1M tablets per dose-strength) require campaign batch scheduling; lead time 4-6 weeks from PO. Named-patient and small-volume orders for hospital pharmacy ship in 5-7 working days from existing campaign stock. Cold-chain not required — ambient transport with desiccant for tropical destinations. FDC combinations (losartan+hydrochlorothiazide) ship on the FDC partner manufacturer's campaign cadence — typically 21-28 working days.
Four buyer-channel models for a losartan pharmaceutical export from India
Pharmaceutical supply isn't one channel. M Care services UK community pharmacy, GCC government tenders, African public-sector procurement and EU/LATAM/SEA contract manufacturing on different paperwork tracks — losartan's NHS NG136 first-line under-55 status and renal-protective evidence base make it volume-dominant in primary-care and nephrology lanes globally.
UK NHS community pharmacy
NHS Drug Tariff Category M generic dispensing — losartan is a high-volume Cat M antihypertensive line in primary-care England, especially after the 2011 MHRA Drug Safety Update on quinapril/captopril cough that drove cohort migration from ACE inhibitors to losartan. M Care supplies UK WDA(H)-licensed wholesalers against NHS framework agreements, with QP audit pack on file for EU/UK GMP equivalence, batch-by-batch Certificate of Analysis (CoA) in BP-aligned format, and Article 40 / EU-IMPD release pathway through partner UK MIA(IMP) holders for non-EEA imports post-Brexit. Pricing follows Cat M reimbursement bands; NHS BSA monthly Drug Tariff updates dictate margin discipline.
GCC government tender supply
Gulf Health Council Central Registration route or state-by-state via SFDA (KSA), MoHAP (UAE), CMSPS (Kuwait), MoPH (Qatar), MoH/OFDA (Oman), NHRA (Bahrain). M Care has the CTD M1 country-specific overlay packs ready and Arabic SmPC + PIL translations on file. Tender-line dosing is typically 50mg and 100mg at high volumes; 25mg titration at lower tender volumes. NUPCO framework response timelines are 14-21 days from RFQ; we hold three Indian partner manufacturers with active SFDA registrations to give NUPCO desks supply-redundancy. FDC combinations (losartan+hydrochlorothiazide) on separate quotes.
African public-sector procurement
NAFDAC (Nigeria), PPB (Kenya), FDA (Ghana), SAHPRA (South Africa), EFDA (Ethiopia), TMDA (Tanzania) registration pathways. WHO Prequalification active for several Indian losartan generic lines, opening Global Fund cardiovascular comorbidity procurement, UNFPA hypertension-in-pregnancy programmes (where losartan is contraindicated and methyldopa preferred — relevant for sister formulary tenders), and PEPFAR HIV-CVD comorbidity. Sea-freight LCL/FCL via Mumbai/Nhava Sheva to Lagos / Mombasa / Durban / Dar es Salaam is the standard logistics lane; 6-8 week sea transit with FFP and pre-shipment QC sampling.
EU and other regulated markets
EU member states via Article 40 importation licence held by partner MIA(IMP) and QP batch certification; LATAM via ANVISA (Brazil), COFEPRIS (Mexico), INVIMA (Colombia), DIGEMID (Peru) registration pathways; SEA via Philippines FDA, Vietnam DAV, Indonesia BPOM, Malaysia NPRA, Bangladesh DGDA, Sri Lanka NMRA. Losartan is registered in 100+ countries via Indian generic manufacturers; M Care's role is dossier and tender-pack assembly, not standalone manufacturing — partner manufacturers handle the API and finished-dosage. Combination products (FDC) require a separate Module 1 dossier per regulator.
ACE-intolerance switch, hyperkalaemia screening, pregnancy contraindicated, NICE NG136 step-up — losartan is the renal-protective ARB but the prescribing nuances matter.
Adult hypertension starting dose 50mg/day; 25mg/day starting in elderly >75 years, hepatic-impaired adults, intravascular volume-depleted patients, and paediatric hypertension. Titration target 100mg/day after 3-6 weeks if BP response inadequate. Heart failure target dose 50mg twice-daily or 150mg once-daily per HEAAL trial — most HFrEF patients should be titrated to maximum tolerated. Diabetic nephropathy target dose 100mg/day per RENAAL. Once-daily dosing at any time of day for hypertension; twice-daily only for HFrEF. ACE-intolerance switch is the most common prescribing pathway — losartan is the standard ARB to substitute when ACE-induced cough (10-15% of ACE-treated patients) or angioedema (rare but serious) preclude ACE class continuation. Counsel that ACE cough resolves within 1-3 weeks of switch; angioedema risk is much lower with ARBs but not zero, particularly in patients with prior ACE-related angioedema where ARB challenge requires specialist supervision. Hyperkalaemia is the major safety signal — baseline U+E mandatory before initiation, repeat at 1-2 weeks and 4-6 weeks, then per NICE schedule. Particular caution if combining with potassium-sparing diuretics (spironolactone, eplerenone, amiloride), potassium supplements, NSAIDs, or trimethoprim. Acute kidney injury risk — ARBs reduce intra-glomerular filtration pressure, so dehydration, sepsis or contrast nephropathy can precipitate AKI. Hold losartan during acute illness with diarrhoea + vomiting per the ‘sick day rules’ on the NHS Yellow Card MHRA-aligned framework. Pregnancy is contraindicated — ARBs cause fetal renal dysgenesis, oligohydramnios, hypotension and skull hypoplasia in the second and third trimesters. Discontinue immediately on confirmed pregnancy and switch to labetalol, nifedipine MR or methyldopa per NICE NG133. Renal impairment: no dose adjustment required for losartan in most CKD stages; monitor potassium and creatinine closely. Hepatic impairment: start at 25mg and titrate slowly; clearance is reduced. Drug interactions: NSAIDs reduce antihypertensive effect (avoid chronic combination), lithium increases (monitor levels), rifampicin reduces losartan exposure (clinical effect minimal at standard dosing). NICE NG136 step-up discipline: do not push to 100mg before 3-6 week trial of 50mg; do not start a second agent before establishing baseline 50mg response; do not skip Step 2 (ARB+CCB) to Step 3 (ARB+CCB+diuretic). M Care does not provide clinical advice — local prescribing formulary, MHRA Drug Safety Updates, and the destination-country regulator's SmPC are the prescribing references.
Five regulatory tracks for an Indian-manufactured losartan pharmaceutical export
Losartan is registered in 100+ countries via Indian generic manufacturers. The dossier work for any new market is typically CTD Module 1 country-specific assembly plus Module 3 reuse — Modules 2-5 don't change between destinations. Combination products require a separate Module 1 dossier track per regulator.
WHO Essential Medicines List
Losartan is on the WHO Model List of Essential Medicines (23rd edition, 2023) as the representative of the angiotensin receptor blocker class. WHO EML status is the gateway to WHO Prequalification assessment and Global Fund cardiovascular-comorbidity tender eligibility — multiple Indian losartan generic manufacturers hold active WHO PQ status. The WHO HEARTS technical package recommends an ACE inhibitor or ARB as the global hypertension primary-care backbone in combination with a CCB.
MHRA (United Kingdom)
Losartan is registered with the MHRA across multiple PL holders covering 25mg, 50mg and 100mg strengths. NHS Drug Tariff Category M generic dispensing applies. NICE Hypertension Guideline NG136 names losartan as a NICE-acceptable ARB at Step 1B (alternate to ACE inhibitor in adults <55 not of Black African or Caribbean origin, switched on ACE-intolerance). Note the historical MHRA Drug Safety Update 2018-2019 on N-nitrosodimethylamine (NDMA) impurity recalls for some valsartan / irbesartan / losartan batches — Indian manufacturer partners that survived the recall cycle have reformulated APIs and are subject to ongoing monitoring; M Care confirms NDMA test certificates batch-by-batch.
EMA (European Union) and EU member states
Decentralised Procedure or Mutual Recognition Procedure registrations across EU/EEA via national medicines agencies. Article 40 importation licence via partner MIA(IMP) holder for non-EEA-manufactured supply with EU-zone QP batch release. EMA Article 31 referral 2018-2020 on sartan-class NDMA / NDEA nitrosamine impurities resulted in tightened API quality requirements; M Care partner manufacturers operate under the post-referral sartan-API quality framework with NDMA / NDEA test methods aligned to the current EU pharmacopoeia.
GCC and Middle East
Gulf Health Council Central Registration route covering KSA, UAE, Kuwait, Qatar, Oman, Bahrain. State-by-state where Central Registration not in scope: SFDA (KSA), MoHAP/DHA (UAE), CMSPS (Kuwait), MoPH (Qatar), MoH/OFDA (Oman), NHRA (Bahrain). Losartan is on every state's essential medicines list. NUPCO framework responses for large hospital tenders; private-sector retail registrations alongside. Saudi NCD initiative places losartan on Mandatory Reserve List for primary-care hypertension management.
African and LMIC markets
NAFDAC (Nigeria), PPB (Kenya), FDA Ghana, SAHPRA (South Africa), EFDA (Ethiopia), TMDA (Tanzania), NDA (Uganda), NRA (Rwanda) registration pathways. WHO Prequalification opens donor-funded pooled procurement at concessional pricing for Global Fund HIV-CVD comorbidity, PEPFAR essential-medicines and PMI (President's Malaria Initiative) cardiovascular comorbidity programmes.
Pharmacovigilance and adverse-event reporting
Losartan is post-marketing surveillance in every regulated market. UK Yellow Card scheme, EU EudraVigilance, SFDA NPC (KSA), NAFDAC PV unit — all handled by the MAH or Indian manufacturer's local responsible person. Reporting timelines are 15 days for serious unexpected adverse reactions and 90 days for non-serious per ICH-E2D. Periodic Safety Update Reports (PSURs) on the standard ICH-E2C(R2) cycle. Major ADR signals: hyperkalaemia (1-3% incidence), AKI on dehydration, dizziness, fatigue, rare hepatotoxicity. Post-2018 NDMA impurity surveillance is part of the active PV cycle.
Losartan's tender-line and clinical companion molecules
Hypertension tenders are rarely single-line. Losartan pairs with calcium channel blockers, statins and diuretics across the NICE NG136 step-up. Internal links to the molecules and services we already cover.
Amlodipine
Dihydropyridine CCB. NICE NG136 Step 2 partner with losartan for adults of any age and ethnicity. Most-prescribed CCB in the UK NHS. The losartan + amlodipine pairing is the global hypertension primary-care backbone.
Atorvastatin
HMG-CoA reductase inhibitor (statin). Cardiovascular comorbidity tender pairing with losartan. Most-prescribed UK NHS drug by volume. Hypertension + dyslipidaemia is the dominant comorbidity bundle.
Cardiovascular cluster overview
Antihypertensives (ARBs, CCBs, beta-blockers, diuretics), antiplatelets, anticoagulants, antiarrhythmics, lipid-lowering agents. Hypertension tender-line procurement is rarely single-molecule.
Diabetes-endocrine overlap
Losartan is first-line in diabetic nephropathy with proteinuria per RENAAL. Diabetes-cardiovascular comorbidity tender pairing.
GCC tender response service
SFDA, NUPCO and state-by-state tender desks for losartan alongside the broader cardiovascular pack. 14-21 day turnaround from RFQ to bid with three-manufacturer-redundancy quotes.
EU-GMP import workflow
Losartan into Germany, France, Italy, Spain, the Netherlands and Belgium via partner MIA(IMP) holders with QP batch release. Article 40 importation licence and EU CTD overlay handled including post-2018 NDMA impurity framework.
How a losartan enquiry becomes a sustained supply contract
- Send us the specifics. WhatsApp the Mumbai line or send the contact form. We need the destination country, the strengths required (25mg / 50mg / 100mg, single or multi), the per-month or per-tender volume, the buyer profile (NHS framework, GCC tender desk, African MoH, NGO, EU community-pharmacy chain), and whether any FDC combinations are required (losartan+hydrochlorothiazide). Reply within one working day with a provisional quote and a confirmation of which Indian partner manufacturer is best-fit, plus current NDMA test certificate status.
- Three-manufacturer-redundancy quote. M Care quotes three Indian partner manufacturers per dose-strength for tender-supply redundancy. Pricing is FOB Mumbai or CIF destination port, packaged in destination-language blister or bottle per buyer specification. Quote includes per-tablet ex-works pricing, freight to destination, dossier preparation fee (if new registration), and any destination-country regulatory fees (typically passed through at cost). FDC combination products quoted on a separate workflow due to FDC partner manufacturer cadence. Quote validity is 30 days from issue.
- Dossier preparation. For existing registrations, M Care provides batch-specific CoA, CoPP per WHO format, NDMA / NDEA nitrosamine impurity test certificates per the post-2018 EU framework, and SmPC/PIL country overlay within 5-10 working days from PO. For new-market registration, we assemble the full CTD Module 1-5 dossier — Module 3 quality data is partner-manufacturer-specific and reused across markets; Module 1 administrative is country-specific and re-overlaid per destination regulator (MHRA, EMA, SFDA, NAFDAC, etc.). Typical full-dossier preparation timeline is 30-45 working days; new-market regulatory review is 6-18 months depending on regulator backlog. FDC combinations require a parallel Module 1 dossier track.
- Manufacturing campaign and freight. Stock-line strengths (50mg, 100mg) ship from existing manufacturer inventory in 10-14 working days from PO. 25mg titration-start strength typically requires campaign batch scheduling — 14-21 working days. Tender quantities >1M tablets per dose-strength require dedicated campaign batches with 4-6 week PO-to-shipment timeline. Air freight via Mumbai / Delhi for time-critical orders; sea freight LCL/FCL for tender volumes via Nhava Sheva for AAA-class container shipping. Destination customs clearance handled by buyer with M Care providing import licence support paperwork (commercial invoice, packing list, CoA, CoPP, NDMA test cert, Form 14).
- Ongoing supply and pharmacovigilance. Post-shipment: M Care provides monthly Drug Tariff line confirmation for UK NHS buyers, SFDA / NUPCO monthly availability confirmations for GCC tender desks, and CSV / Excel tender-line trackers for African public-sector buyers. Pharmacovigilance Yellow Card / EudraVigilance / NPC reporting is the partner manufacturer's MAH responsibility; M Care coordinates the local responsible person paperwork. Quarterly CTD Module 3 update reviews to ensure dossier currency including NDMA / NDEA test method alignment to current pharmacopoeia. Periodic Safety Update Reports (PSUR) on the ICH-E2C(R2) cycle for EU/UK markets.
Losartan tablet supply — buyer FAQ
What strengths of losartan do M Care supply?
25mg, 50mg and 100mg losartan potassium film-coated tablets — the three global strengths registered across all major regulators. 50mg and 100mg are the high-volume tender lines; 25mg is the titration-start strength for elderly, hepatic-impaired and paediatric patients. All three supplied as scored or unscored film-coated tablets per market specification, in HDPE bottles or destination-language blister packaging. The potassium salt form is the global API standard.
Can M Care supply losartan + hydrochlorothiazide fixed-dose combinations?
Yes — losartan + hydrochlorothiazide (Hyzaar generic) is available from M Care's partner manufacturer network in standard 50/12.5mg and 100/25mg ratios. FDC combinations are quoted on a separate workflow because they require a separate Module 1 regulatory dossier per destination, follow the FDC partner manufacturer's campaign cadence (typically 21-28 working days vs single-molecule 10-14), and have different per-tablet pricing structures. Specify the FDC ratio and destination in the enquiry and we'll quote on the FDC manufacturer best-fit.
Is losartan a controlled drug or schedule-restricted in any market?
No — losartan is a standard prescription-only medicine (POM) in every regulated market and is not controlled, scheduled or otherwise restricted under the UN Single Convention on Narcotic Drugs or the UN Convention on Psychotropic Substances. No special transport, customs or destination-country licensing requirements beyond standard pharmaceutical import paperwork. No cold-chain required — ambient transport with standard desiccant for tropical destinations.
How does losartan compare with other ARBs (telmisartan, valsartan, olmesartan) in tender pricing?
Losartan is the off-patent reference ARB and dominates ARB tender volumes by approximately 3:1 over telmisartan, 2:1 over valsartan and 5:1 over olmesartan in NHS dispensing data. Pricing per defined daily dose (DDD) is lowest for losartan due to longest off-patent maturity (since 2010 globally). Telmisartan has longer half-life supporting truer once-daily dosing; valsartan has the deepest heart-failure evidence base (Val-HeFT trial); olmesartan has regulatory restrictions in some markets due to sprue-like enteropathy reports. M Care supplies all four classes — losartan / telmisartan / valsartan / olmesartan — but losartan is the volume default.
Are M Care's losartan lines NDMA-impurity-tested?
Yes — every batch of M Care-supplied losartan is tested for N-nitrosodimethylamine (NDMA) and N-nitrosodiethylamine (NDEA) per the post-2018 EU/MHRA sartan-class quality framework. Indian manufacturer partners that survived the 2018-2020 sartan-API recall cycle reformulated APIs and operate under tightened nitrosamine-impurity test methods aligned to the current EU pharmacopoeia. NDMA / NDEA test certificates are provided batch-by-batch with every shipment; current limits are <0.96 ppm for NDMA and <0.1 ppm for NDEA per ICH M7(R1) acceptable intake calculations.
What's the typical lead time and minimum order quantity?
Stock items 50mg and 100mg ship in 10-14 working days from PO ex-Mumbai. 25mg titration-start strength typically 14-21 working days. Tender quantities >1M tablets per dose-strength require campaign batch scheduling — 4-6 weeks from PO. Named-patient and small-volume orders for hospital pharmacy ship in 5-7 working days from existing campaign stock. Minimum order quantity is buyer- and channel-specific: NHS Cat M dispensing — no MOQ; GCC tender desks — typically 100K+ tablets per dose-strength; African public-sector procurement — typically 500K+ tablets per dose-strength.
Does losartan need cold-chain shipping or special storage?
No cold-chain required. Losartan potassium film-coated tablets store at below 25°C in original blister or HDPE container, protect from moisture and light. Standard ambient transport applies — including for tropical destinations, where desiccant is included in the bottle / blister cassette to manage humidity excursion. No temperature-monitored shipping required, no reefer container, no GDP cold-chain validation pack. Air freight or sea freight via standard pharmaceutical lanes (Mumbai or Nhava Sheva to destination port) is the routine logistics path.
Losartan tablet — three-manufacturer-redundancy supply for the NICE NG136 first-line antihypertensive in adults under 55, GCC and Africa.
Losartan is everyday — global, generic, high-volume — and the buyer-side complexity is in the post-2018 NDMA impurity framework and the FDC combinations. M Care holds three Indian partner manufacturers per dose-strength for supply redundancy, with NHS Cat M, SFDA, NUPCO, NAFDAC, KEMSA, SAHPRA, and EU MIA(IMP) registrations all on file or readily assembled, plus current NDMA / NDEA test certificates batch-by-batch.