Edarbi (azilsartan medoxomil) is a once-daily ARB for hypertension, and with Takeda withdrawing the UK brand at the end of 2026, licensed generic azilsartan is the route buyers are lining up for continuity of supply.
M Care Exports supplies Edarbi (azilsartan medoxomil), an oral angiotensin II receptor blocker originated by Takeda for once-daily blood pressure control, alongside FDA-approved generic azilsartan medoxomil tablets manufactured in India. M Care is a merchant exporter: we source Edarbi and licensed generic lines through authorised Indian distribution and manufacturing channels and dispatch on quote, not from our own manufacturing.
Azilsartan exporter and bulk supplier from India.
For hospital, wholesaler and tender-desk orders, M Care quotes azilsartan tablets against buyer specification: brand (Edarbi) or generic, 40 mg or 80 mg strength mix, and destination-market regulatory documentation, drawn from licensed WHO-GMP manufacturer lines on the M Care roster. Because Takeda UK Ltd has confirmed it is withdrawing Edarbi from the UK market by the end of 2026 for commercial portfolio reasons, we're fielding early enquiries from UK hospital pharmacies and importers wanting a generic azilsartan line confirmed before existing brand stock runs out, and we align CTD/eCTD or country-specific dossier paperwork to the destination regulator's requirements for either route.
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.
Angiotensin II receptor blocker (ARB) prodrug; AT1-receptor antagonist, sourced and documented for export.
Azilsartan medoxomil is an angiotensin II receptor blocker (ARB) prodrug: it is hydrolysed on absorption to the active moiety azilsartan, an AT1-receptor antagonist that blocks the vasoconstrictor and aldosterone-secreting effects of angiotensin II. It is dosed orally, not injected, and needs no reconstitution. The FDA and UK/EU labels' flagship indication is essential hypertension in adults, to lower blood pressure; UK SmPC data note near-maximal antihypertensive effect within two weeks and maximal effect by four weeks, a titration timeline worth flagging to a prescriber switching a patient off another ARB. Edarbi is supplied as 40 mg and 80 mg film-coated tablets in the strengths generic manufacturers hold FDA approval for; UK and EU originator packs additionally include a 20 mg starting-dose tablet, taken once daily with or without food.
Active ingredient
Azilsartan medoxomil. Angiotensin II receptor blocker (ARB) prodrug; AT1-receptor antagonist.
Forms and strengths
40 mg film-coated tablet; 80 mg film-coated tablet.
Indications
Azilsartan medoxomil, a prodrug angiotensin II receptor blocker indicated for essential hypertension in adults, hydrolysed on absorption to the active moiety azilsartan. Supplied as originator Edarbi and FDA-approved 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 azilsartan are hospital cardiology and general-medicine pharmacies managing hypertension formularies, NHS trust buyers and licensed UK importers assessing continuity options ahead of Takeda's UK brand withdrawal, GCC and African MoH tender desks running cardiovascular and NCD medicine lists, and NGO or foundation procurement programmes supporting hypertension-management 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 azilsartan.
Azilsartan dosing starts at 40 mg once daily, increasing to 80 mg if blood pressure control is inadequate; consider the lower 40 mg start in patients already on high-dose diuretics. The FDA label states no renal dose adjustment is required across mild-to-severe renal impairment or end-stage renal disease, though the UK SmPC advises caution in severe renal impairment given limited clinical experience there, so renal function is worth monitoring either way. Hepatic dosing needs no adjustment for mild-to-moderate impairment per the FDA label, though the UK SmPC suggests a lower 20 mg starting dose with close monitoring for mild-to-moderate hepatic impairment; azilsartan has not been studied in severe hepatic disease under either label. Correct volume or salt depletion, for example after diuretic initiation or a low-salt diet, before starting therapy to avoid symptomatic hypotension on the first dose. Azilsartan carries a boxed warning: drugs acting on the renin-angiotensin system can cause foetal injury and death, so therapy should be discontinued as soon as pregnancy is detected, and UK/EU labelling also advises against use in the first trimester and contraindicates use outright in the second and third trimesters. Hyperkalaemia risk rises with dual RAS blockade, renal impairment, diabetes or concomitant potassium-sparing agents, so serum potassium is worth checking at initiation. No cold-chain handling is required; azilsartan tablets travel on standard ambient logistics.
The documentation pack a regulator actually asks for.
Edarbi remains centrally authorised in the EU, with the product information last revised in January 2025, so buyers should not assume the UK move signals an EU-wide exit. In the UK specifically, Takeda UK Ltd announced on 27 April 2026 that it is withdrawing Edarbi 20 mg, 40 mg and 80 mg tablets from the market by the end of 2026 as part of a portfolio review, stating the drug's established efficacy and safety are unchanged; this is a commercial decision, not a safety recall, but it still leaves a supply gap for hospitals and wholesalers holding Edarbi on formulary. On the brand-versus-generic question, Lupin holds FDA approval, granted in July 2022, for a 40 mg and 80 mg generic azilsartan medoxomil tablet manufactured at its Nagpur, India facility as a rated equivalent to Edarbi, so licensed brand and generic are genuinely both available and buyers can choose either. Azilsartan does not appear on the current WHO Model List of Essential Medicines; losartan is the ARB WHO lists as the essential-medicines reference agent for this class, so tender desks should treat azilsartan as a formulary-specific choice rather than an EML first-line ARB. As an oral solid dosage form, it travels on standard ambient-temperature logistics; what buyers need is batch-level certificate of analysis, CDSCO export documentation and, where the destination regulator requires it, CTD/eCTD-format dossier support for local registration.
Permit sequence, registration status and customs handling are documented in importing medicines from India through the licensed route; this page sticks to what is specific to the molecule.
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 azilsartan.
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 azilsartan.
- 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.
Azilsartan supply, the specific questions.
Is a generic version of Edarbi available?
Yes. Lupin holds FDA approval, granted in July 2022, for a generic azilsartan medoxomil tablet in 40 mg and 80 mg strengths, manufactured in India as a rated equivalent to Edarbi. Registration status for the generic varies by destination country, so M Care checks local approval before quoting brand or generic against a specific tender.
Takeda is withdrawing Edarbi from the UK. Can M Care cover the gap?
Takeda UK Ltd confirmed on 27 April 2026 that Edarbi 20 mg, 40 mg and 80 mg tablets will leave the UK market by the end of 2026, for commercial portfolio reasons rather than a safety issue. We're already fielding enquiries from UK hospital pharmacies and importers wanting a generic azilsartan line in place before existing brand stock is exhausted, and can quote against your named-patient import or wholesaler documentation.
What strengths of azilsartan tablets are available?
40 mg and 80 mg film-coated tablets, the strengths generic manufacturers hold FDA approval for. UK and EU originator Edarbi packs also include a 20 mg starting-dose tablet. Tell us your dosing protocol and target market and we quote the strength split accordingly.
Is azilsartan safe in pregnancy?
No. Azilsartan carries a boxed warning for foetal toxicity: drugs acting on the renin-angiotensin system can injure or kill a developing foetus, and UK/EU labelling contraindicates use outright in the second and third trimesters and advises against first-trimester use too. Therapy should be discontinued as soon as pregnancy is detected, and this should be flagged clearly on any dispensing record for a patient of childbearing potential.
Does azilsartan need dose adjustment for kidney or liver impairment?
The FDA label states no adjustment is required across mild-to-severe renal impairment or end-stage renal disease, though the UK SmPC advises caution in severe renal impairment given limited clinical experience there. For hepatic impairment, the FDA label needs no adjustment in mild-to-moderate disease, but the UK SmPC suggests starting at a lower 20 mg dose with close monitoring in that population. Azilsartan has not been studied in severe hepatic impairment under either label.
Is azilsartan on the WHO Essential Medicines List?
No. Azilsartan does not appear on the current WHO Model List of Essential Medicines; losartan is the ARB WHO lists as the reference agent for this drug class. Tender desks should treat azilsartan as a formulary-specific choice rather than an EML first-line ARB when building a specification.
Who stands behind this page, and where its statements come from.
Reviewed by Dr. Rajat Bhatt, PharmD, Managing Director, M Care Exports. Last reviewed 2026-09-25.
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.
Send the specifics. You'll have a price inside one working day.
Form and strength, destination market and indicative volume. The Mumbai desk replies within one working day, including when the honest answer is that the route is not viable yet.