WHO-GMP sourced EU-GMP partners ISO 9001:2015 49+ export markets Since 2003

Telmisartan, Indian WHO-GMP supply for hypertension and cardiovascular risk reduction.

Telmisartan is the long-acting, hepatically-cleared member of the angiotensin receptor blocker class, sourced by M Care Exports from WHO-GMP certified Indian manufacturers as monotherapy and as amlodipine and hydrochlorothiazide fixed-dose combinations for hospital procurement, licensed importers and tender desks across the Gulf, Africa, UK/EU and Southeast Asia.

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WHO-GMP sourcing CDSCO licensed exporter EU-GMP capable partners Cold-chain validated (2–8°C & −25°C) CTD / eCTD dossier-ready ISO 9001:2015
Bulk supply and export terms

Telmisartan exporter and bulk supplier from India.

We handle enquiries for telmisartan as monotherapy tablets in 20 mg, 40 mg and 80 mg strengths, and as fixed-dose combinations with amlodipine (commonly 40/5 mg, 40/10 mg, 80/5 mg, 80/10 mg) and with hydrochlorothiazide (commonly 40/12.5 mg, 80/12.5 mg, 80/25 mg). Triple-combination telmisartan-amlodipine-hydrochlorothiazide is also produced by several of our partner manufacturers where a specific market's tender calls for it. Tell us the strength split, the pack format your regulator requires (blister, bottle, hospital bulk pack), and the destination market, and we confirm sourceable WHO-GMP manufacturers, documentation (CoA, CoPP, stability data, dossier where required) and freight terms against your tender or import file. We do not publish minimum order quantities, price bands, or lead times on this page because they move with strength mix, pack format and destination and would go stale between updates; ask us directly and we quote against your actual requirement.

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.

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At a glance

Angiotensin II receptor blocker (ARB), selective AT1-receptor antagonist, sourced and documented for export.

Telmisartan is an angiotensin II receptor blocker (ARB) that selectively antagonises the AT1 receptor subtype, blocking the vasoconstrictor and aldosterone-secreting effects of angiotensin II without the bradykinin-mediated cough associated with ACE inhibitors. It carries two label indications in most reference markets: essential hypertension, and reduction of cardiovascular morbidity (myocardial infarction, stroke, death from cardiovascular causes) in patients aged 55 and above with high atherothrombotic risk who are unable to tolerate ACE inhibitors, an indication built on the ONTARGET trial where telmisartan was shown non-inferior to ramipril. Two pharmacological features separate it from the rest of the ARB class and matter directly to procurement teams building a formulary: it has the longest terminal half-life in its class (approximately 24 hours), giving a high trough-to-peak ratio and genuine 24-hour blood pressure control on a true once-daily tablet even if a dose is taken a few hours late; and it is eliminated almost entirely through hepatic glucuronidation and biliary excretion, with under 1% recovered unchanged in urine. That second point is a double-edged fact: it means no dose adjustment is required for renal impairment (relevant for the high diabetic-nephropathy burden in several of our served markets), but it also means telmisartan is contraindicated in biliary obstructive disorders and needs caution and dose review in hepatic impairment, since a diseased liver is its only real clearance route. It is supplied as monotherapy tablets and as fixed-dose combinations with amlodipine, with hydrochlorothiazide, and as a telmisartan-amlodipine-hydrochlorothiazide triple combination, all manufactured on the same generic-ARB lines that already run losartan and olmesartan for the Indian export market.

Active ingredient

Telmisartan. Angiotensin II receptor blocker (ARB), selective AT1-receptor antagonist.

Forms and strengths

20 mg; 40 mg; 80 mg; 40/5, 40/10, 80/5, 80/10 mg telmisartan/amlodipine; 40/12.5, 80/12.5, 80/25 mg telmisartan/hydrochlorothiazide.

Indications

Telmisartan selectively and non-competitively blocks angiotensin II at the AT1 receptor in vascular smooth muscle and the adrenal cortex, preventing angiotensin II-mediated vasoconstriction and aldosterone release, which lowers systemic vascular resistance and blood pressure without the ACE-inhibitor bradykinin pathway that causes dry cough. It is indicated for essential hypertension and, separately, for reduction of cardiovascular morbidity in high-risk patients aged 55 and above who cannot tolerate ACE inhibitors. Among ARBs it has the longest half-life (about 24 hours) and the highest oral bioavailability, and it is cleared almost exclusively by hepatic glucuronide conjugation and biliary excretion rather than renally, which shapes both its therapeutic niche in renal impairment and its contraindication in biliary obstruction.

Administration

Oral. Tablet; also supplied as fixed-dose combinations with amlodipine and/or hydrochlorothiazide.

Documentation

Batch-specific CoA, CoPP, manufacturing-site WHO-GMP certificate and stability data compiled per consignment, in the format the destination regulator expects.

Who we supply

Hospital pharmacies, licensed importers and tender desks across our export markets.

India is our origin. We do not sell into the Indian market.

Hospital procurement teams, licensed pharmaceutical importers, wholesale distributors and tender desks sourcing an ARB antihypertensive line for the Gulf, Africa, UK/EU and Southeast Asian markets, excluding India as a destination since M Care exports from India rather than into it. Buyers typically fall into two groups: national or hospital tender authorities building a standard hypertension formulary who want telmisartan alongside losartan or olmesartan as an ARB option with genuine 24-hour coverage, and importers serving markets with a high diabetic-hypertensive comorbidity burden who specifically want an ARB that carries no renal dose-adjustment requirement. We also field enquiries from distributors looking to round out an amlodipine or hydrochlorothiazide combination range where a single-pill regimen improves adherence for chronic hypertension management.

GCC registration routes

Supply against MoH registration held by your local licensed importer, or via the GCC central registration pathway.

MoH registration, GCC →

UK unlicensed routes

Where no UK licence exists, the MHRA Specials and named-patient import routes cover clinically justified demand.

MHRA Specials →

Tender desks

Bid-pack documentation assembled to the tender's specification, from CoPP to batch records.

Tender response →

Dossier support

CTD documentation from the sourcing manufacturer, compiled for your regulator's format.

Dossier preparation →

Pharmacist's note

What the dispensing pharmacist checks on telmisartan.

Two contraindications deserve top billing on any patient-facing material accompanying this product, not buried in a package insert. First, like every drug acting on the renin-angiotensin system, telmisartan is contraindicated in pregnancy: exposure in the second and third trimesters is associated with oligohydramnios, fetal renal failure, skull hypoplasia and neonatal death, and prescribing guidance is to discontinue as soon as pregnancy is confirmed and counsel women of childbearing potential accordingly. Second, telmisartan is contraindicated in biliary obstructive disorders and should be used cautiously, generally at a reduced starting dose, in any degree of hepatic impairment, because unlike most of its ARB siblings it depends on hepatic glucuronidation and biliary excretion for clearance rather than the kidney. That same hepatobiliary route is why telmisartan needs no dose adjustment across mild to moderate renal impairment, which is the clinical argument for stocking it specifically in tender populations with a heavy diabetic-nephropathy overlap.

Dual blockade of the renin-angiotensin system is the other recurring prescribing error worth flagging: co-administering telmisartan with an ACE inhibitor, or with aliskiren in a patient with diabetes or renal impairment, raises the risk of hypotension, hyperkalaemia and renal function decline without added cardiovascular benefit, a result the ONTARGET trial demonstrated directly in its telmisartan-plus-ramipril combination arm. Hyperkalaemia risk also rises with concurrent potassium-sparing diuretics, potassium supplements, or salt substitutes containing potassium, and clinicians should check serum potassium and renal function at baseline and periodically thereafter, especially in patients with pre-existing renal impairment or volume depletion. Bilateral renal artery stenosis, or stenosis in a solitary functioning kidney, is a caution rather than an absolute contraindication but carries a real risk of acute renal failure and should prompt closer monitoring if the drug is used at all. NSAID co-administration can blunt the antihypertensive effect and further compromise renal function in volume-depleted or renally impaired patients, an interaction worth noting for markets where over-the-counter NSAID use alongside prescribed antihypertensives is common.

Regulatory & quality

The documentation pack a regulator actually asks for.

Every telmisartan batch we broker is manufactured by an Indian facility holding current WHO-GMP certification, with a certificate of analysis and, where the importing market requires it, a Certificate of Pharmaceutical Product (CoPP) issued against the WHO Certification Scheme. M Care Exports itself holds ISO 9001:2015 certification for its quality management system; we do not manufacture and we do not hold or claim WHO-GMP or WHO-PQ status in our own name; those credentials belong to the manufacturers whose production we source against your specification. We supply documentation packages to match each destination's import requirements, from free-sale certificates to stability data, and can flag which of our partner manufacturers already carry registration or dossier submissions in a given market versus which would need a fresh submission, so your tender timeline reflects the real regulatory runway rather than an assumed one.

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.

Safety and compliance notes

What a buyer should know before this line enters a formulary.

We publish the awkward facts alongside the useful ones. A supplier who omits them is not saving you work, only deferring it.

Contraindicated in pregnancy (Category D), class-wide ARB restriction, discontinue on confirmed pregnancy

Avoid dual RAAS blockade, do not combine with ACE inhibitors; combination with aliskiren is contraindicated in diabetes or renal impairment

Contraindicated in biliary obstructive disorders and severe hepatic impairment due to hepatobiliary elimination

Prescription-only medicine in all served export markets; not a scheduled or controlled substance

How the enquiry works

Molecule · strength · volume · destination. One working day to a quote.

  1. Send us the specifics. Form and strength, pack preference, destination market and indicative volume for telmisartan.
  2. We route to the right line. The enquiry goes to the WHO-GMP certified manufacturing partner whose certificates fit your regulator.
  3. Commercial and regulatory offer. FOB or CIF price with the documentation list, named manufacturing site and current certificate validity.
  4. Order, produce, release, ship. QC release on the Indian side, batch documents compiled, despatch on the agreed incoterm.
  5. After delivery. Batch records and certificates archived and retrievable for the life of the product on your shelf.
Frequently asked

Telmisartan supply, the specific questions.

Why would a buyer choose telmisartan over losartan or olmesartan for a hypertension tender?

The clinical case is the elimination route and dosing durability rather than potency. Because telmisartan clears mainly through the liver and bile with under 1% renal excretion, prescribers do not need to adjust the dose for renal impairment, which matters in markets with a high burden of diabetic nephropathy alongside hypertension. Its longer half-life also gives more forgiving 24-hour coverage than shorter-acting ARBs if a patient's dosing is inconsistent. The tradeoff is that telmisartan needs closer scrutiny in patients with liver disease or bile duct obstruction, where a renally-cleared ARB would be the safer pick.

Is telmisartan safe in pregnancy?

No. Like every angiotensin II receptor blocker, telmisartan is contraindicated in pregnancy. Drugs acting on the renin-angiotensin system cause fetal and neonatal morbidity and mortality when used in the second and third trimesters, including oligohydramnios, fetal renal failure and skull hypoplasia, and should be discontinued as soon as pregnancy is confirmed. This is a class-wide restriction, not specific to our supply, and it should be reflected on any patient information leaflet accompanying the import.

Can telmisartan be combined with an ACE inhibitor for extra blood pressure control?

This combination should be avoided. Dual blockade of the renin-angiotensin system, ARB plus ACE inhibitor, or either plus aliskiren, increases the risk of hypotension, hyperkalaemia and acute kidney injury without a demonstrated outcomes benefit, a finding confirmed in the ONTARGET trial's telmisartan-plus-ramipril arm. Telmisartan should not be co-prescribed with an ACE inhibitor, and combination with aliskiren is specifically contraindicated in patients with diabetes or renal impairment.

What monitoring does a formulary need to plan around when it lists telmisartan?

Baseline and periodic serum creatinine and potassium, particularly in patients with renal artery stenosis, volume depletion, or on concurrent potassium-sparing diuretics or potassium supplements, since ARBs can precipitate hyperkalaemia and, in bilateral renal artery stenosis, acute renal failure. Liver function should be checked in patients with hepatic impairment given telmisartan's hepatobiliary clearance. Standard blood pressure monitoring applies as with any antihypertensive titration.

Does telmisartan need a dose adjustment for kidney disease, and what about liver disease?

No routine dose adjustment is recommended for mild to moderate renal impairment, which is the specific pharmacological advantage of its hepatobiliary elimination route. Hepatic impairment is the opposite case: telmisartan should be used with caution and generally at a lower starting dose in patients with mild to moderate hepatic impairment, and it is contraindicated outright in patients with biliary obstructive disorders or severe hepatic impairment, because bile is the primary excretion pathway for the parent drug.

What fixed-dose combination options can M Care source alongside plain telmisartan?

Telmisartan-amlodipine combinations (commonly 40/5, 40/10, 80/5 and 80/10 mg) and telmisartan-hydrochlorothiazide combinations (commonly 40/12.5, 80/12.5 and 80/25 mg) are both regularly manufactured by our WHO-GMP partner facilities, and a telmisartan-amlodipine-hydrochlorothiazide triple combination is available from a subset of manufacturers for markets where the tender specifies it. Confirm the exact strength split and destination-market registration status with us before finalising a tender submission, since not every manufacturer carries every combination or every registration.

Telmisartan enquiry

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.

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