Aprovel (irbesartan), sold in the US as Avapro, is licensed for hypertension and, distinctively among ARBs, for diabetic nephropathy in hypertensive adults with type 2 diabetes, and FDA and MHRA-approved generic irbesartan tablets are available alongside the originator brand.
Aprovel (irbesartan), originated by Sanofi and marketed in the United States by Bristol Myers Squibb as Avapro, is an oral angiotensin II receptor blocker (ARB) once-daily for blood pressure control. M Care Exports is a merchant exporter: we source the Sanofi/BMS brand and FDA and MHRA-approved generic irbesartan tablets through licensed Indian distribution and manufacturing channels and dispatch on quote, not from our own manufacturing.
Irbesartan exporter and bulk supplier from India.
For hospital, wholesaler and tender-desk orders, M Care quotes irbesartan tablets against buyer specification: brand (Aprovel/Avapro) or generic, strength mix (75 mg, 150 mg, 300 mg) and destination-market regulatory documentation, drawn from licensed WHO-GMP manufacturer lines on the M Care roster. Because irbesartan's diabetic nephropathy dose (a fixed 300 mg) differs from its titrated hypertension dose, we confirm the buyer's intended indication mix 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.
Angiotensin II receptor blocker (ARB); AT1-receptor antagonist, sourced and documented for export.
Irbesartan is an angiotensin II receptor blocker (ARB), an AT1-receptor antagonist that blocks the vasoconstrictor and aldosterone-secreting effects of angiotensin II, lowering blood pressure without the dry cough associated with ACE inhibitors. It is dosed orally, not injected, and needs no reconstitution. The FDA label's flagship indication is hypertension, to reduce cardiovascular risk including stroke and myocardial infarction; irbesartan also carries a second, more specific licensed indication for diabetic nephropathy in hypertensive patients with type 2 diabetes, elevated serum creatinine and proteinuria, a nephroprotective use not shared by every ARB on a tender shortlist. Destination-country labelling should be checked against this before a quote is finalised. Aprovel/Avapro is supplied as 75 mg, 150 mg and 300 mg film-coated tablets, taken once daily with or without food.
Active ingredient
Irbesartan. Angiotensin II receptor blocker (ARB); AT1-receptor antagonist.
Forms and strengths
75 mg film-coated tablet; 150 mg film-coated tablet; 300 mg film-coated tablet.
Indications
Irbesartan, angiotensin II receptor blocker indicated for hypertension and, distinctively among ARBs, for diabetic nephropathy in hypertensive adults with type 2 diabetes, elevated serum creatinine and proteinuria. Supplied as originator Aprovel/Avapro 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 irbesartan are mainly hospital cardiology and nephrology outpatient pharmacies managing hypertensive patients with type 2 diabetes and early kidney disease, national and regional MoH tender desks running cardiovascular and NCD formulary lists, licensed pharmaceutical wholesalers and importers, 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 irbesartan.
Irbesartan dosing splits by indication: hypertension starts at 150 mg once daily, titrated to 300 mg if control is insufficient, while diabetic nephropathy is dosed at a fixed 300 mg once daily regardless of the hypertension titration schedule, so pack-mix planning should reflect which indication a tender specifies. Volume- or salt-depleted patients, and those over 75 or on haemodialysis, should start at 75 mg to avoid symptomatic hypotension after the first dose. Irbesartan 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 treats the second and third trimesters as an outright contraindication. Hyperkalaemia risk rises with renal impairment, diabetes, or concomitant potassium-sparing diuretics, potassium supplements or salt substitutes, so renal function and serum potassium should be checked at initiation and periodically thereafter. No cold-chain handling or reconstitution is required.
The documentation pack a regulator actually asks for.
As an oral solid dosage form, irbesartan 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. Irbesartan 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 drug class, so buyers should treat irbesartan as a formulary-specific alternative rather than an EML first-line ARB when building a tender specification. On the brand-versus-generic question, Aprovel (EU/UK) and Avapro (US) remain the originator products, marketed by Sanofi and Bristol Myers Squibb respectively; FDA and MHRA-approved generic irbesartan tablets from multiple manufacturers are separately registered in the US, UK and EU, so buyers genuinely have a brand-or-generic choice. Irbesartan was also among the angiotensin II receptor blockers named in the FDA's 2018-onward nitrosamine impurity recalls that affected several generic ARB manufacturers; M Care confirms current lot-level nitrosamine testing status with the sourcing partner before quoting, which we treat as a standing due-diligence step rather than a one-off check.
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 irbesartan.
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 irbesartan.
- 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.
Irbesartan supply, the specific questions.
Does a generic version of Aprovel/Avapro exist?
Yes. FDA and MHRA-approved generic irbesartan tablets are registered and marketed in the US, UK and EU alongside the originator brands Aprovel and Avapro. Registration status for generic irbesartan varies by destination country, so M Care checks local approval before quoting brand or generic against a specific tender.
Can M Care supply Aprovel or Avapro to our market?
Yes, on an import basis. We source Aprovel/Avapro through Sanofi and Bristol Myers Squibb's licensed Indian distribution channels and dispatch against your import authorisation and any local registration your pharmacy, hospital or wholesaler holds.
What strengths of irbesartan tablets are available?
75 mg, 150 mg and 300 mg film-coated tablets, matching the Aprovel/Avapro strengths. Tell us your indication mix, hypertension or diabetic nephropathy, and dosing protocol and we quote the strength split accordingly.
Why choose irbesartan over another ARB for some patients?
Irbesartan carries a specific licensed indication for diabetic nephropathy in hypertensive patients with type 2 diabetes, elevated serum creatinine and proteinuria, a nephroprotective use not every ARB shares. It is not on the WHO Essential Medicines List, which lists losartan as the reference ARB, so tender desks typically specify irbesartan for this diabetic-nephropathy niche or where a formulary already stocks it.
Is irbesartan safe in pregnancy?
No. Irbesartan 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 in the second and third trimesters outright. 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.
What documentation does M Care provide with an irbesartan shipment?
Batch-level certificate of analysis, CDSCO export documentation from the Indian side, CTD/eCTD-aligned dossier support where the destination regulator requires local registration, and confirmation of current nitrosamine-impurity testing status from the sourcing partner, given irbesartan's inclusion in the FDA's ARB nitrosamine recall reviews.
Who stands behind this page, and where its statements come from.
Reviewed by Dr. Rajat Bhatt, PharmD, Managing Director, M Care Exports. Last reviewed 2026-09-13.
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.