Irbesartan Tablets Suppliers & Bulk Manufacturers
Available Forms: Tablets
Available Strengths: 75 mg, 150 mg, 300 mg
Reference Brands: Avapro(Us & EU)
Category: Hypertension
Irbesartan is an angiotensin II receptor blocker (ARB) that prevents angiotensin II from binding to its receptors, causing vasodilation. It lowers blood pressure, reduces kidney damage in diabetics, and decreases cardiovascular risks. Benefits include improved blood pressure control, renal protection, and reduced risk of strokes and heart attacks. Irbesartan tablets is available in Tablets and strengths such as 75 mg, 150 mg, 300 mg. Sourced from GMP-certified and ISO-compliant manufacturers, this API meets global pharmacopeia standards (USP/EP/JP as applicable). Ideal for pharmaceutical formulation and commercial manufacturing, Irbesartan tablets is supplied in bulk quantities with complete regulatory support including DMF, COA, and MSDS.
| Technical Specifications & Supply Details | |
|---|---|
| Lead Time | 7 to 60 days (depending on batch size & schedule) |
| MOQ | As per manufacturer’s batch size |
| COA | Available with every batch |
| Regulatory Dossier / DMF | Available upon request |
| Export Documentation | FSC, COA, Manufacturing License, Product Permission |
| Standards | IP, BP, USP |
| Certifications | WHO-GMP, EU-GMP, USFDA (as applicable) |
Irbesartan tablets can be exported to over 30 countries across Asia, Africa, Europe, and Latin America. Flexible packaging, competitive pricing, and a verified supplier network make Pharmatradz a trusted sourcing partner for pharmaceutical companies and contract manufacturers worldwide.
Product Description:
Irbesartan tablets, marketed as Avapro, are approved in the US by the FDA and in the EU via EMA for hypertension and diabetic nephropathy. Regulatory approval requires a detailed dossier, including clinical efficacy, safety data, manufacturing standards, and pharmacovigilance plans. The FDA reviews comprehensive clinical trial and quality information, while the EMA verifies compliance with regional safety, efficacy, and manufacturing standards. For guidance on dossier preparation, regulatory pathways, and market access, visit PharmaTradz. Ensuring regional compliance supports timely approval, safe medication use, and global availability of irbesartan tablets, helping manage hypertension and protect renal function worldwide effectively.
The Trade Mark owner has been correctly identified under the heading Manufacturer / TM Owner as required by the Act.
Frequently Asked Questions
Irbesartan is used to treat high blood pressure (hypertension) and to protect the kidneys in patients with type 2 diabetes and hypertension. By blocking the action of angiotensin II, it helps relax blood vessels, improving blood flow and reducing the risk of heart attack, stroke, and kidney damage.
Irbesartan tablets are made from the active ingredient Irbesartan, which belongs to the class of angiotensin II receptor blockers (ARBs). The tablets may also contain inactive ingredients such as lactose, microcrystalline cellulose, croscarmellose sodium, povidone, and magnesium stearate, which help in tablet formulation and stability.
The common trade names of Irbesartan include Avapro®, Karvea®, Aprovel®, and Irovel®, which are available in various countries across the USA, UK, EU, and India.
Irbesartan is originally marketed by Sanofi-Aventis under the brand names Avapro®, Aprovel®, and Karvea®. Several pharmaceutical companies such as Torrent Pharmaceuticals, Cipla, Sun Pharma, and Teva Pharmaceuticals also manufacture and supply generic versions of Irbesartan globally.
The generic name of the medicine is Irbesartan.
The brand names of Irbesartan include Avapro®, Karvea®, Aprovel®, and Irovel®.
Irbesartan tablets are manufactured in various regions around the world including France, the United Kingdom, and Ireland by Sanofi-Aventis for their branded products, and in India by companies such as Torrent, Sun Pharma, and Cipla for generic versions. It is also produced in the USA and Canada for Avapro® under Sanofi-Aventis U.S. LLC.
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