Irbesartan Tablets 75 mg, 150 mg, 300 mg Suppliers & Bulk Manufacturers

Available Forms: Tablets

Available Strengths: 75 mg, 150 mg, 300 mg

Reference Brands: Avapro(Us & EU)

Category: Hypertension

Irbesartan tablets 75 mg, 150 mg and 300 mg, an angiotensin II receptor blocker for hypertension and diabetic kidney disease. For importers, distributors, hospitals and tender buyers needing registered generic supply.

Product Description:

Irbesartan is an angiotensin II receptor blocker, often called an ARB or sartan. It blocks the AT1 receptor, so angiotensin II can no longer constrict blood vessels or drive aldosterone release. Unlike ACE inhibitors it does not raise bradykinin, so dry cough is uncommon. This page covers 75 mg, 150 mg and 300 mg tablets. Its long action allows one dose a day.

Irbesartan is used for essential hypertension in adults and for kidney disease in hypertensive patients with type 2 diabetes. The usual dose is 150 mg once a day, taken with or without food, increased to 300 mg if needed. Like other drugs acting on the renin-angiotensin system it is avoided in pregnancy. Dual blockade with an ACE inhibitor or with aliskiren is generally avoided. Potassium and creatinine are monitored, particularly with potassium supplements, potassium-sparing diuretics or NSAIDs, and lithium levels can rise.

Sourcing notes. Irbesartan is prescription-only. Since nitrosamine impurities were found in several sartans, regulators expect a nitrosamine risk assessment for both API and tablets, with testing where a risk is identified, and some also ask about azido impurities. Ask for these with a CTD or ACTD dossier, bioequivalence data and Zone IVb stability for hot, humid markets. Blisters at room temperature are usual. Each batch should have a CoA covering related substances, and the file should include the GMP certificate and a CoPP. In your enquiry, give the strengths, pack size, quantity and target market.