Irbesartan

Irbesartan (CAS 138402-11-6), also referenced under development codes BMS-186295 and marketed as Avapro and Aprovel, is an angiotensin II receptor antagonist API used in the manufacture of antihypertensive drug products. It is a primary active pharmaceutical ingredient sourced by generic drug manufacturers and contract formulators worldwide. Irbesartan is the core API in finished oral solid dosage forms, such as tablets and capsules.

These finished products target hypertension and diabetic nephropathy indications. Generic pharmaceutical manufacturers source it in bulk to produce bioequivalent formulations following patent expiry in major markets. Contract development and manufacturing organizations (CDMOs) use it in combination product development, particularly fixed-dose combinations with hydrochlorothiazide. This is a common practice in the industry.

Regulatory dossier preparation and reference standard procurement represent additional sourcing contexts for QA and analytical laboratories. Irbesartan is supplied as a white to off-white crystalline powder. Quantities range from laboratory scale to multi-tonne commercial lots. It is available to USP, Ph. Eur., and BP specifications, with ICH-compliant impurity profiling expected for GMP-grade material.

Certificate of Analysis, DMF references, and country-specific regulatory support documentation are standard requirements at the commercial supply level. These documents ensure compliance with global safety standards.