Irbesartan Tablets Suppliers & Bulk Manufacturers
Available Forms: Tablets
Available Strengths: 75 mg, 150 mg, 300 mg
Reference Brands: Avapro(Us & EU)
Category: Hypertension
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.
The Trade Mark owner has been correctly identified under the heading Manufacturer / TM Owner as required by the Act.
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.
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