Prasugrel Tablet Suppliers & Bulk Manufacturers
Available Forms: Tablet
Available Strengths: 5 mg, 10 mg
Reference Brands: Effient(EU & US)
Category: Blood Disorder
Prasugrel tablet is available in Tablet and strengths such as 5 mg, 10 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, Prasugrel tablet 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) |
Prasugrel tablet 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: Prasugrel, marketed as Effient, is approved by the FDA in the US and the EMA in the EU for reducing thrombotic events in acute coronary syndrome patients undergoing PCI. Regulatory approval requires a comprehensive dossier with clinical trial data, safety, efficacy, manufacturing, and pharmacovigilance details. In the US, FDA submission involves detailed review, while the EMA's centralized procedure ensures adherence to regional standards. For guidance on dossier preparation, regulatory pathways, and market access strategies, visit PharmaTradz. Ensuring compliance with regional regulations is vital for the successful approval, commercialization, and safe use of prasugrel across global markets.
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