Ambrisentan Tablets Suppliers & Bulk Manufacturers
Available Forms: Tablets
Available Strengths: 5 mg and 10 mg
Reference Brands: Letairis®(US & EU); Volibris®(EU)
Category: Orphan Drugs
Ambrisentan tablets is available in Tablets and strengths such as 5 mg and 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, Ambrisentan 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) |
Ambrisentan 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: Ambrisentan tablets, marketed as Letairis® and Volibris®, are approved in the US and EU for pulmonary arterial hypertension (PAH). Regulatory dossiers include comprehensive clinical trial data, manufacturing standards, and safety profiles, supporting approval by the FDA and EMA. These dossiers demonstrate Ambrisentan’s efficacy in improving exercise capacity and reducing PAH symptoms. Available in 5 mg and 10 mg tablets, dosing can be tailored to patient response. For detailed insights on regulatory processes, dossier submissions, and market approvals in the EU and US, visit PharmaTradz, your trusted source for pharmaceutical regulatory insights and industry updates.
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