
Patisiran Infusion Suppliers & Bulk Manufacturers
Available Forms: Intravenous (IV) infusion
Available Strengths: 0.3 mg/mL
Reference Brands: Onpattro
Category: Nanoemulsion/Nanoparticles
Patisiran Infusion is available in Intravenous (IV) infusion and strengths such as 0.3 mg/mL. 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, Patisiran Infusion 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) |
Patisiran Infusion 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:
Patisiran (Onpattro) is regulated in both the EU and US, supported by dossiers demonstrating safety, efficacy, and manufacturing quality in compliance with GMP standards. In the US, FDA approval involved rigorous clinical validation, safety assessments, and pharmacovigilance. In the EU, CE marking certifies conformity under MDR standards. These biologics undergo validation, stability testing, and audits, with comprehensive documentation including safety profiles, clinical trial data, and manufacturing practices. For licensing procedures, approved dossiers, and the latest regulatory updates, visit Pharmatradz. Ensuring compliance guarantees access to effective, life-saving therapies supporting patients with hereditary ATTR amyloidosis worldwide, promoting safe and optimal patient outcomes.
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