
Givosiran Infusion Suppliers & Bulk Manufacturers
Available Forms: Intravenous infusion
Available Strengths: 2.5 mg/kg IV infusion
Reference Brands: Givlaari
Category: Nanoemulsion/Nanoparticles
Givosiran Infusion is available in Intravenous infusion and strengths such as 2.5 mg/kg IV infusion. 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, Givosiran 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) |
Givosiran 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:
Givlaari (Givosiran) is regulated in the US and EU, supported by dossiers demonstrating safety, efficacy, and quality manufacturing in line with GMP standards. In the US, FDA approval involved extensive clinical validation, safety assessments, and pharmacovigilance. In the EU, approval is pending or granted in some countries, with CE marking certifying conformity with MDR standards. These formulations undergo validation, stability testing, and audits, with comprehensive documentation including safety profiles, clinical trial data, and manufacturing practices. For licensing procedures, approved dossiers, and regulatory updates, visit Pharmatradz. Ensuring compliance guarantees access to effective Givosiran therapy supporting patients with hepatic porphyria worldwide.
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