Givosiran Infusion Suppliers & Bulk Manufacturers
Available Forms: Intravenous infusion
Available Strengths: 2.5 mg/kg IV infusion
Reference Brands: Givlaari
Category:
Nanoemulsion/Nanoparticles
Givlaari (Givosiran) is an RNA interference therapy that reduces the production of hepatic aminolevulinic acid synthase 1 (ALAS1), decreasing neurovisceral attacks in acute hepatic porphyria. Benefits include fewer attacks, improved quality of life, and reduced hospitalization when administered regularly in specialized care settings.
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.
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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