Fitusiran Suppliers & Bulk Manufacturers
Available Forms: injection (prefilled syringe)
Available Strengths: 50 mg/0.5 ml, 20 mg/0.2ml
Reference Brands: Generic formulations marketed under different names
Category:
Critical Care
Fitusiran is available in injection (prefilled syringe)
and strengths such as 50 mg/0.5 ml, 20 mg/0.2ml.
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, Fitusiran is supplied in
bulk quantities with complete regulatory support including DMF, COA, and MSDS.
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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) |
Fitusiran 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:
Fitusiran is a synthetic small interfering RNA (siRNA)–based therapeutic developed for prophylactic use in patients with hemophilia A or hemophilia B. It is designed to reduce the frequency of bleeding episodes in individuals with or without inhibitors to conventional clotting factor therapies. Fitusiran works by selectively targeting antithrombin messenger RNA in the liver, leading to decreased antithrombin levels and enhanced thrombin generation. This mechanism helps restore hemostatic balance and improves blood clot formation in patients with hemophilia.
The medicine is administered as a subcutaneous injection and is intended for long-term preventive treatment rather than on-demand bleeding control. By offering a factor-independent approach, fitusiran represents an important advancement for patients who experience limited efficacy or complications with traditional factor replacement therapies.
During clinical use, fitusiran has been associated with certain safety considerations. Mild to moderate elevations in alanine aminotransferase (ALT) levels have been observed during therapy, and rare cases of acute liver injury accompanied by jaundice have been reported. Additionally, fitusiran has been linked to gallbladder-related events, including cholelithiasis and cholecystitis. As a result, regular monitoring of liver function and careful clinical assessment are important components of patient management during treatment with fitusiran.
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