Fitusiran bulk supplier for pharma manufacturers

Fitusiran 50 mg/0.5 ml, 20 mg/0.2ml 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

Fitusiran is a Critical Care product available as injection (prefilled syringe) in strengths 50 mg/0.5 ml, 20 mg/0.2ml. It corresponds to the reference brand Generic formulations marketed under different names. Verified GMP manufacturers and suppliers on PharmaTradz offer it in bulk for import worldwide, with regulatory documentation and dossier support available on request.

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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.

Fitusiran — third party manufacturing & bulk supply

Fitusiran 50 mg/0.5 ml, 20 mg/0.2ml is available through PharmaTradz for wholesale and bulk supply as well as on a third party (contract) manufacturing basis. Buyers sourcing this product generally take one of three routes:

Wholesale / bulk supply Stock or scheduled supply from an existing manufacturer. The fastest route where the product is already registered in your market.

Third party manufacturing Manufactured to your specification and packed under your own brand and label — suits distributors and brand owners building a portfolio in their market.

Dossier licensing Where a CTD, EU-CTD or ACTD dossier exists it can often be licensed for filing in your name, compressing market entry from years to months.

Indicative minimum order quantity

Fitusiran is supplied as injection (prefilled syringe) — an injectable dosage form, so the indicative MOQ is 50,000 units. Actual MOQ is confirmed by the allocated manufacturer against your pack presentation and destination market. See full supply terms for dossier formats, market availability and shelf life.

Manufacturers of Fitusiran listed on PharmaTradz hold site-level approvals across WHO-GMP, EU-GMP, USFDA, ANVISA and TGA, verified at onboarding.

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Frequently Asked Questions

Fitusiran is used for the prevention and reduction of bleeding episodes in patients with hemophilia A or hemophilia B, including patients who have developed inhibitors to factor VIII or factor IX.

Fitusiran is a synthetic small interfering RNA (siRNA) molecule designed to specifically target antithrombin mRNA in liver cells, thereby reducing antithrombin protein production.

Fitusiran does not currently have an approved trade name, as it is still under regulatory evaluation.

Fitusiran is developed by Sanofi, in collaboration with Alnylam Pharmaceuticals.

The complete generic name is fitusiran.

There is no approved brand name for fitusiran at present.

Fitusiran is manufactured in specialized biotechnology facilities approved for clinical and commercial RNA-based therapeutics, with manufacturing details disclosed by the developer in regulatory filings.