Filgrastim Injection (Subcutaneous And Iv) 300 million IU Suppliers & Bulk Manufacturers
Available Forms: Injection (Subcutaneous and IV)
Available Strengths: 300 million IU
Reference Brands: Neupogen, Granix, Zarxio(US), Religrast (India)
Category: Blood Disorder
Filgrastim stimulates the production of neutrophils by binding to G-CSF receptors on bone marrow cells. It reduces the risk of infections in patients with neutropenia, accelerates white blood cell recovery post-chemotherapy or transplantation, and decreases infection-related complications, improving patient outcomes and supporting cancer treatments.
Product Description:
Filgrastim injection, marketed as Neupogen and biosimilars like Zarxio, is approved in both the US by the FDA and in the EU via EMA for neutropenia treatment. Regulatory approval requires a comprehensive dossier including clinical trial data, biosimilarity evidence, manufacturing quality, safety, and pharmacovigilance plans. In the US, FDA review involves detailed biosimilar and safety assessments, while the EMA ensures strict compliance with regional standards. For guidance on dossier preparation, regulatory strategies, and market access, visit PharmaTradz. Ensuring compliance with regional regulations is essential for the safe, effective, and timely approval of filgrastim injection worldwide, supporting improved patient outcomes in chemotherapy and bone marrow transplantation.
Filgrastim Injection (Subcutaneous And Iv) — third party manufacturing & bulk supply
Filgrastim Injection (Subcutaneous And Iv) 300 million IU 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:
What to include when you enquire
- Destination market — determines which manufacturers hold the right site-level approvals
- First order quantity and estimated annual volume
- Whether you need a registration dossier or the product is already registered
- Packaging, labelling and language requirements
- Incoterms and required shelf life
Manufacturers of Filgrastim Injection (Subcutaneous And Iv) listed on PharmaTradz hold site-level approvals across WHO-GMP, EU-GMP, USFDA, ANVISA and TGA, verified at onboarding. Narcotic drugs and controlled substances are supplied strictly against valid import and export permits issued by the competent authorities.
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Frequently Asked Questions
Filgrastim Injection is used to stimulate the production of white blood cells, particularly neutrophils, in patients receiving chemotherapy. It helps reduce the risk of infection caused by low neutrophil counts.
Filgrastim is a recombinant human granulocyte colony-stimulating factor (G-CSF) produced using biotechnology to stimulate the bone marrow to produce neutrophils.
Common trade names include Neupogen, Zarxio, Nivestym, Granix, Grastofil, Accofil, Leucostim, and Religrast.
The original brand Neupogen was developed by the pharmaceutical company Amgen, while many pharmaceutical companies worldwide manufacture biosimilar filgrastim products.
The generic name is Filgrastim.
Common brand names include Neupogen, Zarxio, Nivestym, Granix, Grastofil, Accofil, Leucostim, and Religrast.
Filgrastim Injection is manufactured in several countries including the United States, Germany, India, and other regions by different pharmaceutical manufacturers.
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