Filgrastim Injection (Subcutaneous And Iv) Suppliers & Bulk Manufacturers
Available Forms: Injection (Subcutaneous and IV)
Available Strengths: 300 million IU
Reference Brands: Neupogen, Granix, Zarxio(US)
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.
Filgrastim Injection (Subcutaneous and IV) is available in Injection (Subcutaneous and IV)
and strengths such as 300 million IU.
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, Filgrastim Injection (Subcutaneous and IV) 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) |
Filgrastim Injection (Subcutaneous and IV) 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:
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.
Disclaimer: By continuing to browse, you agree to the terms of use of this website and the Trade Marks displayed, in compliance with the provisions of the Trademark Act, 1999, Section 30 and 30(1) under 'Fair use.'
The Trade Mark owner has been correctly identified under the heading Manufacturer / TM Owner as required by the Act.
Back to Listing