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 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.

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.