Pegfilgrastim Injection Suppliers & Bulk Manufacturers
Available Forms: Injection
Available Strengths: 6 mg per single-use syringe
Reference Brands: Neulasta, Pelgraz(US)
Category:
Blood Disorder
Pegfilgrastim stimulates the production of neutrophils by binding to G-CSF receptors, reducing the risk of infection during chemotherapy-induced neutropenia. Its benefits include rapid neutrophil recovery, decreased infection rates, fewer hospitalizations, and improved treatment safety, enabling patients to continue chemotherapy effectively with lower complication risks.
Pegfilgrastim injection is available in Injection
and strengths such as 6 mg per single-use syringe.
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, Pegfilgrastim injection 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) |
Pegfilgrastim injection 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:
Pegfilgrastim injection, marketed as Neulasta and biosimilars like Pelgraz, is approved in the US by the FDA and in the EU via EMA for preventing chemotherapy-induced neutropenia. Regulatory approval requires a comprehensive dossier including biosimilarity data, clinical efficacy, safety, manufacturing quality, and pharmacovigilance plans. In the US, FDA review involves detailed assessment of the biosimilar complex, while the EMA ensures compliance with regional standards. For guidance on dossier preparation, regulatory pathways, and successful market access strategies, visit PharmaTradz. Ensuring compliance with regional regulations is essential for the safe, effective, and timely approval of pegfilgrastim injection worldwide, supporting patient safety during cancer chemotherapy.
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