Pegfilgrastim Injection 6 mg per single-use syringe Suppliers & Bulk Manufacturers
Available Forms: Injection
Available Strengths: 6 mg per single-use syringe
Reference Brands: Neulasta, Pelgraz(US), Pegex (Inida)
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.
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.
Pegfilgrastim Injection — third party manufacturing & bulk supply
Pegfilgrastim Injection 6 mg per single-use syringe 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 Pegfilgrastim Injection 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.
Request a quote for Pegfilgrastim Injection →The Trade Mark owner has been correctly identified under the heading Manufacturer / TM Owner as required by the Act.
Frequently Asked Questions
Pegfilgrastim Injection is used to reduce the risk of infection in patients receiving chemotherapy by stimulating the production of white blood cells, particularly neutrophils.
Pegfilgrastim is a pegylated recombinant human granulocyte colony-stimulating factor (G-CSF) that stimulates the bone marrow to produce more neutrophils.
Common trade names include Neulasta, Ziextenzo, Udenyca, Fulphila, Nyvepria, Pelgraz, Pelmeg, and Pegex.
The original brand Neulasta was developed and marketed by the pharmaceutical company Amgen, while several pharmaceutical companies manufacture biosimilar pegfilgrastim products worldwide.
The generic name is Pegfilgrastim.
Common brand names include Neulasta, Ziextenzo, Udenyca, Fulphila, Nyvepria, Pelgraz, Pelmeg, and Pegex.
Pegfilgrastim Injection is manufactured in several countries including the United States, Germany, India, and other regions by different pharmaceutical manufacturers.
Related Products
Anagrelide Hydrochloride
Strength:
0.5 mg
Form: Capsules
Reference Brands: Agrylin (USA)
View Details
Ferric Maltol
Strength:
30 mg
Form: Capsules
Reference Brands: Accrufer (USA), Feraccru (EU)
View Details
Lusutrombopag
Strength:
3 mg
Form: Tablets
Reference Brands: Mulpleta (USA), Mulpleo (EU)
View Details
Quick Response Guaranteed | Verified Suppliers
