WHO-GMP sourced EU-GMP partners ISO 9001:2015 49+ export markets Since 2003

Pegfilgrastim (Neulasta) is a long-acting G-CSF given as one 6 mg subcutaneous dose per chemotherapy cycle to reduce febrile neutropenia, and it needs a cold chain.

M Care Exports supplies pegfilgrastim, including the originator Neulasta from Amgen, regulator-approved pegfilgrastim biosimilars and Indian-made 6 mg lines, to hospital pharmacies, oncology units, importers and tender desks in the GCC, Africa and the UK. If you are looking for the 6 mg/0.6 mL prefilled syringe, send the destination, the brand or line you need and the quantity, and we quote per destination.

Biosimilar brands: Fulphila, Ziextenzo, Pelgraz, Grasustek, Nyvepria, Pelmeg, Udenyca, Fylnetra, Stimufend, Cegfila and Armlupeg.

Neulasta 6 mg pegfilgrastim pre-filled syringe carton (Amgen)
WHO-GMP sourcing CDSCO licensed exporter EU-GMP capable partners Cold-chain validated (2–8°C & −25°C) CTD / eCTD dossier-ready ISO 9001:2015
Bulk supply and export terms

Pegfilgrastim exporter and bulk supplier from India.

"We need a partner for pegfilgrastim" is a typical enquiry from an oncology pharmacy or a tender desk. M Care is a merchant-exporter: we quote against your specification and confirm which brands your destination accepts. Pegfilgrastim is bought in several forms. The originator is Neulasta, which the US label lists as a 6 mg/0.6 mL prefilled syringe for manual use and as a Neulasta Onpro kit, where the same strength of syringe is co-packaged with an on-body injector. Biosimilars referencing Neulasta are approved in the US and the EU under their own brand names. We also supply Indian-made 6 mg lines, for example Peg-ReliGrast, Imupeg and Pegg Trust, for destinations whose registration accepts them. The quote turns on which of these you need, the pack, the quantity, 2 to 8 °C cold-chain packing, the registration route in the destination and Incoterms.

Source

WHO-GMP-certified Indian manufacturing line, named on every quote.

Minimum order

No blanket MOQ. Set by the source manufacturer's minimum batch-release quantity for the strength and pack ordered.

Pricing

On request. Indicative FOB or CIF quote, formal proforma on confirmation.

Incoterms

EXW, FOB, CIF, CIP or DAP.

Payment

Letter of credit (sight or usance) and telegraphic transfer.

Documentation

WHO-GMP certificate of the source line, product-specific CoPP, batch CoA, method of analysis, Free Sale Certificate, Certificate of Origin, CTD or eCTD dossier. On request.

Shelf-life

Minimum remaining shelf-life agreed per order and confirmed on the proforma.

Response

Availability and CoPP status within two working days; pre-alert documents before dispatch.

Request a bulk quote → Send a bulk enquiry by form How bulk supply works
At a glance

Long-acting pegylated granulocyte colony-stimulating factor (G-CSF) for febrile neutropenia, sourced and documented for export.

Pegfilgrastim is a covalent conjugate of filgrastim (recombinant G-CSF) and polyethylene glycol, which the UK SmPC describes as a sustained-duration form of filgrastim. The US label for Neulasta (Amgen, Inc., DailyMed, revised August 2026) calls it a leukocyte growth factor and lists two indications in adult and paediatric patients: to decrease the incidence of infection, shown by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs, and to increase survival in patients acutely exposed to myelosuppressive doses of radiation. It is not indicated for mobilisation of peripheral blood progenitor cells for haematopoietic stem cell transplantation. The US dosage forms are a 6 mg/0.6 mL single-dose prefilled syringe for manual use, a 6 mg/0.6 mL prefilled syringe co-packaged with the on-body injector (the Neulasta Onpro kit), and a 4 mg/0.4 mL single-dose vial used for weight-based dosing in paediatric patients under 45 kg. For chemotherapy the US label gives 6 mg subcutaneously once per chemotherapy cycle for adults and for paediatric patients weighing at least 45 kg, and says not to give it between 14 days before and 24 hours after chemotherapy. The EMA page lists Amgen Europe B.V. as marketing authorisation holder, authorised on 22 August 2002, with status authorised. The UK emc SmPC (Amgen Ltd) covers a 6 mg/0.6 mL prefilled syringe for adults on cytotoxic chemotherapy, given at least 24 hours after chemotherapy; the emc page marks that Neulasta listing as discontinued, so confirm UK availability before quoting.

Active ingredient

Pegfilgrastim. Long-acting pegylated granulocyte colony-stimulating factor (G-CSF) for febrile neutropenia.

Forms and strengths

6 mg/0.6 mL single-dose prefilled syringe; 6 mg/0.6 mL prefilled syringe co-packaged with on-body injector (Neulasta Onpro kit, US); 4 mg/0.4 mL single-dose vial (US, paediatric weight-based dosing).

Indications

Pegfilgrastim (Neulasta) is a long-acting G-CSF from Amgen given as one 6 mg subcutaneous dose per chemotherapy cycle to reduce febrile neutropenia, as set out in the US and UK labelling, with biosimilars approved in the US and EU.

Administration

Subcutaneous. Solution for injection in prefilled syringe (with Onpro on-body injector kit in the US).

Documentation

Batch-specific CoA, CoPP, manufacturing-site WHO-GMP certificate and stability data compiled per consignment, in the format the destination regulator expects.

Who we supply

Hospital pharmacies, licensed importers and tender desks across our export markets.

India is our origin. We do not sell into the Indian market.

Buyers are hospital oncology pharmacists, MoH and hospital tender desks, and licensed importers and distributors in the GCC, Africa and the UK. Typical enquiries read "I'm looking for pegfilgrastim 6 mg prefilled syringes for an oncology ward" or "We need a partner for a pegfilgrastim biosimilar for a tender". Each destination has its own route to registration or import, for example the Emirates Drug Establishment (EDE) in the UAE, NAFDAC in Nigeria and the MHRA in the UK, and we align the offer with it before quoting. For a refrigerated biologic like this, whether the destination has registered the brand you want, or needs a named-patient or unlicensed import, depends on the regulator, and M Care Exports confirms the route per enquiry.

GCC registration routes

Supply against MoH registration held by your local licensed importer, or via the GCC central registration pathway.

MoH registration, GCC →

UK unlicensed routes

Where no UK licence exists, the MHRA Specials and named-patient import routes cover clinically justified demand.

MHRA Specials →

Tender desks

Bid-pack documentation assembled to the tender's specification, from CoPP to batch records.

Tender response →

Dossier support

CTD documentation from the sourcing manufacturer, compiled for your regulator's format.

Dossier preparation →

Pharmacist's note

What the dispensing pharmacist checks on pegfilgrastim.

Pegfilgrastim is one fixed dose per cycle, so pack planning is simple but timing is not. The US label says 6 mg once per chemotherapy cycle and not between 14 days before and 24 hours after chemotherapy. The UK SmPC says at least 24 hours after cytotoxic chemotherapy. Cycle length and the next chemotherapy date therefore decide when the ward draws the syringe. The Neulasta Onpro kit is a different product from the plain syringe: it needs the on-body injector, and the US label lists potential device failures, with missed or partial doses, as a warning. Under the US label, store at 2 to 8 °C in the original carton, protected from light, not frozen and not shaken. The US label says a syringe or vial left at room temperature for more than 48 hours should be discarded, and the Onpro kit should not be held at room temperature for more than 12 hours before use. The UK SmPC allows a single period of up to 72 hours not above 30 °C. The two labels differ, so follow the label of the brand and destination you ship to. The US warnings include splenic rupture, including fatal cases, acute respiratory distress syndrome, sickle cell crises and serious hypersensitivity, and these are worth briefing to nursing staff.

Regulatory & quality

The documentation pack a regulator actually asks for.

Pegfilgrastim is a cold-chain biologic. The US Neulasta label requires 2 to 8 °C in the original carton, protected from light, with no freezing or shaking. Its room-temperature allowance is 48 hours for the syringe and vial, and 12 hours before use for the Onpro kit. The UK SmPC requires 2 to 8 °C and allows one period of up to 72 hours not above 30 °C. Export consignments are packed with qualified insulated shippers and temperature loggers, timed to the receiving site. For biosimilars, the FDA-approved labels on DailyMed and the EMA product pages confirm approval status brand by brand, and we state the source and status of each line before quoting. Indian-made lines are supplied only for destinations whose registration accepts them, and we do not claim they are registered anywhere. M Care documentation covers batch certificates of analysis, export documents and destination-aligned dossier support where the regulator asks for it. M Care Exports is a merchant-exporter and holds no manufacturing authorisation of its own.

CoA and MoA, per batch

Batch-specific certificate and method of analysis from the sourcing manufacturer's QC release.

CoPP, WHO-GMP, MFG licence

Certificate of pharmaceutical product and site GMP certification issued via CDSCO channels, naming the actual manufacturing site.

CTD Module 3

Chemistry, manufacturing and controls documentation available from the sourcing manufacturer for registration filings.

Pack insert, labels, artwork

Destination-language patient information and labelling to the local regulator's standard, locked before shipment.

Pharmacovigilance

A named PV contact arranged in the destination market where the registration requires one.

How the enquiry works

Molecule · strength · volume · destination. One working day to a quote.

  1. Send us the specifics. Form and strength, pack preference, destination market and indicative volume for pegfilgrastim.
  2. We route to the right line. The enquiry goes to the WHO-GMP certified manufacturing partner whose certificates fit your regulator.
  3. Commercial and regulatory offer. FOB or CIF price with the documentation list, named manufacturing site and current certificate validity.
  4. Order, produce, release, ship. QC release on the Indian side, batch documents compiled, despatch on the agreed incoterm.
  5. After delivery. Batch records and certificates archived and retrievable for the life of the product on your shelf.
Frequently asked

Pegfilgrastim supply, the specific questions.

What decides the landed price of pegfilgrastim for an importer?

We do not publish prices. A pegfilgrastim injection price or Neulasta cost for an importer depends on whether you want the originator Neulasta, a regulator-approved biosimilar or an Indian-made 6 mg line, the presentation (plain prefilled syringe or the Onpro kit), the quantity, the registration route in your destination, 2 to 8 °C cold-chain freight and Incoterms. M Care Exports quotes per destination once you send the brand or line, the volume and the country.

What is the brand name and generic name of Neulasta, and are there biosimilars?

The non-proprietary name is pegfilgrastim, and Neulasta from Amgen is the originator brand. In the US, DailyMed carries FDA labels for pegfilgrastim biosimilars to Neulasta, including Fulphila, Udenyca, Ziextenzo, Nyvepria, Fylnetra, Stimufend and Armlupeg. The EMA lists biosimilars of Neulasta that are authorised in the EU, including Pelgraz, Ziextenzo, Fulphila, Pelmeg, Grasustek, Cegfila, Nyvepria and Stimufend. These are biosimilars, not generics. M Care Exports confirms which of them, and which Indian-made lines such as Peg-ReliGrast, Imupeg and Pegg Trust, we can supply for your destination.

Pegfilgrastim vs filgrastim, and Neulasta vs Neupogen: how do they compare on the label?

We compare on label facts only and do not recommend one over the other. The US Neulasta label gives 6 mg subcutaneously once per chemotherapy cycle in a 6 mg/0.6 mL prefilled syringe, with an Onpro kit option. The US Neupogen label (filgrastim, Amgen) gives a starting dose of 5 mcg/kg/day as a single daily subcutaneous injection, short IV infusion or continuous IV infusion, in vials and prefilled syringes of 300 mcg and 480 mcg. Both labels cover febrile neutropenia in non-myeloid cancer patients on myelosuppressive chemotherapy, and Neupogen also lists indications such as AML induction or consolidation chemotherapy, bone marrow transplantation, progenitor cell mobilisation and severe chronic neutropenia. Neulasta is not indicated for progenitor cell mobilisation. Check each label for your destination. See the filgrastim page.

What is the pegfilgrastim 6 mg dose, and what is Neulasta Onpro?

The US label gives 6 mg subcutaneously once per chemotherapy cycle for adults and for paediatric patients weighing at least 45 kg, not between 14 days before and 24 hours after chemotherapy. The UK SmPC gives one 6 mg prefilled syringe per cycle, at least 24 hours after cytotoxic chemotherapy. Neulasta Onpro is the US kit that co-packs the 6 mg/0.6 mL prefilled syringe with an on-body injector. The UK SmPC we fetched does not mention it, so confirm that your destination registers the Onpro kit before ordering.

How is pegfilgrastim stored, and what are the main warnings?

The US label says to store at 2 to 8 °C in the original carton, protected from light, not frozen and not shaken. It says to discard a syringe or vial left at room temperature for more than 48 hours, and not to hold the Onpro kit at room temperature for more than 12 hours before use. The UK SmPC allows one period of up to 72 hours not above 30 °C. Key US warnings include splenic rupture, acute respiratory distress syndrome, serious hypersensitivity including anaphylaxis and sickle cell crises. This is not a full side-effect list, so the full label governs use.

Which pegfilgrastim lines does M Care Exports supply?

M Care Exports supplies both originator or regulator-approved brands and Indian-made lines. Examples of Indian-made 6 mg injections are Peg-ReliGrast, Imupeg and Pegg Trust. We supply them for destinations whose registration accepts them and make no claim that they are registered in any particular country. If you need Neulasta, a named biosimilar or an Indian-made line, tell us the destination and quantity, and we confirm what your regulator allows, including any named-patient route, before we quote.

Sources and review

Who stands behind this page, and where its statements come from.

Reviewed by Dr. Rajat Bhatt, PharmD, Managing Director, M Care Exports. Last reviewed 2026-11-08.

This page is sourcing information for licensed importers, hospital procurement and tender desks. It is not medical, pharmaceutical or prescribing advice, and it is not a substitute for the approved product information of the line on your order. See our full disclaimer.

Pegfilgrastim enquiry

Send the specifics. You'll have a price inside one working day.

Form and strength, destination market and indicative volume. The Mumbai desk replies within one working day, including when the honest answer is that the route is not viable yet.

WhatsApp the Mumbai desk → Enquiry form Back to haematology & biologicals