Hemlibra (emicizumab) is a bispecific antibody for routine prophylaxis of bleeding episodes in haemophilia A, given by subcutaneous injection from single-dose vials of 30 mg/mL and 150 mg/mL, and it is kept refrigerated.
M Care Exports supplies Hemlibra (emicizumab), a Roche group product whose trademark is held by Chugai Pharmaceutical, to hospital haemophilia centres, importers and tender desks in the GCC, Africa and the UK. If you are looking for the 30 mg/mL or 150 mg/mL vials, send the destination, the vial sizes and the quantity, and we quote per destination.
Emicizumab exporter and bulk supplier from India.
"We need a partner for Hemlibra" is a typical enquiry from a haemophilia centre pharmacy or a ministry tender desk. M Care is a merchant-exporter: we quote against your specification and confirm which presentations your destination registers. Hemlibra is not one product but six vials across two concentrations. The US label lists 12 mg/0.4 mL and 30 mg/1 mL at 30 mg/mL, and 60 mg/0.4 mL, 105 mg/0.7 mL, 150 mg/1 mL and 300 mg/2 mL at 150 mg/mL, one vial per carton. The UK emc entry lists the 12 mg and 30 mg vials at 30 mg/mL and the 60 mg, 105 mg and 150 mg vials at 150 mg/mL. Dosing is by body weight, so the vial mix depends on the patient list, not on a single standard pack. The quote also turns on 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.
Bispecific monoclonal antibody that bridges activated factor IX and factor X, for haemophilia A prophylaxis, sourced and documented for export.
Hemlibra is a humanised bispecific monoclonal antibody that bridges activated factor IX and factor X to restore the function of missing activated factor VIII. The US label (Genentech, Inc., DailyMed, updated July 2025) indicates it for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adults and children from birth with haemophilia A (congenital factor VIII deficiency), with or without factor VIII inhibitors. The EU SmPC covers patients with inhibitors, and patients without inhibitors who have severe disease (FVIII below 1%) or moderate disease (FVIII 1% to 5%) with a severe bleeding phenotype, in all age groups. Both labels give a subcutaneous loading dose of 3 mg/kg once weekly for the first 4 weeks, then one maintenance option: 1.5 mg/kg weekly, 3 mg/kg every two weeks or 6 mg/kg every four weeks. The EMA page records authorisation on 23 February 2018. The UK emc entry is held by Roche Products Limited.
Active ingredient
Emicizumab (emicizumab-kxwh in the US). Bispecific monoclonal antibody that bridges activated factor IX and factor X, for haemophilia A prophylaxis.
Forms and strengths
12 mg/0.4 mL (30 mg/mL) single-dose vial; 30 mg/1 mL (30 mg/mL) single-dose vial; 60 mg/0.4 mL (150 mg/mL) single-dose vial; 105 mg/0.7 mL (150 mg/mL) single-dose vial; 150 mg/1 mL (150 mg/mL) single-dose vial; 300 mg/2 mL (150 mg/mL) single-dose vial.
Indications
Emicizumab (Hemlibra) is a humanised bispecific modified IgG4 antibody from the Roche group for routine prophylaxis of bleeding episodes in haemophilia A, given by subcutaneous injection as set out in the US, EU and UK labelling.
Administration
Subcutaneous. Solution for injection in a single-dose vial.
Documentation
Batch-specific CoA, CoPP, manufacturing-site WHO-GMP certificate and stability data compiled per consignment, in the format the destination regulator expects.
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 pharmacists in haemophilia and haematology centres, MoH and hospital tender desks, and licensed importers and distributors in the GCC, Africa and the UK. Typical enquiries read "I'm looking for Hemlibra 150 mg/mL vials for a haemophilia centre" or "We need a partner for emicizumab for a tender". The EU SmPC says treatment is started under a physician experienced in haemophilia or bleeding disorders, so orders usually come through specialist centres. Whether Hemlibra enters as a registered product or through an unlicensed or named-patient route depends on the destination regulator, for example the Emirates Drug Establishment (EDE) in the UAE, NAFDAC in Nigeria or the MHRA in the UK, and M Care Exports confirms the route per enquiry before quoting.
GCC registration routes
Supply against MoH registration held by your local licensed importer, or via the GCC central registration pathway.
UK unlicensed routes
Where no UK licence exists, the MHRA Specials and named-patient import routes cover clinically justified demand.
Tender desks
Bid-pack documentation assembled to the tender's specification, from CoPP to batch records.
Dossier support
CTD documentation from the sourcing manufacturer, compiled for your regulator's format.
What the dispensing pharmacist checks on emicizumab.
Plan the vial list from the patient weights, because every dose is calculated in mg/kg and then converted to a volume. The EU SmPC gives the volume as the total dose in mg divided by the vial concentration, and says the 30 mg/mL and 150 mg/mL concentrations should not be combined in the same syringe. Choose one maintenance schedule per patient: weekly, every two weeks or every four weeks, all after the same 4-week loading phase. The key safety point is thrombotic microangiopathy and thromboembolism when activated prothrombin complex concentrate (aPCC) is given at a cumulative average above 100 U/kg/24 hours for 24 hours or more. The US label carries this as a boxed warning, and its instruction is to discontinue aPCC and suspend Hemlibra dosing if symptoms occur. Hemlibra also distorts intrinsic-pathway clotting tests such as aPTT and ACT, and one-stage factor VIII assays. Chromogenic and immuno-based single-factor assays are not affected, but the EU SmPC notes that chromogenic factor VIII tests with human coagulation proteins respond to emicizumab, while bovine-based tests do not. Ask your laboratory which method it runs. Storage is 2 to 8 °C, not frozen or shaken, protected from light in the carton.
The documentation pack a regulator actually asks for.
Hemlibra is a cold-chain biologic. Both the US label and the EU SmPC require unopened vials at 2 to 8 °C in the original carton, protected from light, not frozen and not shaken. Both allow unopened vials to be kept below 30 °C for up to 7 days in total, including any return to the refrigerator, and the EU SmPC says vials kept longer or exposed above 30 °C should be discarded. The EU SmPC gives an unopened shelf life of 2 years. Export consignments are packed for cold chain with insulated shippers and temperature monitoring, timed to the receiving site. M Care documentation covers batch certificates of analysis, export documents and destination-aligned dossier support where the regulator asks for it. We state the source and status of each line before quoting, and make no claim for M Care itself beyond merchant-exporter documentation.
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.
Adjacent lines procurement desks order alongside emicizumab.
Tranexamic acid
Antifibrinolytic · surgical bleeding, menorrhagia, dental cover in haemophilia
Eculizumab biosimilar
C5 complement inhibitor · PNH · aHUS · cold-chain biological
Human normal immunoglobulin
Plasma-derived IgG (IVIG, SCIG) · primary immunodeficiency, ITP, CIDP
All haematology & biologicals
The full category listing for procurement desks.
Molecule · strength · volume · destination. One working day to a quote.
- Send us the specifics. Form and strength, pack preference, destination market and indicative volume for emicizumab.
- We route to the right line. The enquiry goes to the WHO-GMP certified manufacturing partner whose certificates fit your regulator.
- Commercial and regulatory offer. FOB or CIF price with the documentation list, named manufacturing site and current certificate validity.
- Order, produce, release, ship. QC release on the Indian side, batch documents compiled, despatch on the agreed incoterm.
- After delivery. Batch records and certificates archived and retrievable for the life of the product on your shelf.
Emicizumab supply, the specific questions.
What decides the landed price of Hemlibra for an importer?
We do not publish prices, and any figure quoted online without your destination is a guess. The landed cost depends on the vial sizes and concentrations, the quantity, the registration route in your destination, cold-chain freight and Incoterms. Hemlibra is a refrigerated originator biologic, so insulated packing and temperature monitoring are part of the quote. Dosing is weight-based, so the vial mix for your patient list also shapes the order. M Care Exports quotes per destination once you send the vial sizes, volume and country.
Which Hemlibra injection presentations can you supply?
Hemlibra is a solution for subcutaneous injection in single-dose vials. The US label lists 12 mg/0.4 mL and 30 mg/1 mL at 30 mg/mL, and 60 mg/0.4 mL, 105 mg/0.7 mL, 150 mg/1 mL and 300 mg/2 mL at 150 mg/mL. The EU SmPC lists the same six vials, and the UK emc entry lists the 12 mg and 30 mg vials at 30 mg/mL and the 60 mg, 105 mg and 150 mg vials at 150 mg/mL. Not every size is marketed in every country. If you are looking for a specific vial, M Care Exports confirms availability and registration for your destination.
What is the Hemlibra dosing schedule?
Both the US label and the EU SmPC give 3 mg/kg subcutaneously once weekly for the first 4 weeks as the loading dose. From week 5 the maintenance dose is one of three options: 1.5 mg/kg once weekly, 3 mg/kg every two weeks or 6 mg/kg every four weeks. The EU SmPC says the maintenance schedule is chosen by the physician and the patient or caregiver to support adherence. Treatment is started under a physician experienced in haemophilia. This describes the label, and dosing for a patient is a clinical decision.
What is the Hemlibra mechanism of action?
Emicizumab is a bispecific antibody. According to the EU SmPC it bridges activated factor IX and factor X to restore the function of missing activated factor VIII, which is needed for effective haemostasis. It does not require activation by thrombin, which is why intrinsic clotting tests such as aPTT read overly short during treatment. It is not factor VIII itself, and the SmPC states it has no structural relationship or sequence homology to factor VIII.
Is there a generic or biosimilar of Hemlibra?
The non-proprietary name is emicizumab, and the US label uses emicizumab-kxwh. The US label, the EMA EPAR page and the UK emc entry we reviewed all present Hemlibra as the Roche group's product, and none of them describes a biosimilar or generic emicizumab. Hemlibra is therefore the originator product on offer here. M Care Exports confirms the current position for your destination at quotation.
What should a pharmacy know about aPCC and storage before ordering Hemlibra?
The US boxed warning and the EU SmPC both describe thrombotic microangiopathy and thromboembolism when aPCC was given at a cumulative average above 100 U/kg/24 hours for 24 hours or more. The US label says to discontinue aPCC and suspend Hemlibra dosing if symptoms occur. For storage, unopened vials stay at 2 to 8 °C, and the label allows up to 7 days in total below 30 °C, so the receiving site must log the time out of the refrigerator. Plan for cold-chain receipt on arrival.
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.
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