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

Ebglyss (lebrikizumab) is an IL-13 antibody for moderate-to-severe atopic dermatitis, supplied as a 250 mg/2 mL pen or prefilled syringe, loaded at weeks 0 and 2 and then given every 2 weeks, and it needs a refrigerated cold chain.

M Care Exports supplies Ebglyss (lebrikizumab) to hospital pharmacies, dermatology units, importers and tender desks in the GCC, Africa and the UK. If you are looking for the 250 mg/2 mL pen or prefilled syringe, send the destination, the presentation and the quantity, and we quote per destination.

Ebglyss 250 mg lebrikizumab solution for injection in pre-filled pen, 2-pen carton (Almirall)
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

Lebrikizumab exporter and bulk supplier from India.

"We need a partner for Ebglyss" is a typical enquiry from a hospital dermatology pharmacy or a tender desk. M Care Exports is a merchant-exporter: we quote against your specification and confirm which presentation your destination registers. Ebglyss is one 250 mg/2 mL (125 mg/mL) dose unit in two devices, a single-dose pen and a single-dose prefilled syringe. Quantity planning is driven by the loading phase, because the 500 mg loading dose at weeks 0 and 2 uses two 250 mg injections each time. What sets the landed price for an importer is the device and pack, the quantity, the destination's registration route, the cold chain and the Incoterms, so we quote per destination.

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

Interleukin-13 (IL-13) antagonist monoclonal antibody, sourced and documented for export.

Ebglyss is a monoclonal antibody that targets interleukin-13 (IL-13), for moderate-to-severe atopic dermatitis. The US label (Eli Lilly and Company, DailyMed) covers adults and paediatric patients aged 12 years and older who weigh at least 40 kg, and lists a 250 mg/2 mL single-dose prefilled pen and a 250 mg/2 mL single-dose prefilled syringe. The US dosing is 500 mg (two 250 mg injections) at week 0 and week 2, then 250 mg every 2 weeks until week 16 or later when an adequate response is reached, then maintenance of 250 mg every 4 weeks or every 8 weeks as the current US label states. The EU holder is Almirall, S.A., with authorisation granted on 16 November 2023 for adults and adolescents aged 12 and over weighing at least 40 kg who are candidates for systemic therapy. The UK emc SmPC also names Almirall, S.A. as holder, with first authorisation on 19 December 2023, and gives 250 mg every 4 weeks for maintenance.

Active ingredient

Lebrikizumab (lebrikizumab-lbkz in the US). Interleukin-13 (IL-13) antagonist monoclonal antibody.

Forms and strengths

250 mg/2 mL single-dose prefilled pen; 250 mg/2 mL single-dose prefilled syringe.

Indications

IgG4 monoclonal antibody labelled for moderate-to-severe atopic dermatitis in adults and adolescents aged 12 and over weighing at least 40 kg.

Administration

Subcutaneous. Solution for injection in pre-filled pen or pre-filled syringe.

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 pharmacists in dermatology and immunology units, MoH and hospital tender desks, and licensed importers and distributors in the GCC, Africa and the UK. Typical enquiries read "I'm looking for Ebglyss 250 mg pens for a dermatology unit" or "We need a partner for lebrikizumab prefilled syringes 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. Whether a destination has registered Ebglyss, 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 lebrikizumab.

Plan the pen count from the loading phase, not from maintenance. The US label gives 500 mg at week 0 and week 2 as two 250 mg injections each time, so a new patient uses four units before the every-2-weeks phase begins. Induction continues at 250 mg every 2 weeks to week 16 or later, and the UK SmPC allows partial responders to continue to week 24 and advises considering discontinuation if there is no response by week 16. Maintenance is every 4 weeks in the UK SmPC, and the US label lists every 4 weeks or every 8 weeks. Check the destination label before fixing quantities. Counsel on conjunctivitis, which the US label reports in 10% of monotherapy patients against 3% on placebo through week 16. Treat helminth infections before starting, and complete age-appropriate vaccinations first, avoiding live vaccines. Storage is 2 to 8 °C in the original carton, protected from light, not frozen and not shaken. Both labels allow up to 7 days at room temperature up to 30 °C, and the UK SmPC says not to return the unit to the refrigerator afterwards.

Regulatory & quality

The documentation pack a regulator actually asks for.

Ebglyss is a refrigerated biologic. Both the US label and the UK SmPC require storage at 2 to 8 °C in the original carton, away from light, with no freezing. The US label allows up to 7 days at room temperature up to 30 °C in the carton, and the UK SmPC allows the same 7 days at up to 30 °C and states a 3 year shelf life. For export we plan the shipment as a temperature-controlled cold-chain consignment timed to the receiving site, so the room-temperature allowance is kept for the patient and not spent in transit. The EMA page and the UK SmPC show Ebglyss under additional monitoring. M Care Exports 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 we claim no WHO-GMP or WHO prequalification for M Care itself.

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 lebrikizumab.
  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

Lebrikizumab supply, the specific questions.

What is the Ebglyss injection price and cost for an importer?

We do not publish a price or a cost for Ebglyss. For an importer, the landed price is set by the product and device (pen or prefilled syringe), the pack, the quantity, the destination's registration route, the cold chain needed at 2 to 8 °C, and the Incoterms. M Care Exports quotes per destination once we have the country, the presentation and the volume.

Is Ebglyss 250 mg the only strength, and what is the dosing schedule?

Yes, the labels list one dose unit, 250 mg in 2 mL (125 mg/mL), as a single-dose pen or prefilled syringe. The US label gives a 500 mg loading dose (two 250 mg injections) at week 0 and week 2, then 250 mg every 2 weeks until week 16 or later. Maintenance is 250 mg every 4 weeks in the UK SmPC, and the US label lists every 4 weeks or every 8 weeks. Check the label in your destination before ordering.

Ebglyss vs Dupixent and lebrikizumab vs dupilumab: how do the labels differ?

On label facts only: lebrikizumab targets IL-13, while the EMA describes dupilumab as blocking the receptors for IL-4 and IL-13. The Ebglyss label covers atopic dermatitis in people aged 12 and over weighing at least 40 kg, whereas the EMA page for Dupixent lists several indications, including atopic dermatitis in younger children, asthma and others. Dupixent dosing varies by age, weight and condition. We do not recommend one product over the other, and the prescriber chooses. See our dupilumab page.

What are the Ebglyss side effects?

The US label reports conjunctivitis in 10% of monotherapy patients against 3% on placebo through week 16, and injection site reactions in 3% against 1%. Warnings include hypersensitivity such as angioedema and urticaria, keratitis, and helminth infections, which should be treated before starting. Live vaccines should be avoided during treatment. The EMA lists injection site reactions, dry eye and conjunctivitis among the most common effects. Read the full label for your destination.

Where can I find the Ebglyss FDA label and the lebrikizumab SmPC?

The US label is on DailyMed under Eli Lilly and Company. The EU product information, which is the SmPC, is on the EMA page for Ebglyss, where Almirall, S.A. is the marketing authorisation holder. The UK SmPCs for the pen and the prefilled syringe are on emc. We link these sources from this page so a pharmacist or regulatory team can check each statement.

Is there a generic or biosimilar of Ebglyss, and how is it stored in transit?

The sources we reviewed, the US label, the EMA page and the UK SmPC, name no generic or biosimilar lebrikizumab, so we quote the originator Ebglyss. We can check biosimilar or generic availability per destination on request. Ebglyss is stored at 2 to 8 °C, and both labels allow up to 7 days at room temperature up to 30 °C, so we plan it as a cold-chain shipment.

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.

Lebrikizumab 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.

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