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

Emgality (galcanezumab) is a self-injected anti-CGRP monoclonal antibody from Eli Lilly for preventing migraine, given as a 240 mg loading dose and then 120 mg monthly, and it is bought as the refrigerated originator pen or syringe against each destination's registration.

M Care Exports supplies Emgality (galcanezumab), the Eli Lilly originator, to hospital pharmacies, importers and tender desks in the GCC, Africa and the UK. If you are looking for Emgality 120 mg pens or syringes, send the destination, the presentation and the quantity, and we quote per destination.

Emgality 120 mg galcanezumab pre-filled pens carton (EU pack)
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

Galcanezumab exporter and bulk supplier from India.

"We need a partner for Emgality" is a typical neurology-pharmacy or importer enquiry. M Care is a merchant-exporter: we quote the Eli Lilly originator against your specification. Emgality is a refrigerated biological sold as a single-dose pen or prefilled syringe, so the quote depends on the presentation, the pack count, the quantity, the registration route in the destination and the cold-chain lane. The loading dose uses two 120 mg devices, so a first-month start-up order is larger than a maintenance order. We do not claim a registration in any destination before checking it with the local regulator.

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

Anti-CGRP monoclonal antibody, sourced and documented for export.

Galcanezumab is a recombinant humanised monoclonal antibody produced in Chinese Hamster Ovary cells, given by subcutaneous injection. Per the FDA label, Emgality is indicated in adults for preventive treatment of migraine and for treatment of episodic cluster headache. The EU SmPC is narrower: prophylaxis of migraine in adults who have at least 4 migraine days per month, with no cluster headache indication. The migraine dose in both is 240 mg as a loading dose (two 120 mg injections in the US label) and then 120 mg monthly. The US label lists a 120 mg/mL single-dose prefilled pen, a 120 mg/mL single-dose prefilled syringe and a 100 mg/mL single-dose prefilled syringe; the 100 mg/mL syringe is the cluster headache presentation, supplied in a carton of 3. The EU SmPC lists 120 mg in 1 mL in a pre-filled pen and in a pre-filled syringe, packs of 1, 2 or 3. The US label gives an elimination half-life of 27 days.

Active ingredient

Galcanezumab (galcanezumab-gnlm in the US). Anti-CGRP monoclonal antibody.

Forms and strengths

120 mg/mL single-dose prefilled pen; 120 mg/mL single-dose prefilled syringe; 100 mg/mL single-dose prefilled syringe (US label, episodic cluster headache).

Indications

Galcanezumab, a recombinant humanised monoclonal antibody against calcitonin gene-related peptide, for preventive treatment of migraine and, in the US label, episodic cluster headache. Sold as Emgality (Eli Lilly) and supplied under 2 to 8 °C cold chain to GCC, African and UK buyers.

Administration

Subcutaneous. Solution for injection in single-dose prefilled pen or prefilled 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 neurology 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 Emgality 120 mg pens for a neurology clinic" or "We need a partner for galcanezumab for a tender". Each destination has its own registration route, 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. Pens and syringes are separate lines, and the 120 mg and 100 mg/mL syringes are different products, so state which one your unit buys.

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 galcanezumab.

Five points matter at the clinic. First, the migraine start is two consecutive 120 mg injections (240 mg), then one 120 mg injection monthly; the US label says to give a missed dose as soon as possible and then count monthly from that date. Second, the EU SmPC advises assessing benefit within 3 months and says treatment should be started by a physician experienced in migraine. Third, hypersensitivity can be delayed: the EU SmPC reports onset from more than 1 day to 4 weeks after dosing, and both labels call for stopping on a serious reaction. Fourth, the US label says to discontinue if signs of Raynaud's phenomenon develop and to monitor for new or worsening hypertension. Fifth, storage: keep refrigerated at 2 to 8 °C in the carton, do not freeze, do not shake. Both labels allow up to 7 days out of the fridge at up to 30 °C, and the US label says not to return it to the fridge afterwards. The EU SmPC asks that the product name and batch number be recorded.

Regulatory & quality

The documentation pack a regulator actually asks for.

Emgality is a cold-chain product. The EU SmPC gives a shelf life of 2 years and storage at 2 to 8 °C, so a bulk order needs a validated 2 to 8 °C lane, in-transit logging and a remaining-shelf-life check on arrival. The US label says that once Emgality has been stored out of refrigeration it must not be placed back in the refrigerator, so receiving staff should log any excursion. The originator is Eli Lilly: DailyMed lists Eli Lilly and Company for the US label (BLA 761063, original approval 27 September 2018 per Drugs@FDA), and the EU marketing authorisation holder is Eli Lilly Nederland B.V., with the marketing authorisation issued on 14 November 2018. The EMA page shows the medicine is under additional monitoring. M Care documentation covers batch certificates of analysis, export documents and destination-aligned dossier support where the regulator requires it. M Care is a merchant-exporter and does not manufacture Emgality.

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 galcanezumab.
  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

Galcanezumab supply, the specific questions.

What sets the landed price of Emgality for an importer?

We do not publish prices. The landed cost of Emgality depends on the presentation (120 mg pen, 120 mg syringe, or the US 100 mg/mL syringe), the pack count, the quantity, the registration route in your destination, the 2 to 8 °C cold-chain lane and the Incoterms. Refrigerated freight is a real cost line for a biological with a 2-year shelf life in the EU SmPC. M Care Exports quotes per destination once you send the presentation, volume and country.

Do you supply Emgality 120 mg, and is it a pen or a syringe?

Yes, we quote both. The US label lists a 120 mg/mL single-dose prefilled pen (cartons of 1 or 2) and a 120 mg/mL single-dose prefilled syringe (cartons of 1 or 2). The EU SmPC lists 120 mg in 1 mL as a pre-filled pen and as a pre-filled syringe, in packs of 1, 2 or 3, and notes that not all pack sizes may be marketed. Match the presentation to the licence your unit holds. Send the presentation, pack and destination, and we confirm availability.

What is the Emgality loading dose and how often is it given?

For migraine prevention, the US label gives 240 mg as a loading dose (two consecutive 120 mg injections), then 120 mg once monthly. The EU SmPC gives the same 120 mg monthly dose with a 240 mg loading dose as the initial dose. Both say a missed dose should be injected as soon as possible and monthly dosing resumed. The EU SmPC says patients may self-inject after training if a healthcare professional determines it is appropriate. Doses and indications follow the label in your destination.

What is the Emgality 100 mg injection, and does the EU label cover cluster headache?

The 100 mg/mL prefilled syringe appears in the US label for episodic cluster headache. The dose is 300 mg, given as three consecutive 100 mg injections at the onset of the cluster period, then monthly until the period ends. The syringe is supplied in a carton of 3. The EU SmPC we read lists only migraine prophylaxis in adults with at least 4 migraine days per month and has no cluster headache indication or 100 mg/mL presentation. Which one you can import depends on your destination's registration, so tell us the country when you enquire.

Is there a generic or biosimilar of Emgality?

The sources we fetched show Emgality as an Eli Lilly product only. Drugs@FDA lists Emgality under BLA 761063, held by Eli Lilly and Co., and the EMA page names Eli Lilly Nederland B.V. as the EU holder. Neither page is a register of competitors, so they do not by themselves rule out other galcanezumab products, and we found no regulator page for a galcanezumab biosimilar or generic in the US or EU. We have no primary regulator source for the position in India, so we do not state one. We quote the Eli Lilly originator. Check the position again for your destination before tendering.

Emgality vs Ajovy: how do the labels differ?

They are different products from different companies. Emgality is galcanezumab (Eli Lilly); Ajovy is fremanezumab (Teva GmbH in the EU per the EMA). On dosing, Emgality is a 240 mg loading dose then 120 mg monthly. Ajovy is 225 mg monthly or 675 mg every three months, the latter given as three 225 mg injections. The EU indication for both is migraine prophylaxis in adults with at least 4 migraine days per month, and the US Emgality label also covers episodic cluster headache. Choice rests with the neurologist and the formulary, not the supplier. M Care quotes each as a separate enquiry. Erenumab has its own page: Aimovig (erenumab).

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.

Galcanezumab enquiry

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