Takhzyro (lanadelumab) is a plasma kallikrein inhibitor antibody from Takeda for routine prevention of hereditary angioedema attacks, given as a subcutaneous 300 mg injection every 2 weeks with an every-4-weeks option, and it needs a cold chain.
M Care Exports supplies Takhzyro (lanadelumab), the Takeda plasma kallikrein inhibitor, to hospital pharmacies, immunology units, importers and tender desks in the GCC, Africa and the UK. If you are looking for the 300 mg/2 mL prefilled syringe or pen, send the destination, the presentation and the quantity, and we quote per destination.
Lanadelumab exporter and bulk supplier from India.
"We need a partner for Takhzyro" is a typical enquiry from a hospital immunology pharmacy or a rare-disease tender desk. M Care is a merchant-exporter: we quote against your specification and confirm which presentation your destination registers. The presentations differ by market. The US label (Takeda Pharmaceuticals America, DailyMed) lists a 150 mg/mL prefilled syringe and a 300 mg/2 mL prefilled syringe, one per carton, and lists no vial. The UK emc texts cover a 300 mg/2 mL prefilled syringe and a separate 300 mg/2 mL prefilled pen, each in packs of 1 or 2 and a multipack of 6, with the note that not all pack sizes may be marketed. Takhzyro is refrigerated at 2 to 8 °C, so the quote also turns on cold-chain packing, the registration route in the destination and Incoterms. We name Takhzyro as the originator brand. We found no lanadelumab generic or biosimilar on the US, EU or UK regulator pages we read, and we do not state otherwise.
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.
Plasma kallikrein inhibitor monoclonal antibody, sourced and documented for export.
Takhzyro is a plasma kallikrein inhibitor, a monoclonal antibody, for routine prevention of recurrent attacks of hereditary angioedema (HAE) in patients aged 2 years and older. The EMA page lists Takeda Pharmaceuticals International AG Ireland Branch as the marketing authorisation holder, with the marketing authorisation issued on 22 November 2018 and orphan designation on 9 October 2015. The UK emc SmPCs show the same holder, with a first authorisation date of 1 January 2021. The US label (DailyMed, labeler Takeda Pharmaceuticals America, Inc.) gives 300 mg every 2 weeks from age 12, and states that every 4 weeks may be considered in some patients who have been well controlled for more than 6 months. For ages 6 to under 12 it gives 150 mg every 2 weeks, with the same every-4-weeks option, and for ages 2 to under 6 it gives 150 mg every 4 weeks. The UK SmPC gives 300 mg every 2 weeks for adults and adolescents, with every 4 weeks for stably attack-free patients, and weight bands for children aged 2 to under 12. Takhzyro is prophylaxis only and is not intended to treat acute attacks.
Active ingredient
Lanadelumab. Plasma kallikrein inhibitor monoclonal antibody.
Forms and strengths
300 mg/2 mL single-dose prefilled syringe; 150 mg/mL single-dose prefilled syringe (US); 300 mg/2 mL prefilled pen (UK).
Indications
Lanadelumab is a monoclonal antibody that blocks plasma kallikrein, used for routine prevention of recurrent hereditary angioedema attacks in patients aged 2 years and older.
Administration
Subcutaneous. Solution for injection in prefilled syringe or prefilled pen.
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 immunology and allergy 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 Takhzyro 300 mg syringes for an HAE service" or "We need a partner for lanadelumab pens for a tender". HAE is a rare disease, and 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. Whether the destination has registered Takhzyro, or needs a named-patient or unlicensed import, depends on the regulator, 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 lanadelumab.
Plan the pack list by age band and by device, because the labels differ. The US label doses by age: 300 mg every 2 weeks from age 12, 150 mg every 2 weeks for ages 6 to under 12, and 150 mg every 4 weeks for ages 2 to under 6. The UK SmPC doses children by weight: 10 to under 20 kg takes 150 mg every 4 weeks, 20 to under 40 kg takes 150 mg every 2 weeks, and 40 kg or more takes 300 mg every 2 weeks. The UK pen has not been studied in children aged 2 to under 12 and is not for that group. Adolescents aged 12 to under 18 may self-inject only after training, and younger children need a caregiver. Takhzyro can raise the aPTT in the laboratory assay, and both labels say this was not linked to abnormal bleeding, so the lab should be told. Hypersensitivity reactions have been observed, and a severe one means stopping. Storage is 2 to 8 °C in the carton, away from light, never frozen. The UK SmPC allows one period of up to 14 days below 25 °C, with no return to the fridge. The US label states no room-temperature allowance.
The documentation pack a regulator actually asks for.
Takhzyro is a cold-chain biologic. Both the US label and the UK SmPC require 2 to 8 °C in the original carton, away from light and never frozen, and the US label adds do not shake. The UK emc texts for the syringe and the pen allow one period of up to 14 days below 25 °C, not beyond expiry, and a unit that has been at room temperature must not go back into the refrigerator. The US label states no such allowance, so the receiving site should plan to the stricter text. The UK SmPCs give a shelf life of 2 years. Cold-chain packing and temperature monitoring are agreed per consignment and 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 M Care Exports does not claim any manufacturer certification for 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.
Adjacent lines procurement desks order alongside lanadelumab.
Icatibant
Bradykinin B2 receptor antagonist · acute attacks of hereditary angioedema
Omalizumab
Xolair · anti-IgE antibody for allergic asthma, nasal polyps, food allergy and chronic urticaria
Tranexamic acid
Antifibrinolytic · surgical bleeding, menorrhagia, hereditary angioedema
All allergy & immunology
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 lanadelumab.
- 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.
Lanadelumab supply, the specific questions.
What is Takhzyro used for?
Takhzyro (lanadelumab) is used for routine prevention of recurrent attacks of hereditary angioedema (HAE) in patients aged 2 years and older, per the EMA page and the US label. It is prophylaxis only. The UK SmPC states it is not intended to treat acute HAE attacks, and the US label names rescue medicines such as icatibant for breakthrough attacks.
What is the Takhzyro dosing?
For patients aged 12 and over, the US label gives 300 mg subcutaneously every 2 weeks, and an every-4-weeks interval may be considered in some patients who have been well controlled for more than 6 months. The UK SmPC allows every 4 weeks in stably attack-free adults and adolescents. Children are dosed by age on the US label and by weight on the UK SmPC, so confirm the label of your destination.
Is there a Takhzyro 300 mg injection, and in what form?
Yes. The US label lists a 300 mg/2 mL (150 mg/mL) single-dose prefilled syringe and a 150 mg/mL prefilled syringe, and no vial. The UK emc has a 300 mg/2 mL prefilled syringe and a separate 300 mg/2 mL prefilled pen, in packs of 1 or 2 and a multipack of 6, though not all pack sizes may be marketed. M Care Exports confirms the presentation your destination registers before quoting.
Who is the Takhzyro manufacturer and marketing authorisation holder?
The EMA page and the UK emc SmPCs list Takeda Pharmaceuticals International AG Ireland Branch as the marketing authorisation holder. The US label is held by Takeda Pharmaceuticals America, Inc. M Care is a merchant-exporter and does not manufacture Takhzyro. We supply the originator brand and quote per destination.
What sets the price of lanadelumab or Takhzyro for an importer?
We do not publish a price. For an importer the landed price depends on the presentation (syringe or pen), the pack size, the quantity, the destination's registration route, the cold-chain packing and the Incoterms. M Care Exports quotes per destination, so send the country, the presentation and the quantity. Takhzyro is the originator, and we found no lanadelumab generic or biosimilar on the US, EU or UK regulator pages we read.
How does Takhzyro differ from icatibant on label facts?
Takhzyro is labelled for routine prevention of HAE attacks, given subcutaneously, usually every 2 weeks with a 4-week interval possible in well-controlled patients, and the UK SmPC states it is not intended for treatment of acute HAE attacks. The US Takhzyro label names icatibant among the rescue medications used for breakthrough attacks. The two serve different purposes and we make no recommendation between them. Our icatibant page covers the acute-attack product, and M Care Exports can quote both.
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.
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.