Firazyr (icatibant) is a bradykinin B2 receptor antagonist given by subcutaneous injection for acute attacks of hereditary angioedema, supplied as a 30 mg in 3 mL pre-filled syringe and bought as the Takeda originator or as an icatibant generic depending on what the destination registers.
M Care Exports supplies Firazyr (icatibant), the Takeda originator, together with confirmed generic icatibant injection, to hospital pharmacies, importers and tender desks in the GCC, Africa and the UK. If you are looking for Firazyr or icatibant injection, send the destination, the quantity and the registration route you need, and we quote per destination.
Icatibant exporter and bulk supplier from India.
"We need a partner for Firazyr" is a typical enquiry from a hospital pharmacy that runs a hereditary angioedema (HAE) service, or from a tender desk covering rare-disease medicines. M Care is a merchant-exporter: we quote the originator and any generic icatibant your destination registers, and we state which one we are offering before you commit. HAE is a rare disease and icatibant is ordered in small volumes, so the quote turns on originator or generic, pack, quantity, the registration route and Incoterms. The US label allows storage from 2 to 25 °C, so it is not a refrigerated-only product. For other products in this category, see our anti-allergy and immunology range.
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.
Bradykinin B2 receptor antagonist, sourced and documented for export.
Icatibant is a competitive antagonist selective for the bradykinin B2 receptor. The US Firazyr label (Takeda Pharmaceuticals America) lists acute attacks of hereditary angioedema in adults aged 18 and over, and states that safety and effectiveness below 18 years have not been established. The EMA overview describes use in adults, adolescents and children aged over 2 years whose angioedema is linked to low levels of C1 esterase inhibitor, with the dose for adolescents and children depending on body weight. Each pre-filled syringe holds 30 mg of icatibant in 3 mL (10 mg/mL) for subcutaneous injection. The US label dose is 30 mg in the abdominal area, with further 30 mg doses at least 6 hours apart if the response is inadequate or symptoms recur, and no more than 3 doses in 24 hours. The FDA approved Firazyr (NDA 022150) on 25 August 2011. The EU marketing authorisation was issued on 11 July 2008 and is held by Takeda Pharmaceuticals International AG.
Active ingredient
Icatibant acetate. Bradykinin B2 receptor antagonist.
Forms and strengths
30 mg in 3 mL (10 mg/mL) solution for subcutaneous injection, single-dose pre-filled syringe.
Indications
Icatibant, a bradykinin B2 receptor antagonist for acute attacks of hereditary angioedema. Sold as the Takeda originator Firazyr and as confirmed generics, supplied to GCC, African and UK buyers.
Administration
Subcutaneous. Solution for injection in single-dose 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.
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, MoH and hospital tender desks, and licensed importers and distributors in the GCC, Africa and the UK. Typical enquiries read "I'm looking for Firazyr 30 mg syringes for an HAE service" or "We need a partner for icatibant for a rare-disease tender". The EMA designated Firazyr an orphan medicine because HAE is rare, so order volumes are small. 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 whether a product can be imported as a registered product or through an unlicensed route depends on that regulator. M Care 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 icatibant.
Icatibant is labelled for acute attacks of HAE. The US label dose is one 30 mg injection in the abdominal area, given over at least 30 seconds and repeated no sooner than 6 hours later if needed, with a ceiling of 3 doses in 24 hours. Patients may self-administer on recognising an attack, but only after training under a healthcare professional. The presentation is a single-dose 3 mL glass syringe, supplied in the US with one 25 G needle per carton, in a single-syringe carton or a pack of three cartons. The US label says store at 2 to 25 °C, do not freeze and keep in the carton until use, so build the lane to those limits and record the batch. The label warns that laryngeal attacks can obstruct the airway, so patients should seek medical attention at once as well as using Firazyr. It also advises using it in acute coronary ischaemia, unstable angina or the weeks after a stroke only where the benefit exceeds the theoretical risk. For children, a UK icatibant SmPC gives weight-banded doses for ages 2 to 17, which the US label does not cover, so check the label of the product your destination registers.
The documentation pack a regulator actually asks for.
The US label gives 2 to 25 °C, do not freeze, and a UK icatibant SmPC says do not store above 25 °C and do not freeze, so a lane held within those limits with temperature logging is the minimum; check the destination label for its own storage statement. The EMA lists Takeda Pharmaceuticals International AG as the EU marketing authorisation holder, and emc lists Takeda UK Ltd for the UK Firazyr entry, which emc marks as discontinued. emc also lists generic icatibant 30 mg pre-filled syringes from other UK licence holders, among them Cipla (EU) Limited. The FDA lists eight therapeutically equivalent (AP-rated) icatibant acetate products against Firazyr. M Care documentation covers batch certificates of analysis, export documents and destination-aligned dossier support where the regulator requires it. We state each manufacturer's quality status per 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 icatibant.
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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 icatibant.
- 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.
Icatibant supply, the specific questions.
What decides the landed price of Firazyr for an importer?
We do not publish prices. The landed cost of icatibant depends on whether you want the Firazyr originator or a generic, the pack and quantity, the registration route in your destination, any storage and temperature-logging requirement and Incoterms. Because HAE is a rare disease, order sizes are small, which also shapes freight and documentation cost. M Care Exports quotes per destination once you send the product, quantity and country.
Is there a generic of Firazyr?
Yes, in the US, the EU and the UK, according to the regulators and emc. The FDA lists eight icatibant acetate 30 mg/3 mL products as therapeutically equivalent to Firazyr, from Alembic, Cipla, Eugia, Fresenius Kabi, Jiangsu Hansoh, Nang Kuang, Teva and Wilshire. Sajazir is a generic sold under Cipla's ANDA 212446 and labelled for Cycle Pharmaceuticals Ltd. In the EU, the EMA lists Icatibant Accord as a generic of Firazyr, authorised on 16 July 2021. In the UK, emc lists generic icatibant 30 mg pre-filled syringes from several licence holders, including Cipla (EU) Limited. Which of these your destination accepts is confirmed per enquiry.
Who is the Firazyr manufacturer, and who holds the licence?
Per the labels and regulator pages, Takeda holds the Firazyr authorisations we checked: Takeda Pharmaceuticals America for the US label, Takeda Pharmaceuticals International AG for the EU, and Takeda UK Ltd on the emc entry, which is marked discontinued. M Care Exports is a merchant-exporter, not the manufacturer. We source the originator and generics from the supply chain and tell you which one we are offering before you commit.
What is the Firazyr dose, and how often can it be repeated?
On the US label, the dose is 30 mg by subcutaneous injection in the abdominal area. Further 30 mg doses may follow at least 6 hours later if the response is inadequate or symptoms recur, with no more than 3 doses in 24 hours. The label permits self-administration after training. The EMA gives the same 6-hour repeat interval and three-injection limit in 24 hours, and says the dose for adolescents and children depends on body weight.
What age groups is Firazyr labelled for?
The labels differ by market. The US label covers adults aged 18 and over and says paediatric safety and effectiveness have not been established. The EMA overview describes use in adults, adolescents and children aged over 2 years, with the dose for adolescents and children depending on body weight. Check the label of the product your destination registers before ordering.
Can icatibant be used for ACE inhibitor angioedema?
The sources we read list acute attacks of hereditary angioedema only. The EMA page for Firazyr and the US label do not list ACE inhibitor-induced angioedema as an indication. It is not a labelled use, and we do not suggest using icatibant for it. A buyer asking about it should refer to the prescriber and the destination regulator.
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.
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