Medicine
Icatibant 30 mg/3 mL injection
Icatibant 30 mg/3 mL injection is a generic prescription medicine for subcutaneous use, made by 6 labelers, with its source record on the US FDA register. It is available on request for export supply from India to licensed hospitals, importers and physicians.
Availability
Export supply from India to licensed buyers
Typical lead time
On request
Counted from payment and complete documents
Shipping
Ambient
Do not freeze. Store between 2°C to 25°C (36°F to 77°F). Store in carton until…
Key facts
- Active ingredient (INN)
- Icatibant
- Brand
- Sold under the generic name
- Strength
- 30 mg/3 mL
- Dosage form
- Injection
- Route
- Subcutaneous
- Packs
- 1 syringe of 3 mL, 3 syringes of 3 mL, 3 cartons of 3 mL and 11 more
- Manufacturers
- Alembic PharmaceuticalsIndiaCiplaIndiaEugiaIndiaFresenius KabiHikma PharmaceuticalsTeva Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Do not freeze. Store between 2°C to 25°C (36°F to 77°F). Store in carton until time of administration.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- B06AC02 Icatibant
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 15 July 2019
- Identifiers
- RxCUI 1148141DailyMed set ID 94a53361-4eda-4e30-a153-44cd142983dd, 8c149392-d281-4311-880f-3be2b4752f40, 52c12c15-c00b-4efc-952d-1425c907706a +4NDC 24201-207, 46708-654, 63323-574 +4Application ANDA211021, ANDA213773, ANDA208317 +3
Record updated 12 November 2026
Documents available
Documents that can be provided with this medicine. Your regulator may ask for more, and the quote lists the full set.
No document list is recorded for this medicine yet. Tell us which documents your regulator needs (for example a CoA, COPP or GMP certificate) when you request a quote.
Packs
Packs from every labeler of this generic presentation.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 1 syringe, glass in 1 carton / 3 mL in 1 syringe, glass | 46708-654-03 | Alembic PharmaceuticalsIndia | 14 June 2024 |
| 3 syringe, glass in 1 carton / 3 mL in 1 syringe, glass | 46708-654-09 | Alembic PharmaceuticalsIndia | 14 June 2024 |
| 1 syringe, glass in 1 carton / 3 mL in 1 syringe, glass | 62332-654-03 | Alembic PharmaceuticalsIndia | 14 June 2024 |
| 3 syringe, glass in 1 carton / 3 mL in 1 syringe, glass | 62332-654-09 | Alembic PharmaceuticalsIndia | 14 June 2024 |
| 1 syringe, glass in 1 carton / 3 mL in 1 syringe, glass | 69097-664-34 | CiplaIndia | 13 July 2020 |
| 3 syringe, glass in 1 carton / 3 mL in 1 syringe, glass | 69097-664-68 | CiplaIndia | 13 July 2020 |
| 1 syringe, glass in 1 carton / 3 mL in 1 syringe, glass | 55150-351-01 | EugiaIndia | 14 August 2023 |
| 3 carton in 1 carton / 1 syringe, glass in 1 carton / 3 mL in 1 syringe, glass | 55150-351-03 | EugiaIndia | 14 August 2023 |
| 1 syringe in 1 carton / 3 mL in 1 syringe | 63323-574-86 | Fresenius Kabi | 15 November 2020 |
| 3 carton in 1 box / 1 syringe in 1 carton / 3 mL in 1 syringe | 63323-574-93 | Fresenius Kabi | 15 November 2020 |
| 1 syringe, glass in 1 carton / 3 mL in 1 syringe, glass | 24201-207-01 | Hikma Pharmaceuticals | 9 March 2020 |
| 3 carton in 1 carton / 1 syringe, glass in 1 carton / 3 mL in 1 syringe, glass | 24201-207-03 | Hikma Pharmaceuticals | 9 March 2020 |
| 1 syringe in 1 carton / 3 mL in 1 syringe | 0093-3066-34 | Teva Pharmaceuticals | 15 July 2019 |
| 3 carton in 1 box / 1 syringe in 1 carton / 3 mL in 1 syringe | 0093-3066-93 | Teva Pharmaceuticals | 15 July 2019 |
Status by register
Where this medicine is registered, from the source record and the regulator data we hold. Ask us about a country that is not listed.
Import route
Pick the destination country to see the legal import route, who applies and typical timelines, from our import guide for that country.
Import guides are available for 25 countries. Pick one to see its route summary.
BrazilColombiaEgyptEthiopiaGhanaIraqKazakhstanKenyaAll import guides
Alternatives
Other makers and brands of Icatibant 30 mg/3 mL injection.
Clinical summary
Icatibant is a bradykinin B2 receptor antagonist indicated for the treatment of acute attacks of hereditary angioedema (HAE) in adults 18 years of age and older. It is available as injection for subcutaneous use. MedsAcross supplies Icatibant for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
Read about IcatibantFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Firazyr prescribing information (Takeda Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
- Firazyr: European public assessment report (EPAR) · European Medicines Agency
- Icatibant Accord: European public assessment report (EPAR) · European Medicines Agency
Need Icatibant 30 mg/3 mL injection for your hospital or patient?
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