bradykinin B2 antagonist
Icatibant companies
Answer
Public registers name 22 licence holders, 16 ingredient makers with a drug master file, 12 bulk ingredient labelers, 9 US labelers and 14 trial sponsors for Icatibant.
Each row is what a register states. A company named here is not endorsed or accused by this site.
MARKETING AUTHORISATION HOLDER
22 companies
Holds the licence to sell the medicine in a country (EMA, MHRA, Health Canada).
| ACCORD HEALTHCARE LIMITED | ICATIBANT ACCORD 30 MG SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE, PLGB 20075/1455, Authorised Regulator MHRA |
|---|---|
| Accord Healthcare S.L.U. | Icatibant Accord (EMEA/H/C/005083), Authorised Regulator EMA |
| Accord Healthcare, Inc. | ICATIBANT INJECTION (DIN 02516608), Cancelled Pre Market Regulator Health Canada |
| AMAROX LIMITED | ICATIBANT 30 MG SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE, PL 49445/0406, Authorised Regulator MHRA |
| CELIX PHARMA LTD | ICATIBANT 30 MG SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE, PLGB 53835/0005, Authorised Regulator MHRA |
| CIPLA (EU) LIMITED | ICATIBANT 30 MG SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE, PLGB 36390/0285, Authorised Regulator MHRA |
| FRESENIUS KABI LIMITED | ICATIBANT 30 MG SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE, PL 08828/0294, Authorised Regulator MHRA |
| GENERICS (UK) LIMITED | ICATIBANT 30 MG SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE, PL 04569/1838, Authorised Regulator MHRA |
| GENUS PHARMACEUTICALS LIMITED | ICATIBANT 30 MG SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE, PL 06831/0349, Authorised Regulator MHRA |
| GLENMARK PHARMACEUTICALS EUROPE LIMITED | ICATIBANT 30 MG SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE, PL 25258/0352, Authorised Regulator MHRA |
| JAMP PHARMA CORPORATION | ICATIBANT INJECTION (DIN 02547562), Marketed Regulator Health Canada |
| JUNO PHARMACEUTICALS CORP. | ICATIBANT INJECTION (DIN 02523337), Cancelled Pre Market Regulator Health Canada |
| MINT PHARMACEUTICALS INC | MINT-ICATIBANT (DIN 02524619), Approved Regulator Health Canada |
| PIRAMAL CRITICAL CARE LIMITED | ICATIBANT 30 MG SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE, PL 37071/0037, Authorised Regulator MHRA |
| SYNCHRONY PHARMA LIMITED | ICATIBANT 30 MG SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE, PL 39280/0034, Authorised Regulator MHRA |
| TAKEDA CANADA INC | FIRAZYR (DIN 02425696), Marketed Regulator Health Canada |
| Takeda Pharmaceuticals International AG | Firazyr (EMEA/H/C/000899), Authorised Regulator EMA FIRAZYR 30 MG SOLUTION FOR INJECTION IN PRE FILLED SYRINGE, PLGB 54937/0004, Authorised Regulator MHRA |
| TEVA CANADA LIMITED | TEVA-ICATIBANT (DIN 02513773), Cancelled Pre Market Regulator Health Canada |
| TEVA UK LIMITED | ICATIBANT TEVA 30 MG SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE, PL 00289/2476, Authorised Regulator MHRA |
| UNIVERSAL FARMA, S.L. | ICATIBANT 30 MG SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE, PL 19706/0010, Authorised Regulator MHRA |
| USV UK LIMITED | ICATIBANT 30 MG SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE, PL 32870/0082, Authorised Regulator MHRA |
| WOCKHARDT UK LIMITED | ICATIBANT 30MG SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE, PL 29831/0725, Authorised Regulator MHRA |
API MANUFACTURER
16 companies
Filed a drug master file with FDA for the active ingredient.
| ALEMBIC PHARMACEUTICALS LTD | DMF 34450, type II, active, submitted 2020-02-06 Regulator FDA drug master file list |
|---|---|
| AMBIO INC | DMF 29225, type II, active, submitted 2015-05-22 Regulator FDA drug master file list |
| AURO PEPTIDES LTD | DMF 33750, type II, active, submitted 2019-04-03 Regulator FDA drug master file list |
| BACHEM AG | DMF 20862, type II, active, submitted 2007-09-17 Regulator FDA drug master file list |
| BCN PEPTIDES SA | DMF 29213, type II, active, submitted 2015-03-26 Regulator FDA drug master file list |
| BIOPHORE INDIA PHARMACEUTICALS PVT LTD | DMF 30526, type II, active, submitted 2016-09-27 Regulator FDA drug master file list |
| CHENGDU SHENGNUO BIOPHARM CO LTD | DMF 28496, type II, active, submitted 2015-03-09 Regulator FDA drug master file list |
| CIPLA LTD | DMF 32318, type II, active, submitted 2018-01-08 Regulator FDA drug master file list |
| DR REDDYS LABORATORIES LTD | DMF 32156, type II, active, submitted 2017-10-30 Regulator FDA drug master file list |
| FRESENIUS KABI IPSUM SRL | DMF 38190, type II, active, submitted 2024-06-24 Regulator FDA drug master file list |
| JIANGSU HANSOH PHARMACEUTICAL GROUP CO LTD | DMF 31106, type II, active, submitted 2016-12-16 Regulator FDA drug master file list |
| MATRIX PHARMACORP PRIVATE LTD | DMF 31260, type II, active, submitted 2016-12-29 Regulator FDA drug master file list |
| MSN LIFE SCIENCES PRIVATE LTD | DMF 30672, type II, active, submitted 2016-07-25 Regulator FDA drug master file list |
| Sun Pharmaceutical Industries Ltd. | DMF 31550, type II, active, submitted 2018-03-30 Regulator FDA drug master file list |
| TAPI NL BV | DMF 30476, type II, active, submitted 2016-06-09 Regulator FDA drug master file list |
| USV PRIVATE LTD | DMF 33212, type II, active, submitted 2018-12-07 Regulator FDA drug master file list |
BULK INGREDIENT LABELER
12 companies
Lists the bulk active ingredient with FDA (NDC directory).
| AMBIOPHARM INC | Icatibant Acetate, BULK INGREDIENT Regulator openFDA |
|---|---|
| Assia Chemical Industries Ltd - Teva Tech Site | Icatibant Acetate, BULK INGREDIENT Regulator openFDA |
| Aurobindo Pharma Limited | Icatibant Acetate, BULK INGREDIENT Regulator openFDA |
| BACHEM AG | Icatibant Acetate, BULK INGREDIENT Regulator openFDA |
| BCN PEPTIDES SA | Icatibant acetate, BULK INGREDIENT Regulator openFDA |
| CHENGDU SHENGNUO BIOPHARM CO LTD | Icatibant Acetate, BULK INGREDIENT Regulator openFDA |
| Dr.Reddy's laboratories Limited | Icatibant Acetate, BULK INGREDIENT Regulator openFDA |
| FRESENIUS KABI IPSUM SRL | ICATIBANT ACETATE, BULK INGREDIENT Regulator openFDA |
| JIANGSU HANSOH PHARMACEUTICAL GROUP CO LTD | Icatibant Acetate, BULK INGREDIENT Regulator openFDA |
| MSN Life Sciences Private Limited | Icatibant Acetate, BULK INGREDIENT Regulator openFDA |
| SUN PHARMACEUTICAL INDUSTRIES INC | Icatibant acetate, BULK INGREDIENT Regulator openFDA |
| USV Private Limited | Icatibant Acetate, BULK INGREDIENT Regulator openFDA |
US LABELER
9 companies
Lists a finished product with FDA (NDC directory); can be a maker, repackager or distributor.
| Alembic Pharmaceuticals Inc. | Icatibant, ANDA Regulator openFDA |
|---|---|
| Alembic Pharmaceuticals Limited | Icatibant, ANDA Regulator openFDA |
| Cipla USA, Inc. | ICATIBANT, ANDA Regulator openFDA |
| Cycle Pharmaceuticals Ltd-Uk | SAJAZIR, ANDA Regulator openFDA |
| Eugia US LLC | Icatibant, ANDA Regulator openFDA |
| Fresenius Kabi USA, LLC | Icatibant, ANDA Regulator openFDA |
| Hikma Pharmaceuticals USA Inc. | Icatibant, ANDA Regulator openFDA |
| Takeda Pharmaceuticals America, Inc. | Firazyr, NDA Regulator openFDA |
| Teva Pharmaceuticals USA, Inc | Icatibant, ANDA Regulator openFDA |
TRIAL SPONSOR
14 companies
Sponsors registered clinical trials of the peptide.
| Shire | 9 registered trials Trial register ClinicalTrials.gov |
|---|---|
| Vanderbilt University Medical Center | 5 registered trials Trial register ClinicalTrials.gov |
| Takeda | 4 registered trials Trial register ClinicalTrials.gov |
| Pharvaris Netherlands B.V. | 3 registered trials Trial register EU CTIS |
| Belfast Health and Social Care Trust | 1 registered trial Trial register ClinicalTrials.gov |
| GCS Ramsay Santé pour l'Enseignement et la Recherche | 1 registered trial Trial register ClinicalTrials.gov |
| KalVista Pharmaceuticals, Ltd. | 1 registered trial Trial register ClinicalTrials.gov |
| Massachusetts General Hospital | 1 registered trial Trial register ClinicalTrials.gov |
| Nang Kuang Pharmaceutical Co., Ltd. | 1 registered trial Trial register ClinicalTrials.gov |
| Oslo University Hospital HF | 1 registered trial Trial register EU CTIS |
| QuantumLeap Healthcare Collaborative | 1 registered trial Trial register ClinicalTrials.gov |
| Sanofi | 1 registered trial Trial register ClinicalTrials.gov |
| Sebastian Videla | 1 registered trial Trial register ClinicalTrials.gov |
| Technical University of Munich | 1 registered trial Trial register ClinicalTrials.gov |
WEEKLY
Register Watch, weekly
New trials, approvals and enforcement actions. One email a week.