GnRH antagonist
Ganirelix companies
Answer
Public registers name 7 licence holders, 6 bulk ingredient labelers, 10 US labelers, 38 trial sponsors and 3 recalling firms for Ganirelix.
Each row is what a register states. A company named here is not endorsed or accused by this site.
MARKETING AUTHORISATION HOLDER
7 companies
Holds the licence to sell the medicine in a country (EMA, MHRA, Health Canada).
| Chemical Works of Gedeon Richter Plc. (Gedeon Richter Plc.) | Ganirelix Gedeon Richter (EMEA/H/C/005641), Authorised Regulator EMA |
|---|---|
| Gedeon Richter Plc. | GANIRELIX GEDEON RICHTER 0.25 MG/0.5 ML SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE, PLGB 04854/0193, Authorised Regulator MHRA |
| ORGANON CANADA INC. | ORGALUTRAN (DIN 02245641), Marketed Regulator Health Canada |
| Organon N.V. | Orgalutran (EMEA/H/C/000274), Authorised Regulator EMA |
| SUN PHARMA CANADA INC | SPC-GANIRELIX (DIN 02569353), Approved Regulator Health Canada |
| SUN PHARMACEUTICAL INDUSTRIES EUROPE BV | FYREMADEL 0.25 MG/0.5 ML SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE, PL 31750/0055, Authorised Regulator MHRA |
| THERAMEX HQ UK LIMITED | OVAMEX 0.25 MG/ 0.5 ML SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE, PL 49105/0019, Authorised Regulator MHRA |
BULK INGREDIENT LABELER
6 companies
Lists the bulk active ingredient with FDA (NDC directory).
| Apicore pharmaceuticals private limited | GANIRELIX ACETATE, BULK INGREDIENT Regulator openFDA |
|---|---|
| Aspen Oss B.V. | Ganirelix Acetate, BULK INGREDIENT Regulator openFDA |
| Aurobindo Pharma Limited | Ganirelix Acetate, BULK INGREDIENT Regulator openFDA |
| BCN PEPTIDES SA | Ganirelix, BULK INGREDIENT Regulator openFDA |
| Chengdu Shengnuo Biopharm Co. Ltd. | Ganirelix Acetate, BULK INGREDIENT Regulator openFDA |
| Hybio Pharmaceutical Co., Ltd. | Ganirelix Acetate, BULK INGREDIENT Regulator openFDA |
US LABELER
10 companies
Lists a finished product with FDA (NDC directory); can be a maker, repackager or distributor.
| AMPHASTAR PHARMACEUTICALS, INC. | Ganirelix Acetate, ANDA Regulator openFDA |
|---|---|
| Ferring Pharmaceuticals Inc | Fyremadel, ANDA Regulator openFDA |
| Fresenius Kabi USA, LLC | Ganirelix Acetate, ANDA Regulator openFDA |
| Gland Pharma Limited | GANIRELIX ACETATE, ANDA Regulator openFDA |
| Lupin Pharmaceuticals Inc. | Ganirelix Acetate, ANDA Regulator openFDA |
| Meitheal Pharmaceuticals, Inc | Ganirelix Acetate, ANDA Regulator openFDA |
| Mullan Pharmaceutical Inc. | Ganirelix Acetate, ANDA Regulator openFDA |
| Organon LLC | Ganirelix Acetate, NDA Regulator openFDA |
| Qilu Pharmaceutical Co., Ltd. | Ganirelix Acetate, ANDA Regulator openFDA |
| Xiromed LLC | Ganirelix Acetate, ANDA Regulator openFDA |
TRIAL SPONSOR
38 companies
Sponsors registered clinical trials of the peptide.
| Organon and Co | 11 registered trials Trial register ClinicalTrials.gov |
|---|---|
| Eugonia | 4 registered trials Trial register ClinicalTrials.gov |
| Yale University | 3 registered trials Trial register ClinicalTrials.gov |
| Yazd Research & Clinical Center for Infertility | 2 registered trials Trial register ClinicalTrials.gov |
| Andros Day Surgery Clinic | 1 registered trial Trial register ClinicalTrials.gov |
| Assaf-Harofeh Medical Center | 1 registered trial Trial register ClinicalTrials.gov |
| Casa di Cura Privata Villa Mafalda | 1 registered trial Trial register ClinicalTrials.gov |
| Centre Hospitalier Universitaire De Lille | 1 registered trial Trial register EU CTIS |
| Centro A.M.B.R.A. (Associazione Medici e Biologi per la Riproduzione Assistita) | 1 registered trial Trial register ClinicalTrials.gov |
| Changchun GeneScience Pharmaceutical Co., Ltd. | 1 registered trial Trial register ClinicalTrials.gov |
| Chong Qing Reproducive and Genetic Institute | 1 registered trial Trial register ClinicalTrials.gov |
| Ferring Pharmaceuticals | 1 registered trial Trial register ClinicalTrials.gov |
| Fundacion Dexeus | 1 registered trial Trial register ClinicalTrials.gov |
| Ginefiv | 1 registered trial Trial register ClinicalTrials.gov |
| Ginefiv S.L. | 1 registered trial Trial register EU CTIS |
| Houston Fertility Institute | 1 registered trial Trial register ClinicalTrials.gov |
| Instituto Bernabeu | 1 registered trial Trial register ClinicalTrials.gov |
| Instituto de Investigacion Sanitaria La Fe | 1 registered trial Trial register ClinicalTrials.gov |
| Instituto Valenciano de Infertilidad, IVI VALENCIA | 1 registered trial Trial register ClinicalTrials.gov |
| IVI Madrid | 1 registered trial Trial register ClinicalTrials.gov |
| Jiangsu HengRui Medicine Co., Ltd. | 1 registered trial Trial register ClinicalTrials.gov |
| Kelly, Maureen, M.D. | 1 registered trial Trial register ClinicalTrials.gov |
| LG Life Sciences | 1 registered trial Trial register ClinicalTrials.gov |
| Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center | 1 registered trial Trial register ClinicalTrials.gov |
| Michigan Reproductive Medicine | 1 registered trial Trial register ClinicalTrials.gov |
| Peter y. Liu | 1 registered trial Trial register ClinicalTrials.gov |
| Reproductive & Genetic Hospital of CITIC-Xiangya | 1 registered trial Trial register ClinicalTrials.gov |
| Santiago Dexeus Font Fundacio Privada | 1 registered trial Trial register EU CTIS |
| The Baruch Padeh Medical Center, Poriya | 1 registered trial Trial register ClinicalTrials.gov |
| UConn Health | 1 registered trial Trial register ClinicalTrials.gov |
| Università degli Studi 'G. d'Annunzio' Chieti e Pescara | 1 registered trial Trial register ClinicalTrials.gov |
| Universitair Ziekenhuis Brussel | 1 registered trial Trial register ClinicalTrials.gov |
| University Hospital, Lille | 1 registered trial Trial register ClinicalTrials.gov |
| University of California, San Francisco | 1 registered trial Trial register ClinicalTrials.gov |
| University of Colorado, Denver | 1 registered trial Trial register ClinicalTrials.gov |
| University of Delaware | 1 registered trial Trial register ClinicalTrials.gov |
| University of Pennsylvania | 1 registered trial Trial register ClinicalTrials.gov |
| University of Utah | 1 registered trial Trial register ClinicalTrials.gov |
RECALLING FIRM
3 companies
Recalled a product naming the peptide (FDA enforcement report).
| Lupin Pharmaceuticals Inc. | Class II recall, Ongoing, 2025-12-17 Regulator openFDA |
|---|---|
| SUN PHARMACEUTICAL INDUSTRIES INC | Class II recall, Terminated, 2021-04-14 Regulator openFDA |
| Sun Pharmaceutical Industries Ltd. | Class II recall, Terminated, 2023-05-03 Regulator openFDA |
Every company across all peptides: companies. Names are matched only when identical apart from case and punctuation, so one group can appear under two spellings.
WEEKLY
Register Watch, weekly
New trials, approvals and enforcement actions. One email a week.