GnRH antagonist

Cetrorelix companies

Answer

Public registers name 4 licence holders, 11 ingredient makers with a drug master file, 6 bulk ingredient labelers, 8 US labelers, 42 trial sponsors and 3 recalling firms for Cetrorelix.

Each row is what a register states. A company named here is not endorsed or accused by this site.

MARKETING AUTHORISATION HOLDER

4 companies

Holds the licence to sell the medicine in a country (EMA, MHRA, Health Canada).

EMD SERONO, A DIVISION OF EMD INC., CANADA	CETROTIDE (DIN 02247766), Marketed Regulator Health Canada CETROTIDE (DIN 02247767), Cancelled Post Market Regulator Health Canada
Merck Europe B.V.	Cetrotide (EMEA/H/C/000233), Authorised Regulator EMA
MERCK SERONO LIMITED	CETROTIDE 0.25 MG POWDER AND SOLVENT FOR SOLUTION FOR INJECTION, PLGB 11648/0263, Authorised Regulator MHRA
SUN PHARMACEUTICAL INDUSTRIES EUROPE BV	CEZIBOE 0.25MG SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE, PL 31750/0174, Authorised Regulator MHRA

API MANUFACTURER

11 companies

Filed a drug master file with FDA for the active ingredient.

ALP PHARM BEIJING CO LTD	DMF 33914, type II, active, submitted 2019-06-05 Regulator FDA drug master file list
APICORE LLC (A WHOLLY OWNED SUB OF RK PHARMA INC)	DMF 41854, type II, active, submitted 2025-05-30 Regulator FDA drug master file list
BCN PEPTIDES SA	DMF 38264, type II, active, submitted 2023-03-31 Regulator FDA drug master file list
BIOPHORE INDIA PHARMACEUTICALS PVT LTD	DMF 34752, type II, active, submitted 2020-05-03 Regulator FDA drug master file list
CHINESE PEPTIDE CO	DMF 34884, type II, active, submitted 2020-06-08 Regulator FDA drug master file list
Harbin Jixianglong Biotech Co., Ltd.	DMF 39986, type II, active, submitted 2024-05-29 Regulator FDA drug master file list
HYBIO PHARMACEUTICAL CO LTD	DMF 37082, type II, active, submitted 2022-04-29 Regulator FDA drug master file list
MERCK HEALTHCARE KGAA	DMF 18077, type II, active, submitted 2005-02-11 Regulator FDA drug master file list
PIRAMAL PHARMA LTD	DMF 34552, type II, active, submitted 2020-03-19 Regulator FDA drug master file list
SINOPEP-ALLSINO BIOPHARMACEUTICAL CO LTD	DMF 35171, type II, active, submitted 2020-09-29 Regulator FDA drug master file list
Sun Pharmaceutical Industries Ltd.	DMF 34704, type II, active, submitted 2020-03-27 Regulator FDA drug master file list

BULK INGREDIENT LABELER

6 companies

Lists the bulk active ingredient with FDA (NDC directory).

AMBIOPHARM INC	Cetrorelix, BULK INGREDIENT Regulator openFDA
Apicore pharmaceuticals private limited	CETRORELIX ACETATE, BULK INGREDIENT Regulator openFDA
Azico Biophore India Private Limited	Cetrorelix acetate, BULK INGREDIENT Regulator openFDA
Chinese Peptide Company	Cetrorelix acetate, BULK INGREDIENT Regulator openFDA
HEMMO PHARMACEUTICALS PVT LTD	Cetrorelix Powder (Synthetic), BULK INGREDIENT Regulator openFDA
SINOPEP-ALLSINO BIOPHARMACEUTICAL CO LTD	Cetrorelix Acetate, BULK INGREDIENT Regulator openFDA

US LABELER

8 companies

Lists a finished product with FDA (NDC directory); can be a maker, repackager or distributor.

Apotex Corp.	Cetrorelix acetate, ANDA Regulator openFDA
EMD Serono, Inc.	Cetrotide, NDA Regulator openFDA
Fareva	CETRORELIX, DRUG FOR FURTHER PROCESSING Regulator openFDA
Fresenius Kabi USA, LLC	cetrorelix acetate, ANDA Regulator openFDA
Gland Pharma Limited	cetrorelix acetate, ANDA Regulator openFDA
GP PHARM SA	cetrorelix acetate, DRUG FOR FURTHER PROCESSING Regulator openFDA
Meitheal Pharmaceuticals, Inc	Cetrorelix Acetate, ANDA Regulator openFDA
QILU PHARMACEUTICAL CO LTD	Cetrorelix acetate, ANDA Regulator openFDA

TRIAL SPONSOR

42 companies

Sponsors registered clinical trials of the peptide.

Damascus University	4 registered trials Trial register ClinicalTrials.gov
AEterna Zentaris	3 registered trials Trial register ClinicalTrials.gov
University of Colorado, Denver	3 registered trials Trial register ClinicalTrials.gov
Ahmed Saad	2 registered trials Trial register ClinicalTrials.gov
Assiut University	2 registered trials Trial register ClinicalTrials.gov
Beni-Suef University	2 registered trials Trial register ClinicalTrials.gov
Cairo University	2 registered trials Trial register ClinicalTrials.gov
Instituto Valenciano de Infertilidad, IVI VALENCIA	2 registered trials Trial register ClinicalTrials.gov
Merck KGaA, Darmstadt, Germany	2 registered trials Trial register ClinicalTrials.gov
Peking University Third Hospital	2 registered trials Trial register ClinicalTrials.gov
Ain Shams University	1 registered trial Trial register ClinicalTrials.gov
Andros Day Surgery Clinic	1 registered trial Trial register ClinicalTrials.gov
Aristotle University Of Thessaloniki	1 registered trial Trial register ClinicalTrials.gov
Assaf-Harofeh Medical Center	1 registered trial Trial register ClinicalTrials.gov
Benha University	1 registered trial Trial register ClinicalTrials.gov
Betanien Hospital	1 registered trial Trial register ClinicalTrials.gov
Bio Genuine (Shanghai) Biotech Co., Ltd.	1 registered trial Trial register ClinicalTrials.gov
Bioroma	1 registered trial Trial register ClinicalTrials.gov
Centre for Endocrinology and Reproductive Medicine, Italy	1 registered trial Trial register ClinicalTrials.gov
Centro A.M.B.R.A. (Associazione Medici e Biologi per la Riproduzione Assistita)	1 registered trial Trial register ClinicalTrials.gov
Clinica de la Mujer Medicina Reproductiva, Chile	1 registered trial Trial register ClinicalTrials.gov
El Shatby University Hospital for Obstetrics and Gynecology	1 registered trial Trial register ClinicalTrials.gov
Eugonia	1 registered trial Trial register ClinicalTrials.gov
Ferring Pharmaceuticals	1 registered trial Trial register ClinicalTrials.gov
Fertility - Assisted Fertilization Center	1 registered trial Trial register ClinicalTrials.gov
Kasr El Aini Hospital	1 registered trial Trial register ClinicalTrials.gov
Mansoura University	1 registered trial Trial register ClinicalTrials.gov
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany	1 registered trial Trial register ClinicalTrials.gov
Mỹ Đức Hospital	1 registered trial Trial register ClinicalTrials.gov
Nippon Kayaku Co., Ltd.	1 registered trial Trial register ClinicalTrials.gov
Northwest Women's and Children's Hospital, Xi'an, Shaanxi	1 registered trial Trial register ClinicalTrials.gov
Seoul National University Bundang Hospital	1 registered trial Trial register ClinicalTrials.gov
Seoul National University Hospital	1 registered trial Trial register ClinicalTrials.gov
ShangHai Ji Ai Genetics & IVF Institute	1 registered trial Trial register ClinicalTrials.gov
Solvay Pharmaceuticals	1 registered trial Trial register ClinicalTrials.gov
Southern Cross Fertility Centre	1 registered trial Trial register ClinicalTrials.gov
Trust Fertility Clinic	1 registered trial Trial register ClinicalTrials.gov
Università degli Studi 'G. d'Annunzio' Chieti e Pescara	1 registered trial Trial register ClinicalTrials.gov
University of Edinburgh	1 registered trial Trial register ClinicalTrials.gov
University of Oxford	1 registered trial Trial register ClinicalTrials.gov

Showing 40 of 42.

RECALLING FIRM

3 companies

Recalled a product naming the peptide (FDA enforcement report).

Akorn, Inc.	Class II recall, Ongoing, 2023-06-07 Regulator openFDA
EMD Serono, Inc.	Class II recall, Terminated, 2020-07-15 Regulator openFDA
Meitheal Pharmaceuticals, Inc	Class II recall, Ongoing, 2026-02-18 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. Trade between countries in all polypeptide hormones, Cetrorelix among them: trade.

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New trials, approvals and enforcement actions. One email a week.