GnRH agonist
Leuprolide companies
Answer
Public registers name 9 licence holders, 25 ingredient makers with a drug master file, 13 bulk ingredient labelers, 21 US labelers, 136 trial sponsors and 3 recalling firms for Leuprolide.
Each row is what a register states. A company named here is not endorsed or accused by this site.
MARKETING AUTHORISATION HOLDER
9 companies
Holds the licence to sell the medicine in a country (EMA, MHRA, Health Canada).
| ABBVIE CORPORATION | LUPRON (DIN 00727695), Cancelled Post Market Regulator Health Canada LUPRON DEPOT (DIN 00836273), Marketed Regulator Health Canada LUPRON DEPOT (DIN 00884502), Marketed Regulator Health Canada and 6 more entries |
|---|---|
| ACCORD HEALTHCARE LIMITED | CAMCEVI 21MG PROLONGED-RELEASE SUSPENSION FOR INJECTION, PL 20075/1580, Authorised Regulator MHRA CAMCEVI 42 MG PROLONGED-RELEASE SUSPENSION FOR INJECTION, PLGB 20075/1528, Authorised Regulator MHRA |
| Accord Healthcare, Inc. | CAMCEVI (DIN 02522446), Approved Regulator Health Canada CAMCEVI (DIN 02567148), Approved Regulator Health Canada |
| ASPIRE PHARMA LIMITED | STALADEX 11.25 MG IMPLANT, PL 35533/0269, Authorised Regulator MHRA |
| NOVOPHARM LIMITED | LEUPROLIDE ACETATE INJECTION (DIN 02240264), Cancelled Pre Market Regulator Health Canada |
| RECORDATI INDUSTRIA CHIMICA & FARMACEUTICA SPA | ELIGARD 22.5 MG POWDER AND SOLVENT FOR SOLUTION FOR INJECTION, PL 04595/0030, Authorised Regulator MHRA ELIGARD 45 MG POWDER AND SOLVENT FOR SOLUTION FOR INJECTION, PL 04595/0031, Authorised Regulator MHRA ELIGARD 7.5 MG POWDER AND SOLVENT FOR SOLUTION FOR INJECTION, PL 04595/0029, Authorised Regulator MHRA |
| TAKEDA UK LIMITED | PROSTAP 3 DCS 11.25MG POWDER FOR PROLONGED-RELEASE SUSPENSION FOR INJECTION IN PRE-FILLED SYRINGE, PL 16189/0013, Authorised Regulator MHRA PROSTAP PD DCS 1.88MG POWDER & SOLVENT FOR PROLONGED-RELEASE SUSPENSION FOR INJECTION IN PRE-FILLED, PL 16189/0038, Authorised Regulator MHRA PROSTAP SR DCS 3.75 MG POWDER FOR PROLONGED-RELEASE SUSPENSION FOR INJECTION IN PRE-FILLED SYRINGE, PL 16189/0012, Authorised Regulator MHRA |
| TOLMAR INTERNATIONAL LTD. | ELIGARD (DIN 02248239), Marketed Regulator Health Canada ELIGARD (DIN 02248240), Marketed Regulator Health Canada ELIGARD (DIN 02248999), Marketed Regulator Health Canada and 1 more entries |
| VERITY PHARMACEUTICALS INC. | ZEULIDE DEPOT (DIN 02429977), Marketed Regulator Health Canada ZEULIDE DEPOT (DIN 02462699), Marketed Regulator Health Canada |
API MANUFACTURER
25 companies
Filed a drug master file with FDA for the active ingredient.
| ALEMBIC PHARMACEUTICALS LTD | DMF 41260, type II, active, submitted 2025-02-24 Regulator FDA drug master file list |
|---|---|
| ALP PHARM BEIJING CO LTD | DMF 34847, type II, active, submitted 2020-04-28 Regulator FDA drug master file list |
| AMBIOPHARM INC | DMF 26380, type II, inactive, submitted 2012-09-05 Regulator FDA drug master file list |
| AURO PEPTIDES LTD | DMF 31170, type II, active, submitted 2016-11-30 Regulator FDA drug master file list |
| BACHEM AG | DMF 13822, type II, active, submitted 1998-11-06 Regulator FDA drug master file list |
| BACHEM AMERICAS INC | DMF 11236, type II, inactive, submitted 1994-12-08 Regulator FDA drug master file list |
| BCN PEPTIDES SA | DMF 26716, type II, active, submitted 2012-12-11 Regulator FDA drug master file list |
| CHEMI SPA | DMF 14763, type II, active, submitted 2000-03-07 Regulator FDA drug master file list |
| CHINESE PEPTIDE CO | DMF 29355, type II, inactive, submitted 2015-04-29 Regulator FDA drug master file list |
| GENZYME CORP | DMF 14440, type II, inactive, submitted 1999-10-08 Regulator FDA drug master file list |
| LIPOTEC SA | DMF 15164, type II, inactive, submitted 2000-11-27 Regulator FDA drug master file list |
| MATRIX PHARMACORP PRIVATE LTD | DMF 32295, type II, active, submitted 2017-12-19 Regulator FDA drug master file list |
| PENINSULA LABS INC | DMF 13922, type II, inactive, submitted 1998-12-29 Regulator FDA drug master file list |
| PIRAMAL PHARMA LTD | DMF 25128, type II, active, submitted 2011-06-30 Regulator FDA drug master file list |
| POLYPEPTIDE LABORATORIES INC | DMF 13150, type II, active, submitted 1998-08-21 Regulator FDA drug master file list |
| POLYPEPTIDE LABORATORIES SWEDEN AB | DMF 26832, type II, active, submitted 2013-02-20 Regulator FDA drug master file list |
| REALI TIDE BIOLOGICAL TECHNOLOGY (WEIHAI) CO LTD | DMF 33765, type II, active, submitted 2019-08-27 Regulator FDA drug master file list |
| SCINOPHARM TAIWAN LTD | DMF 26770, type II, active, submitted 2012-12-28 Regulator FDA drug master file list |
| SHANXI TONGDA PHARMACEUTICAL CO LTD | DMF 40556, type II, active, submitted 2024-09-30 Regulator FDA drug master file list |
| SPECGX LLC | DMF 12052, type II, inactive, submitted 1996-07-18 Regulator FDA drug master file list DMF 24845, type II, inactive, submitted 2013-05-29 Regulator FDA drug master file list |
| Sun Pharmaceutical Industries Ltd. | DMF 27832, type II, active, submitted 2014-01-24 Regulator FDA drug master file list |
| TAKEDA CHEMICAL INDUSTRIES LTD | DMF 4476, type II, inactive, submitted 1982-01-25 Regulator FDA drug master file list DMF 6142, type II, inactive, submitted 1985-12-23 Regulator FDA drug master file list |
| TAKEDA PHARMACEUTICAL CO LTD | DMF 10416, type II, active, submitted 1993-08-13 Regulator FDA drug master file list |
| TEVA PHARMACEUTICAL INDUSTRIES LTD | DMF 15189, type II, inactive, submitted 2000-12-11 Regulator FDA drug master file list |
| ZHEJIANG PEPTITES BIOTECH CO LTD | DMF 35071, type II, active, submitted 2020-09-14 Regulator FDA drug master file list |
BULK INGREDIENT LABELER
13 companies
Lists the bulk active ingredient with FDA (NDC directory).
| AMBIOPHARM INC | Leuprolide, BULK INGREDIENT Regulator openFDA |
|---|---|
| Aspen Oss B.V. | Leuprolide Acetate, BULK INGREDIENT Regulator openFDA LEUPROLIDE, BULK INGREDIENT Regulator openFDA |
| Aurobindo Pharma Limited | Leuprolide Acetate, BULK INGREDIENT Regulator openFDA |
| BCN PEPTIDES SA | Leuprolide, BULK INGREDIENT Regulator openFDA |
| Darmerica, LLC | Leuprolide Acetate, BULK INGREDIENT Regulator openFDA |
| Medisca Inc. | Leuprolide Acetate, BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING Regulator openFDA |
| Piramal Pharma Limited | Leuprolide Acetate, BULK INGREDIENT Regulator openFDA |
| PolyPeptide Laboratories, Pvt. Ltd. | Leuprolide Acetate, BULK INGREDIENT Regulator openFDA |
| Professional Compounding Centers of America | Leuprolide Acetate, BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING Regulator openFDA |
| SCINOPHARM TAIWAN LTD | Leuprolide Mesylate, BULK INGREDIENT Regulator openFDA |
| SUN PHARMACEUTICAL INDUSTRIES INC | Leuprolide Acetate, BULK INGREDIENT Regulator openFDA |
| ZHEJIANG PEPTITES BIOTECH CO LTD | Leuprolide Acetate, BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING Regulator openFDA |
| Zhejiang SyncoTide Bio-pharmaceutical Co., Ltd | Leuprolide Acetate, BULK INGREDIENT Regulator openFDA |
US LABELER
21 companies
Lists a finished product with FDA (NDC directory); can be a maker, repackager or distributor.
| AbbVie Inc | Lupron Depot-PED, NDA Regulator openFDA Lupron Depot, NDA Regulator openFDA |
|---|---|
| Accord BioPharma, Inc. | CAMCEVI, NDA Regulator openFDA |
| Amneal Pharmaceuticals LLC | leuprolide acetate, ANDA Regulator openFDA |
| Avyxa Pharma, LLC | LUTRATE DEPOT, NDA Regulator openFDA |
| Cipla USA, Inc. | LEUPROLIDE ACETATE DEPOT, NDA Regulator openFDA |
| Endo USA, Inc. | LEUPROLIDE ACETATE, ANDA Regulator openFDA |
| Eugia US LLC | LEUPROLIDE ACETATE, ANDA Regulator openFDA |
| Meitheal Pharmaceuticals, Inc | Leuprolide Acetate, ANDA Regulator openFDA |
| NorthStar RxLLC | Leuprolide Acetate, ANDA Regulator openFDA |
| PAI Holdings, LLC dba PAI Pharma | leuprolide acetate, ANDA Regulator openFDA |
| Sandoz Inc | Leuprolide Acetate, ANDA Regulator openFDA |
| SUN PHARMACEUTICAL INDUSTRIES INC | leuprolide acetate, ANDA Regulator openFDA |
| Synergy Health AST | Leuprolide acetate, DRUG FOR FURTHER PROCESSING Regulator openFDA Leuprolide Acetate, DRUG FOR FURTHER PROCESSING Regulator openFDA |
| Takeda Pharmaceutical Company Limited | leuprolide acetate, DRUG FOR FURTHER PROCESSING Regulator openFDA |
| Takeda Pharmaceutical Company LTD | leuprolide acetate, DRUG FOR FURTHER PROCESSING Regulator openFDA |
| Tolmar, Inc. | Eligard, NDA Regulator openFDA ELIGARD, NDA Regulator openFDA Fensolvi, NDA Regulator openFDA |
| UBI Pharma Inc. | leuprolide acetate, ANDA Regulator openFDA |
| URONOVA PHARMACEUTICALS, INC. | Vabrinty, NDA AUTHORIZED GENERIC Regulator openFDA |
| VGYAAN Pharmaceuticals LLC | Leuprolide Acetate, ANDA Regulator openFDA |
| Zydus Lifesciences Limited | LEUPROLIDE ACETATE, ANDA Regulator openFDA |
| Zydus Pharmaceuticals USA Inc. | LEUPROLIDE ACETATE, ANDA Regulator openFDA |
TRIAL SPONSOR
136 companies
Sponsors registered clinical trials of the peptide.
| M.D. Anderson Cancer Center | 11 registered trials Trial register ClinicalTrials.gov |
|---|---|
| National Cancer Institute (NCI) | 10 registered trials Trial register ClinicalTrials.gov |
| Abbott | 7 registered trials Trial register ClinicalTrials.gov |
| Mayo Clinic | 7 registered trials Trial register ClinicalTrials.gov |
| Dana-Farber Cancer Institute | 5 registered trials Trial register ClinicalTrials.gov |
| Ferring Pharmaceuticals | 5 registered trials Trial register ClinicalTrials.gov |
| Memorial Sloan Kettering Cancer Center | 5 registered trials Trial register ClinicalTrials.gov |
| University of Washington | 5 registered trials Trial register ClinicalTrials.gov |
| Alliance for Clinical Trials in Oncology | 4 registered trials Trial register ClinicalTrials.gov |
| Massachusetts General Hospital | 4 registered trials Trial register ClinicalTrials.gov |
| National Center for Research Resources (NCRR) | 4 registered trials Trial register ClinicalTrials.gov |
| Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | 4 registered trials Trial register ClinicalTrials.gov |
| University of Chicago | 4 registered trials Trial register ClinicalTrials.gov |
| University of Colorado, Denver | 4 registered trials Trial register ClinicalTrials.gov |
| City of Hope Medical Center | 3 registered trials Trial register ClinicalTrials.gov |
| Daewoong Pharmaceutical Co. LTD. | 3 registered trials Trial register ClinicalTrials.gov |
| Foresee Pharmaceuticals Co., Ltd. | 3 registered trials Trial register ClinicalTrials.gov |
| Fudan University | 3 registered trials Trial register ClinicalTrials.gov |
| GP-Pharm | 3 registered trials Trial register ClinicalTrials.gov |
| National Institute of Mental Health (NIMH) | 3 registered trials Trial register ClinicalTrials.gov |
| NCIC Clinical Trials Group | 3 registered trials Trial register ClinicalTrials.gov |
| Novartis Pharmaceuticals | 3 registered trials Trial register ClinicalTrials.gov |
| NRG Oncology | 3 registered trials Trial register ClinicalTrials.gov |
| SWOG Cancer Research Network | 3 registered trials Trial register ClinicalTrials.gov |
| University Magna Graecia | 3 registered trials Trial register ClinicalTrials.gov |
| University of North Carolina, Chapel Hill | 3 registered trials Trial register ClinicalTrials.gov |
| VA Office of Research and Development | 3 registered trials Trial register ClinicalTrials.gov |
| Voyager Pharmaceutical Corporation | 3 registered trials Trial register ClinicalTrials.gov |
| Centre for Endocrinology and Reproductive Medicine, Italy | 2 registered trials Trial register ClinicalTrials.gov |
| Changchun GeneScience Pharmaceutical Co., Ltd. | 2 registered trials Trial register ClinicalTrials.gov |
| Colorado Center for Reproductive Medicine | 2 registered trials Trial register ClinicalTrials.gov |
| Eastern Cooperative Oncology Group | 2 registered trials Trial register ClinicalTrials.gov |
| ECOG-ACRIN Cancer Research Group | 2 registered trials Trial register ClinicalTrials.gov |
| Emory University | 2 registered trials Trial register ClinicalTrials.gov |
| Enteris BioPharma Inc. | 2 registered trials Trial register ClinicalTrials.gov |
| National Taiwan University Hospital | 2 registered trials Trial register ClinicalTrials.gov |
| Oakwood Laboratories, LLC | 2 registered trials Trial register ClinicalTrials.gov |
| Oregon Health and Science University | 2 registered trials Trial register ClinicalTrials.gov |
| PFIZER | 2 registered trials Trial register ClinicalTrials.gov |
| Sanofi | 2 registered trials Trial register ClinicalTrials.gov |
Showing 40 of 136.
RECALLING FIRM
3 companies
Recalled a product naming the peptide (FDA enforcement report).
| AbbVie Inc | Class II recall, Terminated, 2014-05-07 Regulator openFDA |
|---|---|
| Perry Drug Inc. | Class II recall, Terminated, 2014-12-03 Regulator openFDA |
| Tolmar, Inc. | Class III recall, Terminated, 2023-10-04 Regulator openFDA |
WEEKLY
Register Watch, weekly
New trials, approvals and enforcement actions. One email a week.