somatostatin analogue
Lanreotide companies
Answer
Public registers name 7 licence holders, 13 ingredient makers with a drug master file, 7 bulk ingredient labelers, 5 US labelers, 41 trial sponsors and 1 recalling firm for Lanreotide.
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).
| ADVANZ PHARMA CANADA INC. | MYTOLAC (DIN 02555867), Marketed Regulator Health Canada MYTOLAC (DIN 02555875), Marketed Regulator Health Canada MYTOLAC (DIN 02555883), Marketed Regulator Health Canada |
|---|---|
| ADVANZ PHARMA LIMITED | LANREOTIDE ADVANZ PHARMA 120 MG SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE, PLGB 56734/0006, Authorised Regulator MHRA LANREOTIDE ADVANZ PHARMA 60 MG SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE, PLGB 56734/0004, Authorised Regulator MHRA LANREOTIDE ADVANZ PHARMA 90 MG SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE, PLGB 56734/0005, Authorised Regulator MHRA |
| GENERICS (UK) LIMITED | LANREOTIDE MYLAN 120 MG SOLUTION FOR INJECTION IN A PRE-FILLED SYRINGE, PL 04569/1875, Authorised Regulator MHRA LANREOTIDE MYLAN 60 MG SOLUTION FOR INJECTION IN A PRE-FILLED SYRINGE, PL 04569/1873, Authorised Regulator MHRA LANREOTIDE MYLAN 90 MG SOLUTION FOR INJECTION IN A PRE-FILLED SYRINGE, PL 04569/1874, Authorised Regulator MHRA |
| IPSEN BIOPHARMACEUTICALS CANADA INC | SOMATULINE AUTOGEL (DIN 02283395), Marketed Regulator Health Canada SOMATULINE AUTOGEL (DIN 02283409), Marketed Regulator Health Canada SOMATULINE AUTOGEL (DIN 02283417), Marketed Regulator Health Canada |
| IPSEN LIMITED | LANREOTIDE IPSEN 120 MG, SOLUTION FOR INJECTION IN A PREFILLED SYRINGE, PL 34926/0007, Authorised Regulator MHRA LANREOTIDE IPSEN 60 MG, SOLUTION FOR INJECTION IN A PREFILLED SYRINGE, PL 34926/0005, Authorised Regulator MHRA LANREOTIDE IPSEN 90 MG, SOLUTION FOR INJECTION IN A PREFILLED SYRINGE, PL 34926/0006, Authorised Regulator MHRA |
| SUN PHARMA UK LIMITED | LANREOTIDE SUN 120 MG SOLUTION FOR INJECTION IN A PRE-FILLED SYRINGE, PL 14894/0830, Authorised Regulator MHRA LANREOTIDE SUN 60 MG SOLUTION FOR INJECTION IN A PRE-FILLED SYRINGE, PL 14894/0828, Authorised Regulator MHRA LANREOTIDE SUN 90 MG SOLUTION FOR INJECTION IN A PRE-FILLED SYRINGE, PL 14894/0829, Authorised Regulator MHRA |
| ZENTIVA PHARMA UK LIMITED | LANREOTIDE ZENTIVA 120 MG SOLUTION FOR INJECTION IN A PRE-FILLED SYRINGE, PL 17780/1319, Authorised Regulator MHRA LANREOTIDE ZENTIVA 60 MG SOLUTION FOR INJECTION IN A PRE-FILLED SYRINGE, PL 17780/1317, Authorised Regulator MHRA LANREOTIDE ZENTIVA 90 MG SOLUTION FOR INJECTION IN A PRE-FILLED SYRINGE, PL 17780/1318, Authorised Regulator MHRA |
API MANUFACTURER
13 companies
Filed a drug master file with FDA for the active ingredient.
| ALP PHARM BEIJING CO LTD | DMF 24378, type II, active, submitted 2010-11-05 Regulator FDA drug master file list |
|---|---|
| BACHEM AMERICAS INC | DMF 33336, type II, active, submitted 2019-02-08 Regulator FDA drug master file list |
| BCN PEPTIDES SA | DMF 39254, type II, active, submitted 2023-12-21 Regulator FDA drug master file list |
| CHENGDU SHENGNUO BIOPHARM CO LTD | DMF 39673, type II, active, submitted 2024-06-14 Regulator FDA drug master file list |
| DR REDDYS LABORATORIES LTD | DMF 39768, type II, active, submitted 2024-06-28 Regulator FDA drug master file list |
| IPSEN MANUFACTURING IRELAND LTD | DMF 8974, type II, inactive, submitted 1991-02-22 Regulator FDA drug master file list |
| PIRAMAL PHARMA LTD | DMF 42310, type II, active, submitted 2025-07-30 Regulator FDA drug master file list |
| RELIANCE LIFE SCIENCES PVT LTD | DMF 42130, type II, active, submitted 2025-09-11 Regulator FDA drug master file list |
| SICHUAN DUORUI BIOPHARMACEUTICAL CO LTD | DMF 41446, type II, active, submitted 2025-03-10 Regulator FDA drug master file list |
| SICHUAN FRONTIER BIOPHARMACEUTICAL CO LTD | DMF 39483, type II, active, submitted 2024-01-29 Regulator FDA drug master file list |
| SICHUAN HUIYU PHARMACEUTICAL CO LTD | DMF 42318, type II, active, submitted 2025-08-09 Regulator FDA drug master file list |
| SINOPEP-ALLSINO BIOPHARMACEUTICAL CO LTD | DMF 29693, type II, active, submitted 2016-08-16 Regulator FDA drug master file list |
| Sun Pharmaceutical Industries Ltd. | DMF 36547, type II, active, submitted 2023-02-02 Regulator FDA drug master file list |
BULK INGREDIENT LABELER
7 companies
Lists the bulk active ingredient with FDA (NDC directory).
| BCN PEPTIDES SA | Lanreotide acetate, BULK INGREDIENT Regulator openFDA |
|---|---|
| CHENGDU SHENGNUO BIOPHARM CO LTD | Lanreotide Acetate, BULK INGREDIENT Regulator openFDA |
| Chunghwa Chemical Synthesis & Biotech. Ltd | lanreotide acetate, BULK INGREDIENT Regulator openFDA |
| Chunghwa Chemical Sysnthsis & Biotech Co.,Ltd. | Lanreotide Acetate, BULK INGREDIENT Regulator openFDA |
| Qingdao Biopeptek Co., Ltd. | Lanreotide Acetate, BULK INGREDIENT Regulator openFDA |
| SINOPEP-ALLSINO BIOPHARMACEUTICAL CO LTD | Lanreotide Acetate, BULK INGREDIENT Regulator openFDA |
| SUN PHARMACEUTICAL INDUSTRIES INC | Lanreotide Acetate, BULK INGREDIENT Regulator openFDA |
US LABELER
5 companies
Lists a finished product with FDA (NDC directory); can be a maker, repackager or distributor.
| Amneal Pharmaceuticals LLC | LANREOTIDE ACETATE, ANDA Regulator openFDA |
|---|---|
| Cipla USA, Inc. | LANREOTIDE ACETATE, ANDA Regulator openFDA Lanreotide Acetate, NDA Regulator openFDA |
| EXELAN PHARMACEUTICALS, INC. | LANREOTIDE ACETATE, ANDA Regulator openFDA |
| Ipsen Biopharmaceuticals, Inc. | SOMATULINE DEPOT, NDA Regulator openFDA |
| Synergy Health AST, LLC | lanreotide acetate, DRUG FOR FURTHER PROCESSING Regulator openFDA |
TRIAL SPONSOR
41 companies
Sponsors registered clinical trials of the peptide.
| Ipsen | 46 registered trials Trial register ClinicalTrials.gov |
|---|---|
| Radboud University Medical Center | 4 registered trials Trial register ClinicalTrials.gov |
| Federico II University | 3 registered trials Trial register ClinicalTrials.gov |
| Camurus AB | 1 registered trial Trial register EU CTIS 1 registered trial Trial register ClinicalTrials.gov |
| Cedars-Sinai Medical Center | 2 registered trials Trial register ClinicalTrials.gov |
| Fondazione IRCCS Istituto Nazionale Dei Tumori | 2 registered trials Trial register EU CTIS |
| Fondazione IRCCS Istituto Nazionale dei Tumori, Milano | 2 registered trials Trial register ClinicalTrials.gov |
| Rayzebio Inc. | 1 registered trial Trial register EU CTIS 1 registered trial Trial register ClinicalTrials.gov |
| Samsung Medical Center | 2 registered trials Trial register ClinicalTrials.gov |
| Universitaire Ziekenhuizen KU Leuven | 2 registered trials Trial register ClinicalTrials.gov |
| University Hospital, Ghent | 2 registered trials Trial register ClinicalTrials.gov |
| University of Aarhus | 2 registered trials Trial register ClinicalTrials.gov |
| Alexion Pharmaceuticals Inc. | 1 registered trial Trial register EU CTIS |
| Antonio Fojo | 1 registered trial Trial register ClinicalTrials.gov |
| Antwerp University Hospital | 1 registered trial Trial register EU CTIS |
| Asan Medical Center | 1 registered trial Trial register ClinicalTrials.gov |
| Assistance Publique - Hôpitaux de Paris | 1 registered trial Trial register ClinicalTrials.gov |
| Debiopharm International S.A. | 1 registered trial Trial register EU CTIS |
| Duke University | 1 registered trial Trial register ClinicalTrials.gov |
| European Organisation for Research and Treatment of Cancer - EORTC | 1 registered trial Trial register ClinicalTrials.gov |
| Federation Francophone de Cancerologie Digestive | 1 registered trial Trial register ClinicalTrials.gov |
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS | 1 registered trial Trial register ClinicalTrials.gov |
| GERCOR - Multidisciplinary Oncology Cooperative Group | 1 registered trial Trial register ClinicalTrials.gov |
| Grupo Espanol de Tumores Neuroendocrinos | 1 registered trial Trial register ClinicalTrials.gov |
| Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting | 1 registered trial Trial register EU CTIS |
| Memorial Sloan Kettering Cancer Center | 1 registered trial Trial register ClinicalTrials.gov |
| National Health Research Institutes, Taiwan | 1 registered trial Trial register ClinicalTrials.gov |
| Northwell Health | 1 registered trial Trial register ClinicalTrials.gov |
| Novartis Pharmaceuticals | 1 registered trial Trial register ClinicalTrials.gov |
| Odense University Hospital | 1 registered trial Trial register ClinicalTrials.gov |
| Saint John's Cancer Institute | 1 registered trial Trial register ClinicalTrials.gov |
| SCRI Development Innovations, LLC | 1 registered trial Trial register ClinicalTrials.gov |
| Shanghai Jiao Tong University School of Medicine | 1 registered trial Trial register ClinicalTrials.gov |
| Sheba Medical Center | 1 registered trial Trial register ClinicalTrials.gov |
| SWOG Cancer Research Network | 1 registered trial Trial register ClinicalTrials.gov |
| Universitair Ziekenhuis Brussel | 1 registered trial Trial register ClinicalTrials.gov |
| University Hospital, Grenoble | 1 registered trial Trial register ClinicalTrials.gov |
| University Hospital, Limoges | 1 registered trial Trial register ClinicalTrials.gov |
| University Hospital, Strasbourg, France | 1 registered trial Trial register ClinicalTrials.gov |
| University Medical Center Groningen | 1 registered trial Trial register ClinicalTrials.gov |
Showing 40 of 41.
RECALLING FIRM
1 company
Recalled a product naming the peptide (FDA enforcement report).
| Cipla USA, Inc. | Class II recall, Ongoing, 2026-01-21 Regulator openFDA Class II recall, Ongoing, 2026-04-15 Regulator openFDA |
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WEEKLY
Register Watch, weekly
New trials, approvals and enforcement actions. One email a week.