GLP-2 analogue
Teduglutide companies
Answer
Public registers name 6 licence holders, 5 ingredient makers with a drug master file, 5 bulk ingredient labelers, 2 US labelers and 17 trial sponsors for Teduglutide.
Each row is what a register states. A company named here is not endorsed or accused by this site.
MARKETING AUTHORISATION HOLDER
6 companies
Holds the licence to sell the medicine in a country (EMA, MHRA, Health Canada).
| CIPLA (EU) LIMITED | TEDUGLUTIDE CIPLA 5 MG/VIAL POWDER AND SOLVENT FOR SOLUTION FOR INJECTION, PL 36390/0454, Authorised Regulator MHRA |
|---|---|
| GENERICS (UK) LIMITED | TEDUGLUTIDE 5 MG POWDER AND SOLVENT FOR SOLUTION FOR INJECTION, PL 04569/1897, Authorised Regulator MHRA |
| TAKEDA CANADA INC | REVESTIVE (DIN 02445727), Marketed Regulator Health Canada |
| Takeda Pharmaceuticals International AG | REVESTIVE 1.25 MG POWDER AND SOLVENT FOR SOLUTION FOR INJECTION, PLGB 54937/0015, Authorised Regulator MHRA REVESTIVE 5 MG POWDER AND SOLVENT FOR SOLUTION FOR INJECTION, PLGB 54937/0016, Authorised Regulator MHRA |
| Takeda Pharmaceuticals International AG Ireland | Revestive (EMEA/H/C/002345), Authorised Regulator EMA |
| Viatris Limited | Teduglutide Viatris (EMEA/H/C/006564), Authorised Regulator EMA |
API MANUFACTURER
5 companies
Filed a drug master file with FDA for the active ingredient.
| ALP PHARM BEIJING CO LTD | DMF 35438, type II, active, submitted 2020-12-08 Regulator FDA drug master file list |
|---|---|
| AMBIO INC | DMF 30583, type II, active, submitted 2016-08-12 Regulator FDA drug master file list |
| BIOCON LTD | DMF 43910, type II, active, submitted 2026-03-31 Regulator FDA drug master file list |
| MSN LIFE SCIENCES PRIVATE LTD | DMF 37596, type II, active, submitted 2022-12-15 Regulator FDA drug master file list |
| OLON SPA | DMF 43291, type II, active, submitted 2026-01-26 Regulator FDA drug master file list |
BULK INGREDIENT LABELER
5 companies
Lists the bulk active ingredient with FDA (NDC directory).
| Boehringer Ingelheim RCV GmbH & Co KG | Teduglutide, BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING Regulator openFDA |
|---|---|
| MSN Life Sciences Private Limited | Teduglutide, BULK INGREDIENT Regulator openFDA |
| Olon S.p.A. | Teduglutide, BULK INGREDIENT Regulator openFDA |
| POLYPEPTIDE LABORATORIES INC | Teduglutide, BULK INGREDIENT Regulator openFDA |
| Shanghai Ambiopharm, Inc | Teduglutide, BULK INGREDIENT Regulator openFDA |
US LABELER
2 companies
Lists a finished product with FDA (NDC directory); can be a maker, repackager or distributor.
| Patheon Italia S.p.A | teduglutide, DRUG FOR FURTHER PROCESSING Regulator openFDA |
|---|---|
| Takeda Pharmaceuticals America, Inc. | Gattex, NDA Regulator openFDA |
TRIAL SPONSOR
17 companies
Sponsors registered clinical trials of the peptide.
| Shire | 20 registered trials Trial register ClinicalTrials.gov |
|---|---|
| Takeda | 8 registered trials Trial register ClinicalTrials.gov |
| University Health Network, Toronto | 4 registered trials Trial register ClinicalTrials.gov |
| Medical University Of Vienna | 2 registered trials Trial register ClinicalTrials.gov |
| Nycomed | 2 registered trials Trial register ClinicalTrials.gov |
| Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute) | 1 registered trial Trial register ClinicalTrials.gov |
| Assistance Publique - Hôpitaux de Paris | 1 registered trial Trial register ClinicalTrials.gov |
| Boston Children's Hospital | 1 registered trial Trial register ClinicalTrials.gov |
| Charite University, Berlin, Germany | 1 registered trial Trial register ClinicalTrials.gov |
| Daniel Dante Yeh | 1 registered trial Trial register ClinicalTrials.gov |
| International Centre for Diarrhoeal Disease Research, Bangladesh | 1 registered trial Trial register ClinicalTrials.gov |
| Massachusetts General Hospital | 1 registered trial Trial register ClinicalTrials.gov |
| Mayo Clinic | 1 registered trial Trial register ClinicalTrials.gov |
| Meyer Children's Hospital IRCCS | 1 registered trial Trial register ClinicalTrials.gov |
| Queen Mary University of London | 1 registered trial Trial register ClinicalTrials.gov |
| University of Freiburg | 1 registered trial Trial register ClinicalTrials.gov |
| UZ Leuven | 1 registered trial Trial register EU CTIS |
WEEKLY
Register Watch, weekly
New trials, approvals and enforcement actions. One email a week.