guanylate cyclase-C agonist
Plecanatide companies
Answer
Public registers name 1 licence holder, 6 ingredient makers with a drug master file, 5 bulk ingredient labelers, 1 US labeler and 3 trial sponsors for Plecanatide.
Each row is what a register states. A company named here is not endorsed or accused by this site.
MARKETING AUTHORISATION HOLDER
1 company
Holds the licence to sell the medicine in a country (EMA, MHRA, Health Canada).
| BAUSCH HEALTH, CANADA INC. | TRULANCE (DIN 02493012), Marketed Regulator Health Canada |
|---|
API MANUFACTURER
6 companies
Filed a drug master file with FDA for the active ingredient.
| ALP PHARM BEIJING CO LTD | DMF 35439, type II, active, submitted 2020-12-08 Regulator FDA drug master file list |
|---|---|
| AURO PEPTIDES LTD | DMF 36321, type II, active, submitted 2021-09-24 Regulator FDA drug master file list |
| CHUNGHWA CHEMICAL SYNTHESIS AND BIOTECH CO LTD | DMF 41493, type II, active, submitted 2025-03-31 Regulator FDA drug master file list |
| HYBIO PHARMACEUTICAL CO LTD | DMF 42062, type II, active, submitted 2025-06-26 Regulator FDA drug master file list |
| MATRIX PHARMACORP PRIVATE LTD | DMF 34227, type II, active, submitted 2019-11-27 Regulator FDA drug master file list |
| MSN LIFE SCIENCES PRIVATE LTD | DMF 34049, type II, active, submitted 2019-09-11 Regulator FDA drug master file list |
BULK INGREDIENT LABELER
5 companies
Lists the bulk active ingredient with FDA (NDC directory).
| AMBIOPHARM INC | Plecanatide, BULK INGREDIENT Regulator openFDA |
|---|---|
| Aurobindo Pharma Limited | Plecanatide, BULK INGREDIENT Regulator openFDA |
| Chunghwa Chemical Synthesis & Biotech. Ltd | PLECANATIDE, BULK INGREDIENT Regulator openFDA |
| Matrix Pharmacorp Private Limited | Plecanatide, BULK INGREDIENT Regulator openFDA |
| MSN Life Sciences Private Limited | Plecanatide, BULK INGREDIENT Regulator openFDA |
US LABELER
1 company
Lists a finished product with FDA (NDC directory); can be a maker, repackager or distributor.
| Salix Pharmaceuticals Inc. | Trulance Immediate release, NDA Regulator openFDA |
|---|
TRIAL SPONSOR
3 companies
Sponsors registered clinical trials of the peptide.
| Bausch Health Americas, Inc. | 12 registered trials Trial register ClinicalTrials.gov |
|---|---|
| Shandong Luoxin Pharmaceutical Group Stock Co., Ltd. | 1 registered trial Trial register ClinicalTrials.gov |
| University of Wisconsin, Madison | 1 registered trial Trial register ClinicalTrials.gov |
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