kappa opioid receptor agonist
Difelikefalin companies
Answer
Public registers name 2 licence holders, 8 ingredient makers with a drug master file, 4 bulk ingredient labelers, 2 US labelers and 4 trial sponsors for Difelikefalin.
Each row is what a register states. A company named here is not endorsed or accused by this site.
MARKETING AUTHORISATION HOLDER
2 companies
Holds the licence to sell the medicine in a country (EMA, MHRA, Health Canada).
| Vifor Fresenius Medical Care Renal Pharma France | Kapruvia (EMEA/H/C/005612), Authorised Regulator EMA KAPRUVIA 50 MICROGRAMS/ML SOLUTION FOR INJECTION, PLGB 50784/0009, Authorised Regulator MHRA |
|---|---|
| VIFOR FRESENIUS MEDICAL CARE RENAL PHARMA LTD | KORSUVA (DIN 02529688), Marketed Regulator Health Canada |
API MANUFACTURER
8 companies
Filed a drug master file with FDA for the active ingredient.
| ALP PHARM BEIJING CO LTD | DMF 38645, type II, active, submitted 2023-08-02 Regulator FDA drug master file list |
|---|---|
| CHUNGHWA CHEMICAL SYNTHESIS AND BIOTECH CO LTD | DMF 38511, type II, active, submitted 2023-06-19 Regulator FDA drug master file list |
| CIPLA LTD | DMF 37712, type II, active, submitted 2023-01-25 Regulator FDA drug master file list |
| HYBIO PHARMACEUTICAL CO LTD | DMF 42266, type II, active, submitted 2025-12-30 Regulator FDA drug master file list |
| MSN LIFE SCIENCES PRIVATE LTD | DMF 40537, type II, active, submitted 2024-09-27 Regulator FDA drug master file list |
| NEULAND LABORATORIES LTD | DMF 41503, type II, active, submitted 2025-03-26 Regulator FDA drug master file list |
| SUZHOU YIFAN PHARMACEUTICAL CO LTD | DMF 43195, type II, active, submitted 2025-12-11 Regulator FDA drug master file list |
| WISDOM PHARMACEUTICAL CO LTD | DMF 41341, type II, active, submitted 2025-02-21 Regulator FDA drug master file list |
BULK INGREDIENT LABELER
4 companies
Lists the bulk active ingredient with FDA (NDC directory).
| Chunghwa Chemical Sysnthsis & Biotech Co.,Ltd. | Difelikefalin acetate, BULK INGREDIENT Regulator openFDA |
|---|---|
| MSN Life Sciences Private Limited | Difelikefalin Acetate, BULK INGREDIENT Regulator openFDA |
| PolyPeptide Laboratories France | DIFELIKEFALIN, BULK INGREDIENT Regulator openFDA |
| WISDOM PHARMACEUTICAL CO LTD | Difelikefalin Acetate, 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 | DIFELIKEFALIN ACETATE, DRUG FOR FURTHER PROCESSING Regulator openFDA |
|---|---|
| Vifor (International), Inc. | Korsuva, NDA Regulator openFDA |
TRIAL SPONSOR
4 companies
Sponsors registered clinical trials of the peptide.
| Cara Therapeutics Inc. | 1 registered trial Trial register EU CTIS 11 registered trials Trial register ClinicalTrials.gov |
|---|---|
| Vifor Fresenius Medical Care Renal Pharma | 3 registered trials Trial register ClinicalTrials.gov |
| Chittagong Medical College | 1 registered trial Trial register ClinicalTrials.gov |
| VIFOR FRESENIUS MEDICAL CARE RENAL PHARMA LTD | 1 registered trial Trial register EU CTIS |
WEEKLY
Register Watch, weekly
New trials, approvals and enforcement actions. One email a week.