melanocortin-1 receptor agonist
Afamelanotide companies
Answer
Public registers name 3 licence holders, 1 ingredient maker with a drug master file, 2 bulk ingredient labelers, 2 US labelers and 4 trial sponsors for Afamelanotide.
Each row is what a register states. A company named here is not endorsed or accused by this site.
MARKETING AUTHORISATION HOLDER
3 companies
Holds the licence to sell the medicine in a country (EMA, MHRA, Health Canada).
| CLINUVEL (UK) LIMITED | SCENESSE 16MG IMPLANT, PLGB 30619/0002, Authorised Regulator MHRA |
|---|---|
| Clinuvel Europe Limited | Scenesse (EMEA/H/C/002548), Authorised Regulator EMA |
| CLINUVEL, INC. | SCENESSE (DIN 02569825), Approved Regulator Health Canada |
API MANUFACTURER
1 company
Filed a drug master file with FDA for the active ingredient.
| CLINUVEL, INC. | DMF 17471, type II, active, submitted 2004-06-17 Regulator FDA drug master file list |
|---|
BULK INGREDIENT LABELER
2 companies
Lists the bulk active ingredient with FDA (NDC directory).
| Chinese Peptide Company | Afamelanotide, BULK INGREDIENT Regulator openFDA |
|---|---|
| Qingdao Biopeptek Co., Ltd. | Afamelanotide, BULK INGREDIENT Regulator openFDA |
US LABELER
2 companies
Lists a finished product with FDA (NDC directory); can be a maker, repackager or distributor.
| CLINUVEL, INC. | SCENESSE, NDA Regulator openFDA |
|---|---|
| Synergy Health AST | afamelanotide, DRUG FOR FURTHER PROCESSING Regulator openFDA |
TRIAL SPONSOR
4 companies
Sponsors registered clinical trials of the peptide.
| Clinuvel Pharmaceuticals Limited | 17 registered trials Trial register ClinicalTrials.gov |
|---|---|
| Clinuvel Europe Limited | 3 registered trials Trial register ClinicalTrials.gov 5 registered trials Trial register EU CTIS |
| CLINUVEL, INC. | 2 registered trials Trial register ClinicalTrials.gov |
| Clinuvel (UK) Ltd. | 1 registered trial Trial register ClinicalTrials.gov |
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