calcimimetic peptide
Etelcalcetide companies
Answer
Public registers name 2 licence holders, 5 bulk ingredient labelers, 2 US labelers and 9 trial sponsors for Etelcalcetide.
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).
| Amgen Europe B.V. | Parsabiv (EMEA/H/C/003995), Authorised Regulator EMA |
|---|---|
| AMGEN LIMITED | PARSABIV 10 MG SOLUTION FOR INJECTION, PLGB 13832/0039, Authorised Regulator MHRA PARSABIV 2.5 MG SOLUTION FOR INJECTION, PLGB 13832/0040, Authorised Regulator MHRA PARSABIV 5 MG SOLUTION FOR INJECTION, PLGB 13832/0041, Authorised Regulator MHRA |
BULK INGREDIENT LABELER
5 companies
Lists the bulk active ingredient with FDA (NDC directory).
| Aurobindo Pharma Limited | Etelcalcetide Hydrochloride, BULK INGREDIENT Regulator openFDA |
|---|---|
| Bachem AG | ETELCALCETIDE, BULK INGREDIENT Regulator openFDA |
| Chunghwa Chemical Synthesis & Biotech. Ltd | ETELCALCETIDE HYDROCHLORIDE, BULK INGREDIENT Regulator openFDA ETELCALCETIDE, BULK INGREDIENT Regulator openFDA |
| MSN Life Sciences Private Limited | Etelcalcetide Hydrochloride, BULK INGREDIENT Regulator openFDA |
| USV Private Limited | Etelcalcetide Hydrochloride, BULK INGREDIENT Regulator openFDA |
US LABELER
2 companies
Lists a finished product with FDA (NDC directory); can be a maker, repackager or distributor.
| Amgen, Inc. | PARSABIV, NDA Regulator openFDA |
|---|---|
| Patheon Manufacturing Services LLC | ETELCALCETIDE HYDROCHLORIDE, DRUG FOR FURTHER PROCESSING Regulator openFDA |
TRIAL SPONSOR
9 companies
Sponsors registered clinical trials of the peptide.
| Amgen | 12 registered trials Trial register ClinicalTrials.gov |
|---|---|
| KAI Pharmaceuticals | 5 registered trials Trial register ClinicalTrials.gov |
| Amgen, Inc. | 1 registered trial Trial register EU CTIS |
| Hospices Civils De Lyon | 1 registered trial Trial register ClinicalTrials.gov |
| Istituto di Fisiologia Clinica CNR | 1 registered trial Trial register ClinicalTrials.gov |
| Prim. Priv. Doz. Dr. Daniel Cejka | 1 registered trial Trial register ClinicalTrials.gov |
| Rainer Oberbauer | 1 registered trial Trial register ClinicalTrials.gov |
| Shaanxi Micot Pharmaceutical Technology Co., Ltd. | 1 registered trial Trial register ClinicalTrials.gov |
| Thomas Nickolas, MD MS | 1 registered trial Trial register ClinicalTrials.gov |
Every company across all peptides: companies. Names are matched only when identical apart from case and punctuation, so one group can appear under two spellings.
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Register Watch, weekly
New trials, approvals and enforcement actions. One email a week.