amylin analogue
Pramlintide companies
Answer
Public registers name 3 ingredient makers with a drug master file, 3 bulk ingredient labelers, 1 US labeler and 26 trial sponsors for Pramlintide.
Each row is what a register states. A company named here is not endorsed or accused by this site.
API MANUFACTURER
3 companies
Filed a drug master file with FDA for the active ingredient.
| MALLINCKRODT CHEMICAL INC | DMF 12646, type II, inactive, submitted 1997-09-05 Regulator FDA drug master file list |
|---|---|
| POLYPEPTIDE SA | DMF 15096, type II, inactive, submitted 2000-10-16 Regulator FDA drug master file list |
| Sun Pharmaceutical Industries Ltd. | DMF 31548, type II, active, submitted 2018-03-29 Regulator FDA drug master file list |
BULK INGREDIENT LABELER
3 companies
Lists the bulk active ingredient with FDA (NDC directory).
| BACHEM AMERICAS INC | Pramlintide, BULK INGREDIENT Regulator openFDA |
|---|---|
| Qingdao Biopeptek Co., Ltd. | Pramlintide, BULK INGREDIENT Regulator openFDA |
| SUN PHARMACEUTICAL INDUSTRIES INC | Pramlintide Acetate, BULK INGREDIENT Regulator openFDA |
US LABELER
1 company
Lists a finished product with FDA (NDC directory); can be a maker, repackager or distributor.
| ASTRAZENECA PHARMACEUTICALS LP | SymlinPen, NDA Regulator openFDA |
|---|
TRIAL SPONSOR
26 companies
Sponsors registered clinical trials of the peptide.
| AstraZeneca | 20 registered trials Trial register ClinicalTrials.gov |
|---|---|
| McGill University | 5 registered trials Trial register ClinicalTrials.gov |
| Baylor College of Medicine | 4 registered trials Trial register ClinicalTrials.gov |
| University of Virginia | 3 registered trials Trial register ClinicalTrials.gov |
| Adocia | 2 registered trials Trial register ClinicalTrials.gov |
| Albert Einstein College of Medicine | 2 registered trials Trial register ClinicalTrials.gov |
| McGill University Health Centre/Research Institute of the McGill University Health Centre | 2 registered trials Trial register ClinicalTrials.gov |
| Oregon Health and Science University | 2 registered trials Trial register ClinicalTrials.gov |
| University of Colorado, Denver | 2 registered trials Trial register ClinicalTrials.gov |
| University of Texas Southwestern Medical Center | 2 registered trials Trial register ClinicalTrials.gov |
| Boston University | 1 registered trial Trial register ClinicalTrials.gov |
| Cheryl Rosenfeld, DO | 1 registered trial Trial register ClinicalTrials.gov |
| Danish Headache Center | 1 registered trial Trial register ClinicalTrials.gov |
| Diabetes Care Center | 1 registered trial Trial register ClinicalTrials.gov |
| Esbjerg Hospital - University Hospital of Southern Denmark | 1 registered trial Trial register ClinicalTrials.gov |
| Esbjerg Sygehus | 1 registered trial Trial register EU CTIS |
| Filip Krag Knop | 1 registered trial Trial register ClinicalTrials.gov |
| H. Lee Moffitt Cancer Center and Research Institute | 1 registered trial Trial register ClinicalTrials.gov |
| Joslin Diabetes Center | 1 registered trial Trial register ClinicalTrials.gov |
| Ludwig-Maximilians - University of Munich | 1 registered trial Trial register ClinicalTrials.gov |
| Montefiore Medical Center | 1 registered trial Trial register ClinicalTrials.gov |
| University Diabetes & Endocrine Consultants | 1 registered trial Trial register ClinicalTrials.gov |
| University Hospital, Gentofte, Copenhagen | 1 registered trial Trial register ClinicalTrials.gov |
| University of Copenhagen | 1 registered trial Trial register ClinicalTrials.gov |
| University of Maryland, Baltimore | 1 registered trial Trial register ClinicalTrials.gov |
| Xeris Pharmaceuticals | 1 registered trial Trial register ClinicalTrials.gov |
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New trials, approvals and enforcement actions. One email a week.