cyclic polypeptide antibiotic
Colistin companies
Answer
Public registers name 11 licence holders, 3 ingredient makers with a drug master file, 1 bulk ingredient labeler, 1 US labeler and 72 trial sponsors for Colistin.
Each row is what a register states. A company named here is not endorsed or accused by this site.
MARKETING AUTHORISATION HOLDER
11 companies
Holds the licence to sell the medicine in a country (EMA, MHRA, Health Canada).
| ACCORD-UK LIMITED | COLISTIMETHATE SODIUM 1 MILLION INTERNATIONAL UNITS (IU) POWDER FOR SOLUTION FOR INJECTION/INFUSION, PL 00142/1288, Authorised Regulator MHRA COLISTIMETHATE SODIUM 2 MILLION INTERNATIONAL UNITS (IU) POWDER FOR SOLUTION FOR INJECTION/INFUSION, PL 00142/1289, Authorised Regulator MHRA |
|---|---|
| ESSENTIAL PHARMA LIMITED | COLOBREATHE 1,662,500 IU INHALATION POWDER, HARD CAPSULES, PLGB 41871/0023, Authorised Regulator MHRA |
| FRESENIUS KABI CANADA LTD | COLISTIMETHATE FOR INJECTION, USP (DIN 02403544), Marketed Regulator Health Canada |
| HIKMA FARMACEUTICA (PORTUGAL) SA | COLISTIMETHATE SODIUM 1 MIU POWDER FOR NEBULISER SOLUTION, PL 15413/0143, Authorised Regulator MHRA COLISTIMETHATE SODIUM 1 MIU POWDER FOR SOLUTION FOR INJECTION/INFUSION, PL 15413/0135, Authorised Regulator MHRA COLISTIMETHATE SODIUM 2 MIU POWDER FOR NEBULISER SOLUTION, PL 15413/0164, Authorised Regulator MHRA and 1 more entries |
| KENT PHARMA UK LIMITED | COLISTIMETHATE SODIUM 1 MILLION I.U. POWDER FOR SOLUTION FOR INJECTION, PL 51463/0087, Authorised Regulator MHRA |
| NORIDEM ENTERPRISES LIMITED | COLICYM 1 MIU POWDER FOR NEBULISER SOLUTION, PL 24598/0089, Authorised Regulator MHRA COLICYM 2 MIU POWDER FOR NEBULISER SOLUTION, PL 24598/0090, Authorised Regulator MHRA COLISTIMETHATE SODIUM 1 MIU POWDER FOR SOLUTION FOR INJECTION/INFUSION, PL 24598/0091, Authorised Regulator MHRA and 1 more entries |
| SEARCHLIGHT PHARMA INC | COLY-MYCIN M (DIN 00476420), Marketed Regulator Health Canada |
| SGS PHARMA MAGYARORSZAG KFT. | COLISTIMETHATE SODIUM 1 MILLION INTERNATIONAL UNITS (IU) POWDER FOR NEBULISER SOLUTION, PL 55807/0018, Authorised Regulator MHRA COLISTIMETHATE SODIUM 1 MILLION INTERNATIONAL UNITS (IU) POWDER FOR SOLUTION, PL 55807/0008, Authorised Regulator MHRA COLISTIMETHATE SODIUM 2 MILLION INTERNATIONAL UNITS (IU) POWDER FOR NEBULISER SOLUTION, PL 55807/0019, Authorised Regulator MHRA and 1 more entries |
| STERIMAX INC | COLISTIMETHATE FOR INJECTION U.S.P. (DIN 02244849), Marketed Regulator Health Canada |
| TEVA UK LIMITED | COLOMYCIN 1 MILLION INTERNATIONAL UNITS. POWDER FOR SOLN FOR INJ, INFUSION OR INHALATION, PL 00289/2255, Authorised Regulator MHRA COLOMYCIN 2 MILLION INTERNATIONAL UNITS. POWDER FOR SOLN FOR INJ, INFUSION OR INHALATION, PL 00289/2256, Authorised Regulator MHRA |
| ZAMBON SPA | PROMIXIN, 1 MILLION INTERNATIONAL UNITS (IU) POWDER FOR NEBULISER SOLUTION., PL 31654/0008, Authorised Regulator MHRA |
API MANUFACTURER
3 companies
Filed a drug master file with FDA for the active ingredient.
| DUMEX ALPHARMA AS | DMF 14424, type II, inactive, submitted 1999-10-21 Regulator FDA drug master file list |
|---|---|
| KAYAKU CO LTD | DMF 13289, type II, inactive, submitted 1998-09-01 Regulator FDA drug master file list DMF 13301, type II, inactive, submitted 1998-09-01 Regulator FDA drug master file list |
| XELLIA PHARMACEUTICALS APS | DMF 13362, type II, active, submitted 1998-09-01 Regulator FDA drug master file list |
BULK INGREDIENT LABELER
1 company
Lists the bulk active ingredient with FDA (NDC directory).
| XELLIA PHARMACEUTICALS APS | Colistin Sulfate, BULK INGREDIENT Regulator openFDA |
|---|
US LABELER
1 company
Lists a finished product with FDA (NDC directory); can be a maker, repackager or distributor.
| Endo USA, Inc. | Cortisporin TC, NDA Regulator openFDA |
|---|
TRIAL SPONSOR
72 companies
Sponsors registered clinical trials of the peptide.
| Mahidol University | 8 registered trials Trial register ClinicalTrials.gov |
|---|---|
| Ain Shams University | 4 registered trials Trial register ClinicalTrials.gov |
| Beni-Suef University | 3 registered trials Trial register ClinicalTrials.gov |
| Rambam Health Care Campus | 3 registered trials Trial register ClinicalTrials.gov |
| Fundación Pública Andaluza para la gestión de la Investigación en Sevilla | 2 registered trials Trial register ClinicalTrials.gov |
| Maimónides Biomedical Research Institute of Córdoba | 2 registered trials Trial register ClinicalTrials.gov |
| Parc de Salut Mar | 2 registered trials Trial register ClinicalTrials.gov |
| Southeast University, China | 2 registered trials Trial register ClinicalTrials.gov |
| University of Pittsburgh | 2 registered trials Trial register ClinicalTrials.gov |
| University of Thessaly | 2 registered trials Trial register ClinicalTrials.gov |
| Achaogen, Inc. | 1 registered trial Trial register ClinicalTrials.gov |
| Al-Azhar University | 1 registered trial Trial register ClinicalTrials.gov |
| Assistance Publique - Hôpitaux de Paris | 1 registered trial Trial register ClinicalTrials.gov |
| Assistance Publique Hopitaux De Paris | 1 registered trial Trial register EU CTIS |
| Assiut University | 1 registered trial Trial register ClinicalTrials.gov |
| Bioversys S.A.S. | 1 registered trial Trial register EU CTIS |
| BioVersys SAS | 1 registered trial Trial register ClinicalTrials.gov |
| CCDRD Cooperative Clinical Drug Research and Development AG, PureIMS B.V. | 1 registered trial Trial register EU CTIS |
| Centre Hospitalier Intercommunal Creteil | 1 registered trial Trial register EU CTIS |
| Centre Hospitalier Universitaire De Nimes | 1 registered trial Trial register EU CTIS |
| Chang Gung University | 1 registered trial Trial register ClinicalTrials.gov |
| Charite University, Berlin, Germany | 1 registered trial Trial register ClinicalTrials.gov |
| Chiang Mai University | 1 registered trial Trial register ClinicalTrials.gov |
| DongGuk University | 1 registered trial Trial register ClinicalTrials.gov |
| Entasis Therapeutics | 1 registered trial Trial register ClinicalTrials.gov |
| Erasmus Medical Center | 1 registered trial Trial register ClinicalTrials.gov |
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS | 1 registered trial Trial register ClinicalTrials.gov |
| Fu Jen Catholic University | 1 registered trial Trial register ClinicalTrials.gov |
| Gangnam Severance Hospital | 1 registered trial Trial register ClinicalTrials.gov |
| GlaxoSmithKline | 1 registered trial Trial register ClinicalTrials.gov |
| Goethe University Frankfurt | 1 registered trial Trial register EU CTIS |
| H. Jaap Bonjer, PhD | 1 registered trial Trial register ClinicalTrials.gov |
| Hannover Medical School | 1 registered trial Trial register ClinicalTrials.gov |
| Hat Yai Medical Education Center | 1 registered trial Trial register ClinicalTrials.gov |
| Helwan University | 1 registered trial Trial register ClinicalTrials.gov |
| Hoffmann-La Roche | 1 registered trial Trial register ClinicalTrials.gov |
| Hospital Barros Luco Trudeau | 1 registered trial Trial register ClinicalTrials.gov |
| Hospitales Universitarios Virgen del Rocío | 1 registered trial Trial register ClinicalTrials.gov |
| Institute of Liver and Biliary Sciences, India | 1 registered trial Trial register ClinicalTrials.gov |
| King Faisal Specialist Hospital & Research Center | 1 registered trial Trial register ClinicalTrials.gov |
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