cyclic lipopeptide antibiotic
Daptomycin companies
Answer
Public registers name 29 licence holders, 8 bulk ingredient labelers, 26 US labelers, 71 trial sponsors and 12 recalling firms for Daptomycin.
Each row is what a register states. A company named here is not endorsed or accused by this site.
MARKETING AUTHORISATION HOLDER
29 companies
Holds the licence to sell the medicine in a country (EMA, MHRA, Health Canada).
| ACCORD HEALTHCARE LIMITED | DAPTOMYCIN 350 MG POWDER FOR SOLUTION FOR INJECTION/INFUSION, PL 20075/1171, Authorised Regulator MHRA DAPTOMYCIN 350 MG POWDER FOR SOLUTION FOR INJECTION/INFUSION, PL 20075/1386, Authorised Regulator MHRA DAPTOMYCIN 500 MG POWDER FOR SOLUTION FOR INJECTION/INFUSION, PL 20075/1172, Authorised Regulator MHRA and 1 more entries |
|---|---|
| Accord Healthcare, Inc. | DAPTOMYCIN FOR INJECTION (DIN 02494590), Cancelled Post Market Regulator Health Canada |
| ACCORD-UK LIMITED | DAPTOMYCIN 350 MG POWDER FOR SOLUTION FOR INJECTION/INFUSION, PL 00142/1301, Authorised Regulator MHRA DAPTOMYCIN 500 MG POWDER FOR SOLUTION FOR INJECTION/INFUSION, PL 00142/1302, Authorised Regulator MHRA |
| ADVANZ PHARMA LIMITED | DAPTOMYCIN ADVANZ PHARMA 350 MG POWDER FOR SOLUTION FOR INJECTION OR INFUSION, PLGB 56734/0013, Authorised Regulator MHRA DAPTOMYCIN ADVANZ PHARMA 500 MG POWDER FOR SOLUTION FOR INJECTION OR INFUSION, PLGB 56734/0014, Authorised Regulator MHRA |
| AFT PHARMA UK LIMITED | DAPTOMYCIN 350 MG POWDER FOR SOLUTION FOR INJECTION OR INFUSION, PLGB 57592/0020, Authorised Regulator MHRA DAPTOMYCIN 500 MG POWDER FOR SOLUTION FOR INJECTION OR INFUSION, PLGB 57592/0021, Authorised Regulator MHRA |
| AMAROX LIMITED | DAPTOMYCIN 350 MG POWDER FOR SOLUTION FOR INJECTION OR INFUSION, PL 49445/0173, Authorised Regulator MHRA DAPTOMYCIN 500 MG POWDER FOR SOLUTION FOR INJECTION OR INFUSION, PL 49445/0174, Authorised Regulator MHRA |
| AURO PHARMA INC | DAPTOMYCIN FOR INJECTION RF (DIN 02540266), Approved Regulator Health Canada |
| BAXTER CORPORATION | DAPTOMYCIN FOR INJECTION RF (DIN 02518856), Cancelled Pre Market Regulator Health Canada |
| CIPLA (EU) LIMITED | DAPTOMYCIN 350 MG POWDER FOR SOLUTION FOR INJECTION OR INFUSION, PLGB 36390/0374, Authorised Regulator MHRA DAPTOMYCIN 500 MG POWDER FOR SOLUTION FOR INJECTION OR INFUSION, PLGB 36390/0375, Authorised Regulator MHRA |
| CUBIST PHARMACEUTICALS LLC | CUBICIN (DIN 02299909), Cancelled Post Market Regulator Health Canada CUBICIN RF (DIN 02465493), Cancelled Post Market Regulator Health Canada |
| DR REDDY'S LABORATORIES (UK) LIMITED | DAPTOMYCIN DR. REDDY'S 350 MG POWDER FOR SOLUTION FOR INJECTION/INFUSION, PL 08553/0580, Authorised Regulator MHRA DAPTOMYCIN DR. REDDY'S 500 MG POWDER FOR SOLUTION FOR INJECTION/INFUSION, PL 08553/0581, Authorised Regulator MHRA |
| DR REDDY'S LABORATORIES LTD | DAPTOMYCIN FOR INJECTION (DIN 02490463), Marketed Regulator Health Canada DAPTOMYCIN FOR INJECTION (DIN 02526743), Cancelled Pre Market Regulator Health Canada |
| EUGIA PHARMA INC. | DAPTOMYCIN FOR INJECTION RF (DIN 02541920), Marketed Regulator Health Canada |
| HAMELN PHARMA LTD | DAPTOMYCIN 350 MG POWDER FOR SOLUTION FOR INJECTION/INFUSION, PL 01502/0120, Authorised Regulator MHRA DAPTOMYCIN 500 MG POWDER FOR SOLUTION FOR INJECTION/INFUSION, PL 01502/0121, Authorised Regulator MHRA |
| HIKMA FARMACEUTICA (PORTUGAL) SA | DAPTOMYCIN 350 MG POWDER FOR SOLUTION FOR INJECTION/INFUSION, PL 15413/0126, Authorised Regulator MHRA DAPTOMYCIN 350MG POWDER FOR SOLUTION FOR INJECTION/INFUSION, PL 15413/0173, Authorised Regulator MHRA DAPTOMYCIN 500 MG POWDER FOR SOLUTION FOR INJECTION/INFUSION, PL 15413/0127, Authorised Regulator MHRA and 1 more entries |
| ISTITUTO BIOCHIMICO ITALIANO GIOVANNI LORENZINI SPA | DAPTOMYCIN 350 MG POWDER FOR SOLUTION FOR INJECTION OR INFUSION, PL 05448/0019, Authorised Regulator MHRA DAPTOMYCIN 500 MG POWDER FOR SOLUTION FOR INJECTION OR INFUSION, PL 05448/0020, Authorised Regulator MHRA |
| JUNO PHARMACEUTICALS CORP. | DAPTOMYCIN FOR INJECTION (DIN 02511738), Cancelled Pre Market Regulator Health Canada |
| MERCK SHARP & DOHME (UK) LIMITED | CUBICIN 350 MG POWDER FOR SOLUTION FOR INJECTION OR INFUSION, PLGB 53095/0013, Authorised Regulator MHRA CUBICIN 500 MG POWDER FOR SOLUTION FOR INJECTION OR INFUSION, PLGB 53095/0014, Authorised Regulator MHRA |
| MIP PHARMA GMBH | DAPTOMYCIN 350 MG POWDER FOR SOLUTION FOR INJECTION/INFUSION, PL 26928/0017, Authorised Regulator MHRA DAPTOMYCIN 500 MG POWDER FOR SOLUTION FOR INJECTION/INFUSION, PL 26928/0018, Authorised Regulator MHRA |
| NORIDEM ENTERPRISES LIMITED | DAPTOMYCIN NORIDEM 350 MG POWDER FOR SOLUTION FOR INJECTION/INFUSION, PL 24598/0065, Authorised Regulator MHRA DAPTOMYCIN NORIDEM 500 MG POWDER FOR SOLUTION FOR INJECTION/INFUSION, PL 24598/0066, Authorised Regulator MHRA |
| PFIZER CANADA ULC | DAPTOMYCIN FOR INJECTION (DIN 02460009), Cancelled Pre Market Regulator Health Canada DAPTOMYCIN FOR INJECTION (DIN 02460017), Cancelled Pre Market Regulator Health Canada |
| Pfizer Europe MA EEIG | Daptomycin Hospira (EMEA/H/C/004310), Authorised Regulator EMA |
| REIG JOFRE UK LIMITED | DAPTOMYCIN 350 MG POWDER FOR SOLUTION FOR INJECTION OR INFUSION, PL 44095/0020, Authorised Regulator MHRA DAPTOMYCIN 500 MG POWDER FOR SOLUTION FOR INJECTION OR INFUSION, PL 44095/0029, Authorised Regulator MHRA |
| SANDOZ CANADA INCORPORATED | DAPTOMYCIN FOR INJECTION (DIN 02490838), Marketed Regulator Health Canada |
| TEVA CANADA LIMITED | DAPTOMYCIN FOR INJECTION (DIN 02462117), Cancelled Pre Market Regulator Health Canada |
| TILLOMED LABORATORIES LIMITED | DAPTOMYCIN TILLOMED 350 MG POWDER FOR SOLUTION FOR INJECTION /INFUSION, PLGB 11311/0699, Authorised Regulator MHRA DAPTOMYCIN TILLOMED 500 MG POWDER FOR SOLUTION FOR INJECTION /INFUSION, PLGB 11311/0700, Authorised Regulator MHRA |
| WOCKHARDT UK LIMITED | DAPTOMYCIN 350 MG POWDER FOR SOLUTION FOR INJECTION OR INFUSION, PL 29831/0723, Authorised Regulator MHRA DAPTOMYCIN 500 MG POWDER FOR SOLUTION FOR INJECTION OR INFUSION, PL 29831/0724, Authorised Regulator MHRA |
| XELLIA PHARMACEUTICALS APS | DAPTOMYCIN 350 MG POWDER FOR SOLUTION FOR INJECTION/INFUSION, PL 17815/0065, Authorised Regulator MHRA DAPTOMYCIN 500 MG POWDER FOR SOLUTION FOR INJECTION/INFUSION, PL 17815/0066, Authorised Regulator MHRA DAPTOXEL 350 MG POWDER FOR SOLUTION FOR INJECTION/INFUSION, PL 17815/0076, Authorised Regulator MHRA and 1 more entries |
| ZENTIVA PHARMA UK LIMITED | DAPTOMYCIN 350 MG POWDER FOR SOLUTION FOR INJECTION/INFUSION, PL 17780/1042, Authorised Regulator MHRA DAPTOMYCIN 500 MG POWDER FOR SOLUTION FOR INJECTION OR INFUSION, PL 17780/1043, Authorised Regulator MHRA |
BULK INGREDIENT LABELER
8 companies
Lists the bulk active ingredient with FDA (NDC directory).
| ACS Dobfar S.p.A. | Daptomycin, BULK INGREDIENT Regulator openFDA |
|---|---|
| Chongqing Daxin Pharmaceutical Co. Ltd. | Daptomycin, BULK INGREDIENT Regulator openFDA |
| Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. | Daptomycin, BULK INGREDIENT Regulator openFDA |
| Hisun Pharmaceutical (Hangzhou) Co., Ltd. | Daptomycin, BULK INGREDIENT Regulator openFDA |
| Livzon Group Fuzhou Fuxing Pharmaceutical Co., Ltd. | Daptomycin, BULK INGREDIENT Regulator openFDA |
| Olon SpA | DAPTOMYCIN, BULK INGREDIENT Regulator openFDA |
| Zhejiang Changhai Pharmaceuticals Co., Ltd. | Daptomycin, BULK INGREDIENT Regulator openFDA |
| Zhejiang Medicine Co., Ltd. Xinchang Pharmaceutical Factory | Daptomycin, BULK INGREDIENT Regulator openFDA |
US LABELER
26 companies
Lists a finished product with FDA (NDC directory); can be a maker, repackager or distributor.
| Accord Healthcare, Inc. | Daptomycin, ANDA Regulator openFDA DAPTOMYCIN, ANDA Regulator openFDA |
|---|---|
| Apotex Corp. | Daptomycin, ANDA Regulator openFDA |
| Aspiro Pharma Limited | Daptomycin, ANDA Regulator openFDA |
| Baxter Healthcare Corporation | Daptomycin in Sodium Chloride, NDA Regulator openFDA DAPZURA RT, NDA Regulator openFDA |
| BE Pharmaceuticals Inc. | daptomycin, ANDA Regulator openFDA |
| Biocon Pharma Inc. | Daptomycin, ANDA Regulator openFDA |
| BluePoint Laboratories | Daptomycin, ANDA Regulator openFDA |
| Camber Pharmaceuticals, Inc. | Daptomycin, ANDA Regulator openFDA |
| Civica, Inc | Daptomycin, ANDA Regulator openFDA Daptomycin, NDA Regulator openFDA |
| Dr. Reddy's Laboratories, Inc. | Daptomycin, ANDA Regulator openFDA |
| Eugia US LLC | DAPTOMYCIN, ANDA Regulator openFDA |
| Fresenius Kabi USA, LLC | Daptomycin, ANDA Regulator openFDA |
| Hainan Poly Pharm., Co., Ltd. | daptomycin, ANDA Regulator openFDA |
| Hikma Pharmaceuticals USA Inc. | Daptomycin, ANDA Regulator openFDA Daptomycin, NDA Regulator openFDA |
| Hospira Inc. | Daptomycin, NDA Regulator openFDA |
| MAIA Pharmaceuticals, Inc. | Daptomycin, NDA Regulator openFDA |
| Meitheal Pharmaceuticals, Inc | DAPTOMYCIN, ANDA Regulator openFDA |
| Mylan Institutional LLC | daptomycin, ANDA Regulator openFDA |
| NorthStar RxLLC | Daptomycin, ANDA Regulator openFDA |
| Par Health USA, LLC | Daptomycin, NDA Regulator openFDA |
| Patheon Italia S.p.A | Daptomycin, DRUG FOR FURTHER PROCESSING Regulator openFDA |
| Qilu Pharmaceutical Co., Ltd. | Daptomycin, ANDA Regulator openFDA |
| Sagent Pharmaceuticals | daptomycin, ANDA Regulator openFDA Daptomycin, NDA Regulator openFDA |
| Sintetica US LLC | daptomycin, ANDA Regulator openFDA |
| Slate Run Pharmaceuticals, LLC | daptomycin, ANDA Regulator openFDA |
| Xellia Pharmaceuticals USA LLC | Daptomycin, ANDA Regulator openFDA Daptomycin, NDA Regulator openFDA |
TRIAL SPONSOR
71 companies
Sponsors registered clinical trials of the peptide.
| Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) | 22 registered trials Trial register ClinicalTrials.gov |
|---|---|
| Hospices Civils De Lyon | 5 registered trials Trial register ClinicalTrials.gov |
| AstraZeneca | 3 registered trials Trial register ClinicalTrials.gov |
| M.D. Anderson Cancer Center | 3 registered trials Trial register ClinicalTrials.gov |
| University of Zurich | 3 registered trials Trial register ClinicalTrials.gov |
| Assistance Publique Hopitaux De Paris | 2 registered trials Trial register EU CTIS |
| Duke University | 2 registered trials Trial register ClinicalTrials.gov |
| Fundacion Publica Andaluza Para La Gestion De La Investigacion En Salud De Sevilla | 2 registered trials Trial register EU CTIS |
| Merck Sharp & Dohme LLC | 2 registered trials Trial register ClinicalTrials.gov |
| Novartis Pharmaceuticals | 2 registered trials Trial register ClinicalTrials.gov |
| University Hospital, Caen | 2 registered trials Trial register ClinicalTrials.gov |
| University of Pittsburgh | 2 registered trials Trial register ClinicalTrials.gov |
| West Virginia University | 2 registered trials Trial register ClinicalTrials.gov |
| Andrej Trampuz | 1 registered trial Trial register ClinicalTrials.gov |
| Assistance Publique - Hôpitaux de Paris | 1 registered trial Trial register ClinicalTrials.gov |
| Azienda Sanitaria-Universitaria Integrata di Udine | 1 registered trial Trial register ClinicalTrials.gov |
| Aziende Chimiche Riunite Angelini Francesco S.p.A | 1 registered trial Trial register ClinicalTrials.gov |
| Basilea Pharmaceutica | 1 registered trial Trial register ClinicalTrials.gov |
| CAMC Health System | 1 registered trial Trial register ClinicalTrials.gov |
| Cellceutix Corporation | 1 registered trial Trial register ClinicalTrials.gov |
| Centre Hospitalier Universitaire De Nice | 1 registered trial Trial register EU CTIS |
| Centre Hospitalier Universitaire De Nimes | 1 registered trial Trial register EU CTIS |
| Centre Hospitalier Universitaire Dijon | 1 registered trial Trial register ClinicalTrials.gov |
| Chang Gung Memorial Hospital | 1 registered trial Trial register ClinicalTrials.gov |
| Clinica Universidad de Navarra, Universidad de Navarra | 1 registered trial Trial register ClinicalTrials.gov |
| Clinical Alliance for Research & Education - Infectious Diseases, LLC. | 1 registered trial Trial register ClinicalTrials.gov |
| Cumberland Pharmaceuticals | 1 registered trial Trial register ClinicalTrials.gov |
| Far Eastern Memorial Hospital | 1 registered trial Trial register ClinicalTrials.gov |
| Friedrich-Schiller-Universitaet Jena | 1 registered trial Trial register EU CTIS |
| Fundacio Institut De Recerca De L Hospital De La Santa Creu I Sant Pau | 1 registered trial Trial register EU CTIS |
| Hannover Medical School | 1 registered trial Trial register ClinicalTrials.gov |
| Heinrich-Heine University, Duesseldorf | 1 registered trial Trial register ClinicalTrials.gov |
| Henry Ford Health System | 1 registered trial Trial register ClinicalTrials.gov |
| Hospital Universitario Evangelico de Curitiba | 1 registered trial Trial register ClinicalTrials.gov |
| Hvidovre Hospital | 1 registered trial Trial register EU CTIS |
| Insel Gruppe AG, University Hospital Bern | 1 registered trial Trial register ClinicalTrials.gov |
| Jiangsu Hengrui Pharmaceutical Co., Ltd. | 1 registered trial Trial register ClinicalTrials.gov |
| Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center | 1 registered trial Trial register ClinicalTrials.gov |
| McGill University Health Centre/Research Institute of the McGill University Health Centre | 1 registered trial Trial register ClinicalTrials.gov |
| Methodist Health System | 1 registered trial Trial register ClinicalTrials.gov |
Showing 40 of 71.
RECALLING FIRM
12 companies
Recalled a product naming the peptide (FDA enforcement report).
| Accord Healthcare, Inc. | Class I recall, Terminated, 2023-01-25 Regulator openFDA Class II recall, Terminated, 2023-03-08 Regulator openFDA |
|---|---|
| Attix Pharmaceuticals | Class II recall, Terminated, 2015-04-29 Regulator openFDA |
| Baptist Health Medical Towers Pharmacy and Infusion Services | Class II recall, Terminated, 2016-06-08 Regulator openFDA |
| Baxter Healthcare Corporation | Class II recall, Ongoing, 2026-09-09 Regulator openFDA |
| Cubist Pharmaceuticals, Inc. | Class I recall, Terminated, 2014-01-29 Regulator openFDA Class I recall, Terminated, 2014-06-18 Regulator openFDA Class I recall, Terminated, 2014-10-08 Regulator openFDA and 1 more entries |
| MERCK SHARP & DOHME CORP | Class I recall, Terminated, 2021-11-10 Regulator openFDA |
| Mylan Institutional LLC | Class I recall, Terminated, 2020-08-12 Regulator openFDA |
| PFIZER | Class II recall, Terminated, 2018-08-08 Regulator openFDA |
| Redline Pharmacy Solutions | Class II recall, Terminated, 2020-03-18 Regulator openFDA |
| Sentara Enterprises | Class II recall, Terminated, 2016-02-03 Regulator openFDA |
| Sentara Infusion Services | Class II recall, Terminated, 2023-02-22 Regulator openFDA |
| Walgreens Infusion Services | Class II recall, Terminated, 2015-01-28 Regulator openFDA |
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.
WEEKLY
Register Watch, weekly
New trials, approvals and enforcement actions. One email a week.