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1. Gsk2696266d
2. S-649266d
3. Ttp8lbp45d
4. Cefiderocol Sulfate Tosylate [usan]
5. Gsk-2696266d
6. 2135543-94-9
7. Unii-ttp8lbp45d
8. Chembl4297211
9. 1-(((6r,7r)-7-((2z)-2-(2-amino-1,3-thiazol-4-yl)-2-(((2-carboxypropan-2-yl)oxy)imino)acetamido)-2-carboxy-8-oxo-5-thia-1-azabicyclo(4.2.0)oct-2-en-3-yl)methyl)-1-(2-(2-chloro-3,4-dihydroxybenzamido)ethyl)pyrrolidin-1-ium 4-methylbenzenesulfonate, 4-methylbenzenesulfonic Acid, Sulfate, Hydrate (3:1:1:3:?)
10. Pyrrolidinium, 1-(((6r,7r)-7-(((2z)-2-(2-amino-4-thiazolyl)-2-((1-carboxy- 1-methylethoxy)imino)acetyl)amino)-2-carboxy-8-oxo-5-thia-1- Azabicyclo(4.2.0)oct-2-en-3-yl)methyl)-1-(2-((2-chloro-3,4- Dihydroxybenzoyl)amino)ethyl)-, 4-methylbenzenesulfonate Sulfate, 4-methylbenzenesulfonate, Hydrate (3:1:1:3:?)
| Molecular Weight | 3061.6 g/mol |
|---|---|
| Molecular Formula | C118H138Cl3N21O47S11 |
| Hydrogen Bond Donor Count | 25 |
| Hydrogen Bond Acceptor Count | 62 |
| Rotatable Bond Count | 42 |
| Exact Mass | 3058.508091 g/mol |
| Monoisotopic Mass | 3057.504737 g/mol |
| Topological Polar Surface Area | 1270 Ų |
| Heavy Atom Count | 200 |
| Formal Charge | 0 |
| Complexity | 1910 |
| Isotope Atom Count | 0 |
| Defined Atom Stereocenter Count | 6 |
| Undefined Atom Stereocenter Count | 0 |
| Defined Bond Stereocenter Count | 3 |
| Undefined Bond Stereocenter Count | 0 |
| Covalently Bonded Unit Count | 9 |
NDC Package Code : 53044-005
Start Marketing Date : 2020-01-31
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT

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NDC Package Code : 53044-005
Start Marketing Date : 2020-01-31
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]
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Details:
Fetroja (cefiderocol) is a siderophore cephalosporin antibiotic under evaluation for treating complicated urinary tract infections, hospital-acquired & ventilator-associated bacterial pneumonia.
Lead Product(s): Cefiderocol sulfate tosylate,Inapplicable
Therapeutic Area: Infections and Infectious Diseases Brand Name: Fetroja
Study Phase: Approved FDFProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable February 22, 2024

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Lead Product(s) : Cefiderocol sulfate tosylate,Inapplicable
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
FETROJA® (cefiderocol) Approved by TFDA in Taiwan
Details : Fetroja (cefiderocol) is a siderophore cephalosporin antibiotic under evaluation for treating complicated urinary tract infections, hospital-acquired & ventilator-associated bacterial pneumonia.
Product Name : Fetroja
Product Type : Miscellaneous
Upfront Cash : Inapplicable
February 22, 2024

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Details:
Cefiderocol Sulfate Tosylate has a novel mechanism for penetrating the outer cell membrane of Gram-negative pathogens. Fetroja achieved clinical cure in 63% of patients with Acinetobacter baumannii infections and 63% of patients with Pseudomonas aeruginosa infections.
Lead Product(s): Cefiderocol sulfate tosylate,Inapplicable
Therapeutic Area: Infections and Infectious Diseases Brand Name: Fetroja
Study Phase: Phase IVProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable October 20, 2022

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Lead Product(s) : Cefiderocol sulfate tosylate,Inapplicable
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Phase IV
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Shionogi Presents Real-World Evidence Showing Strong Efficacy with Fetroja® (cefiderocol) Against...
Details : Cefiderocol Sulfate Tosylate has a novel mechanism for penetrating the outer cell membrane of Gram-negative pathogens. Fetroja achieved clinical cure in 63% of patients with Acinetobacter baumannii infections and 63% of patients with Pseudomonas aerugino...
Product Name : Fetroja
Product Type : Miscellaneous
Upfront Cash : Inapplicable
October 20, 2022

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Details:
The collaboration agreement includes provisions to work with ministries of health and other experts to strengthen hospital-based stewardship programmes that ensure appropriate use. These provisions are especially important to avoid fuelling resistance to Fetroja (cefiderocol).
Lead Product(s): Cefiderocol sulfate tosylate,Inapplicable
Therapeutic Area: Infections and Infectious Diseases Brand Name: Fetroja
Study Phase: Approved FDFProduct Type: Miscellaneous
Sponsor: Clinton Health Access Initiative
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Collaboration June 15, 2022

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Lead Product(s) : Cefiderocol sulfate tosylate,Inapplicable
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Clinton Health Access Initiative
Deal Size : Undisclosed
Deal Type : Collaboration
Details : The collaboration agreement includes provisions to work with ministries of health and other experts to strengthen hospital-based stewardship programmes that ensure appropriate use. These provisions are especially important to avoid fuelling resistance to...
Product Name : Fetroja
Product Type : Miscellaneous
Upfront Cash : Undisclosed
June 15, 2022

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Details:
Publication of two studies in The Lancet Infectious Diseases journal has shown the efficacy and safety of FETROJA for some of the most difficult-to-treat Gram-negative bacterial infections, including nosocomial pneumonia, bloodstream infections, sepsis, and Complicated UTIs.
Lead Product(s): Cefiderocol sulfate tosylate,Inapplicable
Therapeutic Area: Infections and Infectious Diseases Brand Name: Fetroja
Study Phase: Approved FDFProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable October 13, 2020

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass.
Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
Lead Product(s) : Cefiderocol sulfate tosylate,Inapplicable
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Publication of two studies in The Lancet Infectious Diseases journal has shown the efficacy and safety of FETROJA for some of the most difficult-to-treat Gram-negative bacterial infections, including nosocomial pneumonia, bloodstream infections, sepsis, ...
Product Name : Fetroja
Product Type : Miscellaneous
Upfront Cash : Inapplicable
October 13, 2020

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Details:
U.S.FDA has approved a supplemental New Drug Application for FETROJA® (cefiderocol) for the treatment of patients 18 years of age or older with hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP).
Lead Product(s): Cefiderocol sulfate tosylate,Linezolid
Therapeutic Area: Infections and Infectious Diseases Brand Name: Fetroja
Study Phase: Approved FDFProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable September 28, 2020

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Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
Lead Product(s) : Cefiderocol sulfate tosylate,Linezolid
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Shionogi Announces FDA Approval of Fetroja® for Hospital-Acquired Bacterial Pneumonia AND Ventila...
Details : U.S.FDA has approved a supplemental New Drug Application for FETROJA® (cefiderocol) for the treatment of patients 18 years of age or older with hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP).
Product Name : Fetroja
Product Type : Miscellaneous
Upfront Cash : Inapplicable
September 28, 2020

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass.
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Details:
The approval was based on the nonclinical data package, including the PK/PD data package, and data from three clinical studies in complicated UTI, nosocomial pneumonia and critically ill patients with confirmed carbapenem-resistant infection.
Lead Product(s): Cefiderocol sulfate tosylate,Inapplicable
Therapeutic Area: Infections and Infectious Diseases Brand Name: Fetroja
Study Phase: Approved FDFProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable September 14, 2020

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass.
Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
Lead Product(s) : Cefiderocol sulfate tosylate,Inapplicable
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Shionogi Launches Novel Antibiotic Fetcroja in the UK
Details : The approval was based on the nonclinical data package, including the PK/PD data package, and data from three clinical studies in complicated UTI, nosocomial pneumonia and critically ill patients with confirmed carbapenem-resistant infection.
Product Name : Fetroja
Product Type : Miscellaneous
Upfront Cash : Inapplicable
September 14, 2020

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass.
Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
Details:
FDA has accepted the company’s supplemental New Drug Application (sNDA) for FETROJA® (cefiderocol) and granted Priority Review designation with a Prescription Drug User Fee Act (PDUFA) date of September 27, 2020.
Lead Product(s): Cefiderocol sulfate tosylate,Linezolid
Therapeutic Area: Infections and Infectious Diseases Brand Name: Fetroja
Study Phase: Phase IIIProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable June 01, 2020

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass.
Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
Lead Product(s) : Cefiderocol sulfate tosylate,Linezolid
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
FDA Accepts Shionogi’s sNDA with Priority Review for FETROJA® for Hospital-Acquired Pneumonia a...
Details : FDA has accepted the company’s supplemental New Drug Application (sNDA) for FETROJA® (cefiderocol) and granted Priority Review designation with a Prescription Drug User Fee Act (PDUFA) date of September 27, 2020.
Product Name : Fetroja
Product Type : Miscellaneous
Upfront Cash : Inapplicable
June 01, 2020

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Patents & EXCLUSIVITIES
Patent Expiration Date : 2033-11-14
US Patent Number : 9238657
Drug Substance Claim : Y
Drug Product Claim : Y
Application Number : 209445
Patent Use Code : U-3470
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2033-11-14

Patent Expiration Date : 2033-11-14
US Patent Number : 9238657
Drug Substance Claim : Y
Drug Product Claim : Y
Application Number : 209445
Patent Use Code : U-3471
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2033-11-14

Patent Expiration Date : 2035-09-03
US Patent Number : 10004750
Drug Substance Claim : Y
Drug Product Claim : Y
Application Number : 209445
Patent Use Code :
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2035-09-03

Patent Expiration Date : 2035-09-03
US Patent Number : 9949982
Drug Substance Claim :
Drug Product Claim : Y
Application Number : 209445
Patent Use Code :
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2035-09-03

Patent Expiration Date : 2033-11-14
US Patent Number : 9238657
Drug Substance Claim : Y
Drug Product Claim : Y
Application Number : 209445
Patent Use Code : U-282
Delist Requested :
Patent Use Description : METHOD OF TREATING BAC...
Patent Expiration Date : 2033-11-14

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61
PharmaCompass offers a list of Cefiderocol sulfate tosylate API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Cefiderocol sulfate tosylate manufacturer or Cefiderocol sulfate tosylate supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Cefiderocol sulfate tosylate manufacturer or Cefiderocol sulfate tosylate supplier.
PharmaCompass also assists you with knowing the Cefiderocol sulfate tosylate API Price utilized in the formulation of products. Cefiderocol sulfate tosylate API Price is not always fixed or binding as the Cefiderocol sulfate tosylate Price is obtained through a variety of data sources. The Cefiderocol sulfate tosylate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Cefiderocol sulfate tosylate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Cefiderocol sulfate tosylate, including repackagers and relabelers. The FDA regulates Cefiderocol sulfate tosylate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Cefiderocol sulfate tosylate API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
A Cefiderocol sulfate tosylate supplier is an individual or a company that provides Cefiderocol sulfate tosylate active pharmaceutical ingredient (API) or Cefiderocol sulfate tosylate finished formulations upon request. The Cefiderocol sulfate tosylate suppliers may include Cefiderocol sulfate tosylate API manufacturers, exporters, distributors and traders.
click here to find a list of Cefiderocol sulfate tosylate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing Cefiderocol sulfate tosylate as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Cefiderocol sulfate tosylate API and other APIs are published in this directory by the FDA.
The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.
Pharmaceutical companies that manufacture Cefiderocol sulfate tosylate as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.
The NDC directory also contains data on finished compounded human drug products that contain Cefiderocol sulfate tosylate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Cefiderocol sulfate tosylate NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Cefiderocol sulfate tosylate suppliers with NDC on PharmaCompass.
Cefiderocol sulfate tosylate Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.
GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).
PharmaCompass offers a list of Cefiderocol sulfate tosylate GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, API price, and more, enabling you to easily find the right Cefiderocol sulfate tosylate GMP manufacturer or Cefiderocol sulfate tosylate GMP API supplier for your needs.
A Cefiderocol sulfate tosylate CoA (Certificate of Analysis) is a formal document that attests to Cefiderocol sulfate tosylate's compliance with Cefiderocol sulfate tosylate specifications and serves as a tool for batch-level quality control.
Cefiderocol sulfate tosylate CoA mostly includes findings from lab analyses of a specific batch. For each Cefiderocol sulfate tosylate CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.
Cefiderocol sulfate tosylate may be tested according to a variety of international standards, such as European Pharmacopoeia (Cefiderocol sulfate tosylate EP), Cefiderocol sulfate tosylate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Cefiderocol sulfate tosylate USP).