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1. 7-(2-(2-amino-4-thiazolyl)-4-carboxy-2-butenoylamino)-3-cephem-4-carboxylic Acid
2. 7432 S
3. 7432-s
4. Cedax
5. Sch 39720
6. Sch-39720
7. Sch39720
1. 97519-39-6
2. Cedax
3. Ceftibuteno
4. Ceftibutenum
5. Ceftibutene
6. Sch 39720
7. Ceftibuten Hydrate
8. Cis-ceftibuten
9. Sch-39720
10. 7432-s
11. Antibiotic 7432s
12. Nsc-758925
13. Achn383
14. Achn-383
15. Chebi:3510
16. Iw71n46b4y
17. (+)-(6r,7r)-7-((z)-2-(2-amino-4-thiazolyl)-4-carboxycrotonamido)-8-oxo-5-thia-1-azabicyclo(4.2.0)oct-2-ene-2-carboxylic Acid
18. Ceftibuten Dihydrate
19. Cis-ceftibutin
20. 97519-39-6 (free)
21. Isocef
22. Cetb
23. 5-thia-1-azabicyclo(4.2.0)oct-2-ene-2-carboxylic Acid, 7-((2-(2-amino-4-thiazolyl)-4-carboxy-1-oxo-2-butenyl)amino)-8-oxo-, (6r-(6alpha,7beta(z)))-
24. Cephalosporin 7432-s
25. (6r,7r)-7-[[(z)-2-(2-amino-1,3-thiazol-4-yl)-4-carboxybut-2-enoyl]amino]-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic Acid
26. (6r,7r)-7-((z)-2-(2-aminothiazol-4-yl)-4-carboxybut-2-enamido)-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic Acid
27. Ceftibutene [inn-french]
28. Ceftibutenum [inn-latin]
29. Ceftibuteno [inn-spanish]
30. Unii-iw71n46b4y
31. Ceftibutin
32. Ceprifran
33. Ceftem
34. Keimax
35. Ceftibuten [usan:inn:ban]
36. S 7432
37. Ncgc00095137-01
38. Ceftibuten-13c3
39. Ceftibuten, 95%
40. Mfcd00864918
41. Ceftibuten [mi]
42. Ceftibuten [inn]
43. Ceftibuten (usan/inn)
44. Spectrum5_001558
45. Ceftibuten [usan]
46. Ceftibuten [vandf]
47. Ceftibutin [vandf]
48. Ceftibuten [who-dd]
49. Chembl1605
50. Dsstox_cid_25925
51. Dsstox_rid_81227
52. Dsstox_gsid_45925
53. Schembl37054
54. Bspbio_002733
55. Spectrum1505207
56. Dtxsid4045925
57. Gtpl12029
58. Hms1922l17
59. Hms2093k18
60. Hms3715p10
61. Pharmakon1600-01505207
62. Hy-b0698
63. Zinc3871967
64. Tox21_111446
65. Bdbm50370586
66. Ccg-39440
67. Nsc758925
68. Akos005146205
69. Akos015854930
70. Db01415
71. Nsc 758925
72. Ncgc00178501-01
73. Ncgc00178501-04
74. Sbi-0206740.p001
75. Cas-97519-39-6
76. C-2550
77. C08117
78. D00922
79. Ab01563048_01
80. 519c396
81. Ceftibuten, Antibiotic For Culture Media Use Only
82. Q419521
83. Sr-05000001989
84. Sr-05000001989-1
85. 7-[2-(2-amino-1,3-thiazol-4-yl)-4-carboxyisocrotonamide]-3-cephem-4-carboxylicacid
86. (6r,7r)-7-[(2z)-2-(2-amino-1,3-thiazol-4-yl)-4-carboxybut-2-enamido]-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic Acid
87. (6r,7r)-7-[[(2z)-2-(2-amino-4-thiazolyl)-4-carboxy-1-oxo-2-buten-1-yl]amino]-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic Acid
88. (6r,7r)-7-{[(2z)-2-(2-amino-1,3-thiazol-4-yl)-4-carboxybut-2-enoyl]amino}-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic Acid
89. 5-thia-1-azabicyclo(4.2.0)oct-2-ene-2-carboxylic Acid, 7-((2-(2-amino-4-thiazolyl)-4-carboxy-1-oxo-2-butenyl)amino)-8-oxo-, (6r-(6.alpha.,7.beta.(z)))-
90. 7beta-{[(2z)-2-(2-amino-1,3-thiazol-4-yl)-4-carboxybut-2-enoyl]amino}-3,4-didehydrocepham-4-carboxylic Acid
Molecular Weight | 410.4 g/mol |
---|---|
Molecular Formula | C15H14N4O6S2 |
XLogP3 | -0.3 |
Hydrogen Bond Donor Count | 4 |
Hydrogen Bond Acceptor Count | 10 |
Rotatable Bond Count | 6 |
Exact Mass | 410.03547653 g/mol |
Monoisotopic Mass | 410.03547653 g/mol |
Topological Polar Surface Area | 217 Ų |
Heavy Atom Count | 27 |
Formal Charge | 0 |
Complexity | 755 |
Isotope Atom Count | 0 |
Defined Atom Stereocenter Count | 2 |
Undefined Atom Stereocenter Count | 0 |
Defined Bond Stereocenter Count | 1 |
Undefined Bond Stereocenter Count | 0 |
Covalently Bonded Unit Count | 1 |
1 of 2 | |
---|---|
Drug Name | Cedax |
PubMed Health | Ceftibuten (By mouth) |
Drug Classes | Antibiotic |
Drug Label | CEDAX (ceftibuten capsules) and (ceftibuten for oral suspension) contain the active ingredient ceftibuten as ceftibuten dihydrate. Ceftibuten dihydrate is a semisynthetic cephalosporin antibiotic for oral administration. Chemically, it is (+)-(6R,7R)... |
Active Ingredient | Ceftibuten dihydrate |
Dosage Form | Capsule; For suspension |
Route | Oral |
Strength | eq 180mg base/5ml; eq 90mg base/5ml; eq 400mg base |
Market Status | Prescription |
Company | Pernix Therap |
2 of 2 | |
---|---|
Drug Name | Cedax |
PubMed Health | Ceftibuten (By mouth) |
Drug Classes | Antibiotic |
Drug Label | CEDAX (ceftibuten capsules) and (ceftibuten for oral suspension) contain the active ingredient ceftibuten as ceftibuten dihydrate. Ceftibuten dihydrate is a semisynthetic cephalosporin antibiotic for oral administration. Chemically, it is (+)-(6R,7R)... |
Active Ingredient | Ceftibuten dihydrate |
Dosage Form | Capsule; For suspension |
Route | Oral |
Strength | eq 180mg base/5ml; eq 90mg base/5ml; eq 400mg base |
Market Status | Prescription |
Company | Pernix Therap |
Indicated for the treatment of acute bacterial exacerbations of chronic bronchitis (ABECB), acute bacterial otitis media, pharyngitis, and tonsilitis.
Ceftibuten is an antibiotic with bactericidal actions.
Anti-Bacterial Agents
Substances that inhibit the growth or reproduction of BACTERIA. (See all compounds classified as Anti-Bacterial Agents.)
J - Antiinfectives for systemic use
J01 - Antibacterials for systemic use
J01D - Other beta-lactam antibacterials
J01DD - Third-generation cephalosporins
J01DD14 - Ceftibuten
Absorption
Rapidly absorbed following oral administration.
Route of Elimination
Ceftibuten is excreted in the urine; 95% of the administered radioactivity was recovered either in urine or feces.
Volume of Distribution
0.21 L/kg [adult subjects]
0.5 L/kg [fasting pediatric patients]
A study with radiolabeled ceftibuten administered to 6 healthy adult male volunteers demonstrated that cis-ceftibuten is the predominant component in both plasma and urine. About 10% of ceftibuten is converted to the trans-isomer is approximately 1/8 as antimicrobially potent as the cis-isomer.
Ceftibuten exerts its bactericidal action by binding to essential target proteins of the bacterial cell wall. This binding leads to inhibition of cell-wall synthesis.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 6883
Submission : 1987-03-18
Status : Inactive
Type : II
Date of Issue : 2025-07-11
Valid Till : 2028-07-02
Written Confirmation Number : WC-0120
Address of the Firm : UNIT -I, Sy.Nos. 379, 385, 386, 388 to 396, Borpatla Village, Hathnoora Mandal, ...
Date of Issue : 2022-08-02
Valid Till : 2025-09-30
Written Confirmation Number : WC-0190
Address of the Firm : Survey Number 374 Gundlamachanoor Village Hathnoor Mandai, Sangareddy-502296, Te...
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About the Company : Virchow Group comprises of six active pharmaceutical ingredient (API) and drug intermediate manufacturing units and two biotech units. Incorporated in 1981, the flagship company of...
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Details:
The funding will support the development of the novel oral antibiotic ceftibuten-ledaborbactam etzadroxil, a BL/BLI combination, for the treatment of cUTIs, including pyelonephritis.
Lead Product(s): Ceftibuten,Ledaborbactam Etzadroxil
Therapeutic Area: Infections and Infectious Diseases Brand Name: Undisclosed
Study Phase: Phase IProduct Type: Antibiotic
Sponsor: BARDA
Deal Size: $159.0 million Upfront Cash: Undisclosed
Deal Type: Funding September 25, 2025
Lead Product(s) : Ceftibuten,Ledaborbactam Etzadroxil
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Phase I
Partner/Sponsor/Collaborator : BARDA
Deal Size : $159.0 million
Deal Type : Funding
Basilea Awarded BARDA Contract for the Development of Ceftibuten-Ledaborbactam
Details : The funding will support the development of the novel oral antibiotic ceftibuten-ledaborbactam etzadroxil, a BL/BLI combination, for the treatment of cUTIs, including pyelonephritis.
Product Name : Undisclosed
Product Type : Antibiotic
Upfront Cash : Undisclosed
September 25, 2025
Details:
Ledaborbactam Etzadroxil is a Other Small Molecule drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of undefined medical condition.
Lead Product(s): Ledaborbactam Etzadroxil,Ceftibuten
Therapeutic Area: Undisclosed Brand Name: Undisclosed
Study Phase: Phase IProduct Type: Miscellaneous
Sponsor: National Institute of Allergy and Infectious Diseases
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable October 30, 2024
Lead Product(s) : Ledaborbactam Etzadroxil,Ceftibuten
Therapeutic Area : Undisclosed
Highest Development Status : Phase I
Partner/Sponsor/Collaborator : National Institute of Allergy and Infectious Diseases
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Ledaborbactam Etzadroxil is a Other Small Molecule drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of undefined medical condition.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
October 30, 2024
Details:
Ceftibuten is a Other Small Molecule drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of undefined medical condition.
Lead Product(s): Ceftibuten,Avibactam,CTB-AVP
Therapeutic Area: Undisclosed Brand Name: Undisclosed
Study Phase: Phase IProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable September 19, 2024
Lead Product(s) : Ceftibuten,Avibactam,CTB-AVP
Therapeutic Area : Undisclosed
Highest Development Status : Phase I
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Ceftibuten is a Other Small Molecule drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of undefined medical condition.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
September 19, 2024
Details:
Xeruborbactam Prodrug is a drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of Bacterial Infections.
Lead Product(s): Xeruborbactam Prodrug,Ceftibuten
Therapeutic Area: Infections and Infectious Diseases Brand Name: Undisclosed
Study Phase: Phase IProduct Type: Undisclosed
Sponsor: Shionogi | Biomedical Advanced Research and Development Authority
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable December 05, 2023
Lead Product(s) : Xeruborbactam Prodrug,Ceftibuten
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Phase I
Partner/Sponsor/Collaborator : Shionogi | Biomedical Advanced Research and Development Authority
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Xeruborbactam Prodrug is a drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of Bacterial Infections.
Product Name : Undisclosed
Product Type : Undisclosed
Upfront Cash : Inapplicable
December 05, 2023
Details:
Xeruborbactam Prodrug is a drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of Bacterial Infections.
Lead Product(s): Xeruborbactam Prodrug,Ceftibuten
Therapeutic Area: Infections and Infectious Diseases Brand Name: Undisclosed
Study Phase: Phase IProduct Type: Undisclosed
Sponsor: Shionogi | Biomedical Advanced Research and Development Authority
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable October 12, 2023
Lead Product(s) : Xeruborbactam Prodrug,Ceftibuten
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Phase I
Partner/Sponsor/Collaborator : Shionogi | Biomedical Advanced Research and Development Authority
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Xeruborbactam Prodrug is a drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of Bacterial Infections.
Product Name : Undisclosed
Product Type : Undisclosed
Upfront Cash : Inapplicable
October 12, 2023
Details:
VNRX-7145 is a Other Small Molecule drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of undefined medical condition.
Lead Product(s): Ledaborbactam Etzadroxil,Ceftibuten
Therapeutic Area: Undisclosed Brand Name: Undisclosed
Study Phase: Phase IProduct Type: Miscellaneous
Sponsor: National Institute of Allergy and Infectious Diseases
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable September 06, 2022
Lead Product(s) : Ledaborbactam Etzadroxil,Ceftibuten
Therapeutic Area : Undisclosed
Highest Development Status : Phase I
Partner/Sponsor/Collaborator : National Institute of Allergy and Infectious Diseases
Deal Size : Inapplicable
Deal Type : Inapplicable
Food Effect on Ceftibuten/VNRX-7145 in Healthy Participants
Details : VNRX-7145 is a Other Small Molecule drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of undefined medical condition.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
September 06, 2022
Details:
VNRX-7145 is a Other Small Molecule drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of undefined medical condition.
Lead Product(s): Ledaborbactam Etzadroxil,Ceftibuten
Therapeutic Area: Undisclosed Brand Name: Undisclosed
Study Phase: Phase IProduct Type: Miscellaneous
Sponsor: National Institute of Allergy and Infectious Diseases
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable August 04, 2022
Lead Product(s) : Ledaborbactam Etzadroxil,Ceftibuten
Therapeutic Area : Undisclosed
Highest Development Status : Phase I
Partner/Sponsor/Collaborator : National Institute of Allergy and Infectious Diseases
Deal Size : Inapplicable
Deal Type : Inapplicable
Ceftibuten/VNRX-7145 in Participants With Varying Degrees of Renal Function
Details : VNRX-7145 is a Other Small Molecule drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of undefined medical condition.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
August 04, 2022
Details:
VNRX-7145 is a Other Small Molecule drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of undefined medical condition.
Lead Product(s): Ledaborbactam Etzadroxil,Ceftibuten
Therapeutic Area: Undisclosed Brand Name: Undisclosed
Study Phase: Phase IProduct Type: Miscellaneous
Sponsor: National Institute of Allergy and Infectious Diseases
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable May 07, 2021
Lead Product(s) : Ledaborbactam Etzadroxil,Ceftibuten
Therapeutic Area : Undisclosed
Highest Development Status : Phase I
Partner/Sponsor/Collaborator : National Institute of Allergy and Infectious Diseases
Deal Size : Inapplicable
Deal Type : Inapplicable
VNRX-7145 Drug-Drug Interaction in Healthy Adult Volunteers
Details : VNRX-7145 is a Other Small Molecule drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of undefined medical condition.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
May 07, 2021
CAS Number : 36923-21-4
End Use API : Ceftibuten
About The Company : Hubei Ling Sheng Pharmaceutical Co., Ltd. was established in December 29, 2010, the company is located in Xiangyang City, Hubei Province Xiangcheng Economic Dev...
CAS Number : 115065-79-7
End Use API : Ceftibuten
About The Company : Hubei Ling Sheng Pharmaceutical Co., Ltd. was established in December 29, 2010, the company is located in Xiangyang City, Hubei Province Xiangcheng Economic Dev...
7-Phenylacetamido -3-Hydroxy-3- Cephem-4-Carbox yl...
CAS Number : 54639-48-4
End Use API : Ceftibuten
About The Company : Zhejiang Apeloa Medical Technology Co., Ltd.(Zhejiang Apeloa Jiayuan Pharmaceutical Co., Ltd.) is a medicinal industry enterprise integrating R&D, manufacturing...
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REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
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PharmaCompass offers a list of Ceftibuten 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 Ceftibuten manufacturer or Ceftibuten supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Ceftibuten manufacturer or Ceftibuten supplier.
PharmaCompass also assists you with knowing the Ceftibuten API Price utilized in the formulation of products. Ceftibuten API Price is not always fixed or binding as the Ceftibuten Price is obtained through a variety of data sources. The Ceftibuten Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Ceftibuten manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Ceftibuten, including repackagers and relabelers. The FDA regulates Ceftibuten manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Ceftibuten API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
click here to find a list of Ceftibuten manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Ceftibuten supplier is an individual or a company that provides Ceftibuten active pharmaceutical ingredient (API) or Ceftibuten finished formulations upon request. The Ceftibuten suppliers may include Ceftibuten API manufacturers, exporters, distributors and traders.
click here to find a list of Ceftibuten suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Ceftibuten DMF (Drug Master File) is a document detailing the whole manufacturing process of Ceftibuten active pharmaceutical ingredient (API) in detail. Different forms of Ceftibuten DMFs exist exist since differing nations have different regulations, such as Ceftibuten USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Ceftibuten DMF submitted to regulatory agencies in the US is known as a USDMF. Ceftibuten USDMF includes data on Ceftibuten's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Ceftibuten USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Ceftibuten suppliers with USDMF on PharmaCompass.
A Ceftibuten written confirmation (Ceftibuten WC) is an official document issued by a regulatory agency to a Ceftibuten manufacturer, verifying that the manufacturing facility of a Ceftibuten active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Ceftibuten APIs or Ceftibuten finished pharmaceutical products to another nation, regulatory agencies frequently require a Ceftibuten WC (written confirmation) as part of the regulatory process.
click here to find a list of Ceftibuten suppliers with Written Confirmation (WC) on PharmaCompass.
Ceftibuten 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 Ceftibuten 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 Ceftibuten GMP manufacturer or Ceftibuten GMP API supplier for your needs.
A Ceftibuten CoA (Certificate of Analysis) is a formal document that attests to Ceftibuten's compliance with Ceftibuten specifications and serves as a tool for batch-level quality control.
Ceftibuten CoA mostly includes findings from lab analyses of a specific batch. For each Ceftibuten 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.
Ceftibuten may be tested according to a variety of international standards, such as European Pharmacopoeia (Ceftibuten EP), Ceftibuten JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Ceftibuten USP).