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Chemistry

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Also known as: 97519-39-6, Cedax, Ceftibuteno, Ceftibutenum, Ceftibutene, Sch 39720
Molecular Formula
C15H14N4O6S2
Molecular Weight
410.4  g/mol
InChI Key
UNJFKXSSGBWRBZ-BJCIPQKHSA-N
FDA UNII
IW71N46B4Y

Ceftibuten
A cephalosporin antibacterial agent that is used in the treatment of infections, including urinary-tract and respiratory-tract infections.
Ceftibuten is a Cephalosporin Antibacterial.
1 2D Structure

Ceftibuten

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
(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
2.1.2 InChI
InChI=1S/C15H14N4O6S2/c16-15-17-7(5-27-15)6(1-2-9(20)21)11(22)18-10-12(23)19-8(14(24)25)3-4-26-13(10)19/h1,3,5,10,13H,2,4H2,(H2,16,17)(H,18,22)(H,20,21)(H,24,25)/b6-1-/t10-,13-/m1/s1
2.1.3 InChI Key
UNJFKXSSGBWRBZ-BJCIPQKHSA-N
2.1.4 Canonical SMILES
C1C=C(N2C(S1)C(C2=O)NC(=O)C(=CCC(=O)O)C3=CSC(=N3)N)C(=O)O
2.1.5 Isomeric SMILES
C1C=C(N2[C@H](S1)[C@@H](C2=O)NC(=O)/C(=C\CC(=O)O)/C3=CSC(=N3)N)C(=O)O
2.2 Other Identifiers
2.2.1 UNII
IW71N46B4Y
2.3 Synonyms
2.3.1 MeSH Synonyms

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

2.3.2 Depositor-Supplied Synonyms

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

2.4 Create Date
2005-06-24
3 Chemical and Physical Properties
Molecular Weight 410.4 g/mol
Molecular Formula C15H14N4O6S2
XLogP3-0.3
Hydrogen Bond Donor Count4
Hydrogen Bond Acceptor Count10
Rotatable Bond Count6
Exact Mass410.03547653 g/mol
Monoisotopic Mass410.03547653 g/mol
Topological Polar Surface Area217 Ų
Heavy Atom Count27
Formal Charge0
Complexity755
Isotope Atom Count0
Defined Atom Stereocenter Count2
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count1
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count1
4 Drug and Medication Information
4.1 Drug Information
1 of 2  
Drug NameCedax
PubMed HealthCeftibuten (By mouth)
Drug ClassesAntibiotic
Drug LabelCEDAX (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 IngredientCeftibuten dihydrate
Dosage FormCapsule; For suspension
RouteOral
Strengtheq 180mg base/5ml; eq 90mg base/5ml; eq 400mg base
Market StatusPrescription
CompanyPernix Therap

2 of 2  
Drug NameCedax
PubMed HealthCeftibuten (By mouth)
Drug ClassesAntibiotic
Drug LabelCEDAX (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 IngredientCeftibuten dihydrate
Dosage FormCapsule; For suspension
RouteOral
Strengtheq 180mg base/5ml; eq 90mg base/5ml; eq 400mg base
Market StatusPrescription
CompanyPernix Therap

4.2 Drug Indication

Indicated for the treatment of acute bacterial exacerbations of chronic bronchitis (ABECB), acute bacterial otitis media, pharyngitis, and tonsilitis.


5 Pharmacology and Biochemistry
5.1 Pharmacology

Ceftibuten is an antibiotic with bactericidal actions.


5.2 MeSH Pharmacological Classification

Anti-Bacterial Agents

Substances that inhibit the growth or reproduction of BACTERIA. (See all compounds classified as Anti-Bacterial Agents.)


5.3 FDA Pharmacological Classification
5.3.1 Active Moiety
CEFTIBUTEN
5.3.2 FDA UNII
IW71N46B4Y
5.3.3 Pharmacological Classes
Chemical Structure [CS] - Cephalosporins
5.4 ATC Code

J - Antiinfectives for systemic use

J01 - Antibacterials for systemic use

J01D - Other beta-lactam antibacterials

J01DD - Third-generation cephalosporins

J01DD14 - Ceftibuten


5.5 Absorption, Distribution and Excretion

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]


5.6 Metabolism/Metabolites

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.


5.7 Mechanism of Action

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.


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01

FNCE
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Ceftibuten HIS

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, ...

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02

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Ceftibuten JP

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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Ceftibutene

About the Company : Asia Pioneer Pharmaceuticals is a leading supplier of fine chemicals, pharmaceutical intermediates, active pharmaceutical ingredients and other compounds. It also offers finished p...

Asia Pioneer Pharmaceuticals is a leading supplier of fine chemicals, pharmaceutical intermediates, active pharmaceutical ingredients and other compounds. It also offers finished product licensing, custom manufacturing and outsourcing services. In partnership with state-of-the-art manufacturers in China, Asia Pioneer provides world-class quality products at excellent value, in full compliance with standards required by leading regulatory agencies in the USA and Europe.
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DEAFARMA

Italy
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DEAFARMA

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Ceftibuten

About the Company : In the dinamic pharmaceutical field, DEAFARMA is the reference point for primaries Pharmaceutical Laboratories for over twenty years, even in the national and international territo...

In the dinamic pharmaceutical field, DEAFARMA is the reference point for primaries Pharmaceutical Laboratories for over twenty years, even in the national and international territory. DEAFARMA works with success in the pharmaceutical raw materials field through Agencies and professional relations with the most important European and Asiatic factories. Our partners are well known, reliable producers and all of them are operating in accordance with the latest GMP Rules. The APIs mentioned in the DEAFARMA catalogue are always supported by DMF and/or CEP.
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Ceftibuten

About the Company : Dhanuka Agritech Limited is engaged in manufacturing a wide range of pesticides covering herbicides/weedicides, insecticides, fungicides, miticides, plant growth regulators / stimu...

Dhanuka Agritech Limited is engaged in manufacturing a wide range of pesticides covering herbicides/weedicides, insecticides, fungicides, miticides, plant growth regulators / stimulants in various forms – liquid, dust, powder and granules and reaching out to more than 10 million farmers. The Company has a pan-India presence through its marketing offices in all major states in India, with a network of more than 7,500 distributors/ dealers selling to over 70,000 retailers across India. The Company has technical tie-ups with 3 US & 5 Japanese companies.
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Ceftibuten

About the Company : Nectar Lifesciences Ltd. (NLL) is a knowledge driven organization which constitutes a vital part of fast growing Indian Pharmaceutical Industry. In a short span of existence, NLL h...

Nectar Lifesciences Ltd. (NLL) is a knowledge driven organization which constitutes a vital part of fast growing Indian Pharmaceutical Industry. In a short span of existence, NLL has today emerged as 365 ranked organization amongst the top 500 Indian Corporates & is currently among top 25 fore runners of the Indian Pharmaceutical industry with a top 5 ranking in the Indian Bulk Drug Industry from a stand alone Active Pharmaceutical Ingredients (API Manufacture) perspective. NLL has transformed itself to being the most integrated player in the Global Cephalosprins Industry within Anti Infective Therapeutic segment.
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Ceftibuten

About the Company : Established in 1992 as an export-oriented unit (EOU), Orchid Pharma Ltd. (Orchid) is a vertically integrated company spanning the entire pharmaceutical value chain from discovery t...

Established in 1992 as an export-oriented unit (EOU), Orchid Pharma Ltd. (Orchid) is a vertically integrated company spanning the entire pharmaceutical value chain from discovery to delivery with established credentials in research, manufacturing and marketing. We today rank among the top 50 pharmaceutical companies in India and enjoy a multi-therapeutic presence across segments like anti-infectives, anti-inflammatory, central nervous system (CNS), cardio vascular segment (CVS), nutraceuticals and other oral and sterile products.
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Ceftibuten

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...

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 the group, Virchow Laboratories Limited is today the largest producer of Sulfamethoxazole in the world. In fact, Virchow Group services more than 80% of the worldwide Sulfamethoxazole requirement. Other group companies are leading manufacturers of Ranitidine, Cephalosporins and various other APIs and bio-pharmaceuticals. Virchow also undertakes custom synthesis and manufacture of drug intermediates.
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24-Jan-2022
29-Aug-2025
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Drugs in Development

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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

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01

Basilea Pharmaceutica

Switzerland
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FNCE
Not Confirmed

Basilea Pharmaceutica

Switzerland
arrow
FNCE
Not Confirmed

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

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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

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02

FNCE
Not Confirmed
FNCE
Not Confirmed

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

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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

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03

Pfizer Inc

U.S.A
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FNCE
Not Confirmed

Pfizer Inc

U.S.A
arrow
FNCE
Not Confirmed

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

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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

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04

FNCE
Not Confirmed
FNCE
Not Confirmed

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

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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

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05

FNCE
Not Confirmed
FNCE
Not Confirmed

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

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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

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06

FNCE
Not Confirmed
FNCE
Not Confirmed

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

blank

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

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07

FNCE
Not Confirmed
FNCE
Not Confirmed

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

blank

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

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08

FNCE
Not Confirmed
FNCE
Not Confirmed

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

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INTERMEDIATE SUPPLIERS

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01

FNCE
Not Confirmed
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FNCE
Not Confirmed
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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...

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02

FNCE
Not Confirmed
arrow
FNCE
Not Confirmed
arrow

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...

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03

FNCE
Not Confirmed
arrow
FNCE
Not Confirmed
arrow

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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NEWS #PharmaBuzz

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Global Sales Information

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Market Place

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APIs

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FDF DOSSIERS

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REF. STANDARDS & IMPURITIES

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ABOUT THIS PAGE

Looking for 97519-39-6 / Ceftibuten API manufacturers, exporters & distributors?

Ceftibuten manufacturers, exporters & distributors 1

57

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.

API | Excipient name

Ceftibuten

Synonyms

97519-39-6, Cedax, Ceftibuteno, Ceftibutenum, Ceftibutene, Sch 39720

Cas Number

97519-39-6

Unique Ingredient Identifier (UNII)

IW71N46B4Y

About Ceftibuten

A cephalosporin antibacterial agent that is used in the treatment of infections, including urinary-tract and respiratory-tract infections.

Ceftibuten Manufacturers

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.

Ceftibuten Suppliers

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.

Ceftibuten USDMF

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.

Ceftibuten WC

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 GMP

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.

Ceftibuten CoA

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).

Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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