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Also known as: Spectracef, 117467-28-4, Cefditoren pivaloyloxymethyl ester, Cdtr-pi, Meiact, Cefditoren (pivoxil)
Molecular Formula
C25H28N6O7S3
Molecular Weight
620.7  g/mol
InChI Key
AFZFFLVORLEPPO-UVYJNCLZSA-N
FDA UNII
78THA212DH

Cefditoren Pivoxil
Cefditoren Pivoxil is a semi-synthetic, broad-spectrum, beta-lactamase resistant, third-generation cephalosporin antibiotic with bactericidal activity. Cefditoren pivoxil is a prodrug that is rapidly hydrolyzed by intestinal esterases during absorption to the microbiologically active cefditoren, an active aminothiazolyl cephalosporin. Cefditoren inactivates penicillin binding proteins (PBPs) thereby interfering with peptidoglycan synthesis and inhibiting bacterial cell wall synthesis. Another consequence of beta-lactam exposure results in the loss of lipoteichoic acids from the cell wall. Lipoteichoic acids inhibit murein hydrolase activity and their absence from the cell wall triggers uncontrolled autolytic activity rendering bacterial cells susceptible to osmotic shock. This results in a reduction of cell wall stability and causes cell lysis.
1 2D Structure

Cefditoren Pivoxil

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
2,2-dimethylpropanoyloxymethyl (6R,7R)-7-[[(2Z)-2-(2-amino-1,3-thiazol-4-yl)-2-methoxyiminoacetyl]amino]-3-[(Z)-2-(4-methyl-1,3-thiazol-5-yl)ethenyl]-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylate
2.1.2 InChI
InChI=1S/C25H28N6O7S3/c1-12-15(41-10-27-12)7-6-13-8-39-21-17(29-19(32)16(30-36-5)14-9-40-24(26)28-14)20(33)31(21)18(13)22(34)37-11-38-23(35)25(2,3)4/h6-7,9-10,17,21H,8,11H2,1-5H3,(H2,26,28)(H,29,32)/b7-6-,30-16-/t17-,21-/m1/s1
2.1.3 InChI Key
AFZFFLVORLEPPO-UVYJNCLZSA-N
2.1.4 Canonical SMILES
CC1=C(SC=N1)C=CC2=C(N3C(C(C3=O)NC(=O)C(=NOC)C4=CSC(=N4)N)SC2)C(=O)OCOC(=O)C(C)(C)C
2.1.5 Isomeric SMILES
CC1=C(SC=N1)/C=C\C2=C(N3[C@@H]([C@@H](C3=O)NC(=O)/C(=N\OC)/C4=CSC(=N4)N)SC2)C(=O)OCOC(=O)C(C)(C)C
2.2 Other Identifiers
2.2.1 UNII
78THA212DH
2.3 Synonyms
2.3.1 MeSH Synonyms

1. (-)-(6r,7r)-2,2-dimethylpropionyloxymethyl 7-((z)-2-(2-aminothiazol-4-yl)-2-methoxyiminoacetamido)-3-((z)-2-(4-methylthiazol-5-yl)ethenyl)-8-oxo-5-thia-1-azabicyclo(4.2.0)oct-2-ene-2-carboxylate

2. 7-(2-(2-aminothiazol-4-yl)-2-(methoxyimino)acetamido)-3-(2-(4-methylthiazol-5-yl)ethenyl)cephem-4-carboxylic Acid Pivaloyloxymethyl Ester

3. Cdtr-pi

4. Me 1207

5. Me-1207

6. Spectracef

2.3.2 Depositor-Supplied Synonyms

1. Spectracef

2. 117467-28-4

3. Cefditoren Pivaloyloxymethyl Ester

4. Cdtr-pi

5. Meiact

6. Cefditoren (pivoxil)

7. Cefditoren Pivoxil [jan]

8. Me-1207

9. Cefditorin Pivoxil

10. Me1207

11. Cefditoren Pivoxil Hcl

12. 78tha212dh

13. Cefditorin

14. Chebi:560555

15. Me 1207

16. Nsc-759098

17. 2,2-dimethylpropanoyloxymethyl (6r,7r)-7-[[(2z)-2-(2-amino-1,3-thiazol-4-yl)-2-methoxyiminoacetyl]amino]-3-[(z)-2-(4-methyl-1,3-thiazol-5-yl)ethenyl]-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylate

18. Cefditoren Pi Voxil

19. Cefditoren-pivoxil

20. [(2,2-dimethylpropanoyl)oxy]methyl (6r,7r)-7-{[(2z)-2-(2-amino-1,3-thiazol-4-yl)-2-(methoxyimino)acetyl]amino}-3-[(z)-2-(4-methyl-1,3-thiazol-5-yl)ethenyl]-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylate

21. [(2,2-dimethylpropanoyl)oxy]methyl 7beta-(2z)-2-(2-amino-1,3-thiazol-4-yl)-2-(methoxyimino)acetamido-3-[(z)-2-(4-methyl-1,3-thiazol-5-yl)ethenyl]-3,4-didehydrocepham-4-carboxylic Acid

22. 1448435-17-3

23. Pivaloyloxymethyl (+)-(6r,7r)-7-{[(2z)-2-(2-amino-1,3-thiazol-4-yl)-2-(methoxyimino)acetyl]amino}-3-[(z)-2-(4-methyl-1,3-thiazol-5-yl)ethenyl]-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylate

24. Ccris 7768

25. Unii-78tha212dh

26. Spectracef (tn)

27. Ncgc00095175-01

28. Meiact (tn)

29. Mfcd00933166

30. Dsstox_cid_28669

31. Dsstox_rid_82939

32. Dsstox_gsid_48743

33. Schembl182876

34. Chembl454446

35. Cefditoren Pivoxil [usan:jan]

36. Dtxsid2048743

37. Cefditoren Pivoxil [usan]

38. Cefditoren Pivoxil (jp17/usan)

39. Cefditoren Pivoxil [vandf]

40. Cefditoren Pivoxil [mart.]

41. Cefditoren Pivoxil [who-dd]

42. Tox21_113197

43. Hy-17452a

44. S1768

45. Akos025311444

46. Ccg-270254

47. Cs-1949

48. Nsc 759098

49. Cefditoren Pivoxil [orange Book]

50. Ncgc00095175-08

51. (pivaloyloxy)methyl (6r,7r)-7-((z)-2-(2-aminothiazol-4-yl)-2-(methoxyimino)acetamido)-3-((z)-2-(4-methylthiazol-5-yl)vinyl)-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylate

52. 5-thia-1-azabicyclo(4.2.0)oct-2-ene-2-carboxylic Acid, 7-(((2-amino-4-thiazolyl)(methoxyimino)acetyl)amino)-3-((1z)-2-(4-methyl-5-thiazolyl)ethenyl)-8-oxo-,2,2-dimethyl-1-oxopropoxy)methyl Ester, (6r,7r)-

53. 5-thia-1-azabicyclo(4.2.0)oct-2-ene-2-carboxylic Acid, 7-(((2-amino-4-thiazolyl)(methoxyimino)acetyl)amino)-3-(2-(4-methyl-5-thiazolyl)ethenyl)-8-oxo-, (2,2-dimethyl-1-oxopropoxy)methyl Ester, (6r-(3(z),6-alpha,7-beta-(z)))-

54. As-12951

55. B2086

56. Cas-117467-28-4

57. Cefditoren Pivaloyloxymethyl Ester [mi]

58. D01628

59. Ab01274730-01

60. Ab01274730_02

61. 467c284

62. Brd-k72167406-001-03-9

63. (+)-(6r,7r)-7-(2-(2-amino-4-thiazolyl)glyoxylamido)-3-((z)-2-(4-methyl-5-thiazolyl)vinyl)-8-oxo-5-thia-1-azabicyclo(4.2.0)oct-2-ene-2-carboxylate Pivaloyloxy Methyl Ester, 7(sup 2)-(z)-(o-methyloxime)

64. (6r,7r)-(pivaloyloxy)methyl 7-((z)-2-(2-aminothiazol-4-yl)-2-(methoxyimino)acetamido)-3-((z)-2-(4-methylthiazol-5-yl)vinyl)-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylate

65. 5-thia-1-azabicyclo(4.2.0)oct-2-ene-2-carboxylic Acid, 7(((2z)-(2-amino-4-thiazolyl)(methoxyimino)acetyl)amino)-3-((1z)-2-(4-methyl-5-thiazolyl)ethenyl)-8-oxo-, (2,2-dimethyl-1-oxopropoxy)methyl Ester, (6r,7r)-

2.4 Create Date
2006-04-28
3 Chemical and Physical Properties
Molecular Weight 620.7 g/mol
Molecular Formula C25H28N6O7S3
XLogP34.7
Hydrogen Bond Donor Count2
Hydrogen Bond Acceptor Count14
Rotatable Bond Count12
Exact Mass620.11816077 g/mol
Monoisotopic Mass620.11816077 g/mol
Topological Polar Surface Area257 Ų
Heavy Atom Count41
Formal Charge0
Complexity1160
Isotope Atom Count0
Defined Atom Stereocenter Count2
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count2
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count1
4 Drug and Medication Information
4.1 Drug Information
1 of 2  
Drug NameSpectracef
PubMed HealthCefditoren Pivoxil (By mouth)
Drug ClassesAntibiotic
Drug LabelSPECTRACEF tablets contain cefditoren pivoxil, a semi-synthetic cephalosporin antibiotic for oral administration. It is a prodrug which is hydrolyzed by esterases during absorption, and the drug is distributed in the circulating blood as active cef...
Active IngredientCefditoren pivoxil
Dosage FormTablet
RouteOral
Strength200mg; 400mg
Market StatusPrescription
CompanyVansen Pharma

2 of 2  
Drug NameSpectracef
PubMed HealthCefditoren Pivoxil (By mouth)
Drug ClassesAntibiotic
Drug LabelSPECTRACEF tablets contain cefditoren pivoxil, a semi-synthetic cephalosporin antibiotic for oral administration. It is a prodrug which is hydrolyzed by esterases during absorption, and the drug is distributed in the circulating blood as active cef...
Active IngredientCefditoren pivoxil
Dosage FormTablet
RouteOral
Strength200mg; 400mg
Market StatusPrescription
CompanyVansen Pharma

5 Pharmacology and Biochemistry
5.1 MeSH Pharmacological Classification

Anti-Bacterial Agents

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


API SUPPLIERS

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USDMF

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Lupin Ltd

India

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Lupin Ltd

India
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GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 23544

Submission : 2010-04-15

Status : Inactive

Type : II

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03

Orchid Pharma Ltd

India

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GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 19011

Submission : 2005-12-07

Status : Inactive

Type : II

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GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 25086

Submission : 2011-06-12

Status : Active

Type : II

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Cefditoren pivoxil

Registration Number : 219MF10254

Registrant's Address : 343, Sapyeong-daero, Seocho-gu, Seoul, Korea

Initial Date of Registration : 2007-08-06

Latest Date of Registration : 2007-08-06

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Cefditoren pivoxil

Registration Number : 302MF10072

Registrant's Address : 2-4-16 Kyobashi, Chuo-ku, Tokyo

Initial Date of Registration : 2020-06-26

Latest Date of Registration : 2020-06-26

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Cefditoren pivoxil

Registration Number : 228MF10040

Registrant's Address : 13, Olympic-ro 35da-gil, Songpa-gu, Seoul, Korea

Initial Date of Registration : 2016-02-08

Latest Date of Registration : 2016-02-08

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Cefditoren pivoxil

Registration Number : 306MF10127

Registrant's Address : 13, Olympic-ro 35da-gil, Songpa-gu, Seoul, Korea

Initial Date of Registration : 2024-09-18

Latest Date of Registration : 2024-09-18

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API Reference Price

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27-Jan-2021
09-Dec-2024
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ABOUT THIS PAGE

Cefditoren Pivoxil Manufacturers

A Cefditoren Pivoxil manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Cefditoren Pivoxil, including repackagers and relabelers. The FDA regulates Cefditoren Pivoxil manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Cefditoren Pivoxil 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 Cefditoren Pivoxil manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

Cefditoren Pivoxil Suppliers

A Cefditoren Pivoxil supplier is an individual or a company that provides Cefditoren Pivoxil active pharmaceutical ingredient (API) or Cefditoren Pivoxil finished formulations upon request. The Cefditoren Pivoxil suppliers may include Cefditoren Pivoxil API manufacturers, exporters, distributors and traders.

click here to find a list of Cefditoren Pivoxil suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

Cefditoren Pivoxil USDMF

A Cefditoren Pivoxil DMF (Drug Master File) is a document detailing the whole manufacturing process of Cefditoren Pivoxil active pharmaceutical ingredient (API) in detail. Different forms of Cefditoren Pivoxil DMFs exist exist since differing nations have different regulations, such as Cefditoren Pivoxil USDMF, ASMF (EDMF), JDMF, CDMF, etc.

A Cefditoren Pivoxil DMF submitted to regulatory agencies in the US is known as a USDMF. Cefditoren Pivoxil USDMF includes data on Cefditoren Pivoxil's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Cefditoren Pivoxil USDMF is kept confidential to protect the manufacturer’s intellectual property.

click here to find a list of Cefditoren Pivoxil suppliers with USDMF on PharmaCompass.

Cefditoren Pivoxil JDMF

The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.

The Cefditoren Pivoxil Drug Master File in Japan (Cefditoren Pivoxil JDMF) empowers Cefditoren Pivoxil API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).

PMDA reviews the Cefditoren Pivoxil JDMF during the approval evaluation for pharmaceutical products. At the time of Cefditoren Pivoxil JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.

click here to find a list of Cefditoren Pivoxil suppliers with JDMF on PharmaCompass.

Cefditoren Pivoxil KDMF

In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.

Pharmaceutical companies submit a Cefditoren Pivoxil Drug Master File in Korea (Cefditoren Pivoxil KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Cefditoren Pivoxil. The MFDS reviews the Cefditoren Pivoxil KDMF as part of the drug registration process and uses the information provided in the Cefditoren Pivoxil KDMF to evaluate the safety and efficacy of the drug.

After submitting a Cefditoren Pivoxil KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Cefditoren Pivoxil API can apply through the Korea Drug Master File (KDMF).

click here to find a list of Cefditoren Pivoxil suppliers with KDMF on PharmaCompass.

Cefditoren Pivoxil WC

A Cefditoren Pivoxil written confirmation (Cefditoren Pivoxil WC) is an official document issued by a regulatory agency to a Cefditoren Pivoxil manufacturer, verifying that the manufacturing facility of a Cefditoren Pivoxil active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Cefditoren Pivoxil APIs or Cefditoren Pivoxil finished pharmaceutical products to another nation, regulatory agencies frequently require a Cefditoren Pivoxil WC (written confirmation) as part of the regulatory process.

click here to find a list of Cefditoren Pivoxil suppliers with Written Confirmation (WC) on PharmaCompass.

Cefditoren Pivoxil GMP

Cefditoren Pivoxil 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 Cefditoren Pivoxil 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 Cefditoren Pivoxil GMP manufacturer or Cefditoren Pivoxil GMP API supplier for your needs.

Cefditoren Pivoxil CoA

A Cefditoren Pivoxil CoA (Certificate of Analysis) is a formal document that attests to Cefditoren Pivoxil's compliance with Cefditoren Pivoxil specifications and serves as a tool for batch-level quality control.

Cefditoren Pivoxil CoA mostly includes findings from lab analyses of a specific batch. For each Cefditoren Pivoxil 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.

Cefditoren Pivoxil may be tested according to a variety of international standards, such as European Pharmacopoeia (Cefditoren Pivoxil EP), Cefditoren Pivoxil JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Cefditoren Pivoxil 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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