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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
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)-
Molecular Weight | 620.7 g/mol |
---|---|
Molecular Formula | C25H28N6O7S3 |
XLogP3 | 4.7 |
Hydrogen Bond Donor Count | 2 |
Hydrogen Bond Acceptor Count | 14 |
Rotatable Bond Count | 12 |
Exact Mass | 620.11816077 g/mol |
Monoisotopic Mass | 620.11816077 g/mol |
Topological Polar Surface Area | 257 Ų |
Heavy Atom Count | 41 |
Formal Charge | 0 |
Complexity | 1160 |
Isotope Atom Count | 0 |
Defined Atom Stereocenter Count | 2 |
Undefined Atom Stereocenter Count | 0 |
Defined Bond Stereocenter Count | 2 |
Undefined Bond Stereocenter Count | 0 |
Covalently Bonded Unit Count | 1 |
1 of 2 | |
---|---|
Drug Name | Spectracef |
PubMed Health | Cefditoren Pivoxil (By mouth) |
Drug Classes | Antibiotic |
Drug Label | SPECTRACEF 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 Ingredient | Cefditoren pivoxil |
Dosage Form | Tablet |
Route | Oral |
Strength | 200mg; 400mg |
Market Status | Prescription |
Company | Vansen Pharma |
2 of 2 | |
---|---|
Drug Name | Spectracef |
PubMed Health | Cefditoren Pivoxil (By mouth) |
Drug Classes | Antibiotic |
Drug Label | SPECTRACEF 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 Ingredient | Cefditoren pivoxil |
Dosage Form | Tablet |
Route | Oral |
Strength | 200mg; 400mg |
Market Status | Prescription |
Company | Vansen Pharma |
Anti-Bacterial Agents
Substances that inhibit the growth or reproduction of BACTERIA. (See all compounds classified as Anti-Bacterial Agents.)
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23544
Submission : 2010-04-15
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17482
Submission : 2004-06-22
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20292
Submission : 2007-02-22
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19011
Submission : 2005-12-07
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25086
Submission : 2011-06-12
Status : Active
Type : II
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
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
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
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
API Imports and Exports
Importing Country | Total Quantity (KGS) |
Average Price (USD/KGS) |
Number of Transactions |
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ABOUT THIS PAGE
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.
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.
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.
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.
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.
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 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.
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).
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