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1. Benaxima
2. Biosint
3. Cefotaxim
4. Cefotaxime
5. Cefradil
6. Cephotaxim
7. Claforan
8. Fotexina
9. Hr 756
10. Hr-756
11. Hr756
12. Kendrick
13. Klaforan
14. Primafen
15. Ru 24756
16. Ru-24756
17. Ru24756
18. Sodium, Cefotaxime
19. Taporin
1. 64485-93-4
2. Cefotaxime Sodium Salt
3. Sodium Cefotaxime
4. Hr 756
5. Cefotaxime
6. Ru 24756
7. (+)-cefotaxime Sodium Salt
8. Hr-756
9. Cefotaxime (sodium)
10. Ru-24756
11. Mls000028559
12. Chebi:3498
13. 258j72s7tz
14. Sodium 7-(2-(2-amino-4-thiazolyl)-2-methoxyiminoacetamido)cephalosporanate
15. Cefotax
16. Nsc-756666
17. Sodium;(6r,7r)-3-(acetyloxymethyl)-7-[[(2z)-2-(2-amino-1,3-thiazol-4-yl)-2-methoxyiminoacetyl]amino]-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylate
18. Smr000058812
19. Tolycar
20. Pretor
21. Sodium (6r,7r)-7-(2-(2-amino-4-thiazolyl)glyoxylamido)-3-(hydroxymethyl)-8-oxo-5-thia-1-azabicyclo(4.2.0)oct-2-ene-2-carboxylate 7(sup 2)-(z)-(o-methyloxime), Acetate (ester)
22. Sodium;(6r,7r)-3-(acetyloxymethyl)-7-[[(2e)-2-(2-amino-1,3-thiazol-4-yl)-2-methoxyiminoacetyl]amino]-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic Acid
23. Cefotaxime (sodium Salt)
24. Ralopar
25. Tolycor
26. Zariviz
27. Claforan Sodium
28. Mls002222330
29. Cefotaxime Na-salt
30. Cefotaxime Sodium Salt (syn-isomer)
31. Smr001307269
32. Mfcd00079073
33. Unii-258j72s7tz
34. Cefotaxim Sodium
35. Claforan (tn)
36. Prestwick_823
37. Cefotaxime Sodium [usan:usp:jan]
38. Einecs 264-915-9
39. Cefotaxime, Sodium Salt
40. Opera_id_1945
41. Chembl1010
42. Schembl41092
43. Cefotaxime And Dextrose 2.4% In Plastic Container
44. Cefotaxime And Dextrose 3.9% In Plastic Container
45. Mls001077352
46. Mls001333684
47. Sym-methoxyimino Cephalosporin
48. Claforan In Dextrose 5% In Plastic Container
49. Cefotaxime Sodium [jan]
50. Cefotaxime Sodium (jp17/usp)
51. Cefotaxime Sodium [usan]
52. Dtxsid4046991
53. Cefotaxime Sodium [vandf]
54. Cefotaxime Sodium [mart.]
55. Claforan In Sodium Chloride 0.9% In Plastic Container
56. Hms1568k20
57. Hms2095k20
58. Hms2233j21
59. Hms3260h18
60. Hms3712k20
61. Cefotaxime Sodium [usp-rs]
62. Cefotaxime Sodium [who-dd]
63. Amy40166
64. Cefotaxime Sodium Salt [mi]
65. Hy-a0088
66. Tox21_500278
67. S4517
68. Akos015951272
69. Ccg-220139
70. Ccg-221582
71. Cefotaxime Sodium [ep Impurity]
72. Cefotaxime Sodium [orange Book]
73. Cs-4297
74. Ks-1416
75. Nsc 756666
76. Cefotaxime Sodium [usp Impurity]
77. Cefotaxime Sodium [usp Monograph]
78. Ncgc00093734-01
79. Ncgc00093734-02
80. Ncgc00260963-01
81. 5-thia-1-azabicyclo(4.2.0)oct-2-ene-2-carboxylic Acid, 3-((acetyloxy)methyl)-7-(((2-amino-4-thiazolyl)(methoxyimino)acetyl)amino)-8-oxo-, Monosodium Salt, (6r-(6alpha,7beta(z)))-
82. Smr000653480
83. Eu-0100278
84. A16005
85. C 7912
86. C08113
87. D00919
88. Cefadroxil, Antibiotic For Culture Media Use Only
89. Q-200807
90. Cefotaxime Sodium Salt, Potency: 916-964 Mug Per Mg
91. Cefotaxime Sodium, European Pharmacopoeia (ep) Reference Standard
92. Cefotaxime Sodium Salt, Plant Cell Culture Tested, Bioreagent, Powder
93. Cefotaxime Sodium, United States Pharmacopeia (usp) Reference Standard
94. Cefotaxime For Peak Identification, European Pharmacopoeia (ep) Reference Standard
95. 5-thia-1-azabicyclo(4.2.0)oct-2-ene-2-carboxylic Acid, 3-((acetyloxy)methyl)-7-(((2-amino-4-thiazolyl)(methoxyimino)acetyl)amino)-8-oxo-, Monosodium Salt, (6r-(6.alpha.,7.beta.(z)))-
96. Sodium (6r,7r)-3-(acetoxymethyl)-7-((e)-2-(2-aminothiazol-4-yl)-2-(methoxyimino)acetamido)-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylate
97. Sodium (6r,7r)-3-(acetoxymethyl)-7-{[(2z)-2-(2-amino-1,3-thiazol-4-yl)-2-(methoxyimino)acetyl]amino}-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylate
98. Sodium (6r-(6alpha,7beta(z)))-3-(acetoxymethyl)-7-((2-aminothiazol-4-yl)(methoxyimino)acetamido)-8-oxo-5-thia-1-azabicyclo(4.2.0)oct-2-ene-2-carboxylate
99. Sodium 3-(acetoxymethyl)-7beta-{[(2z)-2-(2-amino-1,3-thiazol-4-yl)-2-(methoxyimino)acetyl]amino}-3,4-didehydrocepham-4-carboxylate
| Molecular Weight | 477.5 g/mol |
|---|---|
| Molecular Formula | C16H16N5NaO7S2 |
| Hydrogen Bond Donor Count | 2 |
| Hydrogen Bond Acceptor Count | 12 |
| Rotatable Bond Count | 8 |
| Exact Mass | 477.03888450 g/mol |
| Monoisotopic Mass | 477.03888450 g/mol |
| Topological Polar Surface Area | 230 Ų |
| Heavy Atom Count | 31 |
| Formal Charge | 0 |
| Complexity | 839 |
| 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 | 2 |
| 1 of 4 | |
|---|---|
| Drug Name | Cefotaxime sodium |
| Drug Label | Sterile CLAFORAN (cefotaxime sodium) is a semisynthetic, broad spectrum cephalosporin antibiotic for parenteral administration. It is the sodium salt of 7-[2-(2-amino-4-thiazolyl) glyoxylamido]-3-(hydroxymethyl)-8-oxo-5-thia-1-azabicyclo [4.2.0] oct-... |
| Active Ingredient | Cefotaxime sodium |
| Dosage Form | Injectable |
| Route | Injection |
| Strength | eq 2gm base/vial; eq 500mg base/vial; eq 10gm base/vial; eq 1gm base/vial |
| Market Status | Prescription |
| Company | Wockhardt; Hospira; Lupin |
| 2 of 4 | |
|---|---|
| Drug Name | Claforan |
| Drug Label | Sterile CLAFORAN (cefotaxime sodium) is a semisynthetic, broad spectrum cephalosporin antibiotic for parenteral administration. It is the sodium salt of 7-[2-(2-amino-4-thiazolyl) glyoxylamido]-3-(hydroxymethyl)-8-oxo-5-thia-1-azabicyclo [4.2.0] oct-... |
| Active Ingredient | Cefotaxime sodium |
| Dosage Form | Injectable |
| Route | Injection |
| Strength | eq 2gm base/vial; eq 500mg base/vial; eq 10gm base/vial; eq 1gm base/vial |
| Market Status | Prescription |
| Company | Sanofi Aventis Us |
| 3 of 4 | |
|---|---|
| Drug Name | Cefotaxime sodium |
| Drug Label | Sterile CLAFORAN (cefotaxime sodium) is a semisynthetic, broad spectrum cephalosporin antibiotic for parenteral administration. It is the sodium salt of 7-[2-(2-amino-4-thiazolyl) glyoxylamido]-3-(hydroxymethyl)-8-oxo-5-thia-1-azabicyclo [4.2.0] oct-... |
| Active Ingredient | Cefotaxime sodium |
| Dosage Form | Injectable |
| Route | Injection |
| Strength | eq 2gm base/vial; eq 500mg base/vial; eq 10gm base/vial; eq 1gm base/vial |
| Market Status | Prescription |
| Company | Wockhardt; Hospira; Lupin |
| 4 of 4 | |
|---|---|
| Drug Name | Claforan |
| Drug Label | Sterile CLAFORAN (cefotaxime sodium) is a semisynthetic, broad spectrum cephalosporin antibiotic for parenteral administration. It is the sodium salt of 7-[2-(2-amino-4-thiazolyl) glyoxylamido]-3-(hydroxymethyl)-8-oxo-5-thia-1-azabicyclo [4.2.0] oct-... |
| Active Ingredient | Cefotaxime sodium |
| Dosage Form | Injectable |
| Route | Injection |
| Strength | eq 2gm base/vial; eq 500mg base/vial; eq 10gm base/vial; eq 1gm base/vial |
| Market Status | Prescription |
| Company | Sanofi Aventis Us |
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
J01DD01 - Cefotaxime
API SUPPLIERS
HRV Global Life Sciences - Market Expansion Leader in Pharmaceuticals.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21202
Submission : 2007-12-27
Status : Active
Type : II
Certificate Number : R1-CEP 2000-047 - Rev 03
Issue Date : 2012-10-16
Type : Chemical
Substance Number : 989
Status : Withdrawn by Holder
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17888
Submission : 2004-12-09
Status : Active
Type : II
Certificate Number : CEP 1999-033 - Rev 04
Issue Date : 2024-10-28
Type : Chemical
Substance Number : 989
Status : Valid
Date of Issue : 2022-06-28
Valid Till : 2025-07-21
Written Confirmation Number : WC-0131
Address of the Firm :
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16839
Submission : 2003-09-09
Status : Inactive
Type : II
Certificate Number : R1-CEP 2002-182 - Rev 01
Issue Date : 2011-04-28
Type : Chemical
Substance Number : 989
Status : Withdrawn by Holder
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18154
Submission : 2005-02-28
Status : Inactive
Type : II
Certificate Number : R1-CEP 2005-203 - Rev 01
Issue Date : 2013-06-07
Type : Chemical
Substance Number : 989
Status : Withdrawn by Holder
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25844
Submission : 2012-02-29
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 24892
Submission : 2011-04-18
Status : Inactive
Type : II
Certificate Number : R0-CEP 2012-227 - Rev 00
Issue Date : 2016-05-18
Type : Chemical
Substance Number : 989
Status : Withdrawn by Holder
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 24793
Submission : 2011-03-15
Status : Inactive
Type : II
Certificate Number : R1-CEP 2006-224 - Rev 04
Issue Date : 2022-07-12
Type : Chemical
Substance Number : 989
Status : Valid
Registrant Name : Kyungbo Pharmaceutical Co., Ltd.
Registration Date : 2009-09-24
Registration Number : 20090924-118-G-24-01
Manufacturer Name : Kyungbo Pharmaceutical Co., Ltd.
Manufacturer Address : 174 Silok-ro, Asan-si, Chungcheongnam-do
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13219
Submission : 1998-04-30
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12632
Submission : 1997-08-27
Status : Inactive
Type : II
Certificate Number : CEP 1999-161 - Rev 06
Issue Date : 2024-05-29
Type : Chemical
Substance Number : 989
Status : Valid
Registration Number : 224MF10209
Registrant's Address : 57, Gyeongje-ro, Siheung-si, Gyeonggi-do, Korea
Initial Date of Registration : 2012-10-29
Latest Date of Registration :
Registrant Name : Hanmi Precision Chemical Co., Ltd.
Registration Date : 2009-09-24
Registration Number : 20090924-118-G-23-02
Manufacturer Name : Hanmi Precision Chemical Co., Ltd.
Manufacturer Address : 57 Gyeongje-ro, Siheung-si, Gyeonggi-do
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USDMF
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API Imports and Exports
| Importing Country | Total Quantity (KGS) |
Average Price (USD/KGS) |
Number of Transactions |
|---|
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INTERMEDIATE SUPPLIERS
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]DRUG PRODUCT COMPOSITIONS
DOSAGE - INJECTABLE;INJECTION - EQ 10GM BASE/...DOSAGE - INJECTABLE;INJECTION - EQ 10GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 50547
DOSAGE - INJECTABLE;INJECTION - EQ 1GM BASE/V...DOSAGE - INJECTABLE;INJECTION - EQ 1GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 50547
DOSAGE - INJECTABLE;INJECTION - EQ 2GM BASE/V...DOSAGE - INJECTABLE;INJECTION - EQ 2GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 50547
DOSAGE - INJECTABLE;INJECTION - EQ 500MG BASE...DOSAGE - INJECTABLE;INJECTION - EQ 500MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 50547
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ABOUT THIS PAGE
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PharmaCompass offers a list of Cefotaxime 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 Cefotaxime manufacturer or Cefotaxime supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Cefotaxime manufacturer or Cefotaxime supplier.
PharmaCompass also assists you with knowing the Cefotaxime API Price utilized in the formulation of products. Cefotaxime API Price is not always fixed or binding as the Cefotaxime Price is obtained through a variety of data sources. The Cefotaxime Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Cefotaxime manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Cefotaxime, including repackagers and relabelers. The FDA regulates Cefotaxime manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Cefotaxime 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 Cefotaxime manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Cefotaxime supplier is an individual or a company that provides Cefotaxime active pharmaceutical ingredient (API) or Cefotaxime finished formulations upon request. The Cefotaxime suppliers may include Cefotaxime API manufacturers, exporters, distributors and traders.
click here to find a list of Cefotaxime suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Cefotaxime DMF (Drug Master File) is a document detailing the whole manufacturing process of Cefotaxime active pharmaceutical ingredient (API) in detail. Different forms of Cefotaxime DMFs exist exist since differing nations have different regulations, such as Cefotaxime USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Cefotaxime DMF submitted to regulatory agencies in the US is known as a USDMF. Cefotaxime USDMF includes data on Cefotaxime's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Cefotaxime USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Cefotaxime 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 Cefotaxime Drug Master File in Japan (Cefotaxime JDMF) empowers Cefotaxime 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 Cefotaxime JDMF during the approval evaluation for pharmaceutical products. At the time of Cefotaxime 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 Cefotaxime 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 Cefotaxime Drug Master File in Korea (Cefotaxime KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Cefotaxime. The MFDS reviews the Cefotaxime KDMF as part of the drug registration process and uses the information provided in the Cefotaxime KDMF to evaluate the safety and efficacy of the drug.
After submitting a Cefotaxime 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 Cefotaxime API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Cefotaxime suppliers with KDMF on PharmaCompass.
A Cefotaxime CEP of the European Pharmacopoeia monograph is often referred to as a Cefotaxime Certificate of Suitability (COS). The purpose of a Cefotaxime CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Cefotaxime EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Cefotaxime to their clients by showing that a Cefotaxime CEP has been issued for it. The manufacturer submits a Cefotaxime CEP (COS) as part of the market authorization procedure, and it takes on the role of a Cefotaxime CEP holder for the record. Additionally, the data presented in the Cefotaxime CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Cefotaxime DMF.
A Cefotaxime CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Cefotaxime CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.
click here to find a list of Cefotaxime suppliers with CEP (COS) on PharmaCompass.
A Cefotaxime written confirmation (Cefotaxime WC) is an official document issued by a regulatory agency to a Cefotaxime manufacturer, verifying that the manufacturing facility of a Cefotaxime active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Cefotaxime APIs or Cefotaxime finished pharmaceutical products to another nation, regulatory agencies frequently require a Cefotaxime WC (written confirmation) as part of the regulatory process.
click here to find a list of Cefotaxime suppliers with Written Confirmation (WC) 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 Cefotaxime as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Cefotaxime 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 Cefotaxime 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 Cefotaxime and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Cefotaxime NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Cefotaxime suppliers with NDC on PharmaCompass.
Cefotaxime 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 Cefotaxime 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 Cefotaxime GMP manufacturer or Cefotaxime GMP API supplier for your needs.
A Cefotaxime CoA (Certificate of Analysis) is a formal document that attests to Cefotaxime's compliance with Cefotaxime specifications and serves as a tool for batch-level quality control.
Cefotaxime CoA mostly includes findings from lab analyses of a specific batch. For each Cefotaxime 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.
Cefotaxime may be tested according to a variety of international standards, such as European Pharmacopoeia (Cefotaxime EP), Cefotaxime JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Cefotaxime USP).
