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ACTIVE PHARMA INGREDIENTS

39 API Suppliers, 13 USDMF, 16 CEP/COS, 1 JDMF, 6 EU WC, 6 KDMF, 1 NDC API, 21 Listed Suppliers, $ API Reference Price

39 API Suppliers
13 USDMF
16 CEP/COS
1 JDMF
6 EU WC
6 KDMF
1 NDC API
21 Listed Suppliers
$ API Reference Price

INTERMEDIATES

3 Intermediates Suppliers

3 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

215 FDF Dossiers, 40 FDA Orange Book, 68 Europe, 2 Canada, 2 Australia, 25 South Africa, 78 Listed Dossiers

215 FDF Dossiers
40 FDA Orange Book
68 Europe
2 Canada
2 Australia
25 South Africa
78 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

INJECTABLE;INJECTION - EQ 10GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, INJECTABLE;INJECTION - EQ 1GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, INJECTABLE;INJECTION - EQ 2GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, INJECTABLE;INJECTION - EQ 500MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

drugProductComposition
INJECTABLE;INJECTION - EQ 10GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
INJECTABLE;INJECTION - EQ 1GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
INJECTABLE;INJECTION - EQ 2GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
INJECTABLE;INJECTION - EQ 500MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

DIGITAL CONTENT

6 NEWS #PharmaBuzz

media
6 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

54 Finished Drug Prices

globalSalesInformation
54 Finished Drug Prices

MARKET PLACE

19 APIs, 10 FDF Dossiers

marketPlace
19 APIs
10 FDF Dossiers

REF. STANDARDS & IMPURITIES

3 EDQM , 2 USP , 2 Others

otherSolutions
3 EDQM
2 USP
2 Others

Synopsis

ACTIVE PHARMA INGREDIENTS

API Suppliers

USDMF

CEP/COS

JDMF

EU WC

KDMF

NDC API

VMF

Listed Suppliers

API REF. PRICE (USD/KG)

$ 110

MARKET PLACE

API

FDF

3INTERMEDIATES

FINISHED DOSAGE FORMULATIONS

215

FDF Dossiers

FDA Orange Book

Europe

Canada

Australia

South Africa

Listed Dossiers

0 DRUGS IN DEVELOPMENT

DRUG PRODUCT COMPOSITIONS

REF. STANDARDS OR IMPURITIES

EDQM

USP

Others

PATENTS & EXCLUSIVITIES

US Patents

US Exclusivities

Health Canada Patents

DIGITAL CONTENT

Data Compilation #PharmaFlow

Stock Recap #PipelineProspector

Weekly News Recap #Phispers

News #PharmaBuzz

GLOBAL SALES INFORMATION

US Medicaid (USD)

Annual Reports (USD Million)

Finished Drug Prices

0RELATED EXCIPIENT COMPANIES

0EXCIPIENTS BY APPLICATIONS

Chemistry

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Also known as: 64485-93-4, Cefotaxime sodium salt, Sodium cefotaxime, Hr 756, Cefotaxime, Ru 24756

Molecular Formula

C₁₆H₁₆N₅NaO₇S₂

Molecular Weight

477.5 g/mol

InChI Key

AZZMGZXNTDTSME-JUZDKLSSSA-M

FDA UNII

258J72S7TZ

Semisynthetic broad-spectrum cephalosporin.

1 2D Structure

Cefotaxime

2 Identification

2.1 Computed Descriptors

2.1.1 IUPAC Name

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

2.1.2 InChI

InChI=1S/C16H17N5O7S2.Na/c1-6(22)28-3-7-4-29-14-10(13(24)21(14)11(7)15(25)26)19-12(23)9(20-27-2)8-5-30-16(17)18-8;/h5,10,14H,3-4H2,1-2H3,(H2,17,18)(H,19,23)(H,25,26);/q;+1/p-1/b20-9-;/t10-,14-;/m1./s1

2.1.3 InChI Key

AZZMGZXNTDTSME-JUZDKLSSSA-M

2.1.4 Canonical SMILES

CC(=O)OCC1=C(N2C(C(C2=O)NC(=O)C(=NOC)C3=CSC(=N3)N)SC1)C(=O)[O-].[Na+]

2.1.5 Isomeric SMILES

CC(=O)OCC1=C(N2[C@@H]([C@@H](C2=O)NC(=O)/C(=N\OC)/C3=CSC(=N3)N)SC1)C(=O)[O-].[Na+]

2.2 Other Identifiers

2.2.1 UNII

258J72S7TZ

2.3 Synonyms

2.3.1 MeSH Synonyms

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

2.3.2 Depositor-Supplied Synonyms

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

2.4 Create Date

2006-10-25

3 Chemical and Physical Properties

Molecular Formula	C₁₆H₁₆N₅NaO₇S₂
Molecular Weight	477.5 g/mol
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 Å²
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

4 Drug and Medication Information

4.1 Drug Information

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

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.)

5.2 FDA Pharmacological Classification

5.2.1 Pharmacological Classes

Cephalosporins [CS]; Cephalosporin Antibacterial [EPC]

5.3 ATC Code

J - Antiinfectives for systemic use

J01 - Antibacterials for systemic use

J01D - Other beta-lactam antibacterials

J01DD - Third-generation cephalosporins

J01DD01 - Cefotaxime

API SUPPLIERS

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USDMF

01

Acs Dobfar Spa

Italy

BIO Partnering at JPM

Not Confirmed

02

Acs Dobfar Spa

Italy

BIO Partnering at JPM

Not Confirmed

03

Aurobindo Pharma Ltd

India

BIO Partnering at JPM

Not Confirmed

04

Hamnmi Fine Chemical Co Ltd

South Korea

India

BIO Partnering at JPM

Not Confirmed

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CEP/COS

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JDMF

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EU WC

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KDMF

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NDC API

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Listed Suppliers

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API Reference Price

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LTD","customerCountry":"INDIA","quantity":"3395.00","actualQuantity":"3395","unit":"KGS","unitRateFc":"56","totalValueFC":"191949","currency":"USD","unitRateINR":"4771.2","date":"14-Nov-2024","totalValueINR":"16198224","totalValueInUsd":"191949","indian_port":"JNPT","hs_no":"29419090","bill_no":"6676738","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"QINGDAO","supplierAddress":"NO.1, RUIYANG ROAD, YIYUAN COUNTY, SHANDONG P.R. CHINA , , CHINA SDNF CHINA","customerAddress":"1705, 4TH FLOOR, ONKAR BHAWAN"}]

Number of Transactions

Total Quantity (KGS)

Total Value (USD)

Quantity (KGS) & Unit rate (USD/KGS) over time

API Imports and Exports

Importing Country	Total Quantity (KGS)	Average Price (USD/KGS)	Number of Transactions

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DRUG PRODUCT COMPOSITIONS

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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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Global Sales Information

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Finished Drug Prices

01

Brand Name : Zaiz

France

Duphat

Not Confirmed

Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

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France

Virtual Booth

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RX/OTC/DISCN : Class A

SANOFI SpA

Cefotaxime

Dosage Form : Cefotaxime 1.000Mg 1 Unit Parent...

Dosage Strength : 1 vial IM EV 1 g + 1 ampoule solv 4 ml

Price Per Pack (Euro) : 4.85

Published in :

Country : Italy

RX/OTC/DISCN : Class A

Portfolio PDF

Product Web Link

02

Brand Name : Zaiz

France

Duphat

Not Confirmed

Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

Contact Supplier

France

Virtual Booth

Digital Content

RX/OTC/DISCN : Class A

SANOFI SpA

Cefotaxime

Dosage Form : Cefotaxime 1.000Mg 1 Unit Parent...

Dosage Strength : 1 vial IM 1 g + 1 ampoule solv 4 ml with l...

Price Per Pack (Euro) : 4.85

Published in :

Country : Italy

RX/OTC/DISCN : Class A

Portfolio PDF

Product Web Link

03

Brand Name : Zariviz

France

Duphat

Not Confirmed

Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

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France

Virtual Booth

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RX/OTC/DISCN : Class H

SANOFI SpA

Cefotaxime

Dosage Form : Cefotaxime 2.000Mg 1 Unit Parent...

Dosage Strength : 1 ampoule EV 2 g + 1 ampoule solv 10 ml

Price Per Pack (Euro) : 11.88

Published in :

Country : Italy

RX/OTC/DISCN : Class H

Portfolio PDF

Product Web Link

04

Brand Name : Zaiz

France

Duphat

Not Confirmed

Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

Contact Supplier

France

Virtual Booth

Digital Content

RX/OTC/DISCN : Class A

SANOFI SpA

Cefotaxime

Dosage Form : Cefotaxime 500Mg 1 Unit Parenter...

Dosage Strength : 1 vial IM EV 500 mg + 1 ampoule solv 2 ml

Price Per Pack (Euro) : 2.95

Published in :

Country : Italy

RX/OTC/DISCN : Class A

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Brand Name : Cefotaxa

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Brand Name : Cefotaxa

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Brand Name : Cefotaxa

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ABOUT THIS PAGE

Cefotaxime Sodium Manufacturers

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

Cefotaxime Sodium Suppliers

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

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

Cefotaxime Sodium USDMF

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

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

click here to find a list of Cefotaxime Sodium suppliers with USDMF on PharmaCompass.

Cefotaxime Sodium 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 Cefotaxime Sodium Drug Master File in Japan (Cefotaxime Sodium JDMF) empowers Cefotaxime Sodium 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 Sodium JDMF during the approval evaluation for pharmaceutical products. At the time of Cefotaxime Sodium 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 Sodium suppliers with JDMF on PharmaCompass.

Cefotaxime Sodium KDMF

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

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

After submitting a Cefotaxime Sodium 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 Sodium API can apply through the Korea Drug Master File (KDMF).

click here to find a list of Cefotaxime Sodium suppliers with KDMF on PharmaCompass.

Cefotaxime Sodium CEP

A Cefotaxime Sodium CEP of the European Pharmacopoeia monograph is often referred to as a Cefotaxime Sodium Certificate of Suitability (COS). The purpose of a Cefotaxime Sodium CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Cefotaxime Sodium EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Cefotaxime Sodium to their clients by showing that a Cefotaxime Sodium CEP has been issued for it. The manufacturer submits a Cefotaxime Sodium CEP (COS) as part of the market authorization procedure, and it takes on the role of a Cefotaxime Sodium CEP holder for the record. Additionally, the data presented in the Cefotaxime Sodium CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Cefotaxime Sodium DMF.

A Cefotaxime Sodium CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Cefotaxime Sodium 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 Sodium suppliers with CEP (COS) on PharmaCompass.

Cefotaxime Sodium WC

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

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

Cefotaxime Sodium NDC

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 Sodium as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for Cefotaxime Sodium API and other APIs are published in this directory by the FDA.

Unfinished drugs

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 Sodium 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.

Compounded drug products

The NDC directory also contains data on finished compounded human drug products that contain Cefotaxime Sodium and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Cefotaxime Sodium NDC to their finished compounded human drug products, they may choose to do so.

click here to find a list of Cefotaxime Sodium suppliers with NDC on PharmaCompass.

Cefotaxime Sodium GMP

Cefotaxime Sodium 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 Sodium 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 Sodium GMP manufacturer or Cefotaxime Sodium GMP API supplier for your needs.

Cefotaxime Sodium CoA

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

Cefotaxime Sodium CoA mostly includes findings from lab analyses of a specific batch. For each Cefotaxime Sodium 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 Sodium may be tested according to a variety of international standards, such as European Pharmacopoeia (Cefotaxime Sodium EP), Cefotaxime Sodium JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Cefotaxime Sodium 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.

Find Cefotaxime manufacturers, exporters & distributors on PharmaCompass

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CHEMISTRY

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ACTIVE PHARMA INGREDIENTS

39 API Suppliers

13 USDMF

16 CEP/COS

1 JDMF

6 EU WC

6 KDMF

1 NDC API

21 Listed Suppliers

$ API Reference Price

INTERMEDIATES

3 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

215 FDF Dossiers

40 FDA Orange Book

68 Europe

2 Canada

2 Australia

25 South Africa

78 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

INJECTABLE;INJECTION - EQ 10GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

INJECTABLE;INJECTION - EQ 1GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

INJECTABLE;INJECTION - EQ 2GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

INJECTABLE;INJECTION - EQ 500MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

DIGITAL CONTENT

6 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

54 Finished Drug Prices

MARKET PLACE

19 APIs

10 FDF Dossiers

REF. STANDARDS & IMPURITIES

3 EDQM

2 USP

2 Others

ACTIVE PHARMA INGREDIENTS

API REF. PRICE (USD/KG)

$ 110

MARKET PLACE

FINISHED DOSAGE FORMULATIONS

0 DRUGS IN DEVELOPMENT

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REF. STANDARDS OR IMPURITIES

PATENTS & EXCLUSIVITIES

DIGITAL CONTENT

GLOBAL SALES INFORMATION

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INJECTABLE;INJECTION - EQ 10GM BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

INJECTABLE;INJECTION - EQ 1GM BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

INJECTABLE;INJECTION - EQ 2GM BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

INJECTABLE;INJECTION - EQ 500MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons