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CHEMISTRY
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ACTIVE PHARMA INGREDIENTS

34 API Suppliers, 14 USDMF, 14 CEP/COS, 6 EU WC, 1 KDMF, 1 NDC API, 13 Listed Suppliers, $ API Reference Price

34 API Suppliers
14 USDMF
14 CEP/COS
6 EU WC
1 KDMF
1 NDC API
13 Listed Suppliers
$ API Reference Price

FINISHED DOSAGE FORMULATIONS

214 FDF Dossiers, 35 FDA Orange Book, 70 Europe, 2 Canada, 8 Australia, 52 South Africa, 47 Listed Dossiers

214 FDF Dossiers
35 FDA Orange Book
70 Europe
2 Canada
8 Australia
52 South Africa
47 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

INJECTABLE;INJECTION - EQ 1.5GM BASE/VIAL, INJECTABLE;INJECTION - EQ 7.5GM BASE/VIAL, INJECTABLE;INTRAMUSCULAR, INTRAVENOUS - EQ 750MG BASE/VIAL, INJECTABLE;INJECTION - EQ 30MG BASE/ML

drugProductComposition
INJECTABLE;INJECTION - EQ 1.5GM BASE/VIAL
INJECTABLE;INJECTION - EQ 7.5GM BASE/VIAL
INJECTABLE;INTRAMUSCULAR, INTRAVENOUS - EQ 750MG BASE/VIAL
INJECTABLE;INJECTION - EQ 30MG BASE/ML

RELATED EXCIPIENT COMPANIES

1 Actylis, 1 Kerry, 1 Microlex e.U, 1 Pluviaendo, 1 Roquette

relatedExcipients
1 Actylis
1 Kerry
1 Microlex e.U
1 Pluviaendo
1 Roquette

EXCIPIENTS BY APPLICATIONS

2 Parenteral, 2 Fillers, Diluents & Binders, 1 Taste Masking, 1 Co-Processed Excipients

excipientsByApplications
2 Parenteral
2 Fillers, Diluents & Binders
1 Taste Masking
1 Co-Processed Excipients

DIGITAL CONTENT

1 NEWS #PharmaBuzz

media
1 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

35 Finished Drug Prices

globalSalesInformation
35 Finished Drug Prices

MARKET PLACE

11 APIs, 5 FDF Dossiers

marketPlace
11 APIs
5 FDF Dossiers

REF. STANDARDS & IMPURITIES

1 EDQM , 1 USP , 1 Others

otherSolutions
1 EDQM
1 USP
1 Others

ANALYTICAL

1 BioAnalytical Methods

otherMethods
1 BioAnalytical Methods

Synopsis

ACTIVE PHARMA INGREDIENTS

API Suppliers

USDMF

CEP/COS

JDMF

EU WC

KDMF

NDC API

VMF

Listed Suppliers

API REF. PRICE (USD/KG)

MARKET PLACE

API

FDF

0INTERMEDIATES

FINISHED DOSAGE FORMULATIONS

214

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

6EXCIPIENTS BY APPLICATIONS

Chemistry

Click the arrow to open the dropdown

Click the button for full data set

Also known as: Sodium cefuroxime, Zinacef, Cefuroxime sodium salt, Biociclin, 56238-63-2, Anaptivan

Molecular Formula

C₁₆H₁₅N₄NaO₈S

Molecular Weight

446.4 g/mol

InChI Key

URDOHUPGIOGTKV-JTBFTWTJSA-M

FDA UNII

R8A7M9MY61

Broad-spectrum cephalosporin antibiotic resistant to beta-lactamase. It has been proposed for infections with gram-negative and gram-positive organisms, GONORRHEA, and HAEMOPHILUS.

1 2D Structure

Cefuroxime Sodium

2 Identification

2.1 Computed Descriptors

2.1.1 IUPAC Name

sodium;(6R,7R)-3-(carbamoyloxymethyl)-7-[[(2Z)-2-(furan-2-yl)-2-methoxyiminoacetyl]amino]-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylate

2.1.2 InChI

InChI=1S/C16H16N4O8S.Na/c1-26-19-9(8-3-2-4-27-8)12(21)18-10-13(22)20-11(15(23)24)7(5-28-16(17)25)6-29-14(10)20;/h2-4,10,14H,5-6H2,1H3,(H2,17,25)(H,18,21)(H,23,24);/q;+1/p-1/b19-9-;/t10-,14-;/m1./s1

2.1.3 InChI Key

URDOHUPGIOGTKV-JTBFTWTJSA-M

2.1.4 Canonical SMILES

CON=C(C1=CC=CO1)C(=O)NC2C3N(C2=O)C(=C(CS3)COC(=O)N)C(=O)[O-].[Na+]

2.1.5 Isomeric SMILES

CO/N=C(/C1=CC=CO1)\C(=O)N[C@H]2[C@@H]3N(C2=O)C(=C(CS3)COC(=O)N)C(=O)[O-].[Na+]

2.2 Other Identifiers

2.2.1 UNII

R8A7M9MY61

2.3 Synonyms

2.3.1 MeSH Synonyms

1. Cefuroxime

2. Cephuroxime

3. Ketocef

4. Zinacef

2.3.2 Depositor-Supplied Synonyms

1. Sodium Cefuroxime

2. Zinacef

3. Cefuroxime Sodium Salt

4. Biociclin

5. 56238-63-2

6. Anaptivan

7. Kefurox

8. Cefuroxime (sodium)

9. Cefumax

10. Cefurex

11. Medoxim

12. Kesint

13. Chebi:3517

14. R8a7m9my61

15. Colifossim

16. Sodium (6r,7r)-7-(2-(2-furyl)glyoxylamido)-3-(hydroxymethyl)-8-oxo-5-thia-1-azabicyclo(4.2.0)oct-2-ene-2-carboxylate, 7(sup 2)-(z)-(o-methyloxime), Carbamate (ester)

17. Spectrazolr

18. Bioxima

19. Cefofix

20. Curoxim

21. Curoxima

22. Curoxime

23. Furoxil

24. Ketocef

25. Ultroxim

26. Cefuroxim Hexal

27. Cefuroxim Lilly

28. Cefuroxima Fabra

29. Cefuroxim Aj

30. Cefuroxim Mn

31. Cefuroxim Curasan

32. Cefuroxima Richet

33. Cetroxil [inj.]

34. Cefuroxim Fresenius

35. Cefuroxim Genericsn

36. Froxal [inj.]

37. Sharox [inj.]

38. Zinnat [inj.]

39. Cetroxil

40. Froxal

41. Cefuroxim Norcox

42. Cefuroxim Norcox [inj.]

43. Cefuroxime Na

44. Kefurox In Plastic Container

45. Zinacef In Plastic Container

46. Zinacef (tn)

47. Einecs 260-073-1

48. Cefuroxime And Dextrose In Duplex Container

49. Unii-r8a7m9my61

50. Mls000069576

51. Cefuroxime Sodium [usp:ban:jan]

52. Cefuroxime For Injection And Dextrose For Injection In Duplex Container

53. Sodium;(6r,7r)-3-(carbamoyloxymethyl)-7-[[(2z)-2-(furan-2-yl)-2-methoxyiminoacetyl]amino]-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylate

54. Ks-1040

55. Smr000058808

56. Mls001332625

57. Mls001332626

58. Sodium (6r-(6alpha,7beta(z)))-3-(((aminocarbonyl)oxy)methyl)-7-(2-furyl(methoxyimino)acetamido)-8-oxo-5-thia-1-azabicyclo(4.2.0)oct-2-ene-2-carboxylate

59. Cefuroxime Sodium (jan/usp)

60. Schembl719536

61. Cefuroxime Sodium [jan]

62. Chembl2146124

63. Cefuroxime Sodium [vandf]

64. Cefuroxime Sodium [mart.]

65. Dtxsid201015616

66. Hms2097o21

67. Hms3714o21

68. Cefuroxime Sodium [usp-rs]

69. Cefuroxime Sodium [who-dd]

70. Cefuroxime Sodium Salt [mi]

71. Hy-b1256

72. Mfcd09878727

73. S4620

74. Akos015961772

75. Ccg-220720

76. Cefuroxime Sodium [ep Impurity]

77. Cefuroxime Sodium [orange Book]

78. Cs-4733

79. Nsc 758166

80. Cefuroxime Sodium [ep Monograph]

81. Cefuroxime Sodium [usp Impurity]

82. Cefuroxime Sodium [usp Monograph]

83. 5-thia-1-azabicyclo(4.2.0)oct-2-ene-2-carboxylic Acid, 3-(((aminocarbonyl)oxy)methyl)-7-((2-furanyl(methoxyimino)acetyl)amino)-8-oxo-, Monosodium Salt (6r-(6alpha,7beta(z)))-

84. Ac-15028

85. C08108

86. D00915

87. Cefuroxime Sodium 100 Microg/ml In Acetonitrile/water

88. Cefuroxime Sodium 100 Microg/ml In Acetonitrile:water

89. Cefuroxime Sodium, European Pharmacopoeia (ep) Reference Standard

90. Cefuroxime Sodium, United States Pharmacopeia (usp) Reference Standard

91. (6r,7r)-3-(carbamoyloxymethyl)-7-[[(2z)-2-(2-furyl)-2-methoxyimino-acetyl]amino]-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylate

92. 5-thia-1-azabicyclo(4.2.0)oct-2-ene-2-carboxylic Acid, 3-(((aminocarbonyl)oxy)methyl)-7-((2-furanyl(methoxyimino)acetyl)amino)-8-oxo-, Monosodium Salt (6r-(6.alpha.,7.beta.(z)))-

93. Sodium (6r,7r)-3-(carbamoyloxymethyl)-7-((e)-2-(furan-2-yl)-2-(methoxyimino)acetamido)-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylate

2.4 Create Date

2008-02-05

3 Chemical and Physical Properties

Molecular Formula	C₁₆H₁₅N₄NaO₈S
Molecular Weight	446.4 g/mol
Hydrogen Bond Donor Count	2
Hydrogen Bond Acceptor Count	10
Rotatable Bond Count	8
Exact Mass	446.05082891 g/mol
Monoisotopic Mass	446.05082891 g/mol
Topological Polar Surface Area	202 Å²
Heavy Atom Count	30
Formal Charge	0
Complexity	804
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 6
Drug Name	Cefuroxime and dextrose in duplex container
Active Ingredient	Cefuroxime sodium
Dosage Form	Injectable
Route	Injection
Strength	eq 750mg base/vial; eq 1.5gm base/vial
Market Status	Prescription
Company	B Braun

2 of 6
Drug Name	Cefuroxime sodium
Active Ingredient	Cefuroxime sodium
Dosage Form	Injectable
Route	Intramuscular, intravenous; Im-iv; Injection
Strength	eq 750mg base/vial; eq 7.5gm base/vial; eq 1.5gm base/vial
Market Status	Prescription
Company	Teva Pharms; Hospira; Steri Pharma; Hikma Farmaceutica

3 of 6
Drug Name	Zinacef in plastic container
Drug Label	Cefuroxime is a sterile semisynthetic, broad-spectrum, cephalosporin antibiotic for parenteral administration. It is the sodium salt of (6R, 7R)-3-carbamoyloxymethyl-7-[Z-2-methoxyimino-2-(fur-2-yl)acetamido]ceph-3-em-4-carboxylate, and it has the fo...
Active Ingredient	Cefuroxime sodium
Dosage Form	Injectable
Route	Injection
Strength	eq 30mg base/ml
Market Status	Prescription
Company	Covis Injectables

4 of 6
Drug Name	Cefuroxime and dextrose in duplex container
Active Ingredient	Cefuroxime sodium
Dosage Form	Injectable
Route	Injection
Strength	eq 750mg base/vial; eq 1.5gm base/vial
Market Status	Prescription
Company	B Braun

5 of 6
Drug Name	Cefuroxime sodium
Active Ingredient	Cefuroxime sodium
Dosage Form	Injectable
Route	Intramuscular, intravenous; Im-iv; Injection
Strength	eq 750mg base/vial; eq 7.5gm base/vial; eq 1.5gm base/vial
Market Status	Prescription
Company	Teva Pharms; Hospira; Steri Pharma; Hikma Farmaceutica

6 of 6
Drug Name	Zinacef in plastic container
Drug Label	Cefuroxime is a sterile semisynthetic, broad-spectrum, cephalosporin antibiotic for parenteral administration. It is the sodium salt of (6R, 7R)-3-carbamoyloxymethyl-7-[Z-2-methoxyimino-2-(fur-2-yl)acetamido]ceph-3-em-4-carboxylate, and it has the fo...
Active Ingredient	Cefuroxime sodium
Dosage Form	Injectable
Route	Injection
Strength	eq 30mg base/ml
Market Status	Prescription
Company	Covis Injectables

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]

API SUPPLIERS

01

Axplora

Germany

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

Duphat

Not Confirmed

Axplora- The partner of choice for complex APIs.

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Germany

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USDMF

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CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT

Product Web Link

02

GSK

United Kingdom

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

Duphat

Not Confirmed

03

Sterile India Pvt. Ltd

India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

Duphat

Not Confirmed

Not Confirmed

10

Aurobindo Pharma Limited

India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

Duphat

Not Confirmed

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API Reference Price

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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 1.5GM BASE...DOSAGE - INJECTABLE;INJECTION - EQ 1.5GM BASE/VIAL

USFDA APPLICATION NUMBER - 50558

DOSAGE - INJECTABLE;INJECTION - EQ 7.5GM BASE...DOSAGE - INJECTABLE;INJECTION - EQ 7.5GM BASE/VIAL

USFDA APPLICATION NUMBER - 50558

DOSAGE - INJECTABLE;INTRAMUSCULAR, INTRAVENOU...DOSAGE - INJECTABLE;INTRAMUSCULAR, INTRAVENOUS - EQ 750MG BASE/VIAL

USFDA APPLICATION NUMBER - 50558

DOSAGE - INJECTABLE;INJECTION - EQ 30MG BASE/...DOSAGE - INJECTABLE;INJECTION - EQ 30MG BASE/ML

USFDA APPLICATION NUMBER - 50643

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APIs

Sterile & USP Grade Cefuroxime Sodium API needed in Bangladesh [ENA18035]

A company that deals in various pharmaceutical products is looking for suppliers of Sterile & USP Grade Cefuroxime Sodium (200 kg) API for commercial purposes. The suppliers must support this enquiry with GMP & CoA.

14 Sep 2023

Various APIs needed in India [ENA15233]

A leading Indian pharmaceutical company that focuses on research, development, manufacturing and exporting a wide range of finished formulations is looking for suppliers of Various APIs for commercial purpose. The suppliers must support this enquiry with DMF. 1. Amoxicillin Trihydrate Powder (1150 kg) API 2. Lactulose (600 kg) API 3. Prednisolone Acetate (5 kg) API 4. Sterile Grade Cefuroxime Sodium (20 kg) API 5. Ceftazidime (10 kg) API

07 Oct 2022

Various APIs needed in India [ENA12701]

A company that deals in various pharmaceutical products like injections, syrups & hygiene products is looking for suppliers of Various APIs for commercial purpose. The suppliers must support this enquiry with CoA. 1. Ilaprazole (25 kg & 200 kg) API 2. Sterile Grade Ceftriaxone Sodium (50 kg) API 3. Sterile Grade Sulbactam Sodium (20 kg) API 4. Sterile Grade Tazobactam Sodium (2 kg) API 5. Sterile Grade Cefuroxime Sodium (20 kg) API 6. Sterile Grade Ceftazidime Sodium (10 kg) API 7. Sterile Grade Piperacillin and Tazobactam (50 kg) API 8. Sterile Grade Cefoperazone Sodium (10 kg) API

14 Feb 2022

Various APIs needed in India [ENA11569]

A company that deals in the manufacturing & development of pharmaceutical formulations such as tablets, capsules, powder for injection, syrup, suspensions, ointments, creams & ophthalmic preparations is looking for suppliers of Various APIs for commercial purpose. The suppliers must support this enquiry with CoA. 1. IP Grade Chlorhexidine Gluconate 20% API 2. BP/ USP Grade Mifepristone API 3. BP/ USP Grade Fluconazole API 4. BP/ USP Grade Meclizine Hydrochloride API 5. BP/ USP Grade Beclomethasone Dipropionate API 6. BP/ USP Grade Miconazole Nitrate API 7. BP/ USP Grade Neomycin Sulfate API 8. Trypsin API 9. Chymotrypsin API 10. BP/ USP & Sterile Grade Cefuroxime Sodium API

05 Oct 2021

Various APIs needed in Pakistan [ENA07561]

A pharmaceutical manufacturing company that deals in various pharmaceutical products is looking for suppliers of Various APIs. The suppliers must support this enquiry with GMP. 1. Micronized & Compacted Cefuroxime Axetil (25 kg each) 2. Injectable Grade Cefuroxime Sodium (20 kg) 3. Cefepime HCl (20 kg) with L-Arginine 4. Cefotaxime Sodium (20 kg) 5. Micronized & Compacted Cefaclor Monohydrate (25 kg each)

12 Jun 2020

USP Grade Ceftriaxone Sodium & other APIs needed in Jordan [ENA05737]

A Pharmaceutical Company providing cephalosporins antibiotics in different forms such as dry syrup, tablets, capsules and vials is looking for suppliers of APIs as mentioned below. The supplier must support this enquiry with CoA & GMP Certificate. 1. USP Grade Ceftriaxone Sodium- 40 kg 2. USP Grade Cefuroxime Sodium- 50 kg 3. USP Grade Cefotaxime Sodium- 35 kg 4. USP Grade Cefazolin Sodium- 35 kg 5. USP Grade Ceftazidime Pentahydrate- 40 kg 6. USP Grade Cefepime Dihydrochloride Monohydrate- 20 kg

13 Nov 2019

USP/IP/BP Grade Aminophylline Dihydrate & other APIs needed in India [ENA05643]

A pharmaceutical company with its main focus in manufacturing and supplying a wide range of pharmaceutical products is looking for suppliers of below mentioned APIs. The material should be of at least 3-4 years shelf life. 1. Aminophylline Dihydrate- 2.1 kg 2. Amoxicillin and Clavulanate Potassium (Sterile)- 7.1 kg 3. Azithromycin Dihydrate- 125 kg 4. Beclomethasone Dipropionate- 0.75 kg 5. Benzocaine- 15 kg 6. Calcium D-Saccharate- 20 kg 7. Ceftriaxone Sodium (Sterile)- 108 kg 8. Cefuroxime Sodium (Sterile)- 8.1 kg 9. Cholecalciferol- 1075 g 10. Clotrimazole- 44 kg 11. Cloxacillin Sodium (Sterile)- 19.5 kg 12. Ephedrine HCl- 3 kg 13. Erythromycin Stearate- 315 kg 14. Ethamsylate- 25 kg 15. Ethyl Oleate- 565 kg 16. Fluconazole- 86 kg 17. Gentamicin Sulphate- 75 kg 18. Hydrocortisone Sodium Succinate (Sterile)- 55 kg 19. Itraconazole Pellets (40%) 200mg- 80 kg 20. Lansoprazole Enteric Coated Pellets 30mg- 100 kg 21. Lidocaine HCl- 60 kg 22. Maltodextrin- 2 kg 23. Nandrolone Decanoate- 1.2 kg 24. Nefopam HCl- 2 kg 25. Neomycin Sulfate- 18 kg 26. Oxetacaine- 2.1 kg 27. Piroxicam- 2.5 kg 28. Sodium Metabisulphite- 60 kg 29. Sulbactam Sodium (Sterile)- 45 kg 30. Tranexamic Acid- 100 kg 31. Roxithromycin- 143 kg 32. Mefenamic Acid- 500 kg 33. Metronidazole Benzoate- 350 kg

01 Nov 2019

Terbutaline Sulphate (10 kg) and Cefuroxime Sodium (300 kg) APIs needed in China [ENA05302]

A scientific and technological enterprise specializing in the import and technical services of APIs and preparations is looking for suppliers of Terbutaline Sulphate (10 kg) and Cefuroxime Sodium (300 kg) APIs. The supplier must support this enquiry with CoA.

30 Sep 2019

Cefaclor and various other APIs needed in Pakistan [ENA04247]

Norwich Pharmaceuticals, a pharma company based in Pakistan is looking for suppliers of various APIs mentioned below. All APIs should be of USP grade and suppliers must comply with GMP certificate. 1. Cefaclor 2. Cefixime Hydrate 3. Cefuroxime Axetil 4. Cefoperazone Sodium 5. Cefotaxime Sodium 6. Cefradine 7. Ceftriaxone Sodium 8. Cefuroxime Sodium 9. Cephradine Compacted 10. Ceftazidime 11. Cephalexin 12. Cefepime 13. Cefadroxil Interested suppliers can contact them via Email: shahidhusnain4135@gmail.com.

22 May 2019

Ceftriaxone Sodium and other Injectable grade APIs needed in Brazil [ENA02662]

One of the most notable companies of the pharmaceutical industry of Brazil is looking for suppliers of the following APIs: 1) Ceftriaxone Sodium 2) Cefepime HCl 3) Cefazolin Sodium 4) Cefuroxime Sodium 5) Ceftazidime pentahydrate 6) Cefoxitin Sodium 7) Cefotaxime Sodium 8) Cefpirome

16 Nov 2018

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ABOUT THIS PAGE

Cefuroxime Sodium Manufacturers

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

Cefuroxime Sodium Suppliers

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

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

Cefuroxime Sodium USDMF

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

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

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

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

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

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

Cefuroxime Sodium CEP

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

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

Cefuroxime Sodium WC

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

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

Cefuroxime 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 Cefuroxime Sodium as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for Cefuroxime 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 Cefuroxime 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 Cefuroxime Sodium and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Cefuroxime Sodium NDC to their finished compounded human drug products, they may choose to do so.

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

Cefuroxime Sodium GMP

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

Cefuroxime Sodium CoA

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

Cefuroxime Sodium CoA mostly includes findings from lab analyses of a specific batch. For each Cefuroxime 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.

Cefuroxime Sodium may be tested according to a variety of international standards, such as European Pharmacopoeia (Cefuroxime Sodium EP), Cefuroxime Sodium JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Cefuroxime 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 Cefuroxime Sodium manufacturers, exporters & distributors on PharmaCompass

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DRUG PRODUCT COMPOSITIONS

INJECTABLE;INJECTION - EQ 1.5GM BASE/VIAL

INJECTABLE;INJECTION - EQ 7.5GM BASE/VIAL

INJECTABLE;INTRAMUSCULAR, INTRAVENOUS - EQ 750MG BASE/VIAL

INJECTABLE;INJECTION - EQ 30MG BASE/ML

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Cefuroxime Sodium Manufacturers