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Chemistry

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Also known as: Cefazolin sodium salt, 27164-46-1, Cefazoline sodium, Ancef, Cefazil, Totacef
Molecular Formula
C14H13N8NaO4S3
Molecular Weight
476.5  g/mol
InChI Key
FLKYBGKDCCEQQM-WYUVZMMLSA-M
FDA UNII
P380M0454Z

Cefazolin Sodium
A semisynthetic cephalosporin analog with broad-spectrum antibiotic action due to inhibition of bacterial cell wall synthesis. It attains high serum levels and is excreted quickly via the urine.
1 2D Structure

Cefazolin Sodium

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
sodium;(6R,7R)-3-[(5-methyl-1,3,4-thiadiazol-2-yl)sulfanylmethyl]-8-oxo-7-[[2-(tetrazol-1-yl)acetyl]amino]-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylate
2.1.2 InChI
InChI=1S/C14H14N8O4S3.Na/c1-6-17-18-14(29-6)28-4-7-3-27-12-9(11(24)22(12)10(7)13(25)26)16-8(23)2-21-5-15-19-20-21;/h5,9,12H,2-4H2,1H3,(H,16,23)(H,25,26);/q;+1/p-1/t9-,12-;/m1./s1
2.1.3 InChI Key
FLKYBGKDCCEQQM-WYUVZMMLSA-M
2.1.4 Canonical SMILES
CC1=NN=C(S1)SCC2=C(N3C(C(C3=O)NC(=O)CN4C=NN=N4)SC2)C(=O)[O-].[Na+]
2.1.5 Isomeric SMILES
CC1=NN=C(S1)SCC2=C(N3[C@@H]([C@@H](C3=O)NC(=O)CN4C=NN=N4)SC2)C(=O)[O-].[Na+]
2.2 Other Identifiers
2.2.1 UNII
P380M0454Z
2.3 Synonyms
2.3.1 MeSH Synonyms

1. Ancef

2. Cefamedin

3. Cefamezine

4. Cefazolin

5. Cephamezine

6. Cephazolin

7. Cephazolin Sodium

8. Cephazolin, Sodium

9. Gramaxin

10. Kefzol

11. Sodium Cephazolin

12. Sodium, Cefazolin

13. Sodium, Cephazolin

14. Totacef

2.3.2 Depositor-Supplied Synonyms

1. Cefazolin Sodium Salt

2. 27164-46-1

3. Cefazoline Sodium

4. Ancef

5. Cefazil

6. Totacef

7. Kefzol

8. Sodium Cephazolin

9. Cefamedin

10. Gramaxin

11. Zolicef

12. Sodium Cefazolin

13. Cefacidal

14. Cephazolin Sodium

15. Cefazolin (sodium)

16. Monosodium Cefazolin

17. Sk&f 41558

18. Cefazolin Injection

19. Cefazolin And Dextrose

20. Cefazina

21. Firmacef

22. Liviclina

23. Atirin

24. Acef

25. Chebi:3483

26. Mls000028706

27. Nsc-291561

28. P380m0454z

29. Biazolina

30. Smr000058708

31. Skf 41558

32. Sk&f-41558

33. Sodium Cez

34. Cefazolin Sodium 100 Microg/ml In Acetonitrile/water

35. Ancef In Plastic Container

36. Cefabiozim

37. Cefalomicina

38. Lampocef

39. Neofazol

40. Zolisint

41. Recef

42. Zolin

43. Bor-cefazol

44. Cez Sodium

45. 5-thia-1-azabicyclo(4.2.0)oct-2-ene-2-carboxylic Acid, 3-(((5-methyl-1,3,4-thiadiazol-2-yl)thio)methyl)-8-oxo-7-(((1h-tetrazol-1-yl)acetyl)amino)-, Monosodium Salt (6r-trans)-

46. Monosodium (6r,7r)-3-(((5-methyl-1,3,4-thiadiazol-2-yl)thio)methyl)-8-oxo-7-(2-(1h-tetrazol-1-yl)acetamido)-5-thia-1-azabicyclo(4.2.0)oct-2-ene-2-carboxylate

47. Lilly 46083

48. Unii-p380m0454z

49. Cefazolin Sodium [usan:usp:jan]

50. Sodium;(6r,7r)-3-[(5-methyl-1,3,4-thiadiazol-2-yl)sulfanylmethyl]-8-oxo-7-[[2-(tetrazol-1-yl)acetyl]amino]-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylate

51. Prestwick_975

52. Einecs 248-278-4

53. Monosodium Cephazolin

54. Mfcd00056883

55. Ancef (tn)

56. Nsc 291561

57. Opera_id_1323

58. Ancef In Dextrose 5% In Plastic Container

59. Schembl40735

60. Spectrum1500164

61. Cefazolin Sodium [jan]

62. Cefazolin Sodium (jp17/usp)

63. Sodium Cez; Skf-41558

64. Cefazolin Sodium [usan]

65. Cefazolin Sodium [vandf]

66. Chembl1200523

67. Hms500a16

68. Ancef In Sodium Chloride 0.9% In Plastic Container

69. Cefazolin Sodium [mart.]

70. Cefazolin Sodium [who-dd]

71. Dtxsid901015786

72. Hms1570c14

73. Hms1920k07

74. Hms2091a10

75. Hms2097c14

76. Hms2230i22

77. Hms3260h10

78. Hms3714c14

79. Cefazolin Sodium Salt [mi]

80. Hy-b1078

81. Tox21_500274

82. Bdbm50247885

83. Ccg-40011

84. S4595

85. Akos015895533

86. Cefazolin Sodium [orange Book]

87. Cefazolin Sodium [ep Monograph]

88. Cs-4634

89. Lp00274

90. Cefazolin Sodium [usp Monograph]

91. Cefazolin Sodium Salt, 89.1-110.1%

92. Ncgc00093731-01

93. Ncgc00260959-01

94. 3-(((5-methyl-1,3,4-thiadiazol-2-yl)thio)methyl)-7-(2-(1h-tetrazol-1-yl)acetamido)-3-cephem-4-carboxylate

95. Ac-13166

96. Ac-31729

97. As-12230

98. Sodium (6r,7r)-3-(((5-methyl-1,3,4-thiadiazol-2-yl)thio)methyl)-8-oxo-7-(2-(1h-tetrazol-1-yl)acetamido)-5-thia-1-azabicyclo(4.2.0)oct-2-ene-2-carboxylate

99. Eu-0100274

100. C 5020

101. C-2465

102. C08098

103. D00905

104. Q27106104

105. Cefazolin Sodium Salt, Antibiotic For Culture Media Use Only

106. 5-thia-1-azabicyclo(4.2.0)oct-2-ene-2-carboxylic Acid, 3-(((5-methyl-1,3,4-thiadiazol-2-yl)thio)methyl)-8-oxo-7-(((1h-tetrazol-1-yl)acetyl)amino)-, (6r-trans)-, Sodium Salt

107. 5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic Acid, 3-[[(5-methyl-1,3,4-thiadiazol-2-yl)thio]methyl]-8-oxo-7-[[2-(1h-tetrazol-1-yl)acetyl]amino]-, Sodium Salt, (6r,7r)- (1:1)

108. 5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic Acid, 3-[[(5-methyl-1,3,4-thiadiazol-2-yl)thio]methyl]-8-oxo-7-[[2-(1h-tetrazol-1-yl)acetyl]amino]-,(6r,7r)-,sodium

109. Sodium (6r,7r)-3-{[(5-methyl-1,3,4-thiadiazol-2-yl)sulfanyl]methyl}-8-oxo-7-[(1h-tetrazol-1-ylacetyl)amino]-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylate

110. Sodium (6r,7r)-7-(2-(1h-tetrazol-1-yl)acetamido)-3-(((5-methyl-1,3,4-thiadiazol-2-yl)thio)methyl)-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylate

111. Sodium (6r,7r)-7-(2-(1h-tetrazol-1-yl)acetamido)-3-((5-methyl-1,3,4-thiadiazol-2-ylthio)methyl)-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylate

112. Sodium (6r-trans)-3-(((5-methyl-1,3,4-thiadiazol-2-yl)thio)methyl)-8-oxo-7-(1h-tetrazol-1-ylacetamido)-5-thia-1-azabicyclo(4.2.0)oct-2-ene-2-carboxylate

113. Sodium 3-{[(5-methyl-1,3,4-thiadiazol-2-yl)sulfanyl]methyl}-7beta-[(1h-tetrazol-1-ylacetyl)amino]-3,4-didehydrocepham-4-carboxylate

114. Sodium 7beta-(1h-tetrazol-1-yl)acetamido-3-(2-methyl-1,3,4-thiadiazol-5-yl)thiomethyl-3-cephem-4-carboxylate

115. Sodium 7beta-[2-(1h-tetrazol-1-yl)-acetamido]-3-(2-methyl-1,3,4-thiadiazol-5-yl)thiomethyl-3-cephem-4-carboxylate

116. Sodium 7beta-[2-(1h-tetrazol-1-yl)acetamido]-3-(2-methyl-1,3,4-thiadiazol-5-yl)thiomethyl-3-cephem-4-carboxylate

2.4 Create Date
2008-02-05
3 Chemical and Physical Properties
Molecular Weight 476.5 g/mol
Molecular Formula C14H13N8NaO4S3
Hydrogen Bond Donor Count1
Hydrogen Bond Acceptor Count12
Rotatable Bond Count7
Exact Mass476.01195873 g/mol
Monoisotopic Mass476.01195873 g/mol
Topological Polar Surface Area238 Ų
Heavy Atom Count30
Formal Charge0
Complexity746
Isotope Atom Count0
Defined Atom Stereocenter Count2
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count2
4 Drug and Medication Information
4.1 Drug Information
1 of 8  
Drug NameAncef in plastic container
Active IngredientCefazolin sodium
Dosage FormInjectable
RouteInjection
Strengtheq 20mg base/ml; eq 10mg base/ml
Market StatusPrescription
CompanyBaxter Hlthcare

2 of 8  
Drug NameCefazolin and dextrose
Active IngredientCefazolin sodium
Dosage FormInjectable
RouteInjection
Strengtheq 2gm base/vial; eq 1gm base/vial
Market StatusPrescription
CompanyB Braun

3 of 8  
Drug NameCefazolin sodium
Drug LabelCEFAZOLIN FOR INJECTION is a semi-synthetic cephalosporin for parenteral administration. It is the sodium salt of 3-{[(5-methyl-1,3,4-thiadiazol-2-yl)thio]-methyl}-8-oxo-7-[2-(1H-tetrazol-1-yl)acetamido]-5-thia-1-azabicyclo [4.2.0]oct-2-ene-2-carboxy...
Active IngredientCefazolin sodium
Dosage FormInjectable
RouteInjection
Strengtheq 20gm base/vial; eq 100gm base/vial; eq 500mg base/vial; eq 10gm base/vial; eq 300gm base/vial; eq 1gm base/vial
Market StatusPrescription
CompanyAcs Dobfar; Hospira; Steri Pharma; Hikma Farmaceutica; Samson Medcl; Sandoz

4 of 8  
Drug NameKefzol
Active IngredientCefazolin sodium
Dosage FormInjectable
RouteInjection
Strengtheq 500mg base/vial; eq 10gm base/vial; eq 1gm base/vial
Market StatusPrescription
CompanyAcs Dobfar

5 of 8  
Drug NameAncef in plastic container
Active IngredientCefazolin sodium
Dosage FormInjectable
RouteInjection
Strengtheq 20mg base/ml; eq 10mg base/ml
Market StatusPrescription
CompanyBaxter Hlthcare

6 of 8  
Drug NameCefazolin and dextrose
Active IngredientCefazolin sodium
Dosage FormInjectable
RouteInjection
Strengtheq 2gm base/vial; eq 1gm base/vial
Market StatusPrescription
CompanyB Braun

7 of 8  
Drug NameCefazolin sodium
Drug LabelCEFAZOLIN FOR INJECTION is a semi-synthetic cephalosporin for parenteral administration. It is the sodium salt of 3-{[(5-methyl-1,3,4-thiadiazol-2-yl)thio]-methyl}-8-oxo-7-[2-(1H-tetrazol-1-yl)acetamido]-5-thia-1-azabicyclo [4.2.0]oct-2-ene-2-carboxy...
Active IngredientCefazolin sodium
Dosage FormInjectable
RouteInjection
Strengtheq 20gm base/vial; eq 100gm base/vial; eq 500mg base/vial; eq 10gm base/vial; eq 300gm base/vial; eq 1gm base/vial
Market StatusPrescription
CompanyAcs Dobfar; Hospira; Steri Pharma; Hikma Farmaceutica; Samson Medcl; Sandoz

8 of 8  
Drug NameKefzol
Active IngredientCefazolin sodium
Dosage FormInjectable
RouteInjection
Strengtheq 500mg base/vial; eq 10gm base/vial; eq 1gm base/vial
Market StatusPrescription
CompanyAcs Dobfar

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 Reference Price

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RAILWAY STATION"},{"dataSource":"API Import","activeIngredients":"","year":"2022","qtr":"Q4","strtotime":1668364200,"product":"CEFAZOLIN SODIUM STERILE EP","address":"4TH FLOOR PLOT NO. 16 SECTOR 22 IT PARK","city":"PANCHKULA","supplier":"SINOBRIGHT PHARMACEUTICAL COMPANY LTD","supplierCountry":"CHINA","foreign_port":"NA","customer":"ZEISS PHARMA","customerCountry":"INDIA","quantity":"200.00","actualQuantity":"200","unit":"KGS","unitRateFc":"141","totalValueFC":"28955.8","currency":"USD","unitRateINR":"11815.8","date":"14-Nov-2022","totalValueINR":"2363160","totalValueInUsd":"28955.8","indian_port":"DELHI AIR","hs_no":"29419090","bill_no":"3288226","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Sterile","supplierPort":"NA","supplierAddress":"","customerAddress":"4TH FLOOR PLOT NO. 16 SECTOR 22 IT PARK"},{"dataSource":"API Import","activeIngredients":"","year":"2022","qtr":"Q4","strtotime":1670524200,"product":"CEFAZOLIN SODIUM STERILE USP (QTY: 900 KGS)","address":"PLOT NO.2, MAITRIVIHAR BEHIND MAITRIVANAM, AMEERPET","city":"HYDERABAD","supplier":"SINOBRIGHT PHARMACEUTICAL COMPANY LTD","supplierCountry":"CHINA","foreign_port":"NA","customer":"AUROBINDO PHARMA LIMITED","customerCountry":"INDIA","quantity":"900.00","actualQuantity":"900","unit":"KGS","unitRateFc":"126.5","totalValueFC":"113288.7","currency":"USD","unitRateINR":"10373","date":"09-Dec-2022","totalValueINR":"9335700","totalValueInUsd":"113288.7","indian_port":"HYDERABAD AIR","hs_no":"29419090","bill_no":"3675510","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Sterile","supplierPort":"NA","supplierAddress":"","customerAddress":"PLOT NO.2, MAITRIVIHAR BEHIND MAITRIVANAM, AMEERPET"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q3","strtotime":1692901800,"product":"CEFAZOLIN SODIUM STERILE USP QTY: 500 KGS","address":"PLOT NO.2, MAITRIVIHAR,,BEHIND MAI TRIVANAM, AMEERPET,","city":"Hyderabad","supplier":"SINOBRIGHT PHARMACEUTICAL COMPANY LTD","supplierCountry":"CHINA","foreign_port":"NA","customer":"AUROBINDO PHARMA LIMITED","customerCountry":"INDIA","quantity":"500.00","actualQuantity":"500","unit":"KGS","unitRateFc":"126.5","totalValueFC":"63934.1","currency":"USD","unitRateINR":"10486.2","date":"25-Aug-2023","totalValueINR":"5296061.65","totalValueInUsd":"63934.1","indian_port":"HYDERABAD AIR","hs_no":"29419090","bill_no":"0","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Sterile","supplierPort":"NA","supplierAddress":"","customerAddress":"PLOT NO.2, MAITRIVIHAR,,BEHIND MAI TRIVANAM, AMEERPET,"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q4","strtotime":1696962600,"product":"CEFAZOLIN SODIUM STERILE USP","address":"PLOT NO.2, MAITRIVIHAR,","city":"HYDERABAD\/ANDHRA PRADESH","supplier":"SINOBRIGHT PHARMACEUTICAL COMPANY LTD","supplierCountry":"CHINA","foreign_port":"CHENGDU","customer":"AUROBINDO PHARMA LIMITED","customerCountry":"INDIA","quantity":"700.00","actualQuantity":"700","unit":"KGS","unitRateFc":"126.5","totalValueFC":"89529.6","currency":"USD","unitRateINR":"10645","date":"11-Oct-2023","totalValueINR":"7451482.5","totalValueInUsd":"89529.6","indian_port":"Hyderabad Air","hs_no":"29419090","bill_no":"8248257","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Sterile","supplierPort":"CHENGDU","supplierAddress":"RM D10 F TOWER A BILLION CTR 1 WANGKWONG RD KIN BAY KI,HONG KONG,CHINA MFG-CSPC ZHONGNUO PHARMACEUTICAL China","customerAddress":"PLOT NO.2, MAITRIVIHAR,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q1","strtotime":1706293800,"product":"CEFAZOLIN SODIUM STERILE","address":"304, SAMAAN-II, OPP. RELIANCE","city":"GARDEN SATELLITE, AHMEDABAD-GUJARAT","supplier":"HARBIN HEJIA PHARMACEUTICAL CO., LTD.","supplierCountry":"CHINA","foreign_port":"BEIJING","customer":"SWISS PARENTERALS LIMITED","customerCountry":"INDIA","quantity":"120.00","actualQuantity":"120","unit":"KGS","unitRateFc":"108","totalValueFC":"13114.1","currency":"USD","unitRateINR":"9082.8","date":"27-Jan-2024","totalValueINR":"1089936","totalValueInUsd":"13114.1","indian_port":"Ahmedabad Air","hs_no":"29419090","bill_no":"9854048","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Sterile","supplierPort":"BEIJING","supplierAddress":"ECONOMIC AND TECHNOLOGY DEVELOPMENTZONE, SHANGZHI CITY, HEILONGJIANGPROVINCE, CHINA, 150600 CHINA","customerAddress":"304, SAMAAN-II, OPP. RELIANCE"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q2","strtotime":1718217000,"product":"CEFAZOLIN SODIUM STERILE","address":"304, SAMAAN-II, OPP. RELIANCE","city":"GARDEN SATELLITE, AHMEDABAD-GUJARAT","supplier":"HARBIN HEJIA PHARMACEUTICAL CO.,LTD.","supplierCountry":"CHINA","foreign_port":"BEIJING","customer":"SWISS PARENTERALS LIMITED","customerCountry":"INDIA","quantity":"150.00","actualQuantity":"150","unit":"KGS","unitRateFc":"108","totalValueFC":"16359.2","currency":"USD","unitRateINR":"9104.4","date":"13-Jun-2024","totalValueINR":"1365660","totalValueInUsd":"16359.2","indian_port":"Ahmedabad Air","hs_no":"29419090","bill_no":"3970541","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Sterile","supplierPort":"BEIJING","supplierAddress":"ECONOMIC AND TECHNOLOGICAL DEVELOPMENT ZONE, SHANGZHI CITY,HEILONGJIANG PROVINCE CHINA. CHINA","customerAddress":"304, SAMAAN-II, OPP. RELIANCE"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1729621800,"product":"CEFAZOLIN SODIUM IP\/BP\/USP","address":"SURVEY NO.144 146, VILLAGE","city":"DIST.VADODARA, GUJARAT","supplier":"HARBIN HEJIA PHARMACEUTICAL CO.,LTD","supplierCountry":"CHINA","foreign_port":"XINGANG","customer":"BHARAT PARENTERALS LIMITED","customerCountry":"INDIA","quantity":"7000.00","actualQuantity":"7000","unit":"KGS","unitRateFc":"94","totalValueFC":"665231.4","currency":"USD","unitRateINR":"7985.3","date":"23-Oct-2024","totalValueINR":"55897100","totalValueInUsd":"665231.4","indian_port":"JNPT","hs_no":"29419090","bill_no":"6277429","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"XINGANG","supplierAddress":".ECONOMIC AND TECHNOLOGICAL DEVELOP MENT ZONESHANGZHI CITY, HEILONGJIAN G, CHINA","customerAddress":"SURVEY NO.144 146, VILLAGE"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1734028200,"product":"CEFAZOLIN SODIUM BP USP","address":"SURVEY NO.144 146, VILLAGE","city":"DIST.VADODARA, GUJARAT","supplier":"HARBIN HEJIA PHARMACEUTICAL CO., LT","supplierCountry":"CHINA","foreign_port":"BEIJING","customer":"BHARAT PARENTERALS LIMITED","customerCountry":"INDIA","quantity":"400.00","actualQuantity":"400","unit":"KGS","unitRateFc":"96.5","totalValueFC":"38909.4","currency":"USD","unitRateINR":"8265.2","date":"13-Dec-2024","totalValueINR":"3306090","totalValueInUsd":"38909.4","indian_port":"Ahmedabad Air","hs_no":"29419090","bill_no":"7213673","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"BEIJING","supplierAddress":"ECONOMIC & TECHNOLOGICAL DEVELOPMEN T ZONE SHANGZHI CITY, HEILONGJIANG PROVINCE CHINA CHINA","customerAddress":"SURVEY NO.144 146, VILLAGE"}]
28-Jan-2021
16-Dec-2024
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DRUG PRODUCT COMPOSITIONS

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DOSAGE - SOLUTION;INTRAVENOUS - EQ 1GM BASE/5...DOSAGE - SOLUTION;INTRAVENOUS - EQ 1GM BASE/50ML (EQ 20MG BASE/ML)

USFDA APPLICATION NUMBER - 207131

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DOSAGE - SOLUTION;INTRAVENOUS - EQ 2GM BASE/1...DOSAGE - SOLUTION;INTRAVENOUS - EQ 2GM BASE/100ML (EQ 20MG BASE/ML)

USFDA APPLICATION NUMBER - 207131

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DOSAGE - SOLUTION;INTRAVENOUS - EQ 3GM BASE/1...DOSAGE - SOLUTION;INTRAVENOUS - EQ 3GM BASE/150ML (EQ 20MG BASE/ML)

USFDA APPLICATION NUMBER - 207131

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DOSAGE - INJECTABLE;INJECTION - EQ 1GM BASE/V...DOSAGE - INJECTABLE;INJECTION - EQ 1GM BASE/VIAL

USFDA APPLICATION NUMBER - 50779

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DOSAGE - INJECTABLE;INJECTION - EQ 2GM BASE/V...DOSAGE - INJECTABLE;INJECTION - EQ 2GM BASE/VIAL

USFDA APPLICATION NUMBER - 50779

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ABOUT THIS PAGE

Cefazolin Sodium Manufacturers

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

Cefazolin Sodium Suppliers

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

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

Cefazolin Sodium USDMF

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

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

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

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

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

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

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

Cefazolin Sodium CEP

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

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

Cefazolin Sodium WC

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

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

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

Finished drug products

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

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

Cefazolin Sodium GMP

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

Cefazolin Sodium CoA

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

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

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