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Chemistry

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Also known as: Vantin, Banan, 87239-81-4, Orelox, Doxef, Cs-807
Molecular Formula
C21H27N5O9S2
Molecular Weight
557.6  g/mol
InChI Key
LTINZAODLRIQIX-FBXRGJNPSA-N
FDA UNII
2TB00A1Z7N

Cefpodoxime Proxetil
Cefpodoxime Proxetil is a third generation semi-synthetic cephalosporin and a beta-lactam antibiotic with bactericidal activity. Cefpodoxime's effect is dependent on its binding to penicillin-binding proteins (PBPs) located in the bacterial cytoplasmic membrane. Binding results in the inhibition of the transpeptidase enzymes, thereby preventing cross-linking of the pentaglycine bridge with the fourth residue of the pentapeptide and interrupting consequent synthesis of peptidoglycan chains. As a result, cefpodoxime inhibits bacterial septum and cell wall synthesis formation.
1 2D Structure

Cefpodoxime Proxetil

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
1-propan-2-yloxycarbonyloxyethyl (6R,7R)-7-[[(2Z)-2-(2-amino-1,3-thiazol-4-yl)-2-methoxyiminoacetyl]amino]-3-(methoxymethyl)-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylate
2.1.2 InChI
InChI=1S/C21H27N5O9S2/c1-9(2)33-21(30)35-10(3)34-19(29)15-11(6-31-4)7-36-18-14(17(28)26(15)18)24-16(27)13(25-32-5)12-8-37-20(22)23-12/h8-10,14,18H,6-7H2,1-5H3,(H2,22,23)(H,24,27)/b25-13-/t10?,14-,18-/m1/s1
2.1.3 InChI Key
LTINZAODLRIQIX-FBXRGJNPSA-N
2.1.4 Canonical SMILES
CC(C)OC(=O)OC(C)OC(=O)C1=C(CSC2N1C(=O)C2NC(=O)C(=NOC)C3=CSC(=N3)N)COC
2.1.5 Isomeric SMILES
CC(C)OC(=O)OC(C)OC(=O)C1=C(CS[C@H]2N1C(=O)[C@H]2NC(=O)/C(=N\OC)/C3=CSC(=N3)N)COC
2.2 Other Identifiers
2.2.1 UNII
2TB00A1Z7N
2.3 Synonyms
2.3.1 MeSH Synonyms

1. 1-(isopropoxycarbonyloxy)ethyl-7-(2-(2-amino-4-thiazolyl)-2-(methoxyimino)acetamido)-3-methoxymethyl-8-oxo-5-thia-1-azabicyclo(4,2,0)-oct-2-ene-2-carboxylate

2. Cephalosporin 807

3. Cs 807

4. Cs-807

5. Doxef

6. U 76252

7. U-76,252

8. Vantin

2.3.2 Depositor-Supplied Synonyms

1. Vantin

2. Banan

3. 87239-81-4

4. Orelox

5. Doxef

6. Cs-807

7. Simplicef

8. Otreon

9. U-76252

10. Podomexef

11. Chebi:3505

12. 2tb00a1z7n

13. Cefodox

14. Nsc-759161

15. (rs)-1-((isopropoxycarbonyl)oxy)ethyl (+)-(6r,7r)-7-(2-(2-amino-4-thiazolyl)-2-((z)-methoxyimino)acetamido)-3-(methoxymethyl)-8-oxo-5-thia-1-azabicyclo(4.2.0)oct-2-ene-2-carboxylate

16. Dsstox_cid_2766

17. Dsstox_rid_76722

18. Cefpodoxime 1-(isopropyloxycarbonyloxy)ethyl Ester

19. Dsstox_gsid_22766

20. Xtum-o

21. 1-{[(propan-2-yloxy)carbonyl]oxy}ethyl (6r,7r)-7-{[(2z)-2-(2-amino-1,3-thiazol-4-yl)-2-(methoxyimino)acetyl]amino}-3-(methoxymethyl)-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylate

22. 1-{[(propan-2-yloxy)carbonyl]oxy}ethyl 7beta-[(2z)-2-(2-amino-1,3-thiazol-4-yl)-2-(methoxyimino)acetamido]-3-(methoxymethyl)-3,4-didehydrocepham-4-carboxylate

23. Cas-87239-81-4

24. Simplicef [veterinary]

25. Unii-2tb00a1z7n

26. Orelox Paed

27. Ncgc00164598-01

28. Ncgc00183131-01

29. Mfcd00865088

30. Vantin (tn)

31. Cefpodoxime Proxetil [usan:usp:jan]

32. Schembl27071

33. Mls001401428

34. Chembl1201016

35. Dtxsid1022766

36. Cefpodoxime (as Proxetil)

37. Cefpodoxime Proxetil (jp17/usp)

38. Cefpodoxime Proxetil [jan]

39. Hms3715j22

40. Cefpodoxime Proxetil [usan]

41. Cefpodoxime Proxetil, Vantin

42. Hy-n7101

43. Cefpodoxime Proxetil [vandf]

44. Tox21_113377

45. Tox21_113428

46. Bdbm50248233

47. Cefpodoxime Proxetil [mart.]

48. S5350

49. Cefpodoxime Proxetil [usp-rs]

50. Cefpodoxime Proxetil [who-dd]

51. Akos015994692

52. Ccg-221250

53. Ks-1149

54. Nsc 759161

55. Cefpodoxime Proxetil [green Book]

56. (+-)-1-hydroxyethyl (+)-(6r,7r)-7-(2-(2-amino-4-thiazolyl)glyoxylamido)-3-(methoxymethyl)-8-oxo-5-thia-1-azabicyclo(4.2.0)oct-2-ene-2-carboxylate, 7(sup 2)-(z)-(o-methyloxime), Isopropyl Carbonate (ester)

57. Cefpodoxime Proxetil [orange Book]

58. Ru-51807

59. Smr000469193

60. Cefpodoxime Proxetil [ep Monograph]

61. Cefpodoxime Proxetil [usp Impurity]

62. Cefpodoxime Proxetil [usp Monograph]

63. Cefpodoxime Proxetil For Peak Identification

64. Cs-0027614

65. C08115

66. D00920

67. Ab01209734-01

68. 239c814

69. A842048

70. Cefpodoxime Proxetil For Impurity H Identification

71. Cefpodoxime 1-(isopropoxycarbonyloxy)ethyl Ester

72. Cefpodoxime 1-(isopropoxycarbonyloxy)ethyl Ester [mi]

73. (+/-)-1-hydroxyethyl (+)-(6r,7r)-7-(2-(2-amino-4-thiazolyl)glyoxylamido)-3-(methoxymethyl)-8-oxo-5-thia-1-azabicyclo(4.2.0)oct-2-ene-2-carboxylate, 7 (sup 2)-(z)-(o-methyloxime), Isopropyl Carbonate (ester)

74. (6r,7r)-1-((isopropoxycarbonyl)oxy)ethyl 7-((z)-2-(2-aminothiazol-4-yl)-2-(methoxyimino)acetamido)-3-(methoxymethyl)-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylate

75. (6r,7r)-7-(((2z)-2-(2-amino-4-thiazolyl)-2-(methoxyimino)acetyl)amino)-3-(methoxymethyl)-8-oxo-5-thia-1-azabicyclo(4.2.0)oct-2-ene-2-carboxylic Acid 1-(((1-methylethoxy)carbonyl)oxy)ethyl Ester

76. 1-({[(1-methylethyl)oxy]carbonyl}oxy)ethyl (6r,7r)-7-({(2z)-2-(2-amino-1,3-thiazol-4-yl)-2-[(methyloxy)imino]acetyl}amino)-3-[(methyloxy)methyl]-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylate

77. 5-thia-1-azabicyclo(4.2.0)oct-2-ene-2-carboxylic Acid, 7-(((2-amino-4-thiazolyl)(methoxyimino)acetyl)amino)-3-(methoxymethyl)-8-oxo-, 1-(((1-methylethoxy)carbonyl)oxy)ethyl Ester, (6r-(6.alpha.,7.beta.(z)))-

78. 5-thia-1-azabicyclo(4.2.0)oct-2-ene-2-carboxylic Acid, 7-(((2-amino-4-thiazolyl)(methoxyimino)acetyl)amino)-3-(methoxymethyl)-8-oxo-, 1-(((1-methylethoxy)carbonyl)oxy)ethyl Ester, (6r-(6alpha,7beta(z)))-

79. 5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic Acid, 7-[[(2z)-(2-amino-4-thiazolyl)(methoxyimino)acetyl]amino]-3-(methoxymethyl)-8-oxo-, 1-[[(1-methylethoxy)carbonyl]oxy]ethyl Ester, (6r,7r)-

2.4 Create Date
2006-05-03
3 Chemical and Physical Properties
Molecular Weight 557.6 g/mol
Molecular Formula C21H27N5O9S2
XLogP30.6
Hydrogen Bond Donor Count2
Hydrogen Bond Acceptor Count14
Rotatable Bond Count13
Exact Mass557.12501980 g/mol
Monoisotopic Mass557.12501980 g/mol
Topological Polar Surface Area235 Ų
Heavy Atom Count37
Formal Charge0
Complexity976
Isotope Atom Count0
Defined Atom Stereocenter Count2
Undefined Atom Stereocenter Count1
Defined Bond Stereocenter Count1
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count1
4 Drug and Medication Information
4.1 Drug Information
1 of 2  
Drug NameCefpodoxime proxetil
PubMed HealthCefpodoxime Proxetil (By mouth)
Drug ClassesAntibiotic
Drug LabelCefpodoxime proxetil is an orally administered, extended spectrum, semi-synthetic antibiotic of the cephalosporin class. The chemical name is (RS)-1(isopropoxycarbonyloxy) ethyl (+)-(6R,7R)-7-[2-(2-amino-4-thiazolyl)-2-{(Z)methoxyimino}acetamido]-3-m...
Active IngredientCefpodoxime proxetil
Dosage FormTablet; For suspension
RouteOral
Strengtheq 100mg base; eq 200mg base; eq 100mg base/5ml; eq 50mg base/5ml
Market StatusPrescription
CompanyRanbaxy; Aurobindo Pharma; Sandoz; Orchid Hlthcare

2 of 2  
Drug NameCefpodoxime proxetil
PubMed HealthCefpodoxime Proxetil (By mouth)
Drug ClassesAntibiotic
Drug LabelCefpodoxime proxetil is an orally administered, extended spectrum, semi-synthetic antibiotic of the cephalosporin class. The chemical name is (RS)-1(isopropoxycarbonyloxy) ethyl (+)-(6R,7R)-7-[2-(2-amino-4-thiazolyl)-2-{(Z)methoxyimino}acetamido]-3-m...
Active IngredientCefpodoxime proxetil
Dosage FormTablet; For suspension
RouteOral
Strengtheq 100mg base; eq 200mg base; eq 100mg base/5ml; eq 50mg base/5ml
Market StatusPrescription
CompanyRanbaxy; Aurobindo Pharma; Sandoz; Orchid Hlthcare

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]

JDMF

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Excipient World
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Cefpodoxime Proxetil

Registration Number : 301MF10023

Registrant's Address : Village Saidpura, Tehsil Dera Bassi, District Sahibzada Ajit Singh Nagar-140 507, Pun...

Initial Date of Registration : 2019-06-28

Latest Date of Registration : 2019-06-28

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02

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Cefpodoxime Proxetil

Registration Number : 306MF10078

Registrant's Address : Plot No. 121-128, 128A-133, 138-151, 159-164, SIDCO Industrial Estate, Alathur, Cheng...

Initial Date of Registration : 2024-06-12

Latest Date of Registration : 2024-06-12

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CEFPODOXIME PROXETIL

Registration Number : 223MF10157

Registrant's Address : S. C. O. 99-100, 3rd & 4th Floor, Sector 17-B, Chandigarh-160017, INDIA

Initial Date of Registration : 2011-11-02

Latest Date of Registration : 2011-11-02

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04

Excipient World
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Cefpodoxime proxetil

Registration Number : 303MF10058

Registrant's Address : No. 849 Dongjia Town, Licheng District, Jinan, Shandong, China

Initial Date of Registration : 2021-04-02

Latest Date of Registration : 2023-08-09

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05

Sandoz GmbH

Switzerland
Excipient World
Not Confirmed
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Sandoz GmbH

Switzerland
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Cefpodoxime proxetil

Registration Number : 225MF10129

Registrant's Address : Biochemiesstrasse 10,6250 Kundl, Austria

Initial Date of Registration : 2013-07-09

Latest Date of Registration : 2013-07-09

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CEFPODOXIME PROXETIL

Registration Number : 222MF10026

Registrant's Address : Plot No. 90, Sector 32, Gurgaon, Haryana 122011, India

Initial Date of Registration : 2010-01-22

Latest Date of Registration : 2010-01-22

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07

Excipient World
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Cefpodoxime Proxetil

Registration Number : 227MF10122

Registrant's Address : 13, Olympic-ro 35da-gil, Songpa-gu, Seoul, Korea

Initial Date of Registration : 2015-04-22

Latest Date of Registration : 2015-04-22

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API Reference Price

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","customerCountry":"VIETNAM","quantity":"500.00","actualQuantity":"500","unit":"KGS","unitRateFc":"129","totalValueFC":"63301.3","currency":"USD","unitRateINR":10966.0062,"date":"28-Mar-2025","totalValueINR":"5483003.1","totalValueInUsd":"63301.3","indian_port":"Madras Air","hs_no":"29419090","bill_no":"9454421","productDescription":"API","marketType":"","country":"VIETNAM","selfForZScoreResived":"Pharma Grade","supplierPort":"Madras Air","supplierAddress":"ORCHID TOWERS, 313, VALLUVARKOTTAM, CHENNAI","customerAddress":""},{"dataSource":"API Import","activeIngredients":"CEFPODOXIME PROXETIL","year":"2021","qtr":"Q1","strtotime":1609525800,"product":"CEFPODOXIME PROXETIL EP (RE-IMPORT VIDE SB NO:1685093 DT:26.02.2020)","address":"8-3-677\/18, S.K.D.NAGARYELLAREDDYGUDA","city":"HYDERABAD.AP","supplier":"ULKAR HOLDING","supplierCountry":"INDIA","foreign_port":"ISTANBUL","customer":"VIRCHOW 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GROUP","customerCountry":"INDIA","quantity":"18.00","actualQuantity":"18","unit":"KGS","unitRateFc":"275","totalValueFC":"5252.1","currency":"USD","unitRateINR":"21339.9","date":"02-Jan-2021","totalValueINR":"384118.87","totalValueInUsd":"5252.1","indian_port":"HYDERABAD AIR","hs_no":"29419090","bill_no":"2203920","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"ISTANBUL","supplierAddress":"","customerAddress":"8-3-677\/18, S.K.D.NAGARYELLAREDDYGUDA"},{"dataSource":"API Import","activeIngredients":"CEFPODOXIME PROXETIL","year":"2021","qtr":"Q1","strtotime":1609525800,"product":"CEFPODOXIME PROXETIL USP (RE-IMPORT VIDE SB NO:2933559 DT:22.03.2019)","address":"8-3-677\/18, S.K.D.NAGARYELLAREDDYGUDA","city":"HYDERABAD.AP","supplier":"ULKAR HOLDING","supplierCountry":"INDIA","foreign_port":"ISTANBUL","customer":"VIRCHOW GROUP","customerCountry":"INDIA","quantity":"200.00","actualQuantity":"200","unit":"KGS","unitRateFc":"190","totalValueFC":"40318.8","currency":"USD","unitRateINR":"14744","date":"02-Jan-2021","totalValueINR":"2948791.35","totalValueInUsd":"40318.8","indian_port":"HYDERABAD AIR","hs_no":"29419090","bill_no":"2203920","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"ISTANBUL","supplierAddress":"","customerAddress":"8-3-677\/18, S.K.D.NAGARYELLAREDDYGUDA"},{"dataSource":"API Import","activeIngredients":"","year":"2021","qtr":"Q4","strtotime":1634322600,"product":"CEFPODOXIME PROXETIL USP (RE-IMPORT VIDE SB NO:8028832 DT:20.01.2021)","address":"8-3-677\/18, S K D NAGAR,YELLAREDDY GUDA","city":"HYDERABAD,TELANGANA","supplier":"PHARMA INTERNATIONAL CO.","supplierCountry":"INDIA","foreign_port":"NA","customer":"VIRCHOW GROUP","customerCountry":"INDIA","quantity":"438.12","actualQuantity":"438.12","unit":"KGS","unitRateFc":"135","totalValueFC":"62634.3","currency":"USD","unitRateINR":"10709.5","date":"16-Oct-2021","totalValueINR":"4692056.99","totalValueInUsd":"62634.3","indian_port":"HYDERABAD AIR","hs_no":"29419090","bill_no":"5860855","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"8-3-677\/18, S K D NAGAR,YELLAREDDY GUDA"},{"dataSource":"API Import","activeIngredients":"","year":"2022","qtr":"Q1","strtotime":1642444200,"product":"CEFPODOXIME PROXETIL (RE-IMPORT AFTER REJECTION)","address":"VILLAGE SAIDPURA,TEHSIL DERABASSI","city":"MOHALI,PUNJAB","supplier":"VIVATIS","supplierCountry":"INDIA","foreign_port":"#N\/A","customer":"NECTAR LIFE SCIENCES 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","supplierCountry":"INDIA","foreign_port":"NA","customer":"VIRCHOW GROUP","customerCountry":"INDIA","quantity":"200.00","actualQuantity":"200","unit":"KGS","unitRateFc":"380","totalValueFC":"78396.8","currency":"USD","unitRateINR":"32124.6","date":"29-Apr-2023","totalValueINR":"6424917.35","totalValueInUsd":"78396.8","indian_port":"HYDERABAD AIR","hs_no":"29419090","bill_no":"5736890","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"8-3-677\/18, S K D NAGAR,YELLAREDDY GUDA"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q4","strtotime":1697221800,"product":"CEFPODOXIME PROXETIL (RE-IMPORT AFTER REJECTION)","address":"VILLAGE SAIDPURA,TEHSIL DERABASSI,","city":"MOHALI (PUNJAB)","supplier":"HEMOFARM AD-VRSAC","supplierCountry":"INDIA","foreign_port":"YELGRAD (BEOGRAD)","customer":"NECTAR LIFE SCIENCES LIMITED","customerCountry":"INDIA","quantity":"691.52","actualQuantity":"691.52","unit":"KGS","unitRateFc":"548","totalValueFC":"394757.6","currency":"USD","unitRateINR":"47511.9","date":"14-Oct-2023","totalValueINR":"32855397.32","totalValueInUsd":"394757.6","indian_port":"Delhi Air","hs_no":"29419090","bill_no":"8304575","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"YELGRAD (BEOGRAD)","supplierAddress":"BEOGRADSKI PUT BB VRSAC 26300 SERBIA, , SerbiaSDNF Serbia","customerAddress":"VILLAGE SAIDPURA,TEHSIL DERABASSI,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1723573800,"product":"CEFPODOXIME PROXETIL (QTY: 1 X 0.2GMS, VALUE USD: 15.35) (FOC)","address":"P.NO. D6 D8, SY.NO. 234\/2,234\/3,","city":"TURKAPALLY(V),SHAMEERPET, HYDERABAD","supplier":"UNITED STATES PHARMACOPEIAL","supplierCountry":"INDIA","foreign_port":"WASHINGTON, DULLES I","customer":"UNITED STATES PHARMACOPEIA - INDIA PRIVATE LIMITED","customerCountry":"INDIA","quantity":"0.00","actualQuantity":"0.0002","unit":"KGS","unitRateFc":"76750","totalValueFC":"16","currency":"USD","unitRateINR":"6717750","date":"14-Aug-2024","totalValueINR":"1343.55","totalValueInUsd":"16","indian_port":"Hyderabad Air","hs_no":"29419090","bill_no":"5055144","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"WASHINGTON, DULLES I","supplierAddress":"7135 ENGLISH MUFFIN WAY FREDERICK,MD,US 21704,UNITED STATES OF AMERICASDNF United States","customerAddress":"P.NO. D6 D8, SY.NO. 234\/2,234\/3,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1723573800,"product":"CEFPODOXIME PROXETIL (QTY: 2 X 0.25GMS, VALUE USD: 15.94\/EACH) (FOC)","address":"P.NO. 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D6 D8, SY.NO. 234\/2,234\/3,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1723573800,"product":"CEFPODOXIME PROXETIL (QTY: 3 X 0.1GMS, VALUE USD: 14.18\/EACH) (FOC)","address":"P.NO. 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CO","customerAddress":"8-3-677\/18, S.K.D.NAGAR"}]
02-Jan-2021
28-Mar-2025
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ABOUT THIS PAGE

Looking for 87239-81-4 / Cefpodoxime Proxetil API manufacturers, exporters & distributors?

Cefpodoxime Proxetil manufacturers, exporters & distributors 1

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PharmaCompass offers a list of Cefpodoxime Proxetil 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 Cefpodoxime Proxetil manufacturer or Cefpodoxime Proxetil supplier for your needs.

Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Cefpodoxime Proxetil manufacturer or Cefpodoxime Proxetil supplier.

PharmaCompass also assists you with knowing the Cefpodoxime Proxetil API Price utilized in the formulation of products. Cefpodoxime Proxetil API Price is not always fixed or binding as the Cefpodoxime Proxetil Price is obtained through a variety of data sources. The Cefpodoxime Proxetil Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

API | Excipient name

Cefpodoxime Proxetil

Synonyms

Vantin, Banan, 87239-81-4, Orelox, Doxef, Cs-807

Cas Number

87239-81-4

Unique Ingredient Identifier (UNII)

2TB00A1Z7N

About Cefpodoxime Proxetil

Cefpodoxime Proxetil is a third generation semi-synthetic cephalosporin and a beta-lactam antibiotic with bactericidal activity. Cefpodoxime's effect is dependent on its binding to penicillin-binding proteins (PBPs) located in the bacterial cytoplasmic membrane. Binding results in the inhibition of the transpeptidase enzymes, thereby preventing cross-linking of the pentaglycine bridge with the fourth residue of the pentapeptide and interrupting consequent synthesis of peptidoglycan chains. As a result, cefpodoxime inhibits bacterial septum and cell wall synthesis formation.

Otreon Manufacturers

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

Otreon Suppliers

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

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

Otreon USDMF

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

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

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

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

Otreon KDMF

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

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

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

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

Otreon CEP

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

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

Otreon WC

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

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

Otreon 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 Otreon as an active pharmaceutical ingredient (API).

Finished drug products

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

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

Otreon GMP

Otreon 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 Otreon 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 Otreon GMP manufacturer or Otreon GMP API supplier for your needs.

Otreon CoA

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

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

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