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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]

Listed Suppliers

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LGM Pharma

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  • WHO-GMP

Virtual BoothLGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.

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Cefpodoxime Proxetil

About the Company : LGM Pharma is a global leader in sourcing hard-to-find APIs and intermediates for the pharmaceutical and biotech industries. LGM is also a full service CDMO providing formulation, ...

LGM Pharma is a global leader in sourcing hard-to-find APIs and intermediates for the pharmaceutical and biotech industries. LGM is also a full service CDMO providing formulation, analytical method development and testing, and commercial manufacturing. LGM Pharma offers custom API synthesis, analytical development, and regulatory services. With a network of over 300 accredited CGMP manufacturing partners, LGM provides unparalleled supply chain security. And, with over 100,000 square feet of FDA-inspected cGMP manufacturing and warehouse capacity, LGM Pharma provides a one-stop solution for solid dose, powder, semi-solid and liquid drugs.
LGM Pharma CB

02

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Virtual BoothHRV Global Life Sciences - Market Expansion Leader in Pharmaceuticals.

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Cefpodoxime Proxetil

About the Company : HRV Global is a leading global manufacturer, seller & exporter of a wide range of APIs, advanced intermediates, pellets, food grade chemicals, food additives & food ingredients. It...

HRV Global is a leading global manufacturer, seller & exporter of a wide range of APIs, advanced intermediates, pellets, food grade chemicals, food additives & food ingredients. It offers services such as sourcing, manufacturing & supply, helping partners enter new markets worldwide. Its strong partnerships with major players in the pharma and food additive industries help HRV Global effectively promote projects and products. HRV Global represents over 30 large Indian drugmakers, primarily targeting Europe, the US & the Middle East markets. Headquartered in India, HRV Global has offices in the US, Switzerland, Dubai, Lithuania & Turkey.
HRV Global Life Sciences

03

MAGHREB PHARMA
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Cefpodoxime Proxetil

About the Company : Akums Lifescience Ltd. is a research-based, vertically integrated company specializing in the development, manufacturing and sale of APIs and intermediates. Akums has established i...

Akums Lifescience Ltd. is a research-based, vertically integrated company specializing in the development, manufacturing and sale of APIs and intermediates. Akums has established itself as a leading generic medicine manufacturing company from India, with clients in over 51 countries. It has a facility dedicated to custom research and synthesis. Akums’ manufacturing facilities are spread across three locations in two Indian states. Its stringent policies and procedures ensure that that all regulatory requirements, environmental standards, and technological trends are met. Akums is EU-GMP, KFDA, WHO-GMP and PMDA certified.
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Cefpodoxime Proxetil

About the Company : Asia Pioneer Pharmaceuticals is a leading supplier of fine chemicals, pharmaceutical intermediates, active pharmaceutical ingredients and other compounds. It also offers finished p...

Asia Pioneer Pharmaceuticals is a leading supplier of fine chemicals, pharmaceutical intermediates, active pharmaceutical ingredients and other compounds. It also offers finished product licensing, custom manufacturing and outsourcing services. In partnership with state-of-the-art manufacturers in China, Asia Pioneer provides world-class quality products at excellent value, in full compliance with standards required by leading regulatory agencies in the USA and Europe.
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About the Company : Guangzhou Tosun Pharmaceutical was founded in 1999, which mainly focuses on importation & exportation of Active Pharmaceutical Ingrediants, Chemical Raw Materials, Intermediate, Ex...

Guangzhou Tosun Pharmaceutical was founded in 1999, which mainly focuses on importation & exportation of Active Pharmaceutical Ingrediants, Chemical Raw Materials, Intermediate, Excipients, Herbal extracts, Formulation of Chinese & Western Medicine. With abundant economic strength, the group has successfully developed to a pharmaceutical group enterprise wich intergrets operation of medicine & related products, processing & manufacturing, and importation & exportation together.
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Cefpodoxime Pivoxil

About the Company : Since its foundation in 1959, JEIL Pharm established. its own central research laboratory for the formulation and synthesis of drugs, followed by its successive construction of KGM...

Since its foundation in 1959, JEIL Pharm established. its own central research laboratory for the formulation and synthesis of drugs, followed by its successive construction of KGMP factory in 1986. JEIL's fine chemical production facilities are entirely controlled by the BGMP according to the GMP guideline for bulk chemical production related to general, special, and aseptic pharmaceuticals.On the other hands, JEIL is manufacturing FDF Products sold to Japan and other countries.With marketing strategy of 'First generic' and Innovative drug, JEIL have been extended the market in world-wide.
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MAGHREB PHARMA
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Cefpodoxime Proxetil

About the Company : Neha Chemicals specializes in the production and supply of high-quality Active Pharmaceutical Ingredients (APIs) for various therapeutic applications. Committed to excellence and p...

Neha Chemicals specializes in the production and supply of high-quality Active Pharmaceutical Ingredients (APIs) for various therapeutic applications. Committed to excellence and precision, Neha Chemicals ensures that each API meets stringent industry standards for purity, safety, and efficacy. With a strong focus on innovation and compliance, the company provides reliable solutions to pharmaceutical manufacturers worldwide. Neha Chemicals is dedicated to supporting global healthcare needs by delivering APIs that empower the creation of effective and affordable medicines, fostering better health outcomes across communities.
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About the Company : Public health is always an imperative that implies immense responsibility, not a mere re-adjustable option. As a company operating under world’s second largest industry of Pharma...

Public health is always an imperative that implies immense responsibility, not a mere re-adjustable option. As a company operating under world’s second largest industry of Pharmaceuticals, Nishchem International Pvt. Ltd. (NIPL) stands on the virtue of revolutionizing the ends, as well as the means to safe and secure health. Medicinal drugs have always held an important place in the sphere of healing and treatment, with their applications ranging from diagnosis, treatment and cure right up to prophylaxis.
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Cefpodoxime Proxetil

About the Company : Located in Jinan, Qilu Pharmaceutical is one of the leading pharmaceutical companies in China. It focuses on developing, manufacturing and marketing of generic drugs and active pha...

Located in Jinan, Qilu Pharmaceutical is one of the leading pharmaceutical companies in China. It focuses on developing, manufacturing and marketing of generic drugs and active pharmaceutical ingredients in the therapeutic areas of Oncology, Cerebrovascular & Cardiovascular, Infections, Psychological and Neurological System, Respiratory System, Ophthalmological Diseases, etc. Always committing itself to meet the needs of the patients and the society. Qilu pharmaceutical provides high-quality products by adopting advanced technology. Qilu has 8000 employees , 5,000 of them have junior college or above educational backgrounp.
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Cefpodoxime Proxetil

About the Company : SNEHA MEDICARE PVT LTD., one of the pioneers in API sourcing and supply in India, was established in 1985 by Shri. Kirti M Shah in the name of SNEHA CHEMICALS, which was later chan...

SNEHA MEDICARE PVT LTD., one of the pioneers in API sourcing and supply in India, was established in 1985 by Shri. Kirti M Shah in the name of SNEHA CHEMICALS, which was later changed to M/s SNEHA MEDICARE PVT LTD. in the year 2002. sneha medicare is an established brand its import and exports. We thrive to provide our customers with the highest quality material, and have established ourselves among the most eminent and trustworthy supplier of High Grade APIs and formulations.
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D6 D8, SY.NO. 234\/2,234\/3,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1726079400,"product":"CEFPODOXIME PROXETIL MICRONIZED USP (RE-IMPORT VIDE SB NO:8754156 DT:30.03.2024).","address":"8-3-677\/18, S.K.D.NAGAR","city":"HYDERABAD.AP","supplier":"SYNTOFARMA S.A.DESCARGUE DIRECTO","supplierCountry":"INDIA","foreign_port":"BOGOTA","customer":"VIRCHOW GROUP","customerCountry":"INDIA","quantity":"150.00","actualQuantity":"150","unit":"KGS","unitRateFc":"196","totalValueFC":"31181.8","currency":"USD","unitRateINR":"17420.5","date":"12-Sep-2024","totalValueINR":"2613069.18","totalValueInUsd":"31181.8","indian_port":"Hyderabad Air","hs_no":"29419090","bill_no":"5560195","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Micronized","supplierPort":"BOGOTA","supplierAddress":"Y\/O DEPOSITO DE ADUANAS AINTERCARGA NIT:800.207.192-8,CALLE 166 NO,19 B -42,BOGOTA, CUNDINAMARCA,COLOMBIA. CO","customerAddress":"8-3-677\/18, S.K.D.NAGAR"}]
02-Jan-2021
24-Feb-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.

Cepodem Manufacturers

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

Cepodem Suppliers

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

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

Cepodem USDMF

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

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

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

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

Cepodem KDMF

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

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

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

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

Cepodem CEP

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

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

Cepodem WC

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

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

Cepodem 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 Cepodem as an active pharmaceutical ingredient (API).

Finished drug products

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

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

Cepodem GMP

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

Cepodem CoA

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

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

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