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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
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)-
| Molecular Weight | 557.6 g/mol |
|---|---|
| Molecular Formula | C21H27N5O9S2 |
| XLogP3 | 0.6 |
| Hydrogen Bond Donor Count | 2 |
| Hydrogen Bond Acceptor Count | 14 |
| Rotatable Bond Count | 13 |
| Exact Mass | 557.12501980 g/mol |
| Monoisotopic Mass | 557.12501980 g/mol |
| Topological Polar Surface Area | 235 Ų |
| Heavy Atom Count | 37 |
| Formal Charge | 0 |
| Complexity | 976 |
| Isotope Atom Count | 0 |
| Defined Atom Stereocenter Count | 2 |
| Undefined Atom Stereocenter Count | 1 |
| Defined Bond Stereocenter Count | 1 |
| Undefined Bond Stereocenter Count | 0 |
| Covalently Bonded Unit Count | 1 |
| 1 of 2 | |
|---|---|
| Drug Name | Cefpodoxime proxetil |
| PubMed Health | Cefpodoxime Proxetil (By mouth) |
| Drug Classes | Antibiotic |
| Drug Label | Cefpodoxime 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 Ingredient | Cefpodoxime proxetil |
| Dosage Form | Tablet; For suspension |
| Route | Oral |
| Strength | eq 100mg base; eq 200mg base; eq 100mg base/5ml; eq 50mg base/5ml |
| Market Status | Prescription |
| Company | Ranbaxy; Aurobindo Pharma; Sandoz; Orchid Hlthcare |
| 2 of 2 | |
|---|---|
| Drug Name | Cefpodoxime proxetil |
| PubMed Health | Cefpodoxime Proxetil (By mouth) |
| Drug Classes | Antibiotic |
| Drug Label | Cefpodoxime 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 Ingredient | Cefpodoxime proxetil |
| Dosage Form | Tablet; For suspension |
| Route | Oral |
| Strength | eq 100mg base; eq 200mg base; eq 100mg base/5ml; eq 50mg base/5ml |
| Market Status | Prescription |
| Company | Ranbaxy; Aurobindo Pharma; Sandoz; Orchid Hlthcare |
Anti-Bacterial Agents
Substances that inhibit the growth or reproduction of BACTERIA. (See all compounds classified as Anti-Bacterial Agents.)
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GDUFA
DMF Review : Reviewed
Rev. Date : 2020-03-09
Pay. Date : 2020-01-21
DMF Number : 34502
Submission : 2020-02-17
Status : Active
Type : II
Certificate Number : CEP 2020-399 - Rev 01
Issue Date : 2025-01-03
Type : Chemical
Substance Number : 2341
Status : Valid
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 :
NDC Package Code : 51810-052
Start Marketing Date : 2022-06-28
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Seongi Bio Co., Ltd.
Registration Date : 2022-07-01
Registration Number : 20200618-25-A-359-12(1)
Manufacturer Name : Qilu Antibiotics Pharmaceutical Co., Ltd.
Manufacturer Address : No.849 Dongjia Town, Licheng District, Jinan, Shandong Province, China
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20076
Submission : 2006-12-26
Status : Active
Type : II
Certificate Number : R0-CEP 2013-064 - Rev 00
Issue Date : 2013-09-30
Type : Chemical
Substance Number : 2341
Status : Withdrawn by Holder
Registrant Name : Lee Sung International Co., Ltd.
Registration Date : 2014-06-11
Registration Number : 20140611-25-A-300-07
Manufacturer Name : Sandoz GmbH
Manufacturer Address : Biochemiestraβe 10, 6250 Kundl, Austria
GDUFA
DMF Review : Reviewed
Rev. Date : 2017-02-27
Pay. Date : 2016-12-27
DMF Number : 29791
Submission : 2015-09-14
Status : Active
Type : II
Date of Issue : 2019-09-03
Valid Till : 2022-09-03
Written Confirmation Number : WC-0190
Address of the Firm :
NDC Package Code : 61788-5000
Start Marketing Date : 2004-05-29
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Youngjin Pharmaceutical Co., Ltd.
Registration Date : 2017-08-03
Registration Number : 20150410-25-A-305-10(1)
Manufacturer Name : Covalent Laboratories Pvt. Ltd
Manufacturer Address : Sy. No.374, Gundla Machanoor Village, Hathnoor Mandal, Sangareddy District - 502 296, Telangana State,
GDUFA
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Rev. Date :
Pay. Date :
DMF Number : 18505
Submission : 2005-07-11
Status : Active
Type : II
Registration Number : 306MF10078
Registrant's Address : Plot No. 121-128, 128A-133, 138-151, 159-164, SIDCO Industrial Estate, Alathur, Chengalpattu District-603 110, Tamilnadu, INDIA.
Initial Date of Registration : 2024-06-12
Latest Date of Registration :
Date of Issue : 2019-07-22
Valid Till : 2022-07-21
Written Confirmation Number : WC-0131
Address of the Firm :
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23572
Submission : 2010-02-23
Status : Active
Type : II
Date of Issue : 2022-05-17
Valid Till : 2025-05-16
Written Confirmation Number : WC-0008
Address of the Firm :
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16542
Submission : 2003-04-15
Status : Inactive
Type : II
Certificate Number : R1-CEP 2010-283 - Rev 01
Issue Date : 2017-12-05
Type : Chemical
Substance Number : 2341
Status : Valid
Registration Number : 225MF10129
Registrant's Address : Biochemiesstrasse 10,6250 Kundl, Austria
Initial Date of Registration : 2013-07-09
Latest Date of Registration :
Registrant Name : HKINNOEN Co., Ltd.
Registration Date : 2014-07-25
Registration Number : 20140611-25-A-300-07(1)
Manufacturer Name : Sandoz GmbH
Manufacturer Address : Biochemiestraβe 10, 6250 Kundl, Austria
GDUFA
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DMF Number : 6937
Submission : 1987-04-15
Status : Inactive
Type : II
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DMF Number : 9886
Submission : 1987-04-15
Status : Inactive
Type : II
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NDC Package Code : 65862-381
Start Marketing Date : 2024-01-05
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (50kg/50kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 59651-955
Start Marketing Date : 2024-03-11
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (50kg/50kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 61788-5000
Start Marketing Date : 2004-05-29
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 57297-100
Start Marketing Date : 2020-09-03
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 63785-112
Start Marketing Date : 2015-07-15
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 51810-052
Start Marketing Date : 2022-06-28
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 82608-013
Start Marketing Date : 2022-08-01
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
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INTERMEDIATE SUPPLIERS
CAS Number : 24701-69-7
End Use API : Cefpodoxime Proxetil
About The Company : Hubei Ling Sheng Pharmaceutical Co., Ltd. was established in December 29, 2010, the company is located in Xiangyang City, Hubei Province Xiangcheng Economic Dev...
(z)-4-Bromo-2-methoxyimino-3-oxobutyric acid
CAS Number : 79232-66-9
End Use API : Cefpodoxime Proxetil
About The Company : Established in the early 90’s SCL offers a wide range of Active Pharmaceutical Ingredients and Intermediates to its customers worldwide. SCL’s products are ...
(z)-4-Chloro-2-methoxyimino-3-oxobutyric acid
CAS Number : 111230-59-2
End Use API : Cefpodoxime Proxetil
About The Company : Established in the early 90’s SCL offers a wide range of Active Pharmaceutical Ingredients and Intermediates to its customers worldwide. SCL’s products are ...
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RLD : No
TE Code : AB
Brand Name : CEFPODOXIME PROXETIL
Dosage Form : TABLET;ORAL
Dosage Strength : EQ 100MG BASE
Approval Date : 2007-11-14
Application Number : 65388
RX/OTC/DISCN : RX
RLD : No
TE Code : AB
RLD : No
TE Code : AB
Brand Name : CEFPODOXIME PROXETIL
Dosage Form : TABLET;ORAL
Dosage Strength : EQ 100MG BASE
Approval Date : 2007-06-11
Application Number : 65370
RX/OTC/DISCN : RX
RLD : No
TE Code : AB
RLD : No
TE Code : AB
Brand Name : CEFPODOXIME PROXETIL
Dosage Form : TABLET;ORAL
Dosage Strength : EQ 200MG BASE
Approval Date : 2007-06-11
Application Number : 65370
RX/OTC/DISCN : RX
RLD : No
TE Code : AB
RLD : No
TE Code :
Brand Name : CEFPODOXIME PROXETIL
Dosage Form : FOR SUSPENSION;ORAL
Dosage Strength : EQ 50MG BASE/5ML
Approval Date : 2009-01-14
Application Number : 90031
RX/OTC/DISCN : DISCN
RLD : No
TE Code :
RLD : No
TE Code :
Brand Name : CEFPODOXIME PROXETIL
Dosage Form : FOR SUSPENSION;ORAL
Dosage Strength : EQ 100MG BASE/5ML
Approval Date : 2009-01-14
Application Number : 90031
RX/OTC/DISCN : DISCN
RLD : No
TE Code :
RLD : No
TE Code :
Brand Name : BANAN
Dosage Form : FOR SUSPENSION;ORAL
Dosage Strength : EQ 100MG BASE/5ML
Approval Date : 1992-08-07
Application Number : 50688
RX/OTC/DISCN : DISCN
RLD : No
TE Code :
RLD : Yes
TE Code :
Brand Name : VANTIN
Dosage Form : FOR SUSPENSION;ORAL
Dosage Strength : EQ 100MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date : 1992-08-07
Application Number : 50675
RX/OTC/DISCN : DISCN
RLD : Yes
TE Code :
RLD : No
TE Code : AB
Brand Name : CEFPODOXIME PROXETIL
Dosage Form : TABLET;ORAL
Dosage Strength : EQ 200MG BASE
Approval Date : 2008-05-28
Application Number : 65462
RX/OTC/DISCN : RX
RLD : No
TE Code : AB
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Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
Registration Country : Italy
Brand Name : Orelox
Dosage Form : Cefpodoxime 0.8% 100Ml Oral Use
Dosage Strength : BB os suspe grat 100 ml 40 mg/5 ml
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
Registration Country : Italy
Brand Name : Orelox
Dosage Form : Cefpodoxime 100Mg 12 Combined Oral Use
Dosage Strength : 12 cpr riv 100 mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
Registration Country : Italy
Brand Name : Orelox
Dosage Form : Cefpodoxime 200Mg 6 Combined Oral Use
Dosage Strength : 6 cpr riv 200 mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
Registration Country : Italy
Brand Name : ORELOX
Dosage Form : Granulate For Oral Suspension
Dosage Strength : 0.80%
Packaging : 100 ML 0.8% - ORAL USE
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
Registration Country : Italy
Brand Name : ORELOX
Dosage Form : Film-Coated Tablets
Dosage Strength : 100 mg
Packaging : 12 UNITS 100 MG - ORAL USE
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
Registration Country : Italy
Brand Name : ORELOX
Dosage Form : Film-Coated Tablets
Dosage Strength : 200 mg
Packaging : 6 UNITS 200 MG - ORAL USE
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Regulatory Info :
Registration Country : Italy
Brand Name : OTREON
Dosage Form : Film-Coated Tablets
Dosage Strength : 100 mg
Packaging : 12 UNITS 100 MG - ORAL USE
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Regulatory Info :
Registration Country : Italy
Brand Name : Cefpodoxa
Dosage Form : Cefpodoxime 0.8% 100Ml Oral Use
Dosage Strength : os suspe grat 100 ml 40 mg/5 ml
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Regulatory Info :
Registration Country : Switzerland
Brand Name : Cefpodoxim Sandoz
Dosage Form : Film-Coated Tablets
Dosage Strength : 100mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info :
Registration Country : Italy
Brand Name : CEFODOX
Dosage Form : Film-Coated Tablets
Dosage Strength : 100 mg
Packaging : 12 UNITS 100 MG - ORAL USE
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
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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.
A Cefpodoxime Proxetil manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Cefpodoxime Proxetil, including repackagers and relabelers. The FDA regulates Cefpodoxime Proxetil manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Cefpodoxime Proxetil 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 Cefpodoxime Proxetil manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Cefpodoxime Proxetil supplier is an individual or a company that provides Cefpodoxime Proxetil active pharmaceutical ingredient (API) or Cefpodoxime Proxetil finished formulations upon request. The Cefpodoxime Proxetil suppliers may include Cefpodoxime Proxetil API manufacturers, exporters, distributors and traders.
click here to find a list of Cefpodoxime Proxetil suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Cefpodoxime Proxetil DMF (Drug Master File) is a document detailing the whole manufacturing process of Cefpodoxime Proxetil active pharmaceutical ingredient (API) in detail. Different forms of Cefpodoxime Proxetil DMFs exist exist since differing nations have different regulations, such as Cefpodoxime Proxetil USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Cefpodoxime Proxetil DMF submitted to regulatory agencies in the US is known as a USDMF. Cefpodoxime Proxetil USDMF includes data on Cefpodoxime Proxetil's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Cefpodoxime Proxetil USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Cefpodoxime Proxetil suppliers with USDMF on PharmaCompass.
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 Cefpodoxime Proxetil Drug Master File in Japan (Cefpodoxime Proxetil JDMF) empowers Cefpodoxime Proxetil 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 Cefpodoxime Proxetil JDMF during the approval evaluation for pharmaceutical products. At the time of Cefpodoxime Proxetil 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 Cefpodoxime Proxetil suppliers with JDMF on PharmaCompass.
In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Cefpodoxime Proxetil Drug Master File in Korea (Cefpodoxime Proxetil KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Cefpodoxime Proxetil. The MFDS reviews the Cefpodoxime Proxetil KDMF as part of the drug registration process and uses the information provided in the Cefpodoxime Proxetil KDMF to evaluate the safety and efficacy of the drug.
After submitting a Cefpodoxime Proxetil 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 Cefpodoxime Proxetil API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Cefpodoxime Proxetil suppliers with KDMF on PharmaCompass.
A Cefpodoxime Proxetil CEP of the European Pharmacopoeia monograph is often referred to as a Cefpodoxime Proxetil Certificate of Suitability (COS). The purpose of a Cefpodoxime Proxetil CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Cefpodoxime Proxetil EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Cefpodoxime Proxetil to their clients by showing that a Cefpodoxime Proxetil CEP has been issued for it. The manufacturer submits a Cefpodoxime Proxetil CEP (COS) as part of the market authorization procedure, and it takes on the role of a Cefpodoxime Proxetil CEP holder for the record. Additionally, the data presented in the Cefpodoxime Proxetil CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Cefpodoxime Proxetil DMF.
A Cefpodoxime Proxetil CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Cefpodoxime Proxetil 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 Cefpodoxime Proxetil suppliers with CEP (COS) on PharmaCompass.
A Cefpodoxime Proxetil written confirmation (Cefpodoxime Proxetil WC) is an official document issued by a regulatory agency to a Cefpodoxime Proxetil manufacturer, verifying that the manufacturing facility of a Cefpodoxime Proxetil active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Cefpodoxime Proxetil APIs or Cefpodoxime Proxetil finished pharmaceutical products to another nation, regulatory agencies frequently require a Cefpodoxime Proxetil WC (written confirmation) as part of the regulatory process.
click here to find a list of Cefpodoxime Proxetil suppliers with Written Confirmation (WC) on PharmaCompass.
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 Cefpodoxime Proxetil as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Cefpodoxime Proxetil API and other APIs are published in this directory by the FDA.
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 Cefpodoxime Proxetil 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.
The NDC directory also contains data on finished compounded human drug products that contain Cefpodoxime Proxetil and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Cefpodoxime Proxetil NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Cefpodoxime Proxetil suppliers with NDC on PharmaCompass.
Cefpodoxime Proxetil 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 Cefpodoxime Proxetil 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 Cefpodoxime Proxetil GMP manufacturer or Cefpodoxime Proxetil GMP API supplier for your needs.
A Cefpodoxime Proxetil CoA (Certificate of Analysis) is a formal document that attests to Cefpodoxime Proxetil's compliance with Cefpodoxime Proxetil specifications and serves as a tool for batch-level quality control.
Cefpodoxime Proxetil CoA mostly includes findings from lab analyses of a specific batch. For each Cefpodoxime Proxetil 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.
Cefpodoxime Proxetil may be tested according to a variety of international standards, such as European Pharmacopoeia (Cefpodoxime Proxetil EP), Cefpodoxime Proxetil JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Cefpodoxime Proxetil USP).
