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1. 4 Hydroxycephalexin
2. 4-hydroxycephalexin
3. 5-thia-1-azabicyclo(4.2.0)oct-2-ene-2-carboxylic Acid, 7-((amino(4-hydroxyphenyl)acetyl)amino)-3-methyl-8-oxo-, (6r-(6alpha,7beta(r*)))-
4. Bidocef
5. Bl S 578
6. Bl S578
7. Bl-s 578
8. Bl-s578
9. Bls 578
10. Bls578
11. Cefadroxil Anhydrous
12. Cefadroxil Monohydrate
13. Cephadroxyl
14. Duricef
15. S 578
16. S-578
17. S578
18. Ultracef
1. 50370-12-2
2. Cefadroxil Anhydrous
3. Cephadroxil
4. Cefadroxilo
5. Cefadroxilum
6. D-cefadroxil
7. Cefadroxil [inn]
8. Bl-s578
9. Anhydrous Cefadroxil
10. Chebi:3479
11. (6r,7r)-7-{[(2r)-2-amino-2-(4-hydroxyphenyl)acetyl]amino}-3-methyl-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic Acid
12. (6r,7r)-7-[[(2r)-2-amino-2-(4-hydroxyphenyl)acetyl]amino]-3-methyl-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic Acid
13. Bl-s 578
14. Cdx
15. Q525pa8jjb
16. Duracef
17. Nsc-756664
18. Dsstox_cid_2749
19. Dsstox_rid_76714
20. Dsstox_gsid_22749
21. Mjf-11567-3
22. (6r,7r)-7-((r)-2-amino-2-(4-hydroxyphenyl)acetamido)-3-methyl-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic Acid
23. Cefadroxil (as Monohydrate)
24. Cefadroxilum [inn-latin]
25. Cefadroxilo [inn-spanish]
26. (6r,7r)-7-[(2r)-2-amino-2-(4-hydroxyphenyl)acetamido]-3-methyl-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic Acid
27. 5-thia-1-azabicyclo(4.2.0)oct-2-ene-2-carboxylic Acid, 7-(((2r)-amino(4-hydroxyphenyl)acetyl)amino)-3-methyl-8-oxo-, (6r,7r)-
28. Sumacef (tn)
29. Cefadroxil/cefadroxil Hemihydrate
30. S 578
31. S-578
32. Unii-q525pa8jjb
33. Cefradroxil
34. Cefadrops
35. Ncgc00016858-01
36. (6r,7r)-7-(((2r)-2-amino-2-(4-hydroxyphenyl)acetyl)amino)-3-methyl-8-oxo-5-thia-1-azabicyclo(4.2.0)oct-2-ene-2-carboxylic Acid
37. Einecs 256-555-6
38. Cas-50370-12-2
39. Cefadroxil, Anhydrous
40. Cefadroxil (jp17)
41. Spectrum_000104
42. Cefadroxil [mi]
43. Cefadroxil [jan]
44. (6r,7r)-7-[[(2r)-2-azaniumyl-2-(4-hydroxyphenyl)acetyl]amino]-3-methyl-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylate
45. Prestwick0_000434
46. Prestwick1_000434
47. Prestwick2_000434
48. Prestwick3_000434
49. Spectrum2_000087
50. Spectrum4_000266
51. Spectrum5_000663
52. Epitope Id:117131
53. Cefadroxil [who-dd]
54. Chembl1644
55. Bspbio_000448
56. Kbiogr_000732
57. Kbioss_000544
58. (6r,7r)-7-((r)-2-amino-2-(p-hydroxyphenyl)acetamido)-3-methyl-8-oxo-5-thia-1-azabicyclo(4.2.0)oct-2-ene-2-carboxylic Acid
59. Mls002207219
60. Divk1c_000409
61. Schembl151320
62. Spbio_000014
63. Spbio_002387
64. Cefadroxil, Analytical Standard
65. Bpbio1_000494
66. Gtpl4831
67. Dtxsid8022749
68. Hms501e11
69. Kbio1_000409
70. Kbio2_000544
71. Kbio2_003112
72. Kbio2_005680
73. Ninds_000409
74. Hms1569g10
75. Hms2096g10
76. Hms3713g10
77. Pharmakon1600-01500163
78. 5-thia-1-azabicyclo(4.2.0)oct-2-ene-2-carboxylic Acid, 7-(((2r)-2-amino-2-(4-hydroxyphenyl)acetyl)amino)-3-methyl-8-oxo-, (6r,7r)-
79. Hy-b1190
80. Zinc3830391
81. Tox21_110651
82. Bbl033696
83. Bdbm50350467
84. Mfcd00865091
85. Nsc756664
86. Stk801939
87. Akos005622555
88. Tox21_110651_1
89. Ccg-220434
90. Cs-4696
91. Db01140
92. Idi1_000409
93. Ncgc00179556-01
94. Ncgc00179556-03
95. As-11655
96. Smr001306770
97. Cefprozil Impurity B [ep Impurity]
98. Sbi-0051305.p003
99. Ab00513838
100. Cefprozil E Impurity B [ep Impurity]
101. C-2462
102. C06878
103. D00257
104. D81830
105. 592c878
106. Q2319020
107. Cefprozil Monohydrate Impurity B [ep Impurity]
108. Cefadroxil Monohydrate, Antibiotic For Culture Media Use Only
109. (7r)-7-((r)-2-amino-2-(4-hydroxyphenyl)acetamido)-3-methyl-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic Acid
110. 5-thia-1-azabicyclo(4.2.0)oct-2-ene-2-carboxylic Acid, 7-((amino(4-hydroxyphenyl)acetyl)amino)-3-methyl-8-oxo-, (6r-(6-alpha,7-beta(r*)))-
111. 7beta-{[(2r)-2-amino-2-(4-hydroxyphenyl)acetyl]amino}-3-methyl-3,4-didehydrocepham-4-carboxylic Acid
| Molecular Weight | 363.4 g/mol |
|---|---|
| Molecular Formula | C16H17N3O5S |
| XLogP3 | -2.1 |
| Hydrogen Bond Donor Count | 4 |
| Hydrogen Bond Acceptor Count | 7 |
| Rotatable Bond Count | 4 |
| Exact Mass | 363.08889182 g/mol |
| Monoisotopic Mass | 363.08889182 g/mol |
| Topological Polar Surface Area | 158 Ų |
| Heavy Atom Count | 25 |
| Formal Charge | 0 |
| Complexity | 629 |
| Isotope Atom Count | 0 |
| Defined Atom Stereocenter Count | 3 |
| Undefined Atom Stereocenter Count | 0 |
| Defined Bond Stereocenter Count | 0 |
| Undefined Bond Stereocenter Count | 0 |
| Covalently Bonded Unit Count | 1 |
| 1 of 2 | |
|---|---|
| Drug Name | Cefadroxil |
| PubMed Health | Cefadroxil (By mouth) |
| Drug Classes | Antibiotic |
| Drug Label | Cefadroxil monohydrate, USP is a semisynthetic cephalosporin antibiotic intended for oral administration. It is a white to yellowish-white crystalline powder. It is soluble in water and it is acid-stable. It is chemically designated as 5-Thia-1- azab... |
| Active Ingredient | Cefadroxil/cefadroxil hemihydrate |
| Dosage Form | Tablet; Capsule; For suspension |
| Route | Oral |
| Strength | eq 250mg base/5ml; eq 500mg base; eq 125mg base/5ml; eq 500mg base/5ml; eq 1gm base |
| Market Status | Prescription |
| Company | Ranbaxy; Teva Pharms; Aurobindo; Aurobindo Pharma; Lupin; Sandoz; Hikma Pharms; Orchid Hlthcare; Hikma |
| 2 of 2 | |
|---|---|
| Drug Name | Cefadroxil |
| PubMed Health | Cefadroxil (By mouth) |
| Drug Classes | Antibiotic |
| Drug Label | Cefadroxil monohydrate, USP is a semisynthetic cephalosporin antibiotic intended for oral administration. It is a white to yellowish-white crystalline powder. It is soluble in water and it is acid-stable. It is chemically designated as 5-Thia-1- azab... |
| Active Ingredient | Cefadroxil/cefadroxil hemihydrate |
| Dosage Form | Tablet; Capsule; For suspension |
| Route | Oral |
| Strength | eq 250mg base/5ml; eq 500mg base; eq 125mg base/5ml; eq 500mg base/5ml; eq 1gm base |
| Market Status | Prescription |
| Company | Ranbaxy; Teva Pharms; Aurobindo; Aurobindo Pharma; Lupin; Sandoz; Hikma Pharms; Orchid Hlthcare; Hikma |
For the treatment of the following infections (skin, UTI, ENT) caused by; S. pneumoniae, H. influenzae, staphylococci, S. pyogenes (group A beta-hemolytic streptococci), E. coli, P. mirabilis, Klebsiella sp, coagulase-negative staphylococci and Streptococcus pyogenes
FDA Label
Cefadroxil, a first-generation cephalosporin antibiotic, is used to treat urinary tract infections, skin and skin structure infections, pharyngitis, and tonsillitis.
Anti-Bacterial Agents
Substances that inhibit the growth or reproduction of BACTERIA. (See all compounds classified as Anti-Bacterial Agents.)
J01DB05
S76 | LUXPHARMA | Pharmaceuticals Marketed in Luxembourg | Pharmaceuticals marketed in Luxembourg, as published by d'Gesondheetskeess (CNS, la caisse nationale de sante, www.cns.lu), mapped by name to structures using CompTox by R. Singh et al. (in prep.). List downloaded from https://cns.public.lu/en/legislations/textes-coordonnes/liste-med-comm.html. Dataset DOI:10.5281/zenodo.4587355
J - Antiinfectives for systemic use
J01 - Antibacterials for systemic use
J01D - Other beta-lactam antibacterials
J01DB - First-generation cephalosporins
J01DB05 - Cefadroxil
Absorption
Cefadroxil is well absorbed on oral administration; food does not interfere with its absorption.
Route of Elimination
Over 90% of the drug is excreted unchanged in the urine within 24 hours. Cefadroxil was detected in the placenta and breast milk.
1.5 hours
Like all beta-lactam antibiotics, cefadroxil binds to specific penicillin-binding proteins (PBPs) located inside the bacterial cell wall, causing the inhibition of the third and last stage of bacterial cell wall synthesis. Cell lysis is then mediated by bacterial cell wall autolytic enzymes such as autolysins; it is possible that cefadroxil interferes with an autolysin inhibitor.
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GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17509
Submission : 2004-07-01
Status : Active
Type : II
Certificate Number : R1-CEP 2005-091 - Rev 00
Issue Date : 2011-09-08
Type : Chemical
Substance Number : 813
Status : Valid
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19290
Submission : 2006-03-21
Status : Active
Type : II
Date of Issue : 2019-08-01
Valid Till : 2022-07-31
Written Confirmation Number : WC-0048
Address of the Firm :
Registrant Name : Korea Chorus Co., Ltd.
Registration Date : 2015-07-31
Registration Number : 20120106-19-A-256-09(2)
Manufacturer Name : Lupin Limited
Manufacturer Address : 124, GIDC Estate, Ankleshwar, 393 002, Gujarat, India
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17106
Submission : 2004-01-14
Status : Active
Type : II
Certificate Number : CEP 2002-234 - Rev 03
Issue Date : 2024-09-06
Type : Chemical
Substance Number : 813
Status : Valid
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 : 18331
Submission : 2005-04-30
Status : Active
Type : II
Certificate Number : CEP 2006-203 - Rev 03
Issue Date : 2023-12-13
Type : Chemical
Substance Number : 813
Status : Valid
Date of Issue : 2022-07-15
Valid Till : 2025-07-02
Written Confirmation Number : WC-0120
Address of the Firm :
NDC Package Code : 65862-359
Start Marketing Date : 2024-01-11
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (50kg/50kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13225
Submission : 1998-04-30
Status : Active
Type : II
NDC Package Code : 52946-0903
Start Marketing Date : 2009-12-09
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Korea United Pharmaceutical Co., Ltd.
Registration Date : 2012-03-16
Registration Number : 20050831-19-A-11-02(6)
Manufacturer Name : ACS DOBFAR SpA
Manufacturer Address : Via Marzabotto, 7/9 20871 Vimercate (MB)-Italy
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 14201
Submission : 1999-06-14
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13638
Submission : 1998-09-01
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13220
Submission : 1998-04-30
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13566
Submission : 1998-09-01
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12894
Submission : 1998-03-11
Status : Inactive
Type : II
Certificate Number : R1-CEP 1998-019 - Rev 00
Issue Date : 2003-12-18
Type : Chemical
Substance Number : 813
Status : Withdrawn by Holder
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ABOUT THIS PAGE
A Cefadroxil manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Cefadroxil, including repackagers and relabelers. The FDA regulates Cefadroxil manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Cefadroxil 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 Cefadroxil manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Cefadroxil supplier is an individual or a company that provides Cefadroxil active pharmaceutical ingredient (API) or Cefadroxil finished formulations upon request. The Cefadroxil suppliers may include Cefadroxil API manufacturers, exporters, distributors and traders.
click here to find a list of Cefadroxil suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Cefadroxil DMF (Drug Master File) is a document detailing the whole manufacturing process of Cefadroxil active pharmaceutical ingredient (API) in detail. Different forms of Cefadroxil DMFs exist exist since differing nations have different regulations, such as Cefadroxil USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Cefadroxil DMF submitted to regulatory agencies in the US is known as a USDMF. Cefadroxil USDMF includes data on Cefadroxil's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Cefadroxil USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Cefadroxil suppliers with USDMF 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 Cefadroxil Drug Master File in Korea (Cefadroxil KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Cefadroxil. The MFDS reviews the Cefadroxil KDMF as part of the drug registration process and uses the information provided in the Cefadroxil KDMF to evaluate the safety and efficacy of the drug.
After submitting a Cefadroxil 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 Cefadroxil API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Cefadroxil suppliers with KDMF on PharmaCompass.
A Cefadroxil CEP of the European Pharmacopoeia monograph is often referred to as a Cefadroxil Certificate of Suitability (COS). The purpose of a Cefadroxil CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Cefadroxil EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Cefadroxil to their clients by showing that a Cefadroxil CEP has been issued for it. The manufacturer submits a Cefadroxil CEP (COS) as part of the market authorization procedure, and it takes on the role of a Cefadroxil CEP holder for the record. Additionally, the data presented in the Cefadroxil CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Cefadroxil DMF.
A Cefadroxil CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Cefadroxil 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 Cefadroxil suppliers with CEP (COS) on PharmaCompass.
A Cefadroxil written confirmation (Cefadroxil WC) is an official document issued by a regulatory agency to a Cefadroxil manufacturer, verifying that the manufacturing facility of a Cefadroxil active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Cefadroxil APIs or Cefadroxil finished pharmaceutical products to another nation, regulatory agencies frequently require a Cefadroxil WC (written confirmation) as part of the regulatory process.
click here to find a list of Cefadroxil 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 Cefadroxil as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Cefadroxil 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 Cefadroxil 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 Cefadroxil and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Cefadroxil NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Cefadroxil suppliers with NDC on PharmaCompass.
Cefadroxil 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 Cefadroxil 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 Cefadroxil GMP manufacturer or Cefadroxil GMP API supplier for your needs.
A Cefadroxil CoA (Certificate of Analysis) is a formal document that attests to Cefadroxil's compliance with Cefadroxil specifications and serves as a tool for batch-level quality control.
Cefadroxil CoA mostly includes findings from lab analyses of a specific batch. For each Cefadroxil 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.
Cefadroxil may be tested according to a variety of international standards, such as European Pharmacopoeia (Cefadroxil EP), Cefadroxil JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Cefadroxil USP).
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