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1. 5-thia-1-azabicyclo(4.2.0)oct-2-ene-2-carboxylic Acid, 7-((aminophenylacetyl)amino)-3-chloro-8-oxo-, (6r-(6alpha,7beta(r*)))-
2. Ceclor
3. Cefaclor Anhydrous
4. Cefaclor Monohydrate
5. Keclor
6. Lilly 99638
7. S 6472
8. S-6472
9. S6472
1. 53994-73-3
2. Cephaclor
3. Ceclor
4. Cefaclor Anhydrous
5. Cefaclorum
6. Kefral
7. Panoral
8. Raniclor
9. Cefaclor [inn]
10. Cefaclor Hydrate
11. Cefaclorum [inn-latin]
12. 3-chloro-7-d-(2-phenylglycinamido)-3-cephem-4-carboxylic Acid
13. 143059-69-2
14. S 6472
15. Cefaclor Impurity C
16. Chebi:3478
17. Ccl
18. 3z6fs3ik0k
19. Mls000069617
20. (6r,7r)-7-[[(2r)-2-amino-2-phenylacetyl]amino]-3-chloro-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic Acid
21. 5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic Acid,7-[[(2r)-aminophenylacetyl]amino]-3-chloro-8-oxo-, (6r,7r)-
22. 53994-73-3 (free)
23. (6r,7r)-7-((r)-2-amino-2-phenylacetamido)-3-chloro-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic Acid
24. (6r,7r)-7-{[(2r)-2-amino-2-phenylacetyl]amino}-3-chloro-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic Acid
25. Ncgc00022612-04
26. Alfacet
27. Smr000058250
28. Dsstox_cid_2748
29. Dsstox_rid_76713
30. Dsstox_gsid_22748
31. Dystaclor Mr
32. L-kefral
33. Ceclor Cd
34. Alenfral (tn)
35. (6r,7r)-7-((r)-2-amino-2-phenylacetamido)-3-chloro-8-oxo-5-thia-1-azabicyclo(4.2.0)oct-2-ene-2-carboxylic Acid
36. (6r,7r)-7-[(2r)-2-amino-2-phenylacetamido]-3-chloro-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic Acid
37. Cas-53994-73-3
38. Unii-3z6fs3ik0k
39. Cefaclorimpurityc
40. S-6472
41. Cefaclor,(s)
42. (6r,7r)-7-(((2r)-2-amino-2-phenylacetyl)amino)-3-chloro-8-oxo-5-thia-1-azabicyclo(4.2.0)oct-2-ene-2-carboxylic Acid
43. 5-thia-1-azabicyclo(4.2.0)oct-2-ene-2-carboxylic Acid, 7-(((2r)-2-amino-2-phenylacetyl)amino)-3-chloro-8-oxo-, (6r,7r)-
44. 5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic Acid, 7-[[(2r)-2-amino-2-phenylacetyl]amino]-3-chloro-8-oxo-, (6r,7r)-
45. Einecs 258-909-5
46. Mfcd00151471
47. Cefaclor (jp17)
48. Spectrum_001070
49. Specplus_000947
50. Cefaclor [jan]
51. Cefaclor [mi]
52. Prestwick0_000485
53. Prestwick0_001102
54. Prestwick1_000485
55. Prestwick1_001102
56. Prestwick2_000485
57. Prestwick2_001102
58. Prestwick3_000485
59. Prestwick3_001102
60. Spectrum2_001189
61. Spectrum3_001858
62. Spectrum4_000093
63. Spectrum5_001727
64. Cefaclor [who-dd]
65. Chembl680
66. Epitope Id:117133
67. Schembl33540
68. Bspbio_000349
69. Bspbio_001204
70. Bspbio_003276
71. Kbiogr_000386
72. Kbioss_001550
73. Cid_51039
74. Mls001424193
75. Divk1c_007043
76. Spectrum1500771
77. Spbio_001237
78. Spbio_002270
79. Spbio_003082
80. Bpbio1_000385
81. Bpbio1_001326
82. Dtxsid3022748
83. Bdbm42131
84. Kbio1_001987
85. Kbio2_001550
86. Kbio2_004118
87. Kbio2_006686
88. Kbio3_002777
89. Bcpp000294
90. Hms1571m06
91. Hms1921g22
92. Hms2052c11
93. Hms2092k08
94. Hms2233m13
95. Pharmakon1600-01500771
96. (6r,7r)-7-[[(2s)-2-amino-1-oxo-2-phenylethyl]amino]-3-chloro-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic Acid
97. Hy-b0198
98. Zinc3812869
99. Tox21_110880
100. Ccg-40264
101. Nsc757422
102. Akos024282614
103. Tox21_110880_1
104. Bcp9000501
105. Cefaclor, Analytical Reference Material
106. Db00833
107. Nc00354
108. 7beta-{[(2r)-2-amino-2-phenylacetyl]amino}-3-chloro-3,4-didehydrocepham-4-carboxylic Acid
109. Ncgc00015260-22
110. Ncgc00022612-05
111. Ncgc00022612-06
112. Ncgc00022612-07
113. Ncgc00022612-10
114. Ncgc00022612-11
115. 7-((2r)-2-amino-2-phenylacetylamino)(7r,7ar)-3-chloro-6-oxo-2h,7h-azetidino[2, 1-b]1,3-thiazine-4-carboxylic Acid
116. As-74992
117. Sbi-0051606.p002
118. Ab00052174
119. C3478
120. C-2461
121. C06877
122. D00256
123. Ab00052174_15
124. Ab00052174_16
125. Cefaclor, Antibiotic For Culture Media Use Only
126. A900728
127. Q415167
128. Sr-05000001556
129. Sr-05000001556-1
130. Brd-k20338176-002-03-5
131. 7-(d-2-amino-2-phenylacetamido)-3-chloro-3-cephem-4-carboxylic
132. (6r,7r)-7-((s)-2-amino-2-phenylacetamido)-3-chloro-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic Acid
133. (6r,7r)-7-[(r)-2-amino-2-phenylacetamido]-3-chloro-8-oxo-5-thia-1-azabicyclo[4,2,0]oct-2-ene-2-carboxylic Acid
134. (6r,7r)-7-[[(2r)-2-amino-2-phenyl-acetyl]amino]-3-chloro-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic Acid
135. (6r,7r)-7-[[(2r)-2-azaniumyl-2-phenylacetyl]amino]-3-chloro-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylate
136. 5-thia-1-azabicyclo(4.2.0)oct-2-ene-2-carboxylic Acid, 7-((aminophenylacetyl)amino)-3-chloro-8-oxo-, (6r-(6-alpha,7-beta(r*)))-
| Molecular Weight | 367.8 g/mol |
|---|---|
| Molecular Formula | C15H14ClN3O4S |
| XLogP3 | -1.8 |
| Hydrogen Bond Donor Count | 3 |
| Hydrogen Bond Acceptor Count | 6 |
| Rotatable Bond Count | 4 |
| Exact Mass | 367.0393548 g/mol |
| Monoisotopic Mass | 367.0393548 g/mol |
| Topological Polar Surface Area | 138 Ų |
| Heavy Atom Count | 24 |
| Formal Charge | 0 |
| Complexity | 606 |
| 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 | Cefaclor |
| PubMed Health | Cefaclor (By mouth) |
| Drug Classes | Antibiotic |
| Drug Label | Cefaclor is a semisynthetic cephalosporin antibiotic for oral administration. It is chemically designated as 3-chloro-7-D-(2-phenylglycinamido)-3-cephem-4-carboxylic acid monohydrate. The molecular formula for cefaclor is C15H14ClN3O4SH2O and the... |
| Active Ingredient | Cefaclor |
| Dosage Form | Tablet, extended release; Capsule; For suspension |
| Route | Oral |
| Strength | eq 375mg base/5ml; eq 250mg base/5ml; eq 500mg base; eq 187mg base/5ml; eq 250mg base; eq 125mg base/5ml; eq 375mg base |
| Market Status | Prescription |
| Company | Teva; Yung Shin Pharm; Hikma |
| 2 of 2 | |
|---|---|
| Drug Name | Cefaclor |
| PubMed Health | Cefaclor (By mouth) |
| Drug Classes | Antibiotic |
| Drug Label | Cefaclor is a semisynthetic cephalosporin antibiotic for oral administration. It is chemically designated as 3-chloro-7-D-(2-phenylglycinamido)-3-cephem-4-carboxylic acid monohydrate. The molecular formula for cefaclor is C15H14ClN3O4SH2O and the... |
| Active Ingredient | Cefaclor |
| Dosage Form | Tablet, extended release; Capsule; For suspension |
| Route | Oral |
| Strength | eq 375mg base/5ml; eq 250mg base/5ml; eq 500mg base; eq 187mg base/5ml; eq 250mg base; eq 125mg base/5ml; eq 375mg base |
| Market Status | Prescription |
| Company | Teva; Yung Shin Pharm; Hikma |
For the treatment of certain infections caused by bacteria such as pneumonia and ear, lung, skin, throat, and urinary tract infections.
FDA Label
Cefaclor is a second generation cephalosporin antibiotic with a spectrum resembling first-generation cephalosporins. In vitro tests demonstrate that the bactericidal action of the cephalosporins results from inhibition of cell-wall synthesis. As indicated by _in vitro_ and _in vivo_ clinical studies, cefaclor was shown to be effective against most strains of Gram positive aerobes - Staphylococci (including coagulase-positive, coagulase-negative, and penicillinase-producing strains), Streptococcus pneumoniae, Streptococcus pyogenes (group A ß-hemolytic streptococci), as well as Gram-negative aerobes - Escherichia coli, Haemophilus influenzae (including ß-lactamase-producing ampicillin-resistant strains), Klebsiella sp, and Proteus mirabilis.
Anti-Bacterial Agents
Substances that inhibit the growth or reproduction of BACTERIA. (See all compounds classified as Anti-Bacterial Agents.)
J - Antiinfectives for systemic use
J01 - Antibacterials for systemic use
J01D - Other beta-lactam antibacterials
J01DC - Second-generation cephalosporins
J01DC04 - Cefaclor
Absorption
Well absorbed after oral administration, independent of food intake.
Route of Elimination
Approximately 60% to 85% of the drug is excreted unchanged in the urine within 8 hours, the greater portion being excreted within the first 2 hours.
No appreciable biotransformation in liver (approximately 60% to 85% of the drug is excreted unchanged in the urine within 8 hours).
0.6-0.9 hour
Cefaclor, like the penicillins, is a beta-lactam antibiotic. By binding to specific penicillin-binding proteins (PBPs) located inside the bacterial cell wall, it inhibits 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 cefaclor interferes with an autolysin inhibitor.
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Regulatory Info :
Registration Country : Italy
Brand Name : BACTIGRAM
Dosage Form : Modified-Release Tablets
Dosage Strength : 750 mg
Packaging : 6 UNITS 750 MG - ORAL USE
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Registration Country : Italy
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Registration Country : Switzerland
Brand Name : Ceclor Retard
Dosage Form : Ret Filmtabl
Dosage Strength : 750mg
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Registration Country : Switzerland
Regulatory Info :
Registration Country : Italy
Brand Name : CEFACLOR EG
Dosage Form : Modified-Release Tablets
Dosage Strength : 750 mg
Packaging : 6 UNITS 750 MG - ORAL USE
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Registration Country : Italy
Regulatory Info :
Registration Country : Italy
Brand Name : PERFORMERS
Dosage Form : Granules For Oral Suspension
Dosage Strength : 250 mg/5 ml
Packaging : 100 ML 5% - ORAL USE
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Registration Country : Italy
Regulatory Info :
Registration Country : Italy
Brand Name : PANACEF
Dosage Form : Modified Release Tablets
Dosage Strength : 750 mg
Packaging : 6 UNITS 750 MG - ORAL USE
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Regulatory Info :
Registration Country : Italy
Regulatory Info :
Registration Country : Italy
Brand Name : Cefaclor
Dosage Form : Cefacloro 5% 100Ml Oral Use
Dosage Strength : os suspe grat 100 ml 250 mg/5 ml
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Regulatory Info :
Registration Country : Italy
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Registration Country : Italy
Brand Name : Panacef
Dosage Form : Cefacloro 5% 100Ml Oral Use
Dosage Strength : os suspe grat 100 ml 250 mg/5 ml
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Registration Country : Italy
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Registration Country : Italy
Brand Name : Panacef
Dosage Form : Cefacloro 500Mg 8 Joined' Oral Use
Dosage Strength : 8 cps 500 mg
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Registration Country : Italy
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Registration Country : Italy
Brand Name : Necloral
Dosage Form : Cefacloro 750Mg 6 Combined Oral Use
Dosage Strength : 6 CPR 750 mg modified release
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Registration Country : Italy
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Registration Country : Italy
Brand Name : Panacef
Dosage Form : Cefacloro 750Mg 6 Combined Oral Use
Dosage Strength : 6 CPR 750 mg modified release
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Registration Country : Italy
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ABOUT THIS PAGE
A Cefaclor manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Cefaclor, including repackagers and relabelers. The FDA regulates Cefaclor manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Cefaclor 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 Cefaclor manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Cefaclor supplier is an individual or a company that provides Cefaclor active pharmaceutical ingredient (API) or Cefaclor finished formulations upon request. The Cefaclor suppliers may include Cefaclor API manufacturers, exporters, distributors and traders.
click here to find a list of Cefaclor suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Cefaclor DMF (Drug Master File) is a document detailing the whole manufacturing process of Cefaclor active pharmaceutical ingredient (API) in detail. Different forms of Cefaclor DMFs exist exist since differing nations have different regulations, such as Cefaclor USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Cefaclor DMF submitted to regulatory agencies in the US is known as a USDMF. Cefaclor USDMF includes data on Cefaclor's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Cefaclor USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Cefaclor 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 Cefaclor Drug Master File in Japan (Cefaclor JDMF) empowers Cefaclor 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 Cefaclor JDMF during the approval evaluation for pharmaceutical products. At the time of Cefaclor 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 Cefaclor 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 Cefaclor Drug Master File in Korea (Cefaclor KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Cefaclor. The MFDS reviews the Cefaclor KDMF as part of the drug registration process and uses the information provided in the Cefaclor KDMF to evaluate the safety and efficacy of the drug.
After submitting a Cefaclor 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 Cefaclor API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Cefaclor suppliers with KDMF on PharmaCompass.
A Cefaclor CEP of the European Pharmacopoeia monograph is often referred to as a Cefaclor Certificate of Suitability (COS). The purpose of a Cefaclor CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Cefaclor EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Cefaclor to their clients by showing that a Cefaclor CEP has been issued for it. The manufacturer submits a Cefaclor CEP (COS) as part of the market authorization procedure, and it takes on the role of a Cefaclor CEP holder for the record. Additionally, the data presented in the Cefaclor CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Cefaclor DMF.
A Cefaclor CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Cefaclor 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 Cefaclor suppliers with CEP (COS) on PharmaCompass.
A Cefaclor written confirmation (Cefaclor WC) is an official document issued by a regulatory agency to a Cefaclor manufacturer, verifying that the manufacturing facility of a Cefaclor active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Cefaclor APIs or Cefaclor finished pharmaceutical products to another nation, regulatory agencies frequently require a Cefaclor WC (written confirmation) as part of the regulatory process.
click here to find a list of Cefaclor 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 Cefaclor as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Cefaclor 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 Cefaclor 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 Cefaclor and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Cefaclor NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Cefaclor suppliers with NDC on PharmaCompass.
Cefaclor 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 Cefaclor 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 Cefaclor GMP manufacturer or Cefaclor GMP API supplier for your needs.
A Cefaclor CoA (Certificate of Analysis) is a formal document that attests to Cefaclor's compliance with Cefaclor specifications and serves as a tool for batch-level quality control.
Cefaclor CoA mostly includes findings from lab analyses of a specific batch. For each Cefaclor 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.
Cefaclor may be tested according to a variety of international standards, such as European Pharmacopoeia (Cefaclor EP), Cefaclor JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Cefaclor USP).
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