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1. 5-thia-1-azabicyclo(4.2.0)oct-2-ene-2-carboxylic Acid, 7-((aminophenylacetyl)amino)-3-methyl-8-oxo-, (6r-(6alpha,7beta(r*)))-
2. Cefalexin
3. Cephalexin
4. Cephalexin Dihydride
5. Cephalexin Hemihydrate
6. Cephalexin Hydrochloride
7. Cephalexin Monohydrochloride
8. Cephalexin Monohydrochloride, Monohydrate
9. Cephalexin, (6r-(6alpha,7alpha(r*)))-isomer
10. Cephalexin, (6r-(6alpha,7beta(s*)))-isomer
11. Cephalexin, (6r-(6alpha,7beta))-isomer
12. Cephalexin, Monosodium Salt
13. Cephalexin, Monosodium Salt, (6r-(6alpha,7beta))-isomer
14. Ceporexine
15. Palitrex
1. 23325-78-2
2. Cephalexin Hydrate
3. Cefalexin Monohydrate
4. Keflet
5. Cefalexin Hydrate
6. Palitrex
7. Cefanex
8. Cephalexin (monohydrate)
9. Cephalexin.h2o
10. Cefalexin.h2o
11. Cefalival
12. Cefibacter
13. Ceffanex
14. Novolexin
15. Biocef
16. Lilly 66873
17. Panixine Disperdose
18. Cephalexin Monhydrochloride
19. Obn7uds42y
20. 7-(d-alpha-amino-alpha-phenylacetamido)-3-methyl-3-cephem-4-carboxylic Acid Monohydrate
21. Chebi:3535
22. Sq 20248
23. (6r,7r)-7-((r)-2-amino-2-phenylacetamido)-3-methyl-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic Acid Hydrate
24. (6r,7r)-7-[[(2r)-2-amino-2-phenylacetyl]amino]-3-methyl-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic Acid;hydrate
25. Aristosporin
26. Cefalexgobens
27. Cephalobene
28. Adcadina
29. Azabort
30. Bactopenor
31. Cefacet
32. Cefalekey
33. Domucef
34. Doriman
35. Efemida
36. Karilexina
37. Loisine
38. Losporal
39. Ly-66873
40. Maksipor
41. Medolexin
42. Prindex
43. Rilexine
44. Rogevil
45. Servicef
46. Sintolexyn
47. Theratrex
48. Viosporine
49. Zabytrex
50. Beliam
51. Noveol
52. Ambal
53. Cephalex Von Ct
54. Henina Oral
55. Keftab (tn)
56. Cefalexina Richet
57. Cefalexin Generics
58. Cefalexina Northia
59. Cusisporina-cefalox
60. (6r,7r)-7-((r)-2-amino-2-phenylacetamido)-3-methyl-8-oxo-5-thia-1-azabicyclo(4.2.0)oct-2-ene-2-carboxylic Acid Monohydrate
61. 5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic Acid, 7-[[(2r)-2-amino-2-phenylacetyl]amino]-3-methyl-8-oxo-, Hydrate (1:1), (6r,7r)-
62. Cephalexin 1-wasser
63. Cefalexin Scand Pharm
64. Panixine
65. (6r,7r)-7-{[(2r)-2-amino-2-phenylacetyl]amino}-3-methyl-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic Acid--water (1/1)
66. 7beta-[(2r)-2-amino-2-phenylacetamido]-3-methyl-3,4-didehydrocepham-4-carboxylic Acid--water (1/1)
67. Nsc-758162
68. Unii-obn7uds42y
69. Cephalexin (usp)
70. Prestwick_750
71. Cefalexinsodium
72. Cefalexin Monohydrate 100 Microg/ml In Acetonitrile
73. Cephalexin [usan:usp]
74. Cephalexin [usan]
75. Panixine Disperdose (tn)
76. Cephalexin [vandf]
77. Cephalexin [usp-rs]
78. Schembl41911
79. Cephalexin [orange Book]
80. Chembl1200544
81. Hy-b0200b
82. Dtxsid30945995
83. Cephalexin [usp Monograph]
84. Hms1569g17
85. Hms2096g17
86. Cephalexin Monohydrate [mi]
87. Mfcd00167148
88. S5207
89. Cephalexin Monohydrate [vandf]
90. Akos016340340
91. Cefalexin Monohydrate [who-dd]
92. Ks-1134
93. 5-thia-1-azabicyclo(4.2.0)oct-2-ene-2-carboxylic Acid, 7-((aminophenylacetyl)amino)-3-methyl-8-oxo-, Monohydrate (6r-(6alpha,7beta(r*)))-
94. Cefalexin Monohydrate [ep Impurity]
95. 7-(d-.alpha.-amino-.alpha.-phenylacetamido)-3-methyl-3-cephem-4-carboxylic Acid Monohydrate
96. Cefalexin Monohydrate [ep Monograph]
97. C08099
98. D00906
99. D94616
100. A851265
101. Sr-01000759406
102. Sr-01000759406-3
103. Q27106123
| Molecular Weight | 365.4 g/mol |
|---|---|
| Molecular Formula | C16H19N3O5S |
| Hydrogen Bond Donor Count | 4 |
| Hydrogen Bond Acceptor Count | 7 |
| Rotatable Bond Count | 4 |
| Exact Mass | 365.10454189 g/mol |
| Monoisotopic Mass | 365.10454189 g/mol |
| Topological Polar Surface Area | 139 Ų |
| Heavy Atom Count | 25 |
| Formal Charge | 0 |
| Complexity | 600 |
| 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 | 2 |
Anti-Bacterial Agents
Substances that inhibit the growth or reproduction of BACTERIA. (See all compounds classified as Anti-Bacterial Agents.)
API SUPPLIERS
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USDMF
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Cefalexin Monohydrate (Ph. Eur)
Date of Issue : 2019-06-26
Valid Till : 2022-06-25
Written Confirmation Number : WC-0023
Address of the Firm : Sy.No.1/22, 2/1 To 5, 6 to 18, 61 to 69, Pydibhimavaram Village, Ranasthalam, Sr...
Cephalexin Monohydrate (BP/Ph. Eur)
Date of Issue : 2019-07-05
Valid Till : 2022-07-04
Written Confirmation Number : WC-0202
Address of the Firm : 198-202, New Ind. Area No. 2, Mandideep- 462 046, Dist. Raisan (M.P), India.
Date of Issue : 2019-07-22
Valid Till : 2022-07-21
Written Confirmation Number : WC-0131
Address of the Firm : Plot Nos. 138-147, SIDCO Industrial Estate, Alathur, Kancheepuram District-603 1...
Date of Issue : 2015-08-25
Valid Till : 2018-08-25
Written Confirmation Number : WC-0342
Address of the Firm : 337 Kerala Nalsarovar road Village Kerala, Dist Ahmedabad-383220
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API Imports and Exports
| Importing Country | Total Quantity (KGS) |
Average Price (USD/KGS) |
Number of Transactions |
|---|
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FDF Dossiers
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Europe
Regulatory Info :
Registration Country : Sweden
Brand Name : Keflex
Dosage Form : TABLET
Dosage Strength : 500 MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
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Corporate PDF
Regulatory Info :
Registration Country : Sweden
Brand Name : Keflex
Dosage Form : GRANULES FOR ORAL SUSPENSION
Dosage Strength : 50 MG / ML
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Digital Content
NEWS #PharmaBuzz
22 Mar 2024
// HEALTH CANADA
https://recalls-rappels.canada.ca/en/alert-recall/jamp-cephalexin-suspension-suspendability-out-specification
02 May 2015
// Eric Palmer FIERCE PHARMA MFG
http://www.fiercepharmamanufacturing.com/story/attix-pharmaceuticals-recalls-hundreds-apis-us/2015-04-30
Market Place
REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
A Cephalexin Monohydrate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Cephalexin Monohydrate, including repackagers and relabelers. The FDA regulates Cephalexin Monohydrate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Cephalexin Monohydrate 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 Cephalexin Monohydrate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Cephalexin Monohydrate supplier is an individual or a company that provides Cephalexin Monohydrate active pharmaceutical ingredient (API) or Cephalexin Monohydrate finished formulations upon request. The Cephalexin Monohydrate suppliers may include Cephalexin Monohydrate API manufacturers, exporters, distributors and traders.
click here to find a list of Cephalexin Monohydrate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Cephalexin Monohydrate DMF (Drug Master File) is a document detailing the whole manufacturing process of Cephalexin Monohydrate active pharmaceutical ingredient (API) in detail. Different forms of Cephalexin Monohydrate DMFs exist exist since differing nations have different regulations, such as Cephalexin Monohydrate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Cephalexin Monohydrate DMF submitted to regulatory agencies in the US is known as a USDMF. Cephalexin Monohydrate USDMF includes data on Cephalexin Monohydrate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Cephalexin Monohydrate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Cephalexin Monohydrate 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 Cephalexin Monohydrate Drug Master File in Japan (Cephalexin Monohydrate JDMF) empowers Cephalexin Monohydrate 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 Cephalexin Monohydrate JDMF during the approval evaluation for pharmaceutical products. At the time of Cephalexin Monohydrate 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 Cephalexin Monohydrate 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 Cephalexin Monohydrate Drug Master File in Korea (Cephalexin Monohydrate KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Cephalexin Monohydrate. The MFDS reviews the Cephalexin Monohydrate KDMF as part of the drug registration process and uses the information provided in the Cephalexin Monohydrate KDMF to evaluate the safety and efficacy of the drug.
After submitting a Cephalexin Monohydrate 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 Cephalexin Monohydrate API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Cephalexin Monohydrate suppliers with KDMF on PharmaCompass.
A Cephalexin Monohydrate CEP of the European Pharmacopoeia monograph is often referred to as a Cephalexin Monohydrate Certificate of Suitability (COS). The purpose of a Cephalexin Monohydrate CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Cephalexin Monohydrate EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Cephalexin Monohydrate to their clients by showing that a Cephalexin Monohydrate CEP has been issued for it. The manufacturer submits a Cephalexin Monohydrate CEP (COS) as part of the market authorization procedure, and it takes on the role of a Cephalexin Monohydrate CEP holder for the record. Additionally, the data presented in the Cephalexin Monohydrate CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Cephalexin Monohydrate DMF.
A Cephalexin Monohydrate CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Cephalexin Monohydrate 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 Cephalexin Monohydrate suppliers with CEP (COS) on PharmaCompass.
A Cephalexin Monohydrate written confirmation (Cephalexin Monohydrate WC) is an official document issued by a regulatory agency to a Cephalexin Monohydrate manufacturer, verifying that the manufacturing facility of a Cephalexin Monohydrate active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Cephalexin Monohydrate APIs or Cephalexin Monohydrate finished pharmaceutical products to another nation, regulatory agencies frequently require a Cephalexin Monohydrate WC (written confirmation) as part of the regulatory process.
click here to find a list of Cephalexin Monohydrate suppliers with Written Confirmation (WC) on PharmaCompass.
Cephalexin Monohydrate 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 Cephalexin Monohydrate 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 Cephalexin Monohydrate GMP manufacturer or Cephalexin Monohydrate GMP API supplier for your needs.
A Cephalexin Monohydrate CoA (Certificate of Analysis) is a formal document that attests to Cephalexin Monohydrate's compliance with Cephalexin Monohydrate specifications and serves as a tool for batch-level quality control.
Cephalexin Monohydrate CoA mostly includes findings from lab analyses of a specific batch. For each Cephalexin Monohydrate 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.
Cephalexin Monohydrate may be tested according to a variety of international standards, such as European Pharmacopoeia (Cephalexin Monohydrate EP), Cephalexin Monohydrate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Cephalexin Monohydrate USP).
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