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1. Brl 14151
2. Brl-14151
3. Brl14151
4. Clavulanate
5. Clavulanate, Potassium
6. Clavulanate, Sodium
7. Clavulanic Acid
8. Clavulanic Acid, Monopotassium Salt
9. Clavulanic Acid, Monosodium Salt
10. Mm 14151
11. Mm-14151
12. Mm14151
13. Potassium Clavulanate
14. Potassium, Clavulanate
15. Sodium Clavulanate
1. Potassium Clavulanate
2. 61177-45-5
3. Clavulanic Acid Potassium Salt
4. Brl 14151k
5. Clavulanate (potassium)
6. Q42omw3at8
7. Chebi:85264
8. Brl-14151k
9. Potassium (2r,3z,5r)-3-(2-hydroxyethylidene)-7-oxo-4-oxa-1-azabicyclo[3.2.0]heptane-2-carboxylate
10. Potassium (z)-(2r,5r)-3-(2-hydroxyethylidene)-7-oxo-4-oxa-1-azabicyclo(3.2.0)heptane-2-carboxylate
11. Potassium;(2r,3z,5r)-3-(2-hydroxyethylidene)-7-oxo-4-oxa-1-azabicyclo[3.2.0]heptane-2-carboxylate
12. Amonate
13. Potassium (2r,5r,z)-3-(2-hydroxyethylidene)-7-oxo-4-oxa-1-azabicyclo[3.2.0]heptane-2-carboxylate
14. Clavulansaeure Kaliumsalz
15. Einecs 262-640-9
16. Unii-q42omw3at8
17. Potassium Clavlanate
18. Clavulanate Potassium [usan:usp:jan]
19. Chembl1003
20. Schembl203411
21. Clavulanic Acid Potassium
22. Hy-a0256a
23. Dtxsid60210067
24. Hms3715b13
25. Clavulanate Potassium (jp17/usp)
26. Potassium Clavulanate [jan]
27. Bcp13548
28. Clavulanate Potassium [usan]
29. Clavulanate Potassium [vandf]
30. Potassium Clavulanate [mart.]
31. Potassium Clavulanate Cellulose(1:1)
32. Akos015961326
33. Clavulanate Potassium [who-dd]
34. Ccg-221126
35. 4-oxa-1-azabicyclo(3.2.0)heptane-2-carboxylic Acid, 3-(2-hydroxyethylidene)-7-oxo-, Monopotassium Salt, (2r-(2alpha,3z,5alpha))-
36. Ac-13551
37. Bp-30181
38. Clavulanate Potassium [green Book]
39. Potassium (2r-(2alpha,3z,5alpha))-3-(2-hydroxyethylidene)-7-oxo-4-oxa-1-azabicyclo(3.2.0)heptane-2-carboxylate
40. Clavulanate Potassium [orange Book]
41. Potassium Clavulanate [ep Monograph]
42. Clavulanate Potassium [usp Monograph]
43. Cs-0019771
44. Augmentin Component Clavulanate Potassium
45. C-6660
46. Clavulox Component Clavulanate Potassium
47. D02370
48. D84066
49. Timentin Component Clavulanate Potassium
50. A833076
51. Clavulanate Potassium Component Of Augmentin
52. Clavulanate Potassium Component Of Clavulox
53. Clavulanate Potassium Component Of Timentin
54. Clavulanic Acid (as Clavulanate Potassium)
55. Clavulanic Acid Potassium 100 Microg/ml In Water
56. W-105420
57. Clavulanate Potassium+microcrystalline Cellulose(1:1)
58. Potassium Clavulanate (40%) : Silicon Dioxide Mixture
59. Q27158444
60. Potassium Clavulanate (50%) : Microcrystalline Cellulose
61. Clavulanate Potassium Salt, Antibiotic For Culture Media Use Only
62. Potassium Clavulanate - 1:1 Mixture With Cellulose, Antibiotic For Culture Media Use Only
63. (2r,5r)-3-(2-hydroxyethylidene)-7-oxo-4-oxa-1-azabicyclo[3.2.0]heptane-2beta-carboxylic Acid Potassium Salt
64. 4-oxa-1-azabicyclo(3.2.0)heptane-2-carboxylic Acid, 3-(2-hydroxyethylidene)-7-oxo-, Monopotassium Salt, (2r-(2.alpha.,3z,5.alpha.))-
65. Potassium (2r,3z,5r)-3-(2-oxidanylethylidene)-7-oxidanylidene-4-oxa-1-azabicyclo[3.2.0]heptane-2-carboxylate
66. Potassium (2r,5r,z)- 3-(2-hydroxyethylidene)-7-oxo-4-oxa-1-azabicyclo[3.2.0]heptane-2-carboxylate
67. Potassium(2r,5r,z)-3-(2-hydroxyethylidene)-7-oxo-4-oxa-1-azabicyclo[3.2.0]heptane-2-carboxylate
| Molecular Weight | 237.25 g/mol |
|---|---|
| Molecular Formula | C8H8KNO5 |
| Hydrogen Bond Donor Count | 1 |
| Hydrogen Bond Acceptor Count | 5 |
| Rotatable Bond Count | 2 |
| Exact Mass | 237.00395384 g/mol |
| Monoisotopic Mass | 237.00395384 g/mol |
| Topological Polar Surface Area | 89.9 Ų |
| Heavy Atom Count | 15 |
| Formal Charge | 0 |
| Complexity | 329 |
| Isotope Atom Count | 0 |
| Defined Atom Stereocenter Count | 2 |
| Undefined Atom Stereocenter Count | 0 |
| Defined Bond Stereocenter Count | 1 |
| Undefined Bond Stereocenter Count | 0 |
| Covalently Bonded Unit Count | 2 |
beta-Lactamase Inhibitors
Endogenous substances and drugs that inhibit or block the activity of BETA-LACTAMASES. (See all compounds classified as beta-Lactamase Inhibitors.)
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USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 14065
Submission : 1999-04-07
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 14436
Submission : 1999-10-05
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 7048
Submission : 1987-07-09
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5701
Submission : 1985-02-13
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 4349
Submission : 1981-12-02
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16005
Submission : 2002-06-13
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 15211
Submission : 2000-12-26
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2018-07-13
Pay. Date : 2018-06-21
DMF Number : 14679
Submission : 2000-01-19
Status : Active
Type : II
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Potassium Clavulanate, Diluted, With Microcrysta...
Certificate Number : R1-CEP 2009-358 - Rev 00
Status : Valid
Issue Date : 2015-02-17
Type : Chemical
Substance Number : 1653
Potassium Clavulanate, Diluted, With Silica, Col...
Certificate Number : R1-CEP 2006-018 - Rev 02
Status : Valid
Issue Date : 2014-12-08
Type : Chemical
Substance Number : 1653
Potassium Clavulanate, Sterile
Certificate Number : R1-CEP 1999-113 - Rev 04
Status : Valid
Issue Date : 2014-02-26
Type : Chemical
Substance Number : 1140
Potassium Clavulanate, Diluted, Silica, Colloida...
Certificate Number : R0-CEP 2006-068 - Rev 01
Status : Withdrawn by Holder
Issue Date : 2010-02-02
Type : Chemical
Substance Number : 1653
Potassium Clavulanate, Diluted, With Microcrysta...
Certificate Number : R0-CEP 2004-234 - Rev 01
Status : Expired
Issue Date : 2009-10-13
Type : Chemical
Substance Number : 1653
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DOSAGE - TABLET;ORAL - 250MG;EQ 125MG BASE **...DOSAGE - TABLET;ORAL - 250MG;EQ 125MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 50564
DOSAGE - TABLET;ORAL - 500MG;EQ 125MG BASE **...DOSAGE - TABLET;ORAL - 500MG;EQ 125MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 50564
DOSAGE - FOR SUSPENSION;ORAL - 125MG/5ML;EQ 3...DOSAGE - FOR SUSPENSION;ORAL - 125MG/5ML;EQ 31.25MG BASE/5ML
USFDA APPLICATION NUMBER - 50575
DOSAGE - FOR SUSPENSION;ORAL - 250MG/5ML;EQ 6...DOSAGE - FOR SUSPENSION;ORAL - 250MG/5ML;EQ 62.5MG BASE/5ML
USFDA APPLICATION NUMBER - 50575
DOSAGE - TABLET;ORAL - 875MG;EQ 125MG BASE
USFDA APPLICATION NUMBER - 50720
DOSAGE - FOR SUSPENSION;ORAL - 200MG/5ML;EQ 2...DOSAGE - FOR SUSPENSION;ORAL - 200MG/5ML;EQ 28.5MG BASE/5ML
USFDA APPLICATION NUMBER - 50725
DOSAGE - FOR SUSPENSION;ORAL - 400MG/5ML;EQ 5...DOSAGE - FOR SUSPENSION;ORAL - 400MG/5ML;EQ 57MG BASE/5ML
USFDA APPLICATION NUMBER - 50725
DOSAGE - FOR SUSPENSION;ORAL - 600MG/5ML;EQ 4...DOSAGE - FOR SUSPENSION;ORAL - 600MG/5ML;EQ 42.9MG BASE/5ML
USFDA APPLICATION NUMBER - 50755
DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 1GM;...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 1GM;EQ 62.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 50785
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34
PharmaCompass offers a list of Clavulanic Acid 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 Clavulanic Acid manufacturer or Clavulanic Acid supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Clavulanic Acid manufacturer or Clavulanic Acid supplier.
PharmaCompass also assists you with knowing the Clavulanic Acid API Price utilized in the formulation of products. Clavulanic Acid API Price is not always fixed or binding as the Clavulanic Acid Price is obtained through a variety of data sources. The Clavulanic Acid Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Clavulanic Acid manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Clavulanic Acid, including repackagers and relabelers. The FDA regulates Clavulanic Acid manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Clavulanic Acid 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 Clavulanic Acid manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Clavulanic Acid supplier is an individual or a company that provides Clavulanic Acid active pharmaceutical ingredient (API) or Clavulanic Acid finished formulations upon request. The Clavulanic Acid suppliers may include Clavulanic Acid API manufacturers, exporters, distributors and traders.
click here to find a list of Clavulanic Acid suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Clavulanic Acid DMF (Drug Master File) is a document detailing the whole manufacturing process of Clavulanic Acid active pharmaceutical ingredient (API) in detail. Different forms of Clavulanic Acid DMFs exist exist since differing nations have different regulations, such as Clavulanic Acid USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Clavulanic Acid DMF submitted to regulatory agencies in the US is known as a USDMF. Clavulanic Acid USDMF includes data on Clavulanic Acid's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Clavulanic Acid USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Clavulanic Acid 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 Clavulanic Acid Drug Master File in Korea (Clavulanic Acid KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Clavulanic Acid. The MFDS reviews the Clavulanic Acid KDMF as part of the drug registration process and uses the information provided in the Clavulanic Acid KDMF to evaluate the safety and efficacy of the drug.
After submitting a Clavulanic Acid 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 Clavulanic Acid API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Clavulanic Acid suppliers with KDMF on PharmaCompass.
A Clavulanic Acid CEP of the European Pharmacopoeia monograph is often referred to as a Clavulanic Acid Certificate of Suitability (COS). The purpose of a Clavulanic Acid CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Clavulanic Acid EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Clavulanic Acid to their clients by showing that a Clavulanic Acid CEP has been issued for it. The manufacturer submits a Clavulanic Acid CEP (COS) as part of the market authorization procedure, and it takes on the role of a Clavulanic Acid CEP holder for the record. Additionally, the data presented in the Clavulanic Acid CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Clavulanic Acid DMF.
A Clavulanic Acid CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Clavulanic Acid 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 Clavulanic Acid suppliers with CEP (COS) 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 Clavulanic Acid as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Clavulanic Acid 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 Clavulanic Acid 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 Clavulanic Acid and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Clavulanic Acid NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Clavulanic Acid suppliers with NDC on PharmaCompass.
Clavulanic Acid 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 Clavulanic Acid 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 Clavulanic Acid GMP manufacturer or Clavulanic Acid GMP API supplier for your needs.
A Clavulanic Acid CoA (Certificate of Analysis) is a formal document that attests to Clavulanic Acid's compliance with Clavulanic Acid specifications and serves as a tool for batch-level quality control.
Clavulanic Acid CoA mostly includes findings from lab analyses of a specific batch. For each Clavulanic Acid 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.
Clavulanic Acid may be tested according to a variety of international standards, such as European Pharmacopoeia (Clavulanic Acid EP), Clavulanic Acid JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Clavulanic Acid USP).
