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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.)
API SUPPLIERS
Rochem, your partner in developing, sourcing, and supplying pharmaceutical & animal health ingredients of Chinese origin.
Capital Farma, a leading European pharmaceutical company focusing on the development & distribution of niche APIs & Pharma Services.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 15211
Submission : 2000-12-26
Status : Active
Type : II
Certificate Number : R1-CEP 2007-258 - Rev 02
Issue Date : 2021-03-05
Type : Chemical
Substance Number : 1653
Status : Valid
NDC Package Code : 48866-9981
Start Marketing Date : 2022-11-03
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (20kg/20kg)
Marketing Category : BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING
Registrant Name : Lee Sung International Co., Ltd.
Registration Date : 2022-04-25
Registration Number : 20220425-113-F-95-25
Manufacturer Name : Lek farmacevtska družba dd, Poslovna enota Proizvodnja Lendava
Manufacturer Address : Trimlini 2D, Lendava, 9220, Slovenia
GDUFA
DMF Review : Reviewed
Rev. Date : 2019-10-24
Pay. Date : 2018-05-17
DMF Number : 32777
Submission : 2018-05-17
Status : Active
Type : II
Certificate Number : R1-CEP 2007-259 - Rev 02
Issue Date : 2021-03-05
Type : Chemical
Substance Number : 1653
Status : Valid
NDC Package Code : 48866-9982
Start Marketing Date : 2022-11-03
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (20kg/20kg)
Marketing Category : BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING
Registrant Name : Lee Sung International Co., Ltd.
Registration Date : 2022-04-25
Registration Number : 20220425-113-F-96-26
Manufacturer Name : Lek farmacevtska družba dd, Poslovna enota Proizvodnja Lendava
Manufacturer Address : Trimlini 2D, Lendava, 9220, Slovenia
GDUFA
DMF Review : Reviewed
Rev. Date : 2023-03-07
Pay. Date : 2023-02-02
DMF Number : 36941
Submission : 2023-01-17
Status : Active
Type : II
Certificate Number : R1-CEP 2007-260 - Rev 02
Issue Date : 2021-03-08
Type : Chemical
Substance Number : 1653
Status : Valid
Registrant Name : Yuhan Corporation
Registration Date : 2018-02-08
Registration Number : 20081031-113-F-10-03(4)
Manufacturer Name : lek pharmaceuticals dd
Manufacturer Address : Perzonali 47, SI-2391 Prevalje
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-10-06
Pay. Date : 2014-03-31
DMF Number : 27903
Submission : 2014-02-05
Status : Active
Type : II
Certificate Number : R1-CEP 2014-329 - Rev 00
Issue Date : 2021-03-03
Type : Chemical
Substance Number : 1653
Status : Valid
NDC Package Code : 55657-104
Start Marketing Date : 2006-02-27
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/2kg)
Marketing Category : DRUG FOR FURTHER PROCESSING
Registrant Name : Masung LS Co., Ltd.
Registration Date : 2014-10-10
Registration Number : 20141010-113-F-78-23
Manufacturer Name : Sinopharm Weiqida Pharmaceutical Co., Ltd.
Manufacturer Address : Pharmaceutical Industrial Park, Economic & Technological Development Zone, Datong, Shanxi, China
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-09-08
Pay. Date : 2014-03-31
DMF Number : 27966
Submission : 2014-03-12
Status : Active
Type : II
Certificate Number : R1-CEP 2014-320 - Rev 00
Issue Date : 2021-03-05
Type : Chemical
Substance Number : 1140
Status : Valid
NDC Package Code : 55657-105
Start Marketing Date : 2006-02-27
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/2kg)
Marketing Category : DRUG FOR FURTHER PROCESSING
Registrant Name : Masung LS Co., Ltd.
Registration Date : 2013-07-30
Registration Number : 20130730-113-F-75-21
Manufacturer Name : Sinopharm Weiqida Pharmaceutical Co., Ltd.
Manufacturer Address : Pharmaceutical Industrial Park, Economic & Technological Development Zone, Datong, Shanxi, China
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-07-29
Pay. Date : 2014-02-13
DMF Number : 25714
Submission : 2012-01-16
Status : Active
Type : II
Certificate Number : CEP 2011-375 - Rev 03
Issue Date : 2025-03-11
Type : Chemical
Substance Number : 1653
Status : Valid
NDC Package Code : 42677-105
Start Marketing Date : 2007-02-18
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (0.5kg/kg)
Marketing Category : BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING
Registrant Name : Hwail Pharmaceutical Co., Ltd.
Registration Date : 2017-10-25
Registration Number : 20120615-113-F-68-17(4)
Manufacturer Name : Shandong New Time Pharmaceutical Co.,Ltd.
Manufacturer Address : No.1, North Outer Ring Road, Feixian County, Shandong Province, China
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25718
Submission : 2012-01-16
Status : Active
Type : II
Certificate Number : CEP 2011-376 - Rev 03
Issue Date : 2025-03-17
Type : Chemical
Substance Number : 1653
Status : Valid
Registrant Name : Boryeong Co., Ltd.
Registration Date : 2017-07-27
Registration Number : 20120615-113-F-68-17(3)
Manufacturer Name : Shandong New Time Pharmaceutical Co.,Ltd.
Manufacturer Address : No.1, North Outer Ring Road, Feixian County, Shandong Province, China
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-09-13
Pay. Date : 2014-02-13
DMF Number : 25719
Submission : 2012-01-16
Status : Active
Type : II
Registrant Name : Boryeong Co., Ltd.
Registration Date : 2014-04-10
Registration Number : 20120615-113-F-67-18(3)
Manufacturer Name : Shandong New Time Pharmaceutical Co., Ltd.
Manufacturer Address : No.1, North Outer Ring Road, Feixian County, Shandong Province, China
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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 : 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 : 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 : 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
Potassium Clavulanate, Diluted, With Microcrysta...
Certificate Number : R0-CEP 2008-148 - Rev 00
Status : Expired
Issue Date : 2010-08-05
Type : Chemical
Substance Number : 1653
Certificate Number : R0-CEP 2008-147 - Rev 00
Status : Expired
Issue Date : 2010-08-05
Type : Chemical
Substance Number : 1140
Potassium Clavulanate, Diluted, With Silicon Dio...
Certificate Number : R0-CEP 2008-146 - Rev 00
Status : Expired
Issue Date : 2010-08-05
Type : Chemical
Substance Number : 1653
Potassium Clavulanate, Diluted, With Silica, Col...
Certificate Number : R1-CEP 2002-256 - Rev 01
Status : Withdrawn by Holder
Issue Date : 2010-01-12
Type : Chemical
Substance Number : 1653
Potassium Clavulanate, Diluted, With Microcrysta...
Certificate Number : R1-CEP 2002-235 - Rev 01
Status : Withdrawn by Holder
Issue Date : 2010-01-12
Type : Chemical
Substance Number : 1653
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Rochem, your partner in developing, sourcing, and supplying pharmaceutical & animal health ingredients of Chinese origin.
About the Company : Established in 1994, Rochem is a distributor of pharmaceutical, food, nutritional and animal health ingredients to some of the largest companies in the world. It sources high-quali...
Capital Farma, a leading European pharmaceutical company focusing on the development & distribution of niche APIs & Pharma Services.
About the Company : Capital Farma offers a comprehensive range of pharmaceutical solutions. Our API offering includes active ingredients sourced exclusively from top European manufacturers, ensuring t...
About the Company : Darou Pakhsh Pharma Chem (DPPC Co.) as one of the qualified and leading producers of active pharmaceutical ingredients in the Iranian pharmaceutical industry started production sin...
About the Company : Fuan Pharmaceutical (Group) Co., Ltd. was established on February 25, 2004. The company is located in Chongqing Changshou Economic and Technological Development Zone, covering an a...
About the Company : Founded in the year 1981. GCCPL has grown from a small enterprise to a large corporation serving some of the top pharmaceutical & cosmetic companies across the world. Our focus on ...
About the Company : HENGDIAN GROUP was established in 1975, till now it has become a transnational,conglomerate group and been one of the largest private-owned enterprises in China. The Pharmaceutical...
About the Company : Lunan Pharmaceutical Group is an integrated pharmaceutical group setting production, scientific research and sale of traditional Chinese medicines, chemicals, biological products i...
About the Company : Otto Brandes Gmbh was founded in 1923 and is an independent distributor of high quality Pharmaceutical Active Ingredients and excipients for the pharmaceutical industry. We regard ...
About the Company : Sandoz B2B provides access to an extensive portfolio of high-quality products and services, covering more than 20 therapeutic areas. Delivering unique added value to our partners w...
CLAVULANATE POTASSIUM WITH MICROCRYSTALLINE CELLUL
About the Company : 1. We are listed on Hong Kong Union Stock Exchange. Vertically integrated management for our six Production Bases: Finished Product Plant, HK; Bulk Medicine Plant, Zhuhai; Finished...
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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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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 Clavulanate+Amoxicillin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Clavulanate+Amoxicillin, including repackagers and relabelers. The FDA regulates Clavulanate+Amoxicillin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Clavulanate+Amoxicillin 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 Clavulanate+Amoxicillin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Clavulanate+Amoxicillin supplier is an individual or a company that provides Clavulanate+Amoxicillin active pharmaceutical ingredient (API) or Clavulanate+Amoxicillin finished formulations upon request. The Clavulanate+Amoxicillin suppliers may include Clavulanate+Amoxicillin API manufacturers, exporters, distributors and traders.
click here to find a list of Clavulanate+Amoxicillin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Clavulanate+Amoxicillin DMF (Drug Master File) is a document detailing the whole manufacturing process of Clavulanate+Amoxicillin active pharmaceutical ingredient (API) in detail. Different forms of Clavulanate+Amoxicillin DMFs exist exist since differing nations have different regulations, such as Clavulanate+Amoxicillin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Clavulanate+Amoxicillin DMF submitted to regulatory agencies in the US is known as a USDMF. Clavulanate+Amoxicillin USDMF includes data on Clavulanate+Amoxicillin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Clavulanate+Amoxicillin USDMF is kept confidential to protect the manufacturer’s intellectual property.
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In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Clavulanate+Amoxicillin Drug Master File in Korea (Clavulanate+Amoxicillin KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Clavulanate+Amoxicillin. The MFDS reviews the Clavulanate+Amoxicillin KDMF as part of the drug registration process and uses the information provided in the Clavulanate+Amoxicillin KDMF to evaluate the safety and efficacy of the drug.
After submitting a Clavulanate+Amoxicillin 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 Clavulanate+Amoxicillin API can apply through the Korea Drug Master File (KDMF).
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A Clavulanate+Amoxicillin CEP of the European Pharmacopoeia monograph is often referred to as a Clavulanate+Amoxicillin Certificate of Suitability (COS). The purpose of a Clavulanate+Amoxicillin CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Clavulanate+Amoxicillin EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Clavulanate+Amoxicillin to their clients by showing that a Clavulanate+Amoxicillin CEP has been issued for it. The manufacturer submits a Clavulanate+Amoxicillin CEP (COS) as part of the market authorization procedure, and it takes on the role of a Clavulanate+Amoxicillin CEP holder for the record. Additionally, the data presented in the Clavulanate+Amoxicillin CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Clavulanate+Amoxicillin DMF.
A Clavulanate+Amoxicillin CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Clavulanate+Amoxicillin CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.
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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 Clavulanate+Amoxicillin as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Clavulanate+Amoxicillin 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 Clavulanate+Amoxicillin 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 Clavulanate+Amoxicillin and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Clavulanate+Amoxicillin NDC to their finished compounded human drug products, they may choose to do so.
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Clavulanate+Amoxicillin 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 Clavulanate+Amoxicillin 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 Clavulanate+Amoxicillin GMP manufacturer or Clavulanate+Amoxicillin GMP API supplier for your needs.
A Clavulanate+Amoxicillin CoA (Certificate of Analysis) is a formal document that attests to Clavulanate+Amoxicillin's compliance with Clavulanate+Amoxicillin specifications and serves as a tool for batch-level quality control.
Clavulanate+Amoxicillin CoA mostly includes findings from lab analyses of a specific batch. For each Clavulanate+Amoxicillin 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.
Clavulanate+Amoxicillin may be tested according to a variety of international standards, such as European Pharmacopoeia (Clavulanate+Amoxicillin EP), Clavulanate+Amoxicillin JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Clavulanate+Amoxicillin USP).
