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1. Actimoxi
2. Amoxicillin
3. Amoxicillin Anhydrous
4. Amoxicillin Monopotassium Salt
5. Amoxicillin Monosodium Salt
6. Amoxicillin Trihydrate
7. Amoxicillin, (r*)-isomer
8. Amoxicilline
9. Amoxil
10. Amoxycillin
11. Brl 2333
12. Brl-2333
13. Brl2333
14. Clamoxyl
15. Clamoxyl G.a.
16. Clamoxyl Parenteral
17. Hydroxyampicillin
18. Penamox
19. Polymox
20. Trimox
21. Wymox
1. 34642-77-8
2. Acuotricina
3. Ibiamox
4. Sodium Amoxicillin
5. Amoxicillin Natrium
6. Amoxicillin (sodium)
7. Amoxicillin Sodium Salt
8. Amoxicillin Sodium [usan]
9. Novabritine
10. Brl-2333ab-b
11. Amoxycillin (as Sodium)
12. Amoxicillin Sodium (amox)
13. 544y3d6myh
14. Riotapen
15. Chebi:51255
16. Amoxicillin Sodium (usan)
17. Sodium;(2s,5r,6r)-6-[[(2r)-2-amino-2-(4-hydroxyphenyl)acetyl]amino]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylate
18. Sodium;(2s,5r,6r)-6-[[(2r)-2-amino-2-(4-hydroxyphenyl)acetyl]amino]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic Acid
19. Danoxillin
20. Amitron
21. Penamox
22. Quimiopen
23. Trifamox
24. Alfida
25. Lamoxy
26. Alfoxil Enjektabl
27. Agram Im
28. Riotapen [inj.]
29. Ibiamox [inj.]
30. Moxacin [inj.]
31. Penamox [inj.]
32. Danoxillin [inj.]
33. Lamoxy [inj.]
34. Novabritine [inj.]
35. Brl 23333ab-b
36. Unii-544y3d6myh
37. Einecs 252-124-1
38. Schembl973672
39. Chembl2105950
40. Amoxicillin Sodium [mart.]
41. Amoxicillin Sodium [who-dd]
42. Bcp12668
43. Hy-b0467
44. Sodium (2s,5r,6r)-6-((r)-2-amino-2-(4-hydroxyphenyl)acetamido)-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylate
45. Amoxicillin Sodium Salt [mi]
46. Mfcd08063910
47. S2565
48. Akos015951334
49. Ccg-268488
50. Amoxicillin Sodium [ep Monograph]
51. (2s-(2alpha,5alpha,6beta(s*)))-6-((amino(4-hydroxyphenyl)acetyl)amino)-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo(3.2.0)heptane-2-carboxylic Acid Monosodium Salt
52. Monosodium (-)-(2s,5r,6r)-6-((r)-2-amino(4-hydroxyphenyl)acetamido)-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo(3.2.0)heptane-2-carboxylate
53. D02925
54. F20449
55. Q27122484
56. Na-6-[d-a-amino-p-hydroxyphenylacetamido]penicillanic Acid
57. (2s-(2alpha,5alpha.6beta(s*)))-6-((amino(4-hydroxyphenyl)acetyl)amino)-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo(3.2.0)heptane-2-carboxylic Acid Monosodium Salt
58. 4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic Acid, 6-[[(2r)-2-amino-2-(4-hydroxyphenyl)acetyl]amino]-3,3-dimethyl-7-oxo-, Sodium Salt, (2s,5r,6r)- (1:1)
59. Monosodium (-)-(2s,5r,6r)-6-((r)-2-amino-2-(p-hydroxyphenyl)acetamido)-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo(3.2.0)heptane-2-carboxylate
60. Sodium (2s-(2alpha,5alpha,6beta(s*)))-6-((amino(4-hydroxyphenyl)acetyl)amino)-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo(3.2.0)heptane-2-carboxylate
61. Sodium 6beta-[(2r)-2-amino-2-(4-hydroxyphenyl)acetamido]-2,2-dimethylpenam-3alpha-carboxylate
62. Sodium(2s,5r,6r)-6-((r)-2-amino-2-(4-hydroxyphenyl)acetamido)-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylate
Molecular Weight | 387.4 g/mol |
---|---|
Molecular Formula | C16H18N3NaO5S |
Hydrogen Bond Donor Count | 3 |
Hydrogen Bond Acceptor Count | 7 |
Rotatable Bond Count | 4 |
Exact Mass | 387.08648614 g/mol |
Monoisotopic Mass | 387.08648614 g/mol |
Topological Polar Surface Area | 161 Ų |
Heavy Atom Count | 26 |
Formal Charge | 0 |
Complexity | 596 |
Isotope Atom Count | 0 |
Defined Atom Stereocenter Count | 4 |
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.)
GDUFA
DMF Review : Reviewed
Rev. Date : 2024-01-05
Pay. Date : 2023-11-28
DMF Number : 39198
Submission : 2023-12-01
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18044
Submission : 2005-02-01
Status : Active
Type : II
Certificate Number : CEP 1999-036 - Rev 10
Issue Date : 2024-06-28
Type : Chemical
Substance Number : 577
Status : Valid
Registrant Name : Penmix Co., Ltd.
Registration Date : 2013-05-02
Registration Number : 20101116-30-A-240-15(3)
Manufacturer Name : Sandoz GmbH
Manufacturer Address : Biochemiestrasse 10, A-6250 Kundl, Tyrol
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38349
Submission : 2023-05-17
Status : Active
Type : II
NDC Package Code : 66558-0200
Start Marketing Date : 2021-11-20
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18259
Submission : 2005-04-08
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20128
Submission : 2006-12-30
Status : Inactive
Type : II
Certificate Number : CEP 2008-002 - Rev 03
Issue Date : 2023-11-30
Type : Chemical
Substance Number : 577
Status : Valid
Date of Issue : 2019-07-05
Valid Till : 2022-07-02
Written Confirmation Number : WC-0121
Address of the Firm :
NDC Package Code : 59651-883
Start Marketing Date : 2023-11-29
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 : 5308
Submission : 1984-02-29
Status : Inactive
Type : II
Registrant Name : GlaxoSmithKline Inc.
Registration Date : 2014-04-21
Registration Number : 20140421-30-A-291-19
Manufacturer Name : SmithKline Beecham Pharmaceuticals@[Starting Material (Amoxicillin Trihydrate) Manufacturer] Beecham Pharmaceuticals (Pte) Ltd
Manufacturer Address : Clarendon Road, Worthing, West Sussex, BN14 8QH, United Kingdom@38 Quality Road, Jurong Industrial Estate, Singapore 618809
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 24471
Submission : 2011-02-11
Status : Inactive
Type : II
Certificate Number : CEP 2008-267 - Rev 08
Issue Date : 2025-04-02
Type : Chemical
Substance Number : 577
Status : Valid
Certificate Number : R1-CEP 1998-069 - Rev 01
Issue Date : 2009-06-17
Type : Chemical
Substance Number : 577
Status : Valid
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PharmaCompass offers a list of Amoxicillin Sodium 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 Amoxicillin Sodium manufacturer or Amoxicillin Sodium supplier for your needs.
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A Trifamox manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Trifamox, including repackagers and relabelers. The FDA regulates Trifamox manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Trifamox 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 Trifamox manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Trifamox supplier is an individual or a company that provides Trifamox active pharmaceutical ingredient (API) or Trifamox finished formulations upon request. The Trifamox suppliers may include Trifamox API manufacturers, exporters, distributors and traders.
click here to find a list of Trifamox suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Trifamox DMF (Drug Master File) is a document detailing the whole manufacturing process of Trifamox active pharmaceutical ingredient (API) in detail. Different forms of Trifamox DMFs exist exist since differing nations have different regulations, such as Trifamox USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Trifamox DMF submitted to regulatory agencies in the US is known as a USDMF. Trifamox USDMF includes data on Trifamox's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Trifamox USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Trifamox 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 Trifamox Drug Master File in Korea (Trifamox KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Trifamox. The MFDS reviews the Trifamox KDMF as part of the drug registration process and uses the information provided in the Trifamox KDMF to evaluate the safety and efficacy of the drug.
After submitting a Trifamox 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 Trifamox API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Trifamox suppliers with KDMF on PharmaCompass.
A Trifamox CEP of the European Pharmacopoeia monograph is often referred to as a Trifamox Certificate of Suitability (COS). The purpose of a Trifamox CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Trifamox EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Trifamox to their clients by showing that a Trifamox CEP has been issued for it. The manufacturer submits a Trifamox CEP (COS) as part of the market authorization procedure, and it takes on the role of a Trifamox CEP holder for the record. Additionally, the data presented in the Trifamox CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Trifamox DMF.
A Trifamox CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Trifamox 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 Trifamox suppliers with CEP (COS) on PharmaCompass.
A Trifamox written confirmation (Trifamox WC) is an official document issued by a regulatory agency to a Trifamox manufacturer, verifying that the manufacturing facility of a Trifamox active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Trifamox APIs or Trifamox finished pharmaceutical products to another nation, regulatory agencies frequently require a Trifamox WC (written confirmation) as part of the regulatory process.
click here to find a list of Trifamox 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 Trifamox as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Trifamox 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 Trifamox 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 Trifamox and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Trifamox NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Trifamox suppliers with NDC on PharmaCompass.
Trifamox 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 Trifamox 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 Trifamox GMP manufacturer or Trifamox GMP API supplier for your needs.
A Trifamox CoA (Certificate of Analysis) is a formal document that attests to Trifamox's compliance with Trifamox specifications and serves as a tool for batch-level quality control.
Trifamox CoA mostly includes findings from lab analyses of a specific batch. For each Trifamox 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.
Trifamox may be tested according to a variety of international standards, such as European Pharmacopoeia (Trifamox EP), Trifamox JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Trifamox USP).