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1. Actimoxi
2. Amoxicillin
3. Amoxicillin Anhydrous
4. Amoxicillin Monopotassium Salt
5. Amoxicillin Monosodium Salt
6. Amoxicillin Sodium
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. 61336-70-7
2. Larotid
3. Polymox
4. Trimox
5. Utimox
6. Wymox
7. Clamoxyl
8. Amoxil
9. Amoxipen
10. Moxaline
11. Amodex
12. Zimox
13. Robamox
14. Dispermox
15. Novabritine
16. Hiconcil
17. Imacillin
18. Amoxycillin Trihydrate
19. Brl 2333
20. Moxatag
21. 61336-70-7 (hydrate)
22. Topramoxin
23. Amoxyke
24. Atoksilin
25. Demoksil
26. Largopen
27. Moksilin
28. Promoxil
29. Remoxil
30. Damoxy
31. 804826j2hu
32. (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 Trihydrate
33. Amoksicillin
34. Kentrocyllin
35. Zamocilline
36. Alfamox
37. Amophar
38. Amoxidal
39. Amoxillat
40. Amoxina
41. Amoxine
42. Flemoxine
43. Galenamox
44. Gramidil
45. Himinomax
46. Izoltil
47. Matasedrin
48. Metifarma
49. Pacetocin
50. Pamocil
51. Paradroxil
52. Siganopen
53. Simplamox
54. Sintopen
55. Velamox
56. Zamocillin
57. Amoran
58. Ciblor
59. Amoxicillin Hydrate
60. Amoxi-wolff
61. Uro-clamoxyl
62. Brl-2333
63. Amoxi-diolan
64. Amox
65. Amoksicillin Forte
66. A-gram
67. Dura Ax
68. Amoxicillin [usan]
69. Amoxicillin-ratiopharm
70. Drg-0075
71. Amoxicillin (as Trihydrate)
72. (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-carboxylic Acid Trihydrate
73. (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;trihydrate
74. Amoxicillin Hydrate (1:3)
75. Neotetranase
76. Sawacillin
77. Pasetocin
78. Eupen
79. Amoxil Trihydrate
80. Unii-804826j2hu
81. Alpha-amino-p-hydroxybenzylpenicillin Trihydrate
82. Amoxipen Trihydrate
83. Dispermox (tn)
84. Moxaline Trihydrate
85. Pasetocin (tn)
86. (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 Trihydrate
87. Amoxicillin (usp)
88. Amoxicillin Pulsys
89. Amoxicillin-trihydrat
90. Amoxicilline (inn)
91. Amoxil (tn)
92. Amoxicillin [usan:usp:inn:ban:jan]
93. (2s,5r,6r)-6-[(2r)-2-amino-2-(4-hydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic Acid
94. Amoxicillin [vandf]
95. Amoxicillin Hydrate (jp17)
96. Amoxicillin [usp-rs]
97. (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-carboxylic Acid Trihydrate
98. Dtxsid2022599
99. Chebi:51254
100. Amoxicillin [orange Book]
101. Amoxicillin Hydrate [jan]
102. Apc-111
103. Amoxicillin [usp Impurity]
104. Amoxicillin [usp Monograph]
105. Amoxicillin Trihydrate [mi]
106. Prevpac Component Amoxicillin
107. Talicia Component Amoxicillin
108. Mfcd00072029
109. S5298
110. Amoxicillin Trihydrate [vandf]
111. Augmentin Component Amoxicillin
112. Akos015896673
113. Amoxicillin Trihydrate [mart.]
114. Amoxicillin Component Of Prevpac
115. Amoxicillin Component Of Talicia
116. Amoxicillin Trihydrate [who-dd]
117. Amoxicillin Trihydrate [who-ip]
118. Ccg-268878
119. Ks-5338
120. Amoxicillin Component Of Augmentin
121. 4-thia-1-azabicyclo(3.2.0)heptane-2-carboxylic Acid, 6-((amino(4-hydroxyphenyl)acetyl)amino)-3,3-dimethyl-7-oxo-, Trihydrate (2s-(2alpha,5alpha,6beta(s*)))-
122. 4-thia-1-azabicyclo(3.2.0)heptane-2-carboxylic Acid, 6-((amino(4-hydroxyphenyl)acetyl)amino)-3,3-dimethyl-7-oxo-, Trihydrate(2s-(2alpha,5alpha,6beta(s*)))-
123. Amoxicillin Trihydrate [green Book]
124. Amoxicillin Trihydrate [ep Monograph]
125. Clavulox Component Amoxicillin Trihydrate
126. D00229
127. Amoxicillinum Trihydricum [who-ip Latin]
128. A833170
129. Amoxicillin Trihydrate Component Of Clavulox
130. Q27122483
131. Amoxil Trihydrate;amoxipen Trihydrate;moxaline Trihydrate
132. Amoxicillin Trihydrate, Vetranal(tm), Analytical Standard
133. Amoxicillin, United States Pharmacopeia (usp) Reference Standard
134. Amoxicillin Trihydrate, British Pharmacopoeia (bp) Reference Standard
135. Amoxicillin Trihydrate, European Pharmacopoeia (ep) Reference Standard
136. Amoxicillin Trihydrate, Pharmaceutical Secondary Standard; Certified Reference Material
137. (2s,5r)-6-[[2-amino-2-(4-hydroxyphenyl)acetyl]amino]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic Acid Trihydrate
138. (2s,5r,6r)-6-((r)-(-)-2-amino-2-(p-hydroxyphenyl)acetamido)-3,3-dimethyl-7-oxo-4-thia-1-azabicycl(3.2.0)heptane-2-carboxylic Acid Trihydrate
139. 4-thia-1-azabicyclo(3.2.0)heptane-2-carboxylic Acid, 6-(((2r)-amino(4-hydroxyphenyl)acetyl)amino)-3,3-dimethyl-7-oxo-, Trihydrate, (2s,5r,6r)-
140. 4-thia-1-azabicyclo(3.2.0)heptane-2-carboxylic Acid, 6-((amino(4-hydroxyphenyl)acetyl)amino)-3,3-dimethyl-7-oxo-, Trihydrate(2s-(2.alpha.,5.alpha.,6.beta.(s*)))-
141. 6beta-[(2r)-2-amino-2-(4-hydroxyphenyl)acetamido]-2,2-dimethylpenam-3alpha-carboxylic Acid Trihydrate
142. Amoxicillin Trihydrate For Performance Verification, European Pharmacopoeia (ep) Reference Standard
| Molecular Weight | 419.5 g/mol |
|---|---|
| Molecular Formula | C16H25N3O8S |
| Hydrogen Bond Donor Count | 7 |
| Hydrogen Bond Acceptor Count | 10 |
| Rotatable Bond Count | 4 |
| Exact Mass | 419.13623594 g/mol |
| Monoisotopic Mass | 419.13623594 g/mol |
| Topological Polar Surface Area | 161 Ų |
| Heavy Atom Count | 28 |
| Formal Charge | 0 |
| Complexity | 590 |
| 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 | 4 |
| 1 of 6 | |
|---|---|
| Drug Name | Amoxil |
| Active Ingredient | Amoxicillin |
| Dosage Form | Tablet; Capsule; Tablet, chewable; For suspension |
| Route | Oral |
| Strength | 875mg; 50mg/ml; 200mg/5ml; 250mg; 125mg/5ml; 400mg/5ml; 125mg; 500mg; 250mg/5ml |
| Market Status | Prescription |
| Company | Dr Reddys Labs |
| 2 of 6 | |
|---|---|
| Drug Name | Larotid |
| PubMed Health | Amoxicillin (By mouth) |
| Drug Classes | Antibiotic |
| Drug Label | MOXATAG (amoxicillin extended-release) tablets for oral administration are provided as blue film-coated, oval shaped tablets that contain 775 mg of amoxicillin as the trihydrate and are printed with MB-111 on one side in black edible ink. Amoxi... |
| Active Ingredient | Amoxicillin |
| Dosage Form | For suspension |
| Route | Oral |
| Strength | 250mg/5ml; 125mg/5ml |
| Market Status | Prescription |
| Company | Dr Reddys Labs |
| 3 of 6 | |
|---|---|
| Drug Name | Moxatag |
| Active Ingredient | Amoxicillin |
| Dosage Form | Tablet, extended release |
| Route | Oral |
| Strength | 775mg |
| Market Status | Prescription |
| Company | Pragma Pharms |
| 4 of 6 | |
|---|---|
| Drug Name | Amoxil |
| Active Ingredient | Amoxicillin |
| Dosage Form | Tablet; Capsule; Tablet, chewable; For suspension |
| Route | Oral |
| Strength | 875mg; 50mg/ml; 200mg/5ml; 250mg; 125mg/5ml; 400mg/5ml; 125mg; 500mg; 250mg/5ml |
| Market Status | Prescription |
| Company | Dr Reddys Labs |
| 5 of 6 | |
|---|---|
| Drug Name | Larotid |
| PubMed Health | Amoxicillin (By mouth) |
| Drug Classes | Antibiotic |
| Drug Label | MOXATAG (amoxicillin extended-release) tablets for oral administration are provided as blue film-coated, oval shaped tablets that contain 775 mg of amoxicillin as the trihydrate and are printed with MB-111 on one side in black edible ink. Amoxi... |
| Active Ingredient | Amoxicillin |
| Dosage Form | For suspension |
| Route | Oral |
| Strength | 250mg/5ml; 125mg/5ml |
| Market Status | Prescription |
| Company | Dr Reddys Labs |
| 6 of 6 | |
|---|---|
| Drug Name | Moxatag |
| Active Ingredient | Amoxicillin |
| Dosage Form | Tablet, extended release |
| Route | Oral |
| Strength | 775mg |
| Market Status | Prescription |
| Company | Pragma Pharms |
Anti-Bacterial Agents
Substances that inhibit the growth or reproduction of BACTERIA. (See all compounds classified as Anti-Bacterial Agents.)
API SUPPLIERS
Centrient is a leading manufacturer of Beta-Lactam Antibiotics and a provider of next-generation Statins and Antifungals.
Certificate Number : CEP 2007-226 - Rev 05
Issue Date : 2025-06-12
Type : Chemical
Substance Number : 260
Status : Valid
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
HRV Pharma - Market Expansion Leader in Pharmaceuticals.
Tenatra connects Indian manufacturers with global buyers through active partners in Germany, Switzerland, Belgium, Spain & Turkey.
Bioquim: An European GMP-certified company manufacturing bulk APIs, specializing in sterile lyophilization and chemical synthesis.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 32811
Submission : 2018-05-15
Status : Active
Type : II
Certificate Number : CEP 2021-461 - Rev 02
Issue Date : 2025-03-21
Type : Chemical
Substance Number : 260
Status : Valid
NDC Package Code : 55657-101
Start Marketing Date : 2005-08-31
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Sungjin Exim Co., Ltd.
Registration Date : 2025-10-29
Registration Number : 20191121-30-A-353-23(A)
Manufacturer Name : Sinopharm Weiqida Pharmaceutical Co., Ltd
Manufacturer Address : High-tech Industrial Zone, Economic & Technological Development Zone, Datong, Shanxi, China
GDUFA
DMF Review : Reviewed
Rev. Date : 2022-03-14
Pay. Date : 2022-03-04
DMF Number : 36579
Submission : 2021-12-23
Status : Active
Type : II
Certificate Number : CEP 2019-244 - Rev 03
Issue Date : 2025-07-22
Type : Chemical
Substance Number : 260
Status : Valid
NDC Package Code : 55657-106
Start Marketing Date : 2005-08-31
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Sungjin Exim Co., Ltd.
Registration Date : 2025-10-29
Registration Number : 20200707-30-A-341-24(A)
Manufacturer Name : Sinopharm Weiqida Pharmaceutical Co., Ltd
Manufacturer Address : High-tech Industrial Zone, Economic & Technological Development Zone, Datong, Shanxi, China
GDUFA
DMF Review : Reviewed
Rev. Date : 2022-03-16
Pay. Date : 2022-03-07
DMF Number : 36698
Submission : 2022-02-13
Status : Active
Type : II
Registrant Name : Masung LS Co., Ltd.
Registration Date : 2020-07-07
Registration Number : 20200707-30-A-341-24
Manufacturer Name : Sinopharm Weiqida Pharmaceutical Co., Ltd
Manufacturer Address : High-tech Industrial Zone, Economic & Technological Development Zone, Datong, Shanxi, China
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13772
Submission : 1998-09-01
Status : Inactive
Type : II
Registration Number : 221MF10239
Registrant's Address : 12 BONGEUNSA-RO, 114-GIL, GANGNAM-GU, SEOUL, 135-715 KOREA
Initial Date of Registration : 2009-11-09
Latest Date of Registration :
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13498
Submission : 1998-09-01
Status : Inactive
Type : II
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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
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USFDA APPLICATION NUMBER - 50720
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USFDA APPLICATION NUMBER - 50725
DOSAGE - FOR SUSPENSION;ORAL - 400MG/5ML;EQ 5...DOSAGE - FOR SUSPENSION;ORAL - 400MG/5ML;EQ 57MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 50725
DOSAGE - TABLET;ORAL - 500MG **Federal Regist...DOSAGE - TABLET;ORAL - 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 50754
DOSAGE - TABLET;ORAL - 875MG **Federal Regist...DOSAGE - TABLET;ORAL - 875MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 50754
DOSAGE - FOR SUSPENSION;ORAL - 600MG/5ML;EQ 4...DOSAGE - FOR SUSPENSION;ORAL - 600MG/5ML;EQ 42.9MG BASE/5ML
USFDA APPLICATION NUMBER - 50755
DOSAGE - CAPSULE, TABLET, CAPSULE, DELAYED RE...DOSAGE - CAPSULE, TABLET, CAPSULE, DELAYED REL PELLETS;ORAL - 500MG;500MG;30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 50757
DOSAGE - FOR SUSPENSION;ORAL - 200MG/5ML **Fe...DOSAGE - FOR SUSPENSION;ORAL - 200MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 50760
DOSAGE - FOR SUSPENSION;ORAL - 400MG/5ML
USFDA APPLICATION NUMBER - 50760
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
DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 775M...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 775MG
USFDA APPLICATION NUMBER - 50813
DOSAGE - CAPSULE, TABLET, CAPSULE, DELAYED RE...DOSAGE - CAPSULE, TABLET, CAPSULE, DELAYED RELEASE;ORAL - 500MG,N/A,N/A;N/A,500MG,N/A;N/A,N/A,20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 50824
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EDQM
CAS Number : 66592-87-8
Quantity Per Vial : 250 mg
Sale Unit : 1
Order Code : C0650000
Batch No : 3
Price (€) : 79
Storage : +5°C ± 3°C
CAS Number : 61336-70-7
Quantity Per Vial : 200 mg
Sale Unit : 1
Order Code : A0800000
Batch No : 5
Price (€) : 79
Storage : +5°C ± 3°C
CAS Number : 7177-48-2
Quantity Per Vial : 150 mg
Sale Unit : 1
Order Code : A1100000
Batch No : 2
Price (€) : 79
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PharmaCompass offers a list of Amoxicillin Trihydrate 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 Trihydrate manufacturer or Amoxicillin Trihydrate supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Amoxicillin Trihydrate manufacturer or Amoxicillin Trihydrate supplier.
PharmaCompass also assists you with knowing the Amoxicillin Trihydrate API Price utilized in the formulation of products. Amoxicillin Trihydrate API Price is not always fixed or binding as the Amoxicillin Trihydrate Price is obtained through a variety of data sources. The Amoxicillin Trihydrate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Amoxicillin Anhydrous manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Amoxicillin Anhydrous, including repackagers and relabelers. The FDA regulates Amoxicillin Anhydrous manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Amoxicillin Anhydrous 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 Amoxicillin Anhydrous manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Amoxicillin Anhydrous supplier is an individual or a company that provides Amoxicillin Anhydrous active pharmaceutical ingredient (API) or Amoxicillin Anhydrous finished formulations upon request. The Amoxicillin Anhydrous suppliers may include Amoxicillin Anhydrous API manufacturers, exporters, distributors and traders.
click here to find a list of Amoxicillin Anhydrous suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Amoxicillin Anhydrous DMF (Drug Master File) is a document detailing the whole manufacturing process of Amoxicillin Anhydrous active pharmaceutical ingredient (API) in detail. Different forms of Amoxicillin Anhydrous DMFs exist exist since differing nations have different regulations, such as Amoxicillin Anhydrous USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Amoxicillin Anhydrous DMF submitted to regulatory agencies in the US is known as a USDMF. Amoxicillin Anhydrous USDMF includes data on Amoxicillin Anhydrous's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Amoxicillin Anhydrous USDMF is kept confidential to protect the manufacturer’s intellectual property.
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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 Amoxicillin Anhydrous Drug Master File in Japan (Amoxicillin Anhydrous JDMF) empowers Amoxicillin Anhydrous 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 Amoxicillin Anhydrous JDMF during the approval evaluation for pharmaceutical products. At the time of Amoxicillin Anhydrous JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
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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 Amoxicillin Anhydrous Drug Master File in Korea (Amoxicillin Anhydrous KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Amoxicillin Anhydrous. The MFDS reviews the Amoxicillin Anhydrous KDMF as part of the drug registration process and uses the information provided in the Amoxicillin Anhydrous KDMF to evaluate the safety and efficacy of the drug.
After submitting a Amoxicillin Anhydrous 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 Amoxicillin Anhydrous API can apply through the Korea Drug Master File (KDMF).
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A Amoxicillin Anhydrous CEP of the European Pharmacopoeia monograph is often referred to as a Amoxicillin Anhydrous Certificate of Suitability (COS). The purpose of a Amoxicillin Anhydrous CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Amoxicillin Anhydrous EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Amoxicillin Anhydrous to their clients by showing that a Amoxicillin Anhydrous CEP has been issued for it. The manufacturer submits a Amoxicillin Anhydrous CEP (COS) as part of the market authorization procedure, and it takes on the role of a Amoxicillin Anhydrous CEP holder for the record. Additionally, the data presented in the Amoxicillin Anhydrous CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Amoxicillin Anhydrous DMF.
A Amoxicillin Anhydrous CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Amoxicillin Anhydrous 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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A Amoxicillin Anhydrous written confirmation (Amoxicillin Anhydrous WC) is an official document issued by a regulatory agency to a Amoxicillin Anhydrous manufacturer, verifying that the manufacturing facility of a Amoxicillin Anhydrous active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Amoxicillin Anhydrous APIs or Amoxicillin Anhydrous finished pharmaceutical products to another nation, regulatory agencies frequently require a Amoxicillin Anhydrous WC (written confirmation) as part of the regulatory process.
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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 Amoxicillin Anhydrous as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Amoxicillin Anhydrous 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 Amoxicillin Anhydrous 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 Amoxicillin Anhydrous and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Amoxicillin Anhydrous NDC to their finished compounded human drug products, they may choose to do so.
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Amoxicillin Anhydrous 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 Amoxicillin Anhydrous 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 Amoxicillin Anhydrous GMP manufacturer or Amoxicillin Anhydrous GMP API supplier for your needs.
A Amoxicillin Anhydrous CoA (Certificate of Analysis) is a formal document that attests to Amoxicillin Anhydrous's compliance with Amoxicillin Anhydrous specifications and serves as a tool for batch-level quality control.
Amoxicillin Anhydrous CoA mostly includes findings from lab analyses of a specific batch. For each Amoxicillin Anhydrous 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.
Amoxicillin Anhydrous may be tested according to a variety of international standards, such as European Pharmacopoeia (Amoxicillin Anhydrous EP), Amoxicillin Anhydrous JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Amoxicillin Anhydrous USP).
