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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.)
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.
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 2019-244 - Rev 03
Issue Date : 2025-07-22
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 2021-461 - Rev 02
Issue Date : 2025-03-21
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 : 13525
Submission : 1998-09-01
Status : Inactive
Type : II

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 :

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GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13498
Submission : 1998-09-01
Status : Inactive
Type : II

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13201
Submission : 1998-04-30
Status : Inactive
Type : II

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13481
Submission : 1998-09-01
Status : Inactive
Type : II

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13207
Submission : 1998-04-30
Status : Inactive
Type : II

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 8845
Submission : 1990-11-15
Status : Inactive
Type : II

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13215
Submission : 1998-04-30
Status : Inactive
Type : II

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12895
Submission : 1998-03-11
Status : Inactive
Type : II

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12904
Submission : 1998-03-18
Status : Inactive
Type : II

USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 11481
Submission : 1995-04-28
Status : Inactive
Type : II

Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 11451
Submission : 1995-04-14
Status : Inactive
Type : II

Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
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Centrient is a leading manufacturer of Beta-Lactam Antibiotics and a provider of next-generation Statins and Antifungals.
Centrient is a leading manufacturer of Beta-Lactam Antibiotics and a provider of next-generation Statins and Antifungals.
Amoxicillin Trihydrate, Toansa, India: Powder Gr...
Certificate Number : CEP 2007-226 - Rev 05
Status : Valid
Issue Date : 2025-06-12
Type : Chemical
Substance Number : 260
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Certificate Number : R1-CEP 2004-147 - Rev 00
Status : Withdrawn by Holder
Issue Date : 2013-04-22
Type : Chemical
Substance Number : 260

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Amoxicillin Trihydrate, Powder, Compacted And Mi...
Certificate Number : R0-CEP 1997-129 - Rev 00
Status : Withdrawn by EDQM Failure to CEP pro...
Issue Date : 2005-01-24
Type : Chemical
Substance Number : 260

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Certificate Number : R1-CEP 2004-074 - Rev 00
Status : Withdrawn by Holder
Issue Date : 2013-04-30
Type : Chemical
Substance Number : 260

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Certificate Number : R1-CEP 1996-060 - Rev 03
Status : Withdrawn by EDQM Failure to CEP pro...
Issue Date : 2010-12-20
Type : Chemical
Substance Number : 260

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Certificate Number : R1-CEP 2004-266 - Rev 01
Status : Withdrawn by EDQM Failure to CEP pro...
Issue Date : 2012-11-16
Type : Chemical
Substance Number : 260

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Amoxicillin Trihydrate, Mexico, Powder Material,...
Certificate Number : R2-CEP 1995-030 - Rev 02
Status : Withdrawn by Holder
Issue Date : 2014-06-02
Type : Chemical
Substance Number : 260

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Amoxicillin Trihydrate, For Veterinary Purposes ...
Certificate Number : R0-CEP 2007-018 - Rev 02
Status : Withdrawn by Holder
Issue Date : 2013-05-28
Type : Chemical
Substance Number : 260

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results] Registration Number : 218MF10776
Registrant's Address : Avenida de Antibioticos 59/61 24009 Leon, Spain
Initial Date of Registration : 2006-09-22
Latest Date of Registration : 2006-09-22

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 : 2009-11-09

Registration Number : 306MF10115
Registrant's Address : Biochemiesstrasse 10, 6250 Kundl, Austria
Initial Date of Registration : 2024-08-22
Latest Date of Registration : 2024-08-22

Registration Number : 217MF10761
Registrant's Address : Cl Gorg Moli(´) d'en Puigverd, 37-41. P.G. Mas Puigverd E-08389 Palafolls (Barcelona...
Initial Date of Registration : 2005-10-20
Latest Date of Registration : 2006-05-18

Registration Number : 229MF10091
Registrant's Address : No. 2428, Anji Road, Sanzao Town, Jinwan District, Zhuhai, Guangdong-519040, P. R. Ch...
Initial Date of Registration : 2017-05-01
Latest Date of Registration : 2017-05-01

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API Imports and Exports
| Importing Country | Total Quantity (KGS) |
Average Price (USD/KGS) |
Number of Transactions |
|---|
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Centrient is a leading manufacturer of Beta-Lactam Antibiotics and a provider of next-generation Statins and Antifungals.
Regulatory Info :
Registration Country : Netherlands
Brand Name :
Dosage Form : Hard Capsule
Dosage Strength : 500MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Netherlands
Centrient is a leading manufacturer of Beta-Lactam Antibiotics and a provider of next-generation Statins and Antifungals.
Regulatory Info :
Registration Country : Netherlands
Brand Name :
Dosage Form : Dispersible Tablet
Dosage Strength : 500MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Netherlands
Centrient is a leading manufacturer of Beta-Lactam Antibiotics and a provider of next-generation Statins and Antifungals.
Regulatory Info :
Registration Country : Netherlands
Brand Name :
Dosage Form : Dispersible Tablet
Dosage Strength : 750MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Netherlands
Centrient is a leading manufacturer of Beta-Lactam Antibiotics and a provider of next-generation Statins and Antifungals.
Regulatory Info :
Registration Country : Netherlands
Brand Name :
Dosage Form : Dispersible Tablet
Dosage Strength : 1000MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Netherlands
Centrient is a leading manufacturer of Beta-Lactam Antibiotics and a provider of next-generation Statins and Antifungals.
Regulatory Info :
Registration Country : Netherlands
Brand Name :
Dosage Form : Powder for Oral Suspension
Dosage Strength : 125MG/5ML
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Netherlands
Centrient is a leading manufacturer of Beta-Lactam Antibiotics and a provider of next-generation Statins and Antifungals.
Regulatory Info :
Registration Country : Netherlands
Brand Name :
Dosage Form : Powder for Oral Suspension
Dosage Strength : 250MG/5ML
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Netherlands
Centrient is a leading manufacturer of Beta-Lactam Antibiotics and a provider of next-generation Statins and Antifungals.
Regulatory Info :
Registration Country : Netherlands
Brand Name :
Dosage Form : Powder for Oral Suspension
Dosage Strength : 500MG/5ML
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Netherlands
Centrient is a leading manufacturer of Beta-Lactam Antibiotics and a provider of next-generation Statins and Antifungals.
Regulatory Info : Deregistered
Registration Country : Sweden
Brand Name : Amoxicillin Dsm Sinochem
Dosage Form : Dispersible Tablet
Dosage Strength : 750mg
Packaging :
Approval Date : 28/01/2016
Application Number : 20141010000018
Regulatory Info : Deregistered
Registration Country : Sweden
Centrient is a leading manufacturer of Beta-Lactam Antibiotics and a provider of next-generation Statins and Antifungals.
Regulatory Info : Cancelled
Registration Country : Spain
Brand Name : Amoxicilina/Acido Clavulanico Centrient
Dosage Form : Powder For Oral Suspension
Dosage Strength : 500MG; 125 MG
Packaging :
Approval Date : 2016-12-28
Application Number : 81570
Regulatory Info : Cancelled
Registration Country : Spain
Centrient is a leading manufacturer of Beta-Lactam Antibiotics and a provider of next-generation Statins and Antifungals.
Regulatory Info : Cancelled
Registration Country : Spain
Brand Name : Amoxicilina/Acido Clavulanico Centrient
Dosage Form : Powder For Oral Suspension
Dosage Strength : 875MG; 125 MG
Packaging :
Approval Date : 2016-12-28
Application Number : 81571
Regulatory Info : Cancelled
Registration Country : Spain
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]RLD : No
TE Code :
Brand Name : AMOXICILLIN
Dosage Form : CAPSULE;ORAL
Dosage Strength : 500MG
Approval Date : 1988-02-25
Application Number : 62881
RX/OTC/DISCN : DISCN
RLD : No
TE Code :
RLD : No
TE Code :
Brand Name : AMOXICILLIN
Dosage Form : CAPSULE;ORAL
Dosage Strength : 250MG
Approval Date : 1988-02-25
Application Number : 62884
RX/OTC/DISCN : DISCN
RLD : No
TE Code :
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RLD : No
TE Code : AB
AMOXICILLIN; CLAVULANATE POTASSIUM
Brand Name : AMOXICILLIN AND CLAVULANATE POTASSIUM
Dosage Form : FOR SUSPENSION;ORAL
Dosage Strength : 200MG/5ML;EQ 28.5MG BASE/5ML
Approval Date : 2011-12-20
Application Number : 201090
RX/OTC/DISCN : RX
RLD : No
TE Code : AB

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RLD : No
TE Code :
Brand Name : TRIMOX
Dosage Form : FOR SUSPENSION;ORAL
Dosage Strength : 250MG/5ML
Approval Date : 1982-01-01
Application Number : 61886
RX/OTC/DISCN : DISCN
RLD : No
TE Code :

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RLD : Yes
TE Code :
Brand Name : AMOXIL
Dosage Form : FOR SUSPENSION;ORAL
Dosage Strength : 125MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date : 1982-01-01
Application Number : 50460
RX/OTC/DISCN : DISCN
RLD : Yes
TE Code :

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RLD : No
TE Code :
Brand Name : AMOXICILLIN
Dosage Form : TABLET;ORAL
Dosage Strength : 875MG
Approval Date : 2000-11-24
Application Number : 65059
RX/OTC/DISCN : DISCN
RLD : No
TE Code :

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RLD : No
TE Code :
Brand Name : AMOXICILLIN
Dosage Form : TABLET, CHEWABLE;ORAL
Dosage Strength : 400MG
Approval Date : 2000-11-29
Application Number : 65060
RX/OTC/DISCN : DISCN
RLD : No
TE Code :

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RLD : No
TE Code :
AMOXICILLIN; CLAVULANATE POTASSIUM
Brand Name : AMOXICILLIN AND CLAVULANATE POTASSIUM
Dosage Form : FOR SUSPENSION;ORAL
Dosage Strength : 200MG/5ML;EQ 28.5MG BASE/5ML
Approval Date : 2003-03-19
Application Number : 65132
RX/OTC/DISCN : DISCN
RLD : No
TE Code :

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RLD : No
TE Code :
AMOXICILLIN; CLAVULANATE POTASSIUM
Brand Name : AMOXICILLIN AND CLAVULANATE POTASSIUM
Dosage Form : FOR SUSPENSION;ORAL
Dosage Strength : 600MG/5ML;EQ 42.9MG BASE/5ML
Approval Date : 2007-01-30
Application Number : 65207
RX/OTC/DISCN : DISCN
RLD : No
TE Code :

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RLD : No
TE Code : AB
Brand Name : AMOXICILLIN
Dosage Form : FOR SUSPENSION;ORAL
Dosage Strength : 200MG/5ML
Approval Date : 2002-12-04
Application Number : 65119
RX/OTC/DISCN : RX
RLD : No
TE Code : AB

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]
Centrient is a leading manufacturer of Beta-Lactam Antibiotics and a provider of next-generation Statins and Antifungals.
Regulatory Info : Deregistered
Registration Country : Sweden
Brand Name : Amoxicillin Dsm Sinochem
Dosage Form : Dispersible Tablet
Dosage Strength : 750mg
Packaging :
Approval Date : 28/01/2016
Application Number : 20141010000018
Regulatory Info : Deregistered
Registration Country : Sweden
Centrient is a leading manufacturer of Beta-Lactam Antibiotics and a provider of next-generation Statins and Antifungals.
Regulatory Info : Cancelled
Registration Country : Spain
Brand Name : Amoxicilina/Acido Clavulanico Centrient
Dosage Form : Powder For Oral Suspension
Dosage Strength : 500MG; 125 MG
Packaging :
Approval Date : 2016-12-28
Application Number : 81570
Regulatory Info : Cancelled
Registration Country : Spain
Centrient is a leading manufacturer of Beta-Lactam Antibiotics and a provider of next-generation Statins and Antifungals.
Regulatory Info : Cancelled
Registration Country : Spain
Brand Name : Amoxicilina/Acido Clavulanico Centrient
Dosage Form : Powder For Oral Suspension
Dosage Strength : 875MG; 125 MG
Packaging :
Approval Date : 2016-12-28
Application Number : 81571
Regulatory Info : Cancelled
Registration Country : Spain
Centrient is a leading manufacturer of Beta-Lactam Antibiotics and a provider of next-generation Statins and Antifungals.
Regulatory Info : Cancelled
Registration Country : Spain
Brand Name : Amoxicilina Centrient
Dosage Form : Powder For Oral Suspension
Dosage Strength : 250MG
Packaging :
Approval Date : 2018-08-08
Application Number : 81128
Regulatory Info : Cancelled
Registration Country : Spain
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info : Allowed
Registration Country : Switzerland
Amoxicillin Anhydrous; Clavulanic Acid
Brand Name : Co-Amoxicillin Zentiva
Dosage Form : Film Coated Tablet
Dosage Strength : 875mg;125mg
Packaging :
Approval Date : 18/02/2019
Application Number : 67110
Regulatory Info : Allowed
Registration Country : Switzerland
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info : Allowed
Registration Country : Switzerland
Amoxicillin Anhydrous; Clavulanic Acid
Brand Name : Co-Amoxicillin Zentiva
Dosage Form : Film Coated Tablet
Dosage Strength : 500mg;125mg
Packaging :
Approval Date : 18/02/2019
Application Number : 67111
Regulatory Info : Allowed
Registration Country : Switzerland
Polfa Tarchomin is a leading Polish pharmaceutical company with 200 year tradition in manufacture and sale of pharmaceutical products.
Regulatory Info : Approved
Registration Country : Sweden
Brand Name : Amotax
Dosage Form : Tablet
Dosage Strength : 500mg
Packaging :
Approval Date : 14/10/2024
Application Number : 20240821000016
Regulatory Info : Approved
Registration Country : Sweden
Polfa Tarchomin is a leading Polish pharmaceutical company with 200 year tradition in manufacture and sale of pharmaceutical products.
Regulatory Info : Approved
Registration Country : Sweden
Brand Name : Amotax
Dosage Form : Tablet
Dosage Strength : 750mg
Packaging :
Approval Date : 14/10/2024
Application Number : 20240821000023
Regulatory Info : Approved
Registration Country : Sweden
Polfa Tarchomin is a leading Polish pharmaceutical company with 200 year tradition in manufacture and sale of pharmaceutical products.
Regulatory Info : Authorised
Registration Country : Malta
Brand Name : Amotaks,
Dosage Form : Granule For Oral Suspension
Dosage Strength : 5ML
Packaging :
Approval Date : 2023-01-17
Application Number :
Regulatory Info : Authorised
Registration Country : Malta
Polfa Tarchomin is a leading Polish pharmaceutical company with 200 year tradition in manufacture and sale of pharmaceutical products.
Regulatory Info : Authorised
Registration Country : Malta
Brand Name : Taromentin, (400
Dosage Form : Powder For Oral Suspension
Dosage Strength : 80MG/ML; 11.4MG/ML
Packaging :
Approval Date : 2022-12-22
Application Number :
Regulatory Info : Authorised
Registration Country : Malta
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]
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Regulatory Info : Prescription
Registration Country : Canada
CLAVULANIC ACID (CLAVULANATE POTASSIUM)
Brand Name : AG-AMOXI CLAV
Dosage Form : TABLET
Dosage Strength : 125MG
Packaging :
Approval Date :
Application Number : 2510642
Regulatory Info : Prescription
Registration Country : Canada

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Regulatory Info : Prescription
Registration Country : Canada
CLAVULANIC ACID (CLAVULANATE POTASSIUM)
Brand Name : AURO-AMOXICLAV
Dosage Form : TABLET
Dosage Strength : 125MG
Packaging : 100
Approval Date :
Application Number : 2471701
Regulatory Info : Prescription
Registration Country : Canada

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Regulatory Info : Prescription
Registration Country : Canada
CLAVULANIC ACID (CLAVULANATE POTASSIUM)
Brand Name : JAMP AMOXI CLAV
Dosage Form : TABLET
Dosage Strength : 125MG
Packaging :
Approval Date :
Application Number : 2508249
Regulatory Info : Prescription
Registration Country : Canada

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Regulatory Info : Prescription
Registration Country : Canada
AMOXICILLIN (AMOXICILLIN TRIHYDRATE)
Brand Name : JAMP AMOXI CLAV
Dosage Form : TABLET
Dosage Strength : 500MG
Packaging :
Approval Date :
Application Number : 2508257
Regulatory Info : Prescription
Registration Country : Canada

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Regulatory Info : Prescription
Registration Country : Canada
Brand Name : PARACILLIN SP
Dosage Form : POWDER FOR SOLUTION
Dosage Strength : 800MG/G
Packaging : 250G/1000G
Approval Date :
Application Number : 2281376
Regulatory Info : Prescription
Registration Country : Canada

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Regulatory Info : Prescription
Registration Country : Canada
Brand Name : PMS-AMOXICILLIN
Dosage Form : POWDER FOR SUSPENSION
Dosage Strength : 2505MG/5ML
Packaging : 100ML/150ML
Approval Date :
Application Number :
Regulatory Info : Prescription
Registration Country : Canada

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Regulatory Info : Prescription
Registration Country : Canada
AMOXICILLIN (AMOXICILLIN TRIHYDRATE)
Brand Name : PRO-AMOXI CLAV
Dosage Form : TABLET
Dosage Strength : 875MG
Packaging :
Approval Date :
Application Number : 2536501
Regulatory Info : Prescription
Registration Country : Canada

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Regulatory Info : Prescription
Registration Country : Canada
AMOXICILLIN (AMOXICILLIN TRIHYDRATE)
Brand Name : NOVAMOXIN
Dosage Form : GRANULES FOR SUSPENSION
Dosage Strength : 250MG/5ML
Packaging : 75/100/150ML
Approval Date :
Application Number : 1934163
Regulatory Info : Prescription
Registration Country : Canada

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Regulatory Info : Prescription
Registration Country : Canada
CLAVULANIC ACID (CLAVULANATE POTASSIUM)
Brand Name : CLAVASEPTIN 250 MG
Dosage Form : TABLET (CHEWABLE)
Dosage Strength : 50MG
Packaging : 10X10
Approval Date :
Application Number : 2316919
Regulatory Info : Prescription
Registration Country : Canada

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Regulatory Info : Prescription
Registration Country : Canada
AMOXICILLIN (AMOXICILLIN TRIHYDRATE)
Brand Name : AMOXIL
Dosage Form : TABLET
Dosage Strength : 100MG
Packaging : 500
Approval Date :
Application Number : 2038293
Regulatory Info : Prescription
Registration Country : Canada

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Centrient is a leading manufacturer of Beta-Lactam Antibiotics and a provider of next-generation Statins and Antifungals.
Regulatory Info :
Registration Country : Netherlands
Brand Name :
Dosage Form : Hard Capsule
Dosage Strength : 500MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Netherlands
Centrient is a leading manufacturer of Beta-Lactam Antibiotics and a provider of next-generation Statins and Antifungals.
Packaging :
Regulatory Info :
Dosage : Hard Capsule
Dosage Strength : 500MG
Brand Name :
Approval Date :
Application Number :
Registration Country : Netherlands
Centrient is a leading manufacturer of Beta-Lactam Antibiotics and a provider of next-generation Statins and Antifungals.
Regulatory Info :
Registration Country : Netherlands
Brand Name :
Dosage Form : Dispersible Tablet
Dosage Strength : 500MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Netherlands
Centrient is a leading manufacturer of Beta-Lactam Antibiotics and a provider of next-generation Statins and Antifungals.
Packaging :
Regulatory Info :
Dosage : Dispersible Tablet
Dosage Strength : 500MG
Brand Name :
Approval Date :
Application Number :
Registration Country : Netherlands
Centrient is a leading manufacturer of Beta-Lactam Antibiotics and a provider of next-generation Statins and Antifungals.
Regulatory Info :
Registration Country : Netherlands
Brand Name :
Dosage Form : Dispersible Tablet
Dosage Strength : 750MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Netherlands
Centrient is a leading manufacturer of Beta-Lactam Antibiotics and a provider of next-generation Statins and Antifungals.
Packaging :
Regulatory Info :
Dosage : Dispersible Tablet
Dosage Strength : 750MG
Brand Name :
Approval Date :
Application Number :
Registration Country : Netherlands
Centrient is a leading manufacturer of Beta-Lactam Antibiotics and a provider of next-generation Statins and Antifungals.
Regulatory Info :
Registration Country : Netherlands
Brand Name :
Dosage Form : Dispersible Tablet
Dosage Strength : 1000MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Netherlands
Centrient is a leading manufacturer of Beta-Lactam Antibiotics and a provider of next-generation Statins and Antifungals.
Packaging :
Regulatory Info :
Dosage : Dispersible Tablet
Dosage Strength : 1000MG
Brand Name :
Approval Date :
Application Number :
Registration Country : Netherlands
Centrient is a leading manufacturer of Beta-Lactam Antibiotics and a provider of next-generation Statins and Antifungals.
Regulatory Info :
Registration Country : Netherlands
Brand Name :
Dosage Form : Powder for Oral Suspen...
Dosage Strength : 125MG/5ML
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Netherlands
Centrient is a leading manufacturer of Beta-Lactam Antibiotics and a provider of next-generation Statins and Antifungals.
Packaging :
Regulatory Info :
Dosage : Powder for Oral Suspen...
Dosage Strength : 125MG/5ML
Brand Name :
Approval Date :
Application Number :
Registration Country : Netherlands
Centrient is a leading manufacturer of Beta-Lactam Antibiotics and a provider of next-generation Statins and Antifungals.
Regulatory Info :
Registration Country : Netherlands
Brand Name :
Dosage Form : Powder for Oral Suspen...
Dosage Strength : 250MG/5ML
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Netherlands
Centrient is a leading manufacturer of Beta-Lactam Antibiotics and a provider of next-generation Statins and Antifungals.
Packaging :
Regulatory Info :
Dosage : Powder for Oral Suspen...
Dosage Strength : 250MG/5ML
Brand Name :
Approval Date :
Application Number :
Registration Country : Netherlands
Centrient is a leading manufacturer of Beta-Lactam Antibiotics and a provider of next-generation Statins and Antifungals.
Regulatory Info :
Registration Country : Netherlands
Brand Name :
Dosage Form : Powder for Oral Suspen...
Dosage Strength : 500MG/5ML
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Netherlands
Centrient is a leading manufacturer of Beta-Lactam Antibiotics and a provider of next-generation Statins and Antifungals.
Packaging :
Regulatory Info :
Dosage : Powder for Oral Suspen...
Dosage Strength : 500MG/5ML
Brand Name :
Approval Date :
Application Number :
Registration Country : Netherlands
Polfa Tarchomin is a leading Polish pharmaceutical company with 200 year tradition in manufacture and sale of pharmaceutical products.
Regulatory Info : Dossier Availability: Q3 2024
Registration Country : Poland
Amoxicillin Trihydrate; Clavulanic Acid
Brand Name :
Dosage Form : Powder for Oral Suspen...
Dosage Strength : 600MG; 42.9MG
Packaging :
Approval Date :
Application Number :
Regulatory Info : Dossier Availability: Q3 2024
Registration Country : Poland
Polfa Tarchomin is a leading Polish pharmaceutical company with 200 year tradition in manufacture and sale of pharmaceutical products.
Packaging :
Regulatory Info : Dossier Availability: Q3 2024
Amoxicillin Trihydrate; Clavulanic Acid
Dosage : Powder for Oral Suspen...
Dosage Strength : 600MG; 42.9MG
Brand Name :
Approval Date :
Application Number :
Registration Country : Poland
Regulatory Info :
Registration Country : India
Brand Name : Amoxicillin Trihydrate
Dosage Form : Capsule
Dosage Strength : 500mg
Packaging : Pack Size 10x10; 500 Caps/Jar
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Packaging : Pack Size 10x10; 500 Caps/Jar
Regulatory Info :
Dosage : Capsule
Dosage Strength : 500mg
Brand Name : Amoxicillin Trihydrate
Approval Date :
Application Number :
Registration Country : India
Regulatory Info :
Registration Country : India
Brand Name : Amoxicillin Trihydrate
Dosage Form : Powder for Oral Suspen...
Dosage Strength : 125mg/5ml
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Packaging :
Regulatory Info :
Dosage : Powder for Oral Suspen...
Dosage Strength : 125mg/5ml
Brand Name : Amoxicillin Trihydrate
Approval Date :
Application Number :
Registration Country : India
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]DRUG PRODUCT COMPOSITIONS
Related Excipient Companies
Excipients by Applications
Dosage Form : Capsule, Granule / Pellet, Tablet
Grade : Oral
Category : Coating Systems & Additives, Coloring Agents
Brand Name : Titanium dioxide PRETIOX AV01FG
Application : Coating Systems & Additives, Coloring Agents
Excipient Details : Titanium dioxide Pretiox AV01FG is used as a coloring and coating agent in oral solid dosage forms such as capsules, tablets, granules, and pellets.
Pharmacopoeia Ref : Fami-QS, Kosher, Halal, OHSAS ...
Technical Specs : Ti 59.95% and O 40.05%
Ingredient(s) : Titanium Dioxide
Dosage Form : Capsule, Granule / Pellet, Tablet
Grade : Oral
Category : Coating Systems & Additives, Coloring Agents
Dosage Form : Granule / Pellet, Tablet
Grade : Oral
Category : Coating Systems & Additives, Coloring Agents
Brand Name : SEPIFILM Classic Range
Application : Coating Systems & Additives, Coloring Agents
Excipient Details : Coating
Dosage Form : Granule / Pellet, Tablet
Grade : Oral
Category : Coating Systems & Additives, Coloring Agents
Brand Name : SEPIFILM PW Range
Application : Coating Systems & Additives, Coloring Agents
Excipient Details : Coating
Global Sales Information
Amoxicillin, Clavulanate Potassium
Main Therapeutic Indication : Infectious Diseases
Currency : USD
2020 Revenue in Millions : 679
2019 Revenue in Millions : 835
Growth (%) : -19

Amoxicillin, Clavulanate Potassium
Main Therapeutic Indication : Infectious Diseases
Currency : USD
2021 Revenue in Millions : 577
2020 Revenue in Millions : 671
Growth (%) : -13

Amoxicillin, Clavulanate Potassium
Main Therapeutic Indication : Infectious Diseases
Currency : USD
2022 Revenue in Millions : 710
2021 Revenue in Millions : 577
Growth (%) : 23

Amoxicillin, Clavulanate Potassium
Main Therapeutic Indication : Infectious Diseases
Currency : USD
2023 Revenue in Millions : 678
2022 Revenue in Millions : 710
Growth (%) : 9

Amoxicillin, Clavulanate Potassium
Main Therapeutic Indication : Infectious Diseases
Currency : USD
2024 Revenue in Millions : 790
2023 Revenue in Millions : 678
Growth (%) : 17

Amoxicillin, Clavulanate Potassium
Main Therapeutic Indication : Anti-bacterial
Currency : USD
2015 Revenue in Millions : 814
2014 Revenue in Millions : 750
Growth (%) : -8%

Amoxicillin, Clavulanate Potassium
Main Therapeutic Indication : Anti-bacterial
Currency : USD
2014 Revenue in Millions : -9.00%
2013 Revenue in Millions :
Growth (%) :

Amoxicillin, Clavulanate Potassium
Main Therapeutic Indication : Anti-Bacterial
Currency : USD
2016 Revenue in Millions : 698
2015 Revenue in Millions : 655
Growth (%) : 7

Amoxicillin, Clavulanate Potassium
Main Therapeutic Indication : Anti-bacterial
Currency : USD
2017 Revenue in Millions : 828
2016 Revenue in Millions : 794
Growth (%) : 4

Amoxicillin, Clavulanate Potassium
Main Therapeutic Indication : Anti-Bacterial
Currency : USD
2018 Revenue in Millions : 758
2017 Revenue in Millions : 781
Growth (%) : -3%

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Market Place
Patents & EXCLUSIVITIES
REF. STANDARDS & IMPURITIES
ANALYTICAL
ABOUT THIS PAGE
66
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 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Amoxicillin, including repackagers and relabelers. The FDA regulates Amoxicillin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. 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 Amoxicillin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Amoxicillin supplier is an individual or a company that provides Amoxicillin active pharmaceutical ingredient (API) or Amoxicillin finished formulations upon request. The Amoxicillin suppliers may include Amoxicillin API manufacturers, exporters, distributors and traders.
click here to find a list of Amoxicillin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Amoxicillin DMF (Drug Master File) is a document detailing the whole manufacturing process of Amoxicillin active pharmaceutical ingredient (API) in detail. Different forms of Amoxicillin DMFs exist exist since differing nations have different regulations, such as Amoxicillin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Amoxicillin DMF submitted to regulatory agencies in the US is known as a USDMF. Amoxicillin USDMF includes data on Amoxicillin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Amoxicillin USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Amoxicillin 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 Amoxicillin Drug Master File in Japan (Amoxicillin JDMF) empowers Amoxicillin 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 JDMF during the approval evaluation for pharmaceutical products. At the time of Amoxicillin 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 Amoxicillin 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 Amoxicillin Drug Master File in Korea (Amoxicillin KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Amoxicillin. The MFDS reviews the Amoxicillin KDMF as part of the drug registration process and uses the information provided in the Amoxicillin KDMF to evaluate the safety and efficacy of the drug.
After submitting a 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 Amoxicillin API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Amoxicillin suppliers with KDMF on PharmaCompass.
A Amoxicillin CEP of the European Pharmacopoeia monograph is often referred to as a Amoxicillin Certificate of Suitability (COS). The purpose of a Amoxicillin CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Amoxicillin EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Amoxicillin to their clients by showing that a Amoxicillin CEP has been issued for it. The manufacturer submits a Amoxicillin CEP (COS) as part of the market authorization procedure, and it takes on the role of a Amoxicillin CEP holder for the record. Additionally, the data presented in the Amoxicillin CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Amoxicillin DMF.
A Amoxicillin CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Amoxicillin 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 Amoxicillin suppliers with CEP (COS) on PharmaCompass.
A Amoxicillin written confirmation (Amoxicillin WC) is an official document issued by a regulatory agency to a Amoxicillin manufacturer, verifying that the manufacturing facility of a Amoxicillin active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Amoxicillin APIs or Amoxicillin finished pharmaceutical products to another nation, regulatory agencies frequently require a Amoxicillin WC (written confirmation) as part of the regulatory process.
click here to find a list of Amoxicillin 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 Amoxicillin as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for 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 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 Amoxicillin and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Amoxicillin NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Amoxicillin suppliers with NDC on PharmaCompass.
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 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 Amoxicillin GMP manufacturer or Amoxicillin GMP API supplier for your needs.
A Amoxicillin CoA (Certificate of Analysis) is a formal document that attests to Amoxicillin's compliance with Amoxicillin specifications and serves as a tool for batch-level quality control.
Amoxicillin CoA mostly includes findings from lab analyses of a specific batch. For each 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.
Amoxicillin may be tested according to a variety of international standards, such as European Pharmacopoeia (Amoxicillin EP), Amoxicillin JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Amoxicillin USP).