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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.)
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USDMF
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DMF Number : 13498
Submission : 1998-09-01
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DMF Number : 13481
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Submission : 1998-04-30
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DMF Number : 13201
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DMF Number : 8845
Submission : 1990-11-15
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DMF Number : 13215
Submission : 1998-04-30
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DMF Number : 12895
Submission : 1998-03-11
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DMF Number : 12904
Submission : 1998-03-18
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DMF Number : 11481
Submission : 1995-04-28
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Certificate Number : R1-CEP 2001-123 - Rev 03
Status : Withdrawn by Holder
Issue Date : 2015-02-16
Type : Chemical
Substance Number : 260
Certificate Number : R1-CEP 2004-147 - Rev 00
Status : Withdrawn by Holder
Issue Date : 2013-04-22
Type : Chemical
Substance Number : 260
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
Certificate Number : R1-CEP 2004-074 - Rev 00
Status : Withdrawn by Holder
Issue Date : 2013-04-30
Type : Chemical
Substance Number : 260
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
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
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
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
Certificate Number : R2-CEP 1994-013 - Rev 03
Status : Withdrawn by Holder
Issue Date : 2009-07-03
Type : Chemical
Substance Number : 260
Amoxicillin Trihydrate, India, Process 1
Certificate Number : R1-CEP 2001-351 - Rev 01
Status : Withdrawn by Holder
Issue Date : 2008-01-23
Type : Chemical
Substance Number : 260
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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
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Address of the Firm : Unit-V, Plot No.79-91, IDA, Chemical Zone, Pashamylaram (V), Patancheru (M), Med...
Amoxicillin Trihydrate (Ph. Eur)
Date of Issue : 2019-06-26
Valid Till : 2022-06-25
Written Confirmation Number : WC-0023
Address of the Firm : Sy.No.1/22, 2/1 To 5, 6 to 18, 61 to 69, Pydibhimavaram Village, Ranasthalam, Sr...
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NDC Package Code : 52946-0700
Start Marketing Date : 2009-12-09
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 67367-222
Start Marketing Date : 2009-05-01
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (25kg/25kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 67367-300
Start Marketing Date : 2009-05-01
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (20kg/20kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 67367-111
Start Marketing Date : 2009-05-01
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (25kg/25kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 67367-333
Start Marketing Date : 2009-05-01
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (25kg/25kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 32903-065
Start Marketing Date : 2023-11-20
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT FOR HUMAN P...
NDC Package Code : 62991-2005
Start Marketing Date : 2012-03-05
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT FOR HUMAN P...
NDC Package Code : 58775-010
Start Marketing Date : 1996-01-01
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (25kg/25kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 55984-0218
Start Marketing Date : 2022-04-12
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (25kg/25kg)
Marketing Category : BULK INGREDIENT
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VMF Number : 5595
Submission : 1997-07-21
Status : Active
Type : II
VMF Number : 6185
Submission : 2017-04-10
Status : Inactive
Type : II
VMF Number : 5434
Submission : 1992-10-20
Status : Inactive
Type : II
VMF Number : 5322
Submission : 1990-07-26
Status : Inactive
Type : II
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Drugs in Development
Details:
Vonoprazan is a novel potassium-competitive acid blocker (PCAB). It inhibits gastric acid secretion by acting as a reversible competitive inhibitor against potassium ions.
Lead Product(s): Vonoprazan Fumarate,Amoxicillin Trihydrate,Clarithromycin
Therapeutic Area: Infections and Infectious Diseases Brand Name: Voquezna Triple Pack
Study Phase: ApprovedProduct Type: Small molecule
Sponsor: Phathom Pharmaceuticals
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement October 24, 2022
Lead Product(s) : Vonoprazan Fumarate,Amoxicillin Trihydrate,Clarithromycin
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Phathom Pharmaceuticals
Deal Size : Undisclosed
Deal Type : Agreement
Evonik and Phathom Pharmaceuticals Partner to Produce Novel Acid-Blocker Vonoprazan
Details : Vonoprazan is a novel potassium-competitive acid blocker (PCAB). It inhibits gastric acid secretion by acting as a reversible competitive inhibitor against potassium ions.
Product Name : Voquezna Triple Pack
Product Type : Small molecule
Upfront Cash : Undisclosed
October 24, 2022
Details:
Talicia is a novel, fixed-dose combination of two antibiotics (amoxicillin and rifabutin) and a proton pump inhibitor (omeprazole), approved by the U.S. FDA for the treatment of H. pylori infection.
Lead Product(s): Amoxicillin Trihydrate,Rifabutin,Omeprazole Magnesium
Therapeutic Area: Infections and Infectious Diseases Brand Name: Talicia
Study Phase: Approved FDFProduct Type: Antibiotic
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable March 18, 2025
Lead Product(s) : Amoxicillin Trihydrate,Rifabutin,Omeprazole Magnesium
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
RedHill Biopharma to Submit FDA-Approved Talicia® for UK Marketing Authorisation
Details : Talicia is a novel, fixed-dose combination of two antibiotics (amoxicillin and rifabutin) and a proton pump inhibitor (omeprazole), approved by the U.S. FDA for the treatment of H. pylori infection.
Product Name : Talicia
Product Type : Antibiotic
Upfront Cash : Inapplicable
March 18, 2025
Details:
LP-001 (amoxicillin/clavulanate) oral suspension is currently being investigated as an effective antimicrobial for the treatment of children with acute otitis media in 3-12 moth age pediatric.
Lead Product(s): Amoxicillin Trihydrate,Clavulanic Acid
Therapeutic Area: Infections and Infectious Diseases Brand Name: LP-001
Study Phase: Phase IIIProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 14, 2024
Lead Product(s) : Amoxicillin Trihydrate,Clavulanic Acid
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Kaizen Bioscience Preparing Lead Asset for NDA Submission in 2025
Details : LP-001 (amoxicillin/clavulanate) oral suspension is currently being investigated as an effective antimicrobial for the treatment of children with acute otitis media in 3-12 moth age pediatric.
Product Name : LP-001
Product Type : Small molecule
Upfront Cash : Not Applicable
November 14, 2024
Details:
Talicia is a novel, fixed-dose combination of two antibiotics (amoxicillin and rifabutin) and a proton pump inhibitor (omeprazole), approved by the U.S. FDA for the treatment of H. pylori infection.
Lead Product(s): Amoxicillin Trihydrate,Rifabutin,Omeprazole
Therapeutic Area: Infections and Infectious Diseases Brand Name: Talicia
Study Phase: ApprovedProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 21, 2024
Lead Product(s) : Amoxicillin Trihydrate,Rifabutin,Omeprazole
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Talicia® Launched in the United Arab Emirates
Details : Talicia is a novel, fixed-dose combination of two antibiotics (amoxicillin and rifabutin) and a proton pump inhibitor (omeprazole), approved by the U.S. FDA for the treatment of H. pylori infection.
Product Name : Talicia
Product Type : Small molecule
Upfront Cash : Not Applicable
August 21, 2024
Details:
Talicia is a novel, fixed-dose, all-in-one oral capsule combination of two antibiotics (amoxicillin and rifabutin) and a proton pump inhibitor (PPI) (omeprazole), approved by the U.S. FDA for the treatment of H. pylori infection in adults.
Lead Product(s): Amoxicillin Trihydrate,Rifabutin,Omeprazole
Therapeutic Area: Infections and Infectious Diseases Brand Name: Talicia
Study Phase: ApprovedProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 27, 2023
Lead Product(s) : Amoxicillin Trihydrate,Rifabutin,Omeprazole
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
RedHill Biopharma Announces FDA Grant of 5-Year U.S. Market Exclusivity for Talicia® with IP Prot...
Details : Talicia is a novel, fixed-dose, all-in-one oral capsule combination of two antibiotics (amoxicillin and rifabutin) and a proton pump inhibitor (PPI) (omeprazole), approved by the U.S. FDA for the treatment of H. pylori infection in adults.
Product Name : Talicia
Product Type : Small molecule
Upfront Cash : Not Applicable
November 27, 2023
Details:
VOQUEZNA® TRIPLE PAK® (vonoprazan, amoxicillin, clarithromycin) contain vonoprazan, an oral small molecule potassium-competitive acid blocker (PCAB) co-packaged with antibiotics. It has been approved by FDA for the treatment of H. pylori infection in adults.
Lead Product(s): Vonoprazan Fumarate,Amoxicillin Trihydrate,Clarithromycin
Therapeutic Area: Infections and Infectious Diseases Brand Name: Voquezna Triple Pak
Study Phase: ApprovedProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 30, 2023
Lead Product(s) : Vonoprazan Fumarate,Amoxicillin Trihydrate,Clarithromycin
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Phathom Pharmaceuticals Announces FDA Approval of Reformulated Vonoprazan Tablets for VOQUEZNA® T...
Details : VOQUEZNA® TRIPLE PAK® (vonoprazan, amoxicillin, clarithromycin) contain vonoprazan, an oral small molecule potassium-competitive acid blocker (PCAB) co-packaged with antibiotics. It has been approved by FDA for the treatment of H. pylori infection in a...
Product Name : Voquezna Triple Pak
Product Type : Small molecule
Upfront Cash : Not Applicable
October 30, 2023
Details:
Talicia is a novel, fixed-dose, all-in-one oral capsule combination of two antibiotics (amoxicillin and rifabutin) and a proton pump inhibitor (PPI) (omeprazole), approved by the U.S. FDA for the treatment of H. pylori infection in adults.
Lead Product(s): Omeprazole Magnesium,Amoxicillin Trihydrate,Rifabutin
Therapeutic Area: Infections and Infectious Diseases Brand Name: Talicia
Study Phase: ApprovedProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 18, 2023
Lead Product(s) : Omeprazole Magnesium,Amoxicillin Trihydrate,Rifabutin
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
RedHill Announces FDA sNDA Approval for Talicia®
Details : Talicia is a novel, fixed-dose, all-in-one oral capsule combination of two antibiotics (amoxicillin and rifabutin) and a proton pump inhibitor (PPI) (omeprazole), approved by the U.S. FDA for the treatment of H. pylori infection in adults.
Product Name : Talicia
Product Type : Small molecule
Upfront Cash : Not Applicable
September 18, 2023
Details:
Talicia (omeprazole magnesium, amoxicillin and rifabutin) is a novel, fixed-dose, all-in-one oral capsule combination of two antibiotics and a proton pump inhibitor (PPI) (omeprazole), used for the treatment of H. pylori infection.
Lead Product(s): Omeprazole Magnesium,Amoxicillin Trihydrate,Rifabutin
Therapeutic Area: Infections and Infectious Diseases Brand Name: Talicia
Study Phase: ApprovedProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 01, 2023
Lead Product(s) : Omeprazole Magnesium,Amoxicillin Trihydrate,Rifabutin
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : Talicia (omeprazole magnesium, amoxicillin and rifabutin) is a novel, fixed-dose, all-in-one oral capsule combination of two antibiotics and a proton pump inhibitor (PPI) (omeprazole), used for the treatment of H. pylori infection.
Product Name : Talicia
Product Type : Small molecule
Upfront Cash : Not Applicable
August 01, 2023
Details:
Under the agreement, RedHill will make Talicia, a novel, all-in-one oral capsule combination of two antibiotics (amoxicillin and rifabutin) and a proton pump inhibitor (omeprazole magnesium), approved for H. pylori infection, available via the PhilRx Patient Access Platform.
Lead Product(s): Omeprazole Magnesium,Amoxicillin Trihydrate,Rifabutin
Therapeutic Area: Infections and Infectious Diseases Brand Name: Talicia
Study Phase: ApprovedProduct Type: Small molecule
Sponsor: Phil
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement July 06, 2023
Lead Product(s) : Omeprazole Magnesium,Amoxicillin Trihydrate,Rifabutin
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Phil
Deal Size : Undisclosed
Deal Type : Agreement
Phil and RedHill Biopharma Partner to Increase Access to Talicia®
Details : Under the agreement, RedHill will make Talicia, a novel, all-in-one oral capsule combination of two antibiotics (amoxicillin and rifabutin) and a proton pump inhibitor (omeprazole magnesium), approved for H. pylori infection, available via the PhilRx Pat...
Product Name : Talicia
Product Type : Small molecule
Upfront Cash : Undisclosed
July 06, 2023
Details:
Amoxicillin oral suspension is one of the most commonly prescribed antibiotics for children for the treatment of particular bacterial infections. Amoxicillin represents the first product that Juno will successfully import to address drug shortages through this division.
Lead Product(s): Amoxicillin Trihydrate
Therapeutic Area: Infections and Infectious Diseases Brand Name: Amoxicillin-Generic
Study Phase: ApprovedProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 04, 2023
Lead Product(s) : Amoxicillin Trihydrate
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : Amoxicillin oral suspension is one of the most commonly prescribed antibiotics for children for the treatment of particular bacterial infections. Amoxicillin represents the first product that Juno will successfully import to address drug shortages throug...
Product Name : Amoxicillin-Generic
Product Type : Small molecule
Upfront Cash : Not Applicable
January 04, 2023
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Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
Registration Country : Switzerland
Amoxicillinum anhydrous; Acidum clavulanicum
Brand Name : Co-Amoxicillin Zentiva
Dosage Form : Filmtabl
Dosage Strength : 1000mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
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Registration Country : Switzerland
Amoxicillinum anhydrous; Acidum clavulanicum
Brand Name : Co-Amoxicillin Zentiva
Dosage Form : Filmtabl
Dosage Strength : 1000mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
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Registration Country : Switzerland
Amoxicillinum anhydrous; Acidum clavulanicum
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Dosage Strength : 625mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Towa Pharma is dedicated to researching, developing, producing, and promoting generic drugs.
Regulatory Info :
Registration Country : Italy
Brand Name : AMOXICILLIN AND CLAVULANIC ACID THINK
Dosage Form : Film-Coated Tablets
Dosage Strength : 875 mg + 125 mg
Packaging : 12 UNITS (875+125) MG - ORAL USE
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Towa Pharma is dedicated to researching, developing, producing, and promoting generic drugs.
Regulatory Info :
Registration Country : Italy
Brand Name : AMOXICILLIN AND CLAVULANIC ACID PENSA PHARMA
Dosage Form : Powder For Oral Suspension
Dosage Strength : 875 mg + 125 mg
Packaging : 12 UNITS (875+125) MG - ORAL USE
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Towa Pharma is dedicated to researching, developing, producing, and promoting generic drugs.
Regulatory Info :
Registration Country : Italy
Brand Name : AMOXICILLINA PENSA PHARMA
Dosage Form : Dispersible Tablet
Dosage Strength : 1000 mg
Packaging : 12 UNITS 1000 MG - ORAL USE
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Regulatory Info : Generic
Registration Country : Turkey
Brand Name : KLAVUNAT
Dosage Form : Tablet
Dosage Strength : 500MG; 125MG
Packaging : 10 Film Tablet Alu-Alu Blister
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : Turkey
Regulatory Info : Generic
Registration Country : Turkey
Brand Name : KLAVUNAT BID
Dosage Form : Film Tablet
Dosage Strength : 875MG; 125MG
Packaging : 14 Film Tablet Glass Bottle
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : Turkey
Regulatory Info :
Registration Country : Italy
Brand Name : Amoxycillin And Clavulanic Acid
Dosage Form : Amoxicillin+Clavulanic Acid+11,480 Mg/Ml 35Ml Oral Use
Dosage Strength : os suspe grat 35ml 400 mg/5 ml + 57 mg/5 ml
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Regulatory Info :
Registration Country : Switzerland
Amoxicillinum anhydrous; Acidum clavulanicum
Brand Name : Co-Amoxi-Mepha
Dosage Form : Plv
Dosage Strength : 312.5mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
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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 - 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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ABOUT THIS PAGE
47
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 Trihydrate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Amoxicillin Trihydrate, including repackagers and relabelers. The FDA regulates Amoxicillin Trihydrate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Amoxicillin Trihydrate 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 Trihydrate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Amoxicillin Trihydrate supplier is an individual or a company that provides Amoxicillin Trihydrate active pharmaceutical ingredient (API) or Amoxicillin Trihydrate finished formulations upon request. The Amoxicillin Trihydrate suppliers may include Amoxicillin Trihydrate API manufacturers, exporters, distributors and traders.
click here to find a list of Amoxicillin Trihydrate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Amoxicillin Trihydrate DMF (Drug Master File) is a document detailing the whole manufacturing process of Amoxicillin Trihydrate active pharmaceutical ingredient (API) in detail. Different forms of Amoxicillin Trihydrate DMFs exist exist since differing nations have different regulations, such as Amoxicillin Trihydrate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Amoxicillin Trihydrate DMF submitted to regulatory agencies in the US is known as a USDMF. Amoxicillin Trihydrate USDMF includes data on Amoxicillin Trihydrate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Amoxicillin Trihydrate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Amoxicillin Trihydrate 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 Trihydrate Drug Master File in Japan (Amoxicillin Trihydrate JDMF) empowers Amoxicillin Trihydrate 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 Trihydrate JDMF during the approval evaluation for pharmaceutical products. At the time of Amoxicillin Trihydrate 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 Trihydrate 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 Trihydrate Drug Master File in Korea (Amoxicillin Trihydrate KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Amoxicillin Trihydrate. The MFDS reviews the Amoxicillin Trihydrate KDMF as part of the drug registration process and uses the information provided in the Amoxicillin Trihydrate KDMF to evaluate the safety and efficacy of the drug.
After submitting a Amoxicillin Trihydrate 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 Trihydrate API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Amoxicillin Trihydrate suppliers with KDMF on PharmaCompass.
A Amoxicillin Trihydrate CEP of the European Pharmacopoeia monograph is often referred to as a Amoxicillin Trihydrate Certificate of Suitability (COS). The purpose of a Amoxicillin Trihydrate CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Amoxicillin Trihydrate EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Amoxicillin Trihydrate to their clients by showing that a Amoxicillin Trihydrate CEP has been issued for it. The manufacturer submits a Amoxicillin Trihydrate CEP (COS) as part of the market authorization procedure, and it takes on the role of a Amoxicillin Trihydrate CEP holder for the record. Additionally, the data presented in the Amoxicillin Trihydrate CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Amoxicillin Trihydrate DMF.
A Amoxicillin Trihydrate CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Amoxicillin Trihydrate 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 Trihydrate suppliers with CEP (COS) on PharmaCompass.
A Amoxicillin Trihydrate written confirmation (Amoxicillin Trihydrate WC) is an official document issued by a regulatory agency to a Amoxicillin Trihydrate manufacturer, verifying that the manufacturing facility of a Amoxicillin Trihydrate active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Amoxicillin Trihydrate APIs or Amoxicillin Trihydrate finished pharmaceutical products to another nation, regulatory agencies frequently require a Amoxicillin Trihydrate WC (written confirmation) as part of the regulatory process.
click here to find a list of Amoxicillin Trihydrate 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 Trihydrate as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Amoxicillin Trihydrate 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 Trihydrate 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 Trihydrate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Amoxicillin Trihydrate NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Amoxicillin Trihydrate suppliers with NDC on PharmaCompass.
Amoxicillin Trihydrate 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 Trihydrate 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 Trihydrate GMP manufacturer or Amoxicillin Trihydrate GMP API supplier for your needs.
A Amoxicillin Trihydrate CoA (Certificate of Analysis) is a formal document that attests to Amoxicillin Trihydrate's compliance with Amoxicillin Trihydrate specifications and serves as a tool for batch-level quality control.
Amoxicillin Trihydrate CoA mostly includes findings from lab analyses of a specific batch. For each Amoxicillin Trihydrate 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 Trihydrate may be tested according to a variety of international standards, such as European Pharmacopoeia (Amoxicillin Trihydrate EP), Amoxicillin Trihydrate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Amoxicillin Trihydrate USP).
