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Chemistry

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Also known as: 61336-70-7, Larotid, Polymox, Trimox, Utimox, Wymox
Molecular Formula
C16H25N3O8S
Molecular Weight
419.5  g/mol
InChI Key
MQXQVCLAUDMCEF-CWLIKTDRSA-N
FDA UNII
804826J2HU

Amoxicillin Trihydrate
A broad-spectrum semisynthetic antibiotic similar to AMPICILLIN except that its resistance to gastric acid permits higher serum levels with oral administration.
1 2D Structure

Amoxicillin Trihydrate

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
(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
2.1.2 InChI
InChI=1S/C16H19N3O5S.3H2O/c1-16(2)11(15(23)24)19-13(22)10(14(19)25-16)18-12(21)9(17)7-3-5-8(20)6-4-7;;;/h3-6,9-11,14,20H,17H2,1-2H3,(H,18,21)(H,23,24);3*1H2/t9-,10-,11+,14-;;;/m1.../s1
2.1.3 InChI Key
MQXQVCLAUDMCEF-CWLIKTDRSA-N
2.1.4 Canonical SMILES
CC1(C(N2C(S1)C(C2=O)NC(=O)C(C3=CC=C(C=C3)O)N)C(=O)O)C.O.O.O
2.1.5 Isomeric SMILES
CC1([C@@H](N2[C@H](S1)[C@@H](C2=O)NC(=O)[C@@H](C3=CC=C(C=C3)O)N)C(=O)O)C.O.O.O
2.2 Other Identifiers
2.2.1 UNII
804826J2HU
2.3 Synonyms
2.3.1 MeSH Synonyms

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

2.3.2 Depositor-Supplied Synonyms

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

2.4 Create Date
2005-08-08
3 Chemical and Physical Properties
Molecular Weight 419.5 g/mol
Molecular Formula C16H25N3O8S
Hydrogen Bond Donor Count7
Hydrogen Bond Acceptor Count10
Rotatable Bond Count4
Exact Mass419.13623594 g/mol
Monoisotopic Mass419.13623594 g/mol
Topological Polar Surface Area161 Ų
Heavy Atom Count28
Formal Charge0
Complexity590
Isotope Atom Count0
Defined Atom Stereocenter Count4
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count4
4 Drug and Medication Information
4.1 Drug Information
1 of 6  
Drug NameAmoxil
Active IngredientAmoxicillin
Dosage FormTablet; Capsule; Tablet, chewable; For suspension
RouteOral
Strength875mg; 50mg/ml; 200mg/5ml; 250mg; 125mg/5ml; 400mg/5ml; 125mg; 500mg; 250mg/5ml
Market StatusPrescription
CompanyDr Reddys Labs

2 of 6  
Drug NameLarotid
PubMed HealthAmoxicillin (By mouth)
Drug ClassesAntibiotic
Drug LabelMOXATAG (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 IngredientAmoxicillin
Dosage FormFor suspension
RouteOral
Strength250mg/5ml; 125mg/5ml
Market StatusPrescription
CompanyDr Reddys Labs

3 of 6  
Drug NameMoxatag
Active IngredientAmoxicillin
Dosage FormTablet, extended release
RouteOral
Strength775mg
Market StatusPrescription
CompanyPragma Pharms

4 of 6  
Drug NameAmoxil
Active IngredientAmoxicillin
Dosage FormTablet; Capsule; Tablet, chewable; For suspension
RouteOral
Strength875mg; 50mg/ml; 200mg/5ml; 250mg; 125mg/5ml; 400mg/5ml; 125mg; 500mg; 250mg/5ml
Market StatusPrescription
CompanyDr Reddys Labs

5 of 6  
Drug NameLarotid
PubMed HealthAmoxicillin (By mouth)
Drug ClassesAntibiotic
Drug LabelMOXATAG (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 IngredientAmoxicillin
Dosage FormFor suspension
RouteOral
Strength250mg/5ml; 125mg/5ml
Market StatusPrescription
CompanyDr Reddys Labs

6 of 6  
Drug NameMoxatag
Active IngredientAmoxicillin
Dosage FormTablet, extended release
RouteOral
Strength775mg
Market StatusPrescription
CompanyPragma Pharms

5 Pharmacology and Biochemistry
5.1 MeSH Pharmacological Classification

Anti-Bacterial Agents

Substances that inhibit the growth or reproduction of BACTERIA. (See all compounds classified as Anti-Bacterial Agents.)


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AMOXICILLIN TRIHYDRATE IP.","address":"48, CHANDRA GUPTA ESTATE,","city":"MUMBAI, MAHARASHTRA.","supplier":"BRILLIANT PHARMACEUTICAL LTD","supplierCountry":"CHINA","foreign_port":"SHANGHAI","customer":"GORANG INTERNATIONAL","customerCountry":"INDIA","quantity":"5000.00","actualQuantity":"5000","unit":"KGS","unitRateFc":"23","totalValueFC":"116096.5","currency":"USD","unitRateINR":"1998.4","date":"23-Jul-2025","totalValueINR":"9991949.45","totalValueInUsd":"116096.5","indian_port":"JNPT SEZ\/MUMBAI","hs_no":"29411030","bill_no":"3440761","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI","supplierAddress":"OFFICE F, 32\/F, PLAZA 88 NO.88 YEUN G UK ROAD, TSUEN WAN NT, HONG KONG CHINA ., ., China China","customerAddress":"48, CHANDRA GUPTA ESTATE,"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q3","strtotime":1753468200,"product":"AMOXYCILLIN TRIHYDRATE POWDER BP LOT NO.AMX-D25020393,DOM FEB 2025,DOE JAN 2029(RE-IMPORT)(SB NO.8153511 DT.13.02.2025)AMOXYCILLIN TRIHYDRATE POWDER BP LOT NO","address":"D-34 2ND FLOOR, GULMOHAR PARK","city":"NEW DELHI","supplier":"RHONE MA MALAYSIA SDN BHD","supplierCountry":"INDIA","foreign_port":"SINGAPORE","customer":"DALAS BIOTECH LTD","customerCountry":"INDIA","quantity":"50.00","actualQuantity":"50","unit":"KGS","unitRateFc":"38.3","totalValueFC":"1929.8","currency":"USD","unitRateINR":"3321.8","date":"26-Jul-2025","totalValueINR":"166092.34","totalValueInUsd":"1929.8","indian_port":"Delhi PPG ICD","hs_no":"29411030","bill_no":"3516547","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"SINGAPORE","supplierAddress":"LOT 18A & 18B JALAN 241, SEKSYEN 5 1A 46100 PETALING JAYA, SELANGOR, MALAYSIA","customerAddress":"D-34 2ND FLOOR, GULMOHAR PARK"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q3","strtotime":1753468200,"product":"AMOXICILLIN TRIHYDRATE BP\/USP (AMOXICILLIN TRIHYDRATE COMPACTED BP)AMOXICILLIN TRIHYDRATE COMPACTED BP","address":"25, PULIYUR II MAIN ROAD,","city":"CHENNAI, TAMILNADU","supplier":"SINOBRIGHT PHARMACEUTICAL INDUSTRIES LTD","supplierCountry":"CHINA","foreign_port":"SHANGHAI","customer":"MEDOPHARM PRIVATE LTD","customerCountry":"INDIA","quantity":"1655.00","actualQuantity":"1655","unit":"KGS","unitRateFc":"25.9","totalValueFC":"43146.6","currency":"USD","unitRateINR":"2243.8","date":"26-Jul-2025","totalValueINR":"3713455.9","totalValueInUsd":"43146.6","indian_port":"Madras Sea","hs_no":"29411030","bill_no":"3501638","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI","supplierAddress":"OFFICE F-32\/F,PLAZA88 NO.88 YEUNG ROAD, TSUEN WAN,NT HONG KONG CHINA","customerAddress":"25, PULIYUR II MAIN ROAD,"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q3","strtotime":1753900200,"product":"AMOXICILLIN TRIHYDRATE COMPACTED ANTIBIOTICS","address":"MEDREICH HOUSE, NO12\/8,","city":"SEVA NAGAR, BANGALORE, KARNATAKA","supplier":"TEAM CROWN TRADING LTD","supplierCountry":"CHINA","foreign_port":"QINGDAO","customer":"MEDREICH LTD","customerCountry":"INDIA","quantity":"5000.00","actualQuantity":"5000","unit":"KGS","unitRateFc":"25.5","totalValueFC":"128587.5","currency":"USD","unitRateINR":"2213.4","date":"31-Jul-2025","totalValueINR":"11067000","totalValueInUsd":"128587.5","indian_port":"Madras Sea","hs_no":"29411030","bill_no":"3598164","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"QINGDAO","supplierAddress":"6 FUK WANG STREET YUEN LONG INDUSTRIAL ESTATE YUEN LONG HONGKONG SDNF","customerAddress":"MEDREICH HOUSE, NO12\/8,"}]
01-Jan-2022
31-Jul-2025
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DRUG PRODUCT COMPOSITIONS

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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

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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

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DOSAGE - FOR SUSPENSION;ORAL - 125MG/5ML;EQ 3...DOSAGE - FOR SUSPENSION;ORAL - 125MG/5ML;EQ 31.25MG BASE/5ML

USFDA APPLICATION NUMBER - 50575

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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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DOSAGE - TABLET;ORAL - 875MG;EQ 125MG BASE

USFDA APPLICATION NUMBER - 50720

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DOSAGE - FOR SUSPENSION;ORAL - 200MG/5ML;EQ 2...DOSAGE - FOR SUSPENSION;ORAL - 200MG/5ML;EQ 28.5MG BASE/5ML

USFDA APPLICATION NUMBER - 50725

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DOSAGE - FOR SUSPENSION;ORAL - 400MG/5ML;EQ 5...DOSAGE - FOR SUSPENSION;ORAL - 400MG/5ML;EQ 57MG BASE/5ML

USFDA APPLICATION NUMBER - 50725

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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

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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

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DOSAGE - FOR SUSPENSION;ORAL - 600MG/5ML;EQ 4...DOSAGE - FOR SUSPENSION;ORAL - 600MG/5ML;EQ 42.9MG BASE/5ML

USFDA APPLICATION NUMBER - 50755

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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

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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

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DOSAGE - FOR SUSPENSION;ORAL - 400MG/5ML

USFDA APPLICATION NUMBER - 50760

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DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 1GM;...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 1GM;EQ 62.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 50785

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DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 775M...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 775MG

USFDA APPLICATION NUMBER - 50813

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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

Looking for 61336-70-7 / Amoxicillin Trihydrate API manufacturers, exporters & distributors?

Amoxicillin Trihydrate manufacturers, exporters & distributors 1

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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.

API | Excipient name

Amoxicillin Trihydrate

Synonyms

61336-70-7, Larotid, Polymox, Trimox, Utimox, Wymox

Cas Number

61336-70-7

Unique Ingredient Identifier (UNII)

804826J2HU

About Amoxicillin Trihydrate

A broad-spectrum semisynthetic antibiotic similar to AMPICILLIN except that its resistance to gastric acid permits higher serum levels with oral administration.

Amoxine Manufacturers

A Amoxine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Amoxine, including repackagers and relabelers. The FDA regulates Amoxine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Amoxine 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 Amoxine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

Amoxine Suppliers

A Amoxine supplier is an individual or a company that provides Amoxine active pharmaceutical ingredient (API) or Amoxine finished formulations upon request. The Amoxine suppliers may include Amoxine API manufacturers, exporters, distributors and traders.

click here to find a list of Amoxine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

Amoxine USDMF

A Amoxine DMF (Drug Master File) is a document detailing the whole manufacturing process of Amoxine active pharmaceutical ingredient (API) in detail. Different forms of Amoxine DMFs exist exist since differing nations have different regulations, such as Amoxine USDMF, ASMF (EDMF), JDMF, CDMF, etc.

A Amoxine DMF submitted to regulatory agencies in the US is known as a USDMF. Amoxine USDMF includes data on Amoxine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Amoxine USDMF is kept confidential to protect the manufacturer’s intellectual property.

click here to find a list of Amoxine suppliers with USDMF on PharmaCompass.

Amoxine JDMF

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 Amoxine Drug Master File in Japan (Amoxine JDMF) empowers Amoxine 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 Amoxine JDMF during the approval evaluation for pharmaceutical products. At the time of Amoxine 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 Amoxine suppliers with JDMF on PharmaCompass.

Amoxine KDMF

In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.

Pharmaceutical companies submit a Amoxine Drug Master File in Korea (Amoxine KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Amoxine. The MFDS reviews the Amoxine KDMF as part of the drug registration process and uses the information provided in the Amoxine KDMF to evaluate the safety and efficacy of the drug.

After submitting a Amoxine 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 Amoxine API can apply through the Korea Drug Master File (KDMF).

click here to find a list of Amoxine suppliers with KDMF on PharmaCompass.

Amoxine CEP

A Amoxine CEP of the European Pharmacopoeia monograph is often referred to as a Amoxine Certificate of Suitability (COS). The purpose of a Amoxine CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Amoxine EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Amoxine to their clients by showing that a Amoxine CEP has been issued for it. The manufacturer submits a Amoxine CEP (COS) as part of the market authorization procedure, and it takes on the role of a Amoxine CEP holder for the record. Additionally, the data presented in the Amoxine CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Amoxine DMF.

A Amoxine CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Amoxine 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 Amoxine suppliers with CEP (COS) on PharmaCompass.

Amoxine WC

A Amoxine written confirmation (Amoxine WC) is an official document issued by a regulatory agency to a Amoxine manufacturer, verifying that the manufacturing facility of a Amoxine active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Amoxine APIs or Amoxine finished pharmaceutical products to another nation, regulatory agencies frequently require a Amoxine WC (written confirmation) as part of the regulatory process.

click here to find a list of Amoxine suppliers with Written Confirmation (WC) on PharmaCompass.

Amoxine NDC

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 Amoxine as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for Amoxine API and other APIs are published in this directory by the FDA.

Unfinished drugs

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 Amoxine 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.

Compounded drug products

The NDC directory also contains data on finished compounded human drug products that contain Amoxine and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Amoxine NDC to their finished compounded human drug products, they may choose to do so.

click here to find a list of Amoxine suppliers with NDC on PharmaCompass.

Amoxine GMP

Amoxine 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 Amoxine 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 Amoxine GMP manufacturer or Amoxine GMP API supplier for your needs.

Amoxine CoA

A Amoxine CoA (Certificate of Analysis) is a formal document that attests to Amoxine's compliance with Amoxine specifications and serves as a tool for batch-level quality control.

Amoxine CoA mostly includes findings from lab analyses of a specific batch. For each Amoxine 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.

Amoxine may be tested according to a variety of international standards, such as European Pharmacopoeia (Amoxine EP), Amoxine JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Amoxine USP).

Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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