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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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Corden Pharma Latina Spa

Germany

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Smithkline Beecham

United Kingdom

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Smithkline Beecham

United Kingdom
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GDUFA

DMF Review : N/A

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Submission : 1998-04-30

Status : Inactive

Type : II

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Status : Inactive

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United Kingdom

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United Kingdom
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India

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Sintesis Quimica

Spain

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Rev. Date :

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DMF Number : 13215

Submission : 1998-04-30

Status : Inactive

Type : II

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Submission : 1998-03-18

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Submission : 1995-04-14

Status : Inactive

Type : II

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IL\/BD-014055 RC\/BD-002695)AMOXICILLIN TRIHYDRATE IP","address":"344\/345,KUNDIAM INDL.ESTATE,","city":"GOA,MAHARASHGTRA","supplier":"SINOBRIGHT PHARMACEUTICAL INDUSTRIES LTD","supplierCountry":"CHINA","foreign_port":"SHANGHAI","customer":"MEDISPRAY LABORATORIES PRIVATE LTD","customerCountry":"INDIA","quantity":"10000.00","actualQuantity":"10000","unit":"KGS","unitRateFc":"29.7","totalValueFC":"298856.8","currency":"USD","unitRateINR":"2588.6","date":"29-Mar-2025","totalValueINR":"25886250","totalValueInUsd":"298856.8","indian_port":"JNPT","hs_no":"29411030","bill_no":"9178227","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI","supplierAddress":"OFFICE F, 32\/F, PLAZA 88 NO. 88 YEU NG UK ROAD, TSUEN WAN, NT,HONG KONG , CHINA China","customerAddress":"344\/345,KUNDIAM INDL.ESTATE,"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q2","strtotime":1744309800,"product":"AMOXICILLIN TRIHYDRATE COMPACTED BP AMOXICILLIN TRIHYDRATE COMPACTED BP","address":"218\/219, 2ND FLOOR,KAILASH PLAZA,","city":"GHATKOPAR EAST,MUMBAI, MAHARASTHRA","supplier":"BRILLIANT PHARMACEUTICAL LTD","supplierCountry":"CHINA","foreign_port":"SHANGHAI","customer":"AQUATIC REMEDIES LTD","customerCountry":"INDIA","quantity":"20000.00","actualQuantity":"20000","unit":"KGS","unitRateFc":"24.8","totalValueFC":"502242.6","currency":"USD","unitRateINR":"2149.6","date":"11-Apr-2025","totalValueINR":"42992863.79","totalValueInUsd":"502242.6","indian_port":"JNPT SEZ\/MUMBAI","hs_no":"29411030","bill_no":"9430108","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI","supplierAddress":"OFFICE F, 32\/F, PLAZA 88 NO, 88 YEU NG UK ROAD TSUEN WAN, NT HONG KONG TSUEN, , HONG KONG HONG KONG","customerAddress":"218\/219, 2ND FLOOR,KAILASH PLAZA,"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q2","strtotime":1744655400,"product":"AMOXICILLIN TRIHYDRATE AMOXICILLIN TRIHYDRATE","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":"2000.00","actualQuantity":"2000","unit":"KGS","unitRateFc":"30","totalValueFC":"60699.7","currency":"USD","unitRateINR":"2598","date":"15-Apr-2025","totalValueINR":"5196000","totalValueInUsd":"60699.7","indian_port":"Madras Sea","hs_no":"29411030","bill_no":"9494824","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,"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q2","strtotime":1744655400,"product":"AMOXICILLIN TRIHYDRATE COMPACTED AMOXICILLIN TRIHYDRATE COMPACTED","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":"4000.00","actualQuantity":"4000","unit":"KGS","unitRateFc":"29","totalValueFC":"117352.7","currency":"USD","unitRateINR":"2511.4","date":"15-Apr-2025","totalValueINR":"10045600","totalValueInUsd":"117352.7","indian_port":"Madras Sea","hs_no":"29411030","bill_no":"9494955","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,"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q2","strtotime":1745519400,"product":"AMOXICILLIN TRIHYDRATE (POWDER)USP (USDMF) RA05A AMOXICILLIN TRIHYDRATE (POWDER)USP (USDMF) RA05A","address":"MUMBAI CENTRAL,","city":"MUMBAI, MAHARASHTRA.","supplier":"SANDOZ GMBH","supplierCountry":"SPAIN","foreign_port":"VIENNA","customer":"CIPLA LTD","customerCountry":"INDIA","quantity":"1134.40","actualQuantity":"1134.4","unit":"KGS","unitRateFc":"61.6","totalValueFC":"70571.2","currency":"USD","unitRateINR":"5325.3","date":"25-Apr-2025","totalValueINR":"6041020.32","totalValueInUsd":"70571.2","indian_port":"Bombay Air","hs_no":"29411030","bill_no":"9700064","productDescription":"API","marketType":"REGULATED MARKET","country":"SPAIN","selfForZScoreResived":"Pharma Grade","supplierPort":"VIENNA","supplierAddress":"BIOCHEMIESTRASSE 10 6250 KUNDL SDNF AUSTRIA","customerAddress":"MUMBAI CENTRAL,"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q2","strtotime":1746556200,"product":"AMOXICILLIN TRIHYDRATE IP. 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":"24.8","totalValueFC":"124380.2","currency":"USD","unitRateINR":"2119.5","date":"07-May-2025","totalValueINR":"10597273.66","totalValueInUsd":"124380.2","indian_port":"JNPT SEZ\/MUMBAI","hs_no":"29411030","bill_no":"9914499","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":"Q2","strtotime":1746729000,"product":"AMOXICILLIN TRIHYDRATE IP\/EP (POWDER) AMOXICILLIN TRIHYDRATE IP\/EP (POWDER)","address":"NO.27,RACE COURSE ROAD,","city":"KARNATAKA","supplier":"ZHUHAI UNITED LABORATORIES TRADING CO LTD","supplierCountry":"CHINA","foreign_port":"QINGDAO PT","customer":"MICRO LABS LTD","customerCountry":"INDIA","quantity":"10000.00","actualQuantity":"10000","unit":"KGS","unitRateFc":"30.8","totalValueFC":"308760.9","currency":"USD","unitRateINR":"2630.7","date":"09-May-2025","totalValueINR":"26306625","totalValueInUsd":"308760.9","indian_port":"Madras Sea","hs_no":"29411030","bill_no":"9953838","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"QINGDAO PT","supplierAddress":"7-8 FL, NO. 2428 ANJI ROAD, SANZAO TOWN, JINWAN DISTRICT, ZHUHAI, GUANGDONG, CHINA","customerAddress":"NO.27,RACE COURSE ROAD,"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q2","strtotime":1746815400,"product":"AMOXICILLIN TRIHYDRATE POWDER BP(RE-IMPORT)(SB NO.7830102 DT.26.02.2024)AMOXICILLIN TRIHYDRATE POWDER BP(RE-IMPORT)(SB NO.5844445 D","address":"D-34 2ND FLOOR, GULMOHAR PARK","city":"NEW DELHI","supplier":"FARMABASE SAUDE ANIMAL LTDA","supplierCountry":"INDIA","foreign_port":"SANTOS","customer":"DALAS BIOTECH LTD","customerCountry":"INDIA","quantity":"125.00","actualQuantity":"125","unit":"KGS","unitRateFc":"31.4","totalValueFC":"3936.7","currency":"USD","unitRateINR":"2683.3","date":"10-May-2025","totalValueINR":"335408.04","totalValueInUsd":"3936.7","indian_port":"Delhi PPG ICD","hs_no":"29411030","bill_no":"9979346","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"SANTOS","supplierAddress":"PRACA EMILIO MARCONATO,1000 A1 ATE A6, POSTAL CODE : 13916074 JAGUARIUNA SP BRAZIL BRAZIL","customerAddress":"D-34 2ND FLOOR, GULMOHAR PARK"}]
01-Jan-2022
31-May-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

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.

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.

Ciblor Manufacturers

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

Ciblor Suppliers

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

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

Ciblor USDMF

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

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

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

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

Ciblor KDMF

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

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

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

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

Ciblor CEP

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

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

Ciblor WC

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

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

Ciblor 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 Ciblor as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for Ciblor 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 Ciblor 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 Ciblor and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Ciblor NDC to their finished compounded human drug products, they may choose to do so.

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

Ciblor GMP

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

Ciblor CoA

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

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

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